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Research in Action

Research in Action

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Aug 2024

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"Research in Action" explores the dynamic world of life sciences, covering drug discovery, clinical trials, therapeutic development, and the pivotal role of real-world data and technology in connecting clinical research with patient care. Hear insightful conversations with scientists, clinicians, and leaders from pharma, biotech, and health.

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August 20, 2024Episode 1339 min

AI's Role in Cancer Care Today and Tomorrow

Where are the biggest opportunities to leverage AI in cancer diagnosis and treatment? What are the biggest barriers remaining to move away from a one-treatment-fits-all approach to treating cancer? And how are AI, radiomics, machine learning and deep learning helping to understand which patients will respond best to which treatments?   We will learn all that and more in this episode of Research in Action with Otavio Clark, M.D. Ph.D. and Principal Research Consultant at Oracle Life Sciences.   ---------------------------------------------------------   Episode Transcript:   00;00;00;00 - 00;00;26;16 Where are the biggest opportunities to leverage AI in cancer diagnosis and treatment? What are the biggest barriers remaining to move away from a one treatment fits all approach to treating cancer? And how are ready omics, machine learning and deep learning. Figuring out which patients will respond best to which treatments will learn. All that and more on research and action in the lead in the world.   00;00;26;19 - 00;00;48;02 Hello and welcome to Research and Action, brought to you by Oracle Lifesci Answers. I'm Mike Stiles, and today our guest is Ottavio Clark and Oncology and Specialty Therapeutics executive at Oracle Life Sciences. Now that's a field he's been in his entire career. He has his Ph.D. in oncology and specializes in all things evidence based research, real world data, real world evidence.   00;00;48;02 - 00;01;13;25 And what we're going to be talking about today, AI and the critical field of cancer research. Octavio, thanks a lot for being with us today. I might tinker for the end of the invite. It's a pleasure to be here. And we are really discussing a fascinating issue. That is how the ACA is changing the healthcare landscape. But before we start, I'd like to make a disclaimer.   00;01;13;28 - 00;01;45;27 We would discuss a lot about the study's findings, but we have to to have in our minds that these results that you discuss, they are still early. These findings. We have yet to be validated in prospective longer term studies, but we will discuss the only things that we have a clear direction of the trend. You added that things are going, so it's important for everybody to to think about this product by the cancer, something introductory.   00;01;45;29 - 00;02;10;17 So I think that's pointing towards trends but not about something definitive when you see something moving on in this direction. Okay. Okay. Yeah, that's totally understood and understandable that that would be the case. I do really want to dive right into this so we can make good use of our time. So what are some of the more impressive advancements that we've made in cancer treatment lately?   00;02;10;17 - 00;02;40;18 And does that mean success rates are satisfactory? Has personalized medicine helped to that? Where are those most promising opportunities to improve personalized medicine where cancer is concerned? It's a revolution in personalized medicine. It changes everything in oncology. And honestly, when I was in the medical residence in 1996, 1998, I did not think that we could see these during my lifetime spent This person.   00;02;40;25 - 00;03;15;05 The medicine has changed the way that we practice quality because it's today for many different types of tumors. We can pick treatments that are tailored to read their genetic profiles, and it enhances the precision and the effectiveness of the therapies. We left our scenario before Where do we use the same drug for everything? And now we can get the genetic profile of the patient of the tumor and try to find a targeted therapy that is limited to any specific type of cell.   00;03;15;06 - 00;03;42;03 Sometimes growth genes. This is wonderful. It has improved a lot. The outcomes of the patients have been becoming better and better in the last years, but we still have challenges here. The first one is that we don't have this kind of personalized medicine for all types of tumors, and one very important things. Not all patients respond to the personalized medicine as we would expect.   00;03;42;05 - 00;04;13;05 What it means. We still have patients that do very well, but we still have patients that don't do so well as we would want to to to have it. So the overall success rate in treating cancer with this personalized medicine approach have improved, but they are not yet 653 across all cancer types in demographics. We are still trying to see some improvements in upfront patients elections.   00;04;13;08 - 00;04;39;27 That is, how can I making this personalization even better by selecting out the fraud patients that have a similar genetic profile, but that they can I can identify those that. Do you have a good response to the therapy and those that will not get a good response to the therapy? If we could do this separation based split, we would have a much more effective treatment.   00;04;39;27 - 00;05;10;15 Of course, what are the opportunities and being able to select those patients who are most likely to respond to a particular treatment and identify those who aren't likely to respond? I mean, how might those kind of better patient classifications affect the current staging systems and the epidemiology of cancer? That's a long history. But let's start. If you if you can select patients, we will, of course, be able to do two things.   00;05;10;15 - 00;05;32;29 The first one is offering the patients that whom you will you expect to have a good response to the treatment, to give an effective treatment, and you split the basis that we expect that you not respond to that kind of therapy. To me, you try to offer them some sort of therapy or to select a clinical trial for these patients.   00;05;33;01 - 00;06;06;08 Well, how are we dealing with this? First, there is are there is an artificial intelligence to that we call radio omics today. These are the army is is is a technique that can extract huge quantities of information from medical imaging like key MRI scans and so on. And these really omics can analyze very complex patterns that we human beings can not see and it can give us an additional classification.   00;06;06;08 - 00;06;41;20 And this is something that will help us in dividing this patient, possible responders and possible night responders when we integrated these Arabian Sea tourists in deep learning machine learning technologies, we can identify the subgroups of patients that will really be more beneficial. There is a very interesting study that was recently published this year to the European Studies. This patient included 1300 patients with no small cell lung cancer without early stage disease.   00;06;41;20 - 00;07;17;16 You let these early stage stage one station through this model was able to predict three, six, seven, 6% accuracy. The patients that would be old in not have a nearly relapse just after the treatment. So they analyzed the data from 3000 patients they put inside of these machine learning system. And in this system the tools could be told that around 40% of the patients could have avoided treatment that was not effective for them.   00;07;17;19 - 00;07;44;25 40%. This number is huge and it reflects what we see in practice. Even in this personalized medicine, we still have 46% of patients that would not respond adequately. The problem is we don't know how how to split the patients to be, how to they try to station. So they and these new tools, these artificial intelligence tools, the omics machine learning, deep learning, they are offering the opportunity for this better selection.   00;07;44;28 - 00;08;17;05 And of course it opens huge opportunities for research and development because, okay, we have now these subset of patients that we respond, what do you do with those that don't respond? So it's brought to the need for developing new drugs and new tools that when you get to these subset of patients that are not responding to current treatment into new developments and new new forms of treatment, well, but it is complex and it is still in its infancy.   00;08;17;05 - 00;08;40;27 Everyone's still trying to figure out what it can and can't do best, what the best applications are, What are the complexities of bringing a high end to cancer diagnosis and treatment? And, you know, in what ways do we need to kind of be careful as we start incorporating it? Yeah, we need to be very, very careful with this because we still don't know everything about even the specialists.   00;08;40;28 - 00;09;12;16 They they really don't understand how these tools fully functions. Well, we can really spend a day discussing this topic, but I'd like to call attention to three important feature is here. The first line is we have to care about data, privacy and security because these systems, they use patient data to be treatment. You know, you have to teach the machine about what to do, about what to do, analyze, and we have to have data from real patient.   00;09;12;18 - 00;10;03;21 And often these training data sets that people are using in different approach. So we have to be sure that they have privacy of the data. The security of the data is is assuring and that we have a legal standards like HIPA and that can maintain the confidentiality and the trust of the patient in the system. The second and very important one is the bias in many of these A.I. systems that you see that we have today, because they way that they are trained and again, the machine is learning what we want them to learn and they can sometimes perpetuate or amplify biases if they are trained in data that is not representative of the food   00;10;03;24 - 00;10;32;17 of the food population. One One very good example of these is that the accuracy of some A.I. tools into the noses of a melanoma. Melanoma is that I see that has a black sheet, a black color, and it is very common in people. It can occur in white people and in black people, but they must the A.I. tools, they have a bias for the white people.   00;10;32;20 - 00;10;58;21 They are very accurate in the most melanoma, in white people. But the loss to some of these melanomas in black people because of the way they treated, because it's more common in white people. So we have to find ways to avoid it is the third point is the clinical validation. We have seen an evolution of these A.I. tools during the the last decade.   00;10;58;21 - 00;11;34;29 Don't say we. Until five years ago, we saw some publications with a few small datasets of patient and very strict validation. In the last five years, we started to see a directions towards a better validation in bigger groups of patients, but we still don't have prospective validation for most of these tools going on in our prospect. You a in large group of patients, this is still something that we will have to deal with for most of the cases in the next year.   00;11;35;02 - 00;12;11;03 And importantly, we have to evolve. If the regulation the FDA has has been trying to regulate some of these Albury's machine learning tools that we have there, there are some specific regulations already in place, but we still have to advance a lot here. And of course, and the most important one is the ethical considerations for assessing how much decision making multipolarity should we give to machine is in making decisions about patients that think about the cars, the autonomous cars that we have.   00;12;11;03 - 00;12;35;25 We basically in San Francisco, you can carry a driverless car, just enter and say, I'm going to this place and the car will make all of the decisions for you. How is it going to happen in our health care environment? So it's challenging, but it's evolving and this is working really fast. That's right. I mean, innovation only comes at us faster and these things are only going to get better, we assume.   00;12;35;25 - 00;12;59;23 But there are the remaining challenges when you think about what AI is setting out to accomplish or what you're setting out to accomplish with it, what's the difference between overall survival and progression free survival? Because those are what we want AI to predict, Right, right, right. And these are two types of message remains that you re using in oncology.   00;12;59;23 - 00;13;36;09 Mostly we using not have some specialties also, but in oncology and progression free survival is the time that we have between the date of diagnosis until the disease progresses. It means until the disease grows or the patient dies. And overall survival is the time from the date of diagnosis until the patient dies. Well, it's a it's a small difference, but the PFC, the progression free survival is mostly about the disease evolution itself and the overall survival is about the patient evolution itself.   00;13;36;12 - 00;14;10;28 So the progression free survival, disease, free survival are very treatable to be used in in the types of cancer that have a long evolution time like stage two melanoma, we are talking about melanoma, stage two, stage three melanomas that have an evolution of years, sometimes decades. If you wait until measuring the efficacy of a drug of therapy in overall survival, it would take ten, 15 years because of the time of the evolution of death of the disease.   00;14;11;00 - 00;14;43;17 So we tend to use this progression free survival. That is the time until the disease grows again, relapse or something like this. And overall survival is the same because it is the lifetime of survival of the of the patient. Sure. Well, not all cancers are the same. Of course not all people are the same. So is there any AI driven methodology that can not necessarily personalize, but just segment Ty's patient populations and kind of point them to various treatments that are going to work best for them?   00;14;43;17 - 00;15;16;09 And and if so, how does that dream call for real world data? How is real world data applied in that process? Well, we classify today we classify cancers based on the region of the body or the organ that eat it appear like lung cancer, breast cancer, liver cancer and so on. We have in the last, I would say, true 2 to 3 decades evolving towards a more specific classification.   00;15;16;11 - 00;15;46;28 That is some types of cancer, for instance, that we have in breast cancer. We have today many different types based on the genetic profile of the tumors, like if the tumor has specific times of a symptoms like estrogen progesterone or one that we call how true and why they do, we evolved towards these subclasses situation. We perceive that that inside of breast cancer or lung cancer.   00;15;46;28 - 00;16;19;27 But let's talk about breast cancer. We had patients we have a very different prognosis that would respond very differently to treat to different treatment. And as the knowledge evolved, we were able to classify, let's take of both these three subtypes HER2 positive or negative estrogen receptor positive or negative progesterone receptor positive or negative. So by doing this some classification, we could offer better treatments for each of these subpopulation.   00;16;20;00 - 00;17;05;01 And then this is where the awarded data entries in our in our discussion, because today we have the new tools in a we can get information from huge datasets, from websites that have millions of patients, he said. Like electronic I have to records claims from hospitals, insurance claims, death certificates and everything that we were not able to do before in way because these official tally systems are able to enter in electronic health records like for this has been one that Oracle had.   00;17;05;04 - 00;17;55;25 We can use some tools that we call metrology natural language processor that can read the records that were imputed by the doctor. And it came extracted the patients that we want. We can give a common to the in AP to and say look please select from these 100 million records only patients with stage three breast cancer had two positive had estrogen receptor negative and it can go inside of the electronic I have to and from the 100 million records that you have that he can come back with 500,000 patients and then again using AI tools like deep learning, machine learning, many different tools, we can get to this 500,000 patients in the models, how they   00;17;55;25 - 00;18;27;06 were treated, how they did evolve in the real world, not only in the control edit environment of clinical studies. So we can evaluate how the drugs that are approved out of performance in field would. That is a completely different environment from the, from the clinical studies. We can try to identify subsets of patients that do have a better or worse response to a given treatment in.   00;18;27;08 - 00;18;55;21 We can also use these tools to make very sophisticated integrations. Often the patient profile will be if the genomics of the patients and this is where we are seeing a lot of development in the last year, is this attempt off of trying to identify how this genomics influences the treatment of of the patients. There is a good example for that.   00;18;55;23 - 00;19;28;04 We have we did a study using our electronic health records that was presented at ASCO last year and that we use in the Metro language processing tools to identify among millions of records patients that had a very specific, very rare mutation that is called entity AKI or anthrax. People, as people call it. These mutations very rare. It occurs in 0.22% of the tumors at most.   00;19;28;06 - 00;19;57;14 But the importance of these is that today we have three drugs in the market that very design needed to act against any specific mutation. But this is very rare. These thirds that way, Don, it included 50 patients, seven patients, and that was it. So by looking at our electronic I have to heck with those in these tools, we could identify 200 patients with these.   00;19;57;14 - 00;20;34;06 An entire chemo patient that looks very, very ridiculous is small number, but it's not at the time it was the largest cohort of patients with these mutations that very study and the data were published looking for patterns. How did they respond to treatment? They they said in all of these using here word data. So if we can leverage it, I wish that here were the evidence, we can add this in much better health treatment performances in very diverse populations, and we can adjust the strategies to improve the patient's outcomes effectively.   00;20;34;06 - 00;20;56;10 And this is how I am here with this data interconnect. Well, I think about rank and file health care providers. It feels like we're still pretty far away from it being used by health care providers to definitively make treatment decisions. And I think about how busy they are. They don't have time to make themselves experts in AI technologies.   00;20;56;10 - 00;21;24;03 So what kind of partnerships or collaborations have to happen in order to make A.I. analysis usable by your average doctor? Well, the first thing it has to be easy. It has to be easier than what we have today because today the doctors already spend a lot of time in administrative tasks like the entry date, and then they let them go head to head with the feeling forms.   00;21;24;05 - 00;22;02;06 And the first thing that we have to to keep in mind is that our objective today is about it's talking about the impact of action that is in the health care clinical setting itself decisions, how doctors decide how drugs are delivered. But hey, we also and these are really being integrated in the clinic in the administrative part of the medical practice by selecting codes, building codes by there are some systems that are able to field a little bit for the patient.   00;22;02;08 - 00;22;28;28 So these will make the lives of the doctor easier. And I think that these administrative tools will be very well received by the doctors. That's my impression and good design impression. But we we also have a not I but a part of that is what we're discussing here, is how these tools will be integrated in the decision making process of the doctor and in the practice.   00;22;29;00 - 00;22;59;10 And to do this, we have to find ways to make it easy for the doctor to use. How can we do it? The first thing is we have to put it developers in health care professionals together so those that are developing the system, they can understand the needs, they can understand the difficulties, and they can understand where the improvements are necessary, how it will work to help them better the patient.   00;22;59;13 - 00;23;28;29 The second, of course, academic institutions tend to be early adopters of these of these tools, and they will be very important in not only developing but conducting independent validation of studies that like the ones that we cited here, that that will predict the outcomes of patients. So do the patient selection. Are we talking about to be FDA and the regulatory board?   00;23;28;29 - 00;24;05;21 They are essential for for these to guide us towards the right direction about what we can, what we can do. And this will be a huge impact in everything that we do if or when one of these eight companies or researches is able to develop an interface that will make the life of the doctor easier with information that is very trustable, the adoption will be very quick, I think.   00;24;05;23 - 00;24;35;09 Well, I've heard about a I don't know if it's a tool or a program called Deep Profiler. What is that? I mean, it's, you know, studies undertaken around AI's use in cancer diagnosis and treatment. What is it? What can it do and what are we learning from it? The profile can refer to too many different things. It usually used it to describe different tools that are integrated in a system that can use deep learning techniques.   00;24;35;09 - 00;25;03;10 And they came in. My eyes are very complex data. They can go to a huge data set of genomic information for the users, try to cross the information we should often these genomic database will be information from, let's say, medical images and try to find out to see how they how they are combining together, what they can offer to the medical decision process.   00;25;03;12 - 00;25;50;24 Usually the aim of these deep profilers, these things are to to give me a more accurate biological profile of the tumor of the patient and say, look, this patient with this kind of profile is will respond better if these treatment, the patient with this profile will have a better outcome or a worse outcome or something like this, that these these the profile is they are using it to do, as I said, genomic and molecular characterization predict response to drugs, and they will try to to point towards the gaps in the development and identify where reception developing it is necessary.   00;25;50;26 - 00;26;17;25 This is this is how these how these deep profiler systems works based integrating huge amounts of data from genomic is from molecular, is from saw, from images, and try to make different profiles to help in the decision making process. Well, we all heard about, you know, people who there was a suspicious suspicion of cancer and a biopsy was done.   00;26;17;25 - 00;26;47;06 So that involves examining tissue samples. But are there any other parameters other than the biomarkers found in tissue only samples that might lead to better predicting durable clinical benefit? Yeah, this is what the Radiometer is trying to do. They are trying to identify based on the medical images, not only biopsy, not antibiotics, they are trying to say, okay, this is the image of noise, muscle, lung cancer in a patient.   00;26;47;09 - 00;27;20;21 This has this type of profile and we don't need the complex, time consuming biopsy tests anymore to see that this patient is from A, category A, B, C, or D, and should be treated with the drug H, Z, or the. This is basically what you are doing because this process of the biopsy and sending this sample to to a lab to do the pathology, to do the genetic test, it's it's time consuming.   00;27;20;21 - 00;27;47;28 It's very expensive. So if we can find a way that basically the only on the medical images, PET scan, an MRI could already see what is the profile of the tumor. We would experiment, we would spend time, we could study the treatment of the patient very early so that they are damaged. That's one of the attempts that misread the cell, trying to do well.   00;27;47;28 - 00;28;15;18 We've all known someone with a weird looking mole who went to the dermatologist, got checked for melanoma. Are you kind of saying that A I driven approaches are appearing to outperform, just getting looked at by a dermatologist for spotting things like melanoma early? That's one of the things that we already have data that really points towards to an almost conclusive thing.   00;28;15;20 - 00;28;42;07 But the studies that have been published using these tools to analyze skin spots on their early diagnose of melanoma, they are performing better than dermatologists. They are already 30% better than the dermatologists that they point out. What what they like to call the attention here is that it's not only about the eight to being better than the dermatologists.   00;28;42;07 - 00;29;09;08 So this is this is true, but it's not only based can you imagine about someone in a very remote area that see a sporty skin. He could just take a picture, send the speaker through to a central hospital or to a clinic yet to be analyzed. He does not need it to get a car to go there and then bathe in the only on the photo that he took.   00;29;09;10 - 00;29;29;26 We can see if this is malignant or not. If the patient needs to travel for miles and miles and make an appointment. So it's not only about the air itself, it's about the consequences of the good use of this tools that we have to think about. Well, I want to wrap up with a few relatable kind of point blank questions.   00;29;29;29 - 00;29;56;29 If I'm a patient and it's determined, a typical course of treatment is unlikely to be effective for me. What happens then? I go to a plan B, or do I get referred to a clinical research program or and how does I help make those kinds of determinations? Yeah, that's a very good question, because it will happen as soon as these systems are in place to separate the patients upfront.   00;29;57;01 - 00;30;34;06 When you have a huge number of patients that you needed this kind of case and then it comes to two or three things. The first one is we can also use, as we spoke before, these eight tools in huge electronic I have to here could he word data to try to make the characteristics of this patient that he not responded to a given therapy with other patient that are inside of this 100 million headquarters in an electronic health record that had the same problem, had the same profile.   00;30;34;08 - 00;31;07;23 And then he by matching the patient, we were better treated, which he had better outcomes inside of these he already data electronic to her take on this took it to a practical was this the first one the second one is it you create the need for new research in development of new drugs, develop the development of new clinical trials and we have a systems that they we call it matching.   00;31;07;25 - 00;31;31;05 They match the patient. We have clinical trial. How does it work today? The process of sending a patient for a clinical trial is very time consuming and is really ineffective because I have to to get the data from the patient. Let's get the patient is no is my cell lung cancer EGFR positive? I have to say, okay, where do I have a clinical trial for this patient?   00;31;31;05 - 00;31;50;19 And then I have to look around and see if there is a clinical trial for this patient. So there are already today. Some day I may systems that you research the data of the patient in the system and then you'd say, okay, in this patient feet, this clinical trial that is been doing in this place and this recruiting patient.   00;31;50;19 - 00;32;40;19 So that's the second way that these tools can help these patients that will be, let's see, unselected for the treatment. It's really how we can help this patient. And I think also we have seen it's not directly related to the daily care, but we have seen some new drugs that are designed by a they get the researchers inserts the configuration of a protein from the tumor cell in in one of these machine learning deep learning system and say please design one molecule that can bind here and that could inhibit the proliferation of the tumor.   00;32;40;25 - 00;33;07;14 And there has been some success, not yet specifically in quality, but we have seen some success in antibiotic use and in inflammatory diseases by designing molecules that will be tested in human beings. You know, all this is absolutely amazing and exciting to hear and think about, but the question from the public always comes back when all this is still being tested and vetted.   00;33;07;14 - 00;33;33;11 When can we expect to see the benefits of these capabilities show up in the field? Is that one year, five year, ten years? That's a good question. And of course, if you be headed to and so we would not be here talking about it. But I would like to to give my impression and again, this is my impression we to talk about short term, let's say up to three years.   00;33;33;14 - 00;34;00;28 What I see happening makes it three years is a better integration of some of these supports diagnostic tools that we some of them that you talk about early in their clinical practice that will improve. They did some of the decisions not not largely by but in some very specific cases like melanoma and mammography for breast cancer. Some of these radiometer from a my cell lung cancer.   00;34;01;00 - 00;34;28;12 And it's going to be of course, in mainly in the major health care centers. Then we can talk about, let's say, medium term, 3 to 5, six, six years. And then in this length of time, what I see is that they studies, I will matter and they will gain regulatory approval. They will be validated in the clinical settings and they use you.   00;34;28;12 - 00;35;02;10 You will expand maybe exposure in this period of time because it will be you have it in my view, already the system, the regulator approval and the validation in in prospective studies. So it you basically make the adoption of these tools not only desirable but almost mandatory. It would be like if I knew I new drugs that is is these is efficient to treat the patient comes to the market.   00;35;02;15 - 00;35;32;06 I think that this is how it will be seen and in the long term, let's say ten years these tools will be widespread everywhere and it's not going to be restricted to more sophisticated places. It will be I see it being taken the word everywhere because we have to remember a good part of these decisions, tools. They not only help, but they make the system more efficient and less costly.   00;35;32;08 - 00;36;00;25 So to me, you likely take the word fast. What I'd like to to call that definition is that they speed of the adoption of these tools with you depend on many different factors, but you defend in the one thing also that I think is very important is how how much do we tolerate mistakes made by machines? Because one things about a human being make a mistake.   00;36;00;27 - 00;36;32;10 A person can give a different perception and in a medical MRI, for instance. But what happens if a machine does it? Is it going to be tolerated or not? And I like to think about it when I think about the autonomous cars every single day we have it is maybe thousands of patients being heard in car accidents, then somehow reported in the TV or in the newspapers or something like this.   00;36;32;10 - 00;37;09;24 But if we have one accident, we should one of these autonomous cars that does not injury anybody, It is reported everywhere. So I think about how we make these how we. So yeah how is our our room in this because objectively the accident that I caused and I checked it this is that this is the accidents that are caused by autonomous car they are much less severe than those that are caused by human beings in a million driven basis analysis.   00;37;09;27 - 00;37;34;28 But you have to really press them if the accidents that are caused by autonomous car, how are you going to act? If there is things that to happen? It's unavoidable. When one of these machine tools make a mistake that this even if we prove mathematically that it's better, it makes less mistakes than if a doctor see an MRI or a mammogram.   00;37;34;28 - 00;37;58;07 So basically, our our ability to tolerate errors that will have a huge role in the adoption of A.I.. Yeah, we're we're very forgiving of humans and not forgiving at all of technology and and machines. So, yeah, we it's on us to be open to adoption. All of that sounds great. And thanks again so much for being our guest today.   00;37;58;12 - 00;38;22;17 Otavio Again, cancer is something that's touched almost everyone's life in some way and we're excited for any advancements we can expect. And it's diagnosis and treatment. If our listeners want to learn more about Oracle's initiative or to get back in touch with you, is there a way for them to do that? Yeah, they can reach us out at Oracle dot com and Oracle has a lot of initiatives in.   00;38;22;20 - 00;39;10;11 Yeah, in health care we have a huge team here studying, especially the integration of Iris here. We do have this data. Great. Got it. Well thanks again, Octavio. And to our listeners, we don't want you to miss any episodes of research and action, so please subscribe and if you want to learn more about how Oracle can accelerate your own life sciences research, you can just go to Oracle dot com slash life dash sciences and we'll see you next time.

July 23, 2024Episode 1235 min

Transforming public health with unstructured data and NLP in FDA's Sentinel Initiative

What is the MOSAIC-NLP project around structured and unstructured EHR data? Why is structured data not really enough for drug safety studies? And to what degree is NLP speeding up access to data and research results? We will learn all that and more in this episode of Research in Action with Dr. Darren Toh, Professor at Harvard Medical School and Principal Investigator at Sentinel Operations Center. www.oracle.com/health www.oracle.com/life  www.sentinelinitiative.org -------------------------------------------------------- Episode Transcript: 00;00;00;00 - 00;00;26;14 What is the MOSAIC and LP project around structured and unstructured data? Why is structured data not really enough for drug safety studies? And to what degree is NLP speeding up access to data and research results? We'll find all that out and more on this episode of Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;26;14 - 00;00;50;14 I'm Mike Stiles. And today our guest is Dr. Darren Toh, professor at Harvard Medical School and principal investigator at Sentinel Operations Center. He's got a lot of expertise in Pharmacoepidemiology as well as comparative effectiveness research and real-world data. So, Darren, really glad to have you with us today. Thank you. My pleasure to be here. Well, tell us how you wound up where you are today.   00;00;50;14 - 00;01;26;22 What what attracted you in the beginning to public health? Good question. So I trained in pharmacy originally, and I got my Masters degree in Pharmaceutical Outcomes Research at a University of Chicago, Illinois, Chicago. And it's where I first learned about a field called Pharmacoepidemiology, which sort of very interesting to me because I like to solve problems with methods and data and pharmacoepidemiology.   00;01;26;22 - 00;02;00;29 It seems to be able to teach me how to do that. So I got into the program at the Harvard School of Public Health, and when I was finishing up, I was deciding between staying in academia and going somewhere and getting a real job. And that's when I found out about an opportunity within my current organization and I've heard great things about this organization.   00;02;00;29 - 00;02;29;26 So I thought I would give it a try. And the timing turned out to be perfect because when I joined, our group was responding to a request for proposal for what is called a mini sentinel pilot, which ultimately became the sentinel system that we have today. So I've been involved in the Sentinel system since the very beginning or before we began.   00;02;29;28 - 00;03;02;25 And for the past 15 years I've been with the system and the program and because I really like its public health mission and I'm also very drawn to the dedication of FDA, our partners and my colleagues to make this a successful program. Well, so now here you are, a principal investigator. What exactly is the Sentinel Operations Center? What's what's the mission there and what part do you specifically play in it?   00;03;02;27 - 00;03;52;26 Sentinel is a pretty unique system because it is a congressionally mandated system. So the Congress passed what is called the FDA Amendments Act in 2007. And within that FDA, the Congress asked FDA to create a new program to complement FDA existing systems to monitor medical product safety and more specifically, the Congress, US FDA, to create a post-market risk identification and analysis system that will be using data from multiple sources that will cover at least 1 million lives to to look at the safety of medical products after they are approved and marketed.   00;03;52;28 - 00;04;33;07 So in response to this congressional mandate, FDA launched what is called a Sentinel initiative in 2008 and in 2009 as I mentioned, FDA issued its request for proposal to launch the Mini Sentinel Pilot program, and the program grew into the sentinel system that we have today. So it's for my involvement. It sort of grew over time. So when I joined, as I mentioned, we were responding to this request for a proposal and we were very lucky to be awarded the contract.   00;04;33;09 - 00;05;04;05 So when it was starting, I serve as a one of the many epidemiologists on the team and I led several studies and I gradually took on more leadership responsibility and became the principal investigator of the Sentinel Operations Center in 2022. So I've been very fortunate to have a team of very professional and very dedicated colleagues within the operations center.   00;05;04;05 - 00;05;27;26 So on a day to day basis, we work with FDA to make sure that we can help them answer the questions they would like to get addressed. And we also work with our partners to make sure that they have the resources that they need to answer the questions for FDA. And most of the time I'm just the cheerleader in chief just to share my colleagues and our collaborators.   00;05;27;28 - 00;06;11;23 Now that's great. And and then specifically, there's the Mosaic NLP project that you're involved with. What is that trying to achieve and what are the collaborations being leveraged to get that done? So Sentinel Systems has always had access to medical claims data and electronic health record data or year data. One of the main goals for the current sentinel system is to incorporate even more data, both structured and unstructured, into the sentinel system and to combine it with advanced analytic methods so that FDA can answer even more regulatory questions.   00;06;11;25 - 00;06;40;09 So the Mosaic and NLP project was one of the projects that FDA funded to accomplish this goal. So the main goal of this project is to demonstrate how billing claims and data from multiple sources when combined with advanced machine learning and natural language processing methods, could be used to extract useful information from unstructured clinical data to perform a more robust drug safety assessment.   00;06;40;11 - 00;07;21;18 When we tried to launch this project, we decided that we would issue our own request for proposal. So there was an open and competitive process, and Oracle, together with their collaborators, were selected to lead this project. So I want to talk in broad or general terms right now about data sharing, the standards and practices around that. It kind of feels silly for anyone to say it's not needed, that we can get a comprehensive view and analysis of diseases and how they're impacting the population without it.   00;07;21;20 - 00;07;46;15 NIH is on board. It updated the DMS policy to promote data sharing. You know, the FDA obviously is leaning into this. So is data sharing now happening and advancing research as expected, or are there still hang ups? So I think we are making good progress. So I think the good news is data are just being accrued at an unprecedented rate.   00;07;46;17 - 00;08;28;21 So there are just so much data now for us to potentially access and analyze. There's always this concern about proper safeguard of individual privacy. And through our work, we also became very appreciative of other considerations, for example, the fishery responsibilities of the delivery systems and payers to protect patient data and make sure that they are used properly. So you mentioned the recent changes, including in data management, ensuring policy, which I think are moving us in the right direction.   00;08;28;26 - 00;08;56;23 But if you look closer at the NIH policy, it makes special considerations for proprietary data. So I would say that we have made some progress, but access to proprietary data remains very challenging. And the FDA, the NIH policy doesn't actually fully resolve that yet. When you think about the people who do make that argument for limited data sharing, they do mostly talk about what you just said about patient privacy.   00;08;56;23 - 00;09;25;20 IT proprietary data. Pharma is especially sensitive to that, I would imagine. So how do we incentivize the reluctant how can we ease their risks and concerns or can we? Yeah, it's a tough question. I think that this require a multi-pronged approach and I can only comment on some aspects of this. So I would say that at least based on our experience, the willingness or ability to share data often depends on the purpose.   00;09;25;23 - 00;09;55;29 That is, why do we need the data? Many data partners participate in Sentinel because of its public health mission, and our consideration is how would the data be used again, Is there proper safeguard of patient privacy and institutional interest? There are other ways to share data. For example, instead of asking the data to come to us, we can send analysis to where the data is.   00;09;56;06 - 00;10;34;22 And that is actually the principle follow by federated system like Sentinel. So we don't pull the data centrally. We send an analysis to the data partners and only get back what we need it. And it's usually in the summary level format. So that actually encourages more data sharing instead of less sharing. I would say that recent advances in some domains, such as tokenization and encryption, might also reduce some concern about a data sharing, a patient privacy concerns in academic settings.   00;10;34;29 - 00;11;24;26 We've been talking a lot about days, for example, for individual who collect the data and the people I propose to offer them authorship or proper acknowledgment if they are willing to share their data. But that is not sufficient in many cases outside of academic settings. If you look at what is happening in the past ten years or so, there are now a lot of what people call data aggregators that are able to bring together data from multiple delivery systems or health plans, and they seem to be able to develop a pretty effective model to convince the data provider to share that data in some way.   00;11;24;29 - 00;11;55;28 And a way to do that could be to help these data providers to manage their data more efficiently or to help them identify individuals who might be eligible for clinical trials. More quickly. So there are some incentives that we could think of to allow people to to share that data more openly but personally, I think that scientific data should be considered public good and hopefully that will become a reality one day.   00;11;56;00 - 00;12;23;21 Yeah, that's really interesting because it sounds like it's both a combination of centralized and decentralized tactics in terms of of data sharing and gathering. Why is it so important to use unstructured data in pharmacoepidemiology studies? And does NLP really make a huge difference in overcoming the limitations and extracting that data? So in the past, I think that that's true.   00;12;23;21 - 00;12;58;07 Now, many pharmaco epidemiologic studies rely on data. They are not collected for research purposes. So we use a lot of medical claims, data that are maintained by payers. We use each our data that are maintained by delivery systems. So this data are not created for research purposes and much of this data, at least for claim, is data stored in structured format using established coding systems like ICD ten.   00;12;58;10 - 00;13;39;06 Coding system and structured data sometimes are not granular enough for a given drug safety study and certain data or set of variables that are required for claims reimbursements or other business purposes might not be collected at all. And people felt that, well, maybe the information that we need could be extracted from unstructured data because as part of clinical care, the physicians or nurse practitioner or the health care provider might include that information in the notes, but use user data also pretty messy, especially that unstructured data.   00;13;39;08 - 00;14;05;25 So instead of going through the unstructured notes manually to extract this information manually, technique by natural language processing could help us do this task much more efficiently so that we can mind a larger model of unstructured data. Well, obviously, when it comes to real world evidence, you're a fan. Tell us what excites you about using it to complement clinical research.   00;14;05;25 - 00;14;42;07 Get us more evidence based insights and help practitioners make better decisions. Yeah, that's a great question. Yes, I'm a fan of so I personally don't quite like the dichotomy between conventional, randomized, controlled trial and real world data studies because they actually sit along a continuum. But is true that conventional randomized trials cannot address all the questions in clinical practice.   00;14;42;09 - 00;15;30;17 So that's where real data and real data studies come in, because real data like we discussed come from clinical practice. So they capture what happens in day to day clinical practice. So if we are thoughtful enough, we will be able to analyze the data properly and generate useful information to fill some of the knowledge gap. The truth is we have been using real data throughout the lifecycle of medical product development for many years now, ranging from understanding the natural history or burden of diseases to using real data as controls for single arm trials, and that we have been doing this before the term real data became popular.   00;15;30;19 - 00;15;57;11 So I see real data to complement what we could do in conventional randomized trials. So real data studies don't replace clinical trials. I see them to be complementary, and real data studies sometimes are the only way for us to get certain evidence. We already talked about Mosaic and LP that project, but I kind of want to go a little deeper with it.   00;15;57;11 - 00;16;42;02 The idea is to tackle the challenges of using link data structured and unstructured at scale. Tell us about a use case for that project and why it was chosen for this project. We actually, Cerner proposed to use the association between Montelukast, which is an asthma drug and neuropsychiatric events as a motivating example. It is also important to note that the project is not designed to answer this particular safety question, because if you look at the label of Montelukast, there's also already a box warning on neuropsychiatric events.   00;16;42;02 - 00;17;18;26 So FDA already has some knowledge about this being a potential adverse event associated with the medication. The reason why or recalls is has proposed this project was because we actually did look at this association in a previous sentinel study that only used structured data, although the study provided provided some very useful information. We also recognized that certain information that we needed was available in such a data, but may be available in unstructured data.   00;17;18;28 - 00;17;42;18 So if we are able to get more data from unstructured data, we might be able to understand this association better. So that's why this motivating example was chosen. Well, this is an Oracle podcast and Oracle is involved in Mosaic, so I think it's fair to ask you about the technology challenges that are involved in what you're trying to do.   00;17;42;19 - 00;18;17;24 What does the technology have to be able to do for you to experience success? So Mosaic in LP is I was at a very ambitious project because it is using an LP to extract multiple variables that are important for the study. That includes the study outcome, which when you look at it, is a composite of multiple clinical outcomes and it's also trying to extract important covariates that could help us reduce the bias associated with real data study.   00;18;17;26 - 00;19;01;24 So I think technology comes in well is powerful in many ways. First, thanks to technology, the project is able to access very large amount of data from millions of patients who seek care in more than 100 healthcare delivery systems across the country. So this was hard to imagine maybe ten or 15 years ago. But now we have access to lots and lots of data at our fingertips because of advances in technology, because of the large amount and the complexity of the data methods side and LP becomes even more important.   00;19;01;26 - 00;19;33;19 And for this project, we are also particularly interested in whether an LP algorithm developed in one year trial system could be applied to another system, which has been a challenge in our field because each year our system is created very differently. So one, an algorithm that works in one system might not work in another. So we are hoping that through advanced methods and technology, we will be able to address this problem.   00;19;33;21 - 00;19;57;15 So without this technology advances, we might not be able to do this study as efficiently as we could all So the task might might not be possible. So where are we going with this? I mean, let's say the project is a success. What will that mean in terms of the FDA's goals and how NLP gets applied in medical therapeutics safety surveillance?   00;19;57;18 - 00;20;38;03 The hope is that Sentinel system can answer even more questions than it can address today. And the way that we are trying to accomplish that is to see whether or how this complex, unstructured data, we combine it with advanced analytic methods can help us answer questions that could not be addressed by structured data alone. I think through this project we also learned a lot about how the challenges associated with analyzing a very large amount of data from multiple sources.   00;20;38;06 - 00;21;11;14 Again, service data is compiled from more than 100 systems, so it is big but also very complex. And in many of our studies we really need that large amount of data just to be able to answer the question because we may be focusing on rare exposures or real come. So you really need to start with very large from our data just to get to maybe the ten patients that are taking a medication.   00;21;11;17 - 00;21;44;15 And what you learn with Mosaic, can that get applied to addressing other public health issues like disparate ease and asthma diagnosis and treatment, especially when you think about diverse groups? Yeah, that's a great question. So is the project is not designed to address these important questions, but if we are able to better understand the completeness of social drivers of health in these data sources, then we will be able to leverage this data to answer these questions in the future.   00;21;44;18 - 00;22;04;26 I think about how a project like this gets a evaluated at various steps along the way. I guess that's my question. How I mean, what what methods are used to ensure the validity of real world evidence? So the good news is in the past few decades we have been using real data, even though we might not be using the term.   00;22;04;28 - 00;22;36;22 So there's been a lot of progress in the field to improve the validity of Real-World Data studies. So we now have a pretty good framework to identify fit for purpose data, and we also have very good understanding of appropriate design and analytic methods. So to target trial emulation and propensity score methods. So this project and many other projects in Sentinel are following this principle.   00;22;36;24 - 00;23;14;03 And one thing to also note that this project is also following the overall sentinel principle in transparency. So everything we do will be in the public domain to allow people to reproduce, so replicate the analysis. So the protocol is available in public domain, and when we are done with the study, everything will be made publicly available. So that's one way to make sure that the the work at least is reproducible or replicable.   00;23;14;05 - 00;23;43;00 And through that process, we hope to be able to improve the validity of this study. And what about comparisons? How do you compare the results from different data sources like claims data, structured data? You know, I extracted unstructured data, all of that. How was that done, the comparisons? So if you're talking about the Mosaic and LP study, so we have a pretty structured approach to address that question.   00;23;43;02 - 00;24;13;14 So we are using this proven principle of changing one thing and keeping everything else fixed to see what happens. So the project will start by using only claims data to replicate the previously done Sentinel study. And then we are going to add on such data to see whether the results are different. And then we add on an LP extract that unstructured data one at a time to see whether the results change.   00;24;13;21 - 00;24;40;24 So by fixing everything else to be constant and changing one thing, we'll be able to assess the added value of each how data, both structure and structure. And that's how we are going to do it within the Mosaic and LP study. And then what about scalability? How would you make sure the NLP models that you develop are scalable and transportable across all these different health systems of which there are many?   00;24;40;27 - 00;25;10;10 Yeah. The question again is about transport ability. So one thing that is unique about this study, as we briefly discussed earlier, was that the the survey yesterday to actually come from multiple healthcare systems. So the end up models that we are developing will be trained in tune on a sample of patients from this system and not from a single hospital network.   00;25;10;10 - 00;25;42;18 So at the development phase, we are already taking into account the potential diversity of different delivery system. And as part of this project, we also include another delivery system to apply and test the method as part of the transport ability assessment. So we are doing that to make sure that the LPI models that we are developing for this project will be useful for other system as well.   00;25;42;20 - 00;26;12;29 Unknown There is a larger question about computational resources, so that will be the issue that would still need to be addressed because a train and tuning this and NLP models within such a huge amount of data requires a lot of computing resources. So that is something that we could only partially address in our study. But if we want to apply or do the same thing in our system, that would be something to consider.   00;26;13;02 - 00;26;43;13 We talked a little bit about the collaboration with your tech partner, but these things usually have so many stakeholders and disciplines and silos. Tell us first why collaboration is a good thing and unavoidable anyway, and then what the challenges of collaboration are. Maybe some tips on how to best make them work. The problems that we face, at least many of the problems that I face quite complex and they require expertise from multiple domains.   00;26;43;13 - 00;27;18;19 So that calls for collaboration from multiple stakeholders. And we always have our blind spots. So we only see things in a certain way and we always miss things. So that's why I think collaboration is important. But it's really hard sometimes because we all have our priorities and perspectives and sometimes they don't align. And I also learned throughout the years that we don't communicate enough and we may also not have time to communicate or we may be under pressure to deliver.   00;27;18;21 - 00;27;47;21 So all of that sort of contribute to the challenges of collaborating effectively, especially when you collaborate across disciplines, because we might be using different languages to mean the same thing or use the same term to describe different things. So even though we can all speak the same language less English, we might not be talking about the same thing and not communicate at all.   00;27;47;21 - 00;28;17;25 Because because we are using different joggers and terminology. So that has been tough. But I think we are getting better. And so I think that it is for us within the center of operation center, we try to communicate honestly and respectfully and we try to understand different perspectives and we try to find common ground. And but I think ultimately what brings us together is that we have a shared common goal.   00;28;17;27 - 00;28;44;17 A lot of the work that we do. So for music and NLP, we are all trying to answer the same question, which is that how do we use unstructured data and advanced analytic methods to answer safety question? So once we apply on this common goal, things become easier because we start to understand each other better or be able to communicate more effectively.   00;28;44;19 - 00;29;19;16 Just out of curiosity, what are the different stakeholders involved in Mosaic? Who falls on the roster? we have people from different disciplines, so we have experts in natural language processing and artificial intelligence. We have epidemiologists, both statisticians, clinicians, we experts in psychiatric conditions and respiratory disease. We have data scientists, we have engineers, we have project managers. So it's a very big group of individuals with different expertise in this project.   00;29;19;18 - 00;29;46;14 Well, you probably noticed Oracle's really thrown itself into and committed huge resources to health and life sciences. Things got really exciting with the acquisition of Cerner and Cerner and Visa. What's Oracle doing right and what do you think it should be doing to make itself even more valuable in health and life sciences? Well, this is a great but very difficult question, so I cannot comment too much what Oracle is doing or will be doing.   00;29;46;17 - 00;30;23;06 But I can say more generally that there have been a number of technology companies that have tried to foray into health or life sciences. I would say with mixed results. And one reason is that our health care system remains highly fragmented and complex, so it takes a lot of energy to break the status quo. So you probably know that we were one of the last countries in the world to transition from ICD nine to ICD ten coding system, and we are soon going to move into the ICD 11 system.   00;30;23;06 - 00;31;00;05 So I'll be interested to see whether the US is ready for that. And that again, is maybe a reflection of just how complex and fragmented our system is and disruptive innovation and I think are great, but they may or may not translate into successes when they applied to health care. That is not to say tempesta mistake. I'm actually pretty optimistic that the perspectives and solutions and ideas brought by technology companies could help us solve a lot of problems that we have today.   00;31;00;07 - 00;31;31;26 But I think that it will be good to engage people who will be struggling with these issues early on and to work together with them to develop solutions that are not just good on paper, but also feasible in practice. So at least in my very limited experience, we have seen some very cool technology that ended up not being useful for health care just because it's very hard to change what people have been doing.   00;31;31;28 - 00;31;56;09 So again, disruptive innovations are good, but sometimes it's just very hard to adopt, at least not quickly enough for for us to see meaningful changes. Yeah, that's really fascinating. It's, you know, it is disruptive innovation, but it's not always applicable to the to the goals you're pursuing. But it does feel like technology where that's concerned, the future is coming at us faster and faster.   00;31;56;11 - 00;32;32;21 So what are the technologies that are most interesting to you? Is it A.I. or what big advances in public health do you see coming? Maybe sooner than we thought. Yeah. Yeah. You know, I feel like you said some of this came too fast. Like, I wish I. And closer to retirement, I don't worry about this. But so even though I say disruptive innovation sometime might not work in health care, but I will say generative A.I. seems to be a recent exception.   00;32;32;24 - 00;33;10;14 So I would say that generative is definitely on the list of things that surprised me in a very nice way. I will also say that the continue fast accrual of better real data is also something that excites me and the continue recognition or increased recognition of the potential real data of. It's also something that I think is good to have for things that came sooner than I found it again, generative.   00;33;10;19 - 00;33;44;13 AI So if you ask me when, we'll be ready for generally. AI Last year or two years ago, I would say not yet, but now we in the era where everything seems possible. So I remain extremely optimistic about generative in some of these last language models that will help us analyze unstructured data even more efficiently. Well, therein it's deeply fascinating and exciting stuff.   00;33;44;14 - 00;34;10;27 Thanks again for letting me pester you with these questions. If our listeners want to learn more about Sentinel, Operation Center or Mosaic or you, what's the best way for them to do that? So Sentinel has a poverty website where we post everything that we do. So is Sentinel initiative dot org. So I am a member of the Department of Population Medicine at Harvard Medical School.   00;34;10;29 - 00;35;00;16 So our website's population is a thought, but these would be two places that would be very informative for audience. Who wants to know more? All right. We appreciate that. And to our listeners, go ahead and subscribe to the show. Feel free to listen to past episodes because they are free. There's a lot to learn here. And if you want to learn more about how Oracle can accelerate your own life sciences research, just go to Oracle dot com slash life dash sciences and we'll see you next time on Research in Action.

July 9, 2024Episode 1138 min

Empowering Patient-Centered Research Through Technology and Engagement

How do clinical research funders operate? Why do patient-centered outcomes matter so much and improve the quality of research? And how is patient-led research being applied to clinical care? We will learn all that and more in this episode of Research in Action with Greg Martin, Chief Officer for Engagement, Dissemination, and Implementation at the Patient-Centered Outcomes Research Institute (PCORI).   www.oracle.com/health www.oracle.com/life  www.pcori.org/   --------------------------------------------------------   Episode Transcript:   00;00;00;00 - 00;00;21;14 How do clinical research funders operate? Why do patient centered outcomes matter so much and improve the quality of research? And how is patient led research being applied to clinical care? We'll find all that out and more on this episode of Research in Action.   00;00;21;16 - 00;00;45;16 Hello and welcome to Research in Action, brought to you by Oracle Life Sciences. I'm Mike Stiles and today our guest is Greg Martin, chief officer for engagement, dissemination and implementation at the Patient Centered Outcomes Research Institute, referred to as PCORI. Greg's been with the organization 12 years or so, and prior to that spent time as manager of State government affairs for the American Academy of Family Physicians.   00;00;45;19 - 00;01;05;09 And we're going to be talking about no big surprise here, patient centered outcomes. So, Greg, we really appreciate you being with us. Well, thank you, Mike. It's a real pleasure and an honor to be here with you. I've listened to some of the podcasts and greatly benefited from the insights and the advice that you're bringing to folks through this, through this series.   00;01;05;09 - 00;01;23;29 So really just a real pleasure to be a part of it. Yeah, the show is really picking up steam and audience and getting some legs under it. All right. I guess let's start off by just having you describe your specific role at PCORI. What's your primary goal every day? And kind of also tell us about the overall purpose of PCORI.   00;01;24;02 - 00;01;46;12 Yeah, that's a great question. You know, and I always kind of joke around with folks that, you know, my mom does the classic two Bobs question from office space here. Remember that movie when I asked you about my job? What what exactly, son, would you say it is that a chief officer for engagement, dissemination and implementation does and it's a limited it's an uncommon title.   00;01;46;12 - 00;02;15;27 But the way I simplify it is that, you know, I get to work with a great team that is focused every day on how it is that people can be involved in the work that PCORI does as a funder, how they can be involved in the work that PCORI has funded and also how they can use in their everyday lives the evidence that property is funded and that last bit they're around evidence that that's why we're here.   00;02;15;28 - 00;02;57;06 PCORI is a clinical research funder. We were authorized by Congress. And interestingly though, even though we were authorized by Congress, we are an independent nonprofit and we're solely federally funded to do one thing, really, which is to fund patient centered comparative clinical effectiveness research or C.R. for short and C.R. as a specific type of research that's looking at intervention and approaches to health and care that are common in practice in the US health care system that stacks those interventions are approaches up against each other to really try and figure out what works best for whom.   00;02;57;08 - 00;03;19;14 But that patient centricity part in our name we take very seriously and we apply that to the C.R. We fund because it's not just about what works best for whom. It's about what works best for home according to their preferences. And that's where you get to the patient centricity. We all want to be healthy. We all want to live well, but we also want to do it in our own way.   00;03;19;14 - 00;03;48;06 We have slightly different definitions and that gets to that, that personalization of care, where we want to understand, given the options, what what should I reasonably expect will happen to me or what can I reasonably expect may come out of this for my loved one? That's the Cory Sweet spot. That's where we sit. And so I work with a great team that finds ways for people to be involved in that work, both again, what we're doing as a funder and the work that we fund.   00;03;48;09 - 00;04;12;23 Where does your passion for this work come from? Was there something you saw long ago in your work at the Academy of Family Physicians that kind of grew your interest in patient centered outcomes and how important that is? Yeah, that that's a great question, Mike. You know, and it's not something that's born from any single source. You know, I think all of us bring different lenses, different perspectives, different experiences to the table.   00;04;12;23 - 00;04;50;07 And one of the reasons why I'm so honored to have this job with PCORI is the fact that we recognize that and we in a way celebrate that and experiences that brought me to this to this point include, you know, that time working for American Academy of Family Physicians. It was a great time with them thinking through and working on issues related to the primary care workforce, health system delivery, health system design, how we pay for health care, how we pay for the myriad of services that make a difference in people's lives.   00;04;50;09 - 00;05;16;14 Prior to that, I've been with the National Conference of State Legislatures and working with state legislators and legislative staff of all stripes, thinking through how it is that we design and arrange systems of care to meet the needs of the people. And then that's the professional lens. But also, candidly, on the on the personal side, we all approach health care as patients, as families, as carers for people.   00;05;16;14 - 00;05;47;17 And we see and we live and we experience the multitude of ways in which our system works or does not. And we see the ways in which questions that we have those dilemmas around the decisions that we're faced with in our health and care and our families. Health and care have answers or don't. Those are the things that really drive me every day when I wake up and I think, okay, how can we advance the ball just a little bit to make life a little bit better for the next person?   00;05;47;19 - 00;06;07;27 Yeah, there's no one that doesn't touch and there's no one who's not affected by the system, the success of it or the shortcomings of it, whichever those may be. But research and especially research that involves the general public, that's not easy. What what does bakery do to create and foster engagement with patients and communities that really work and that matter?   00;06;07;29 - 00;06;41;00 It's no one simple answer. You know, we tend to think of it in terms of recognizing and appreciating the different contexts in which people exist and thinking through, okay, how is it that we can create an approach to engaging individuals from this community or this community itself in a way that's humble, responsive, resonant with the way in which they live their lives and they experience care.   00;06;41;02 - 00;07;14;20 And we also think about it in terms of a few different domains of activities that we can pursue that can foster an environment or an ecosystem where we can start breaking down these silos and breaking down these barriers that may have traditionally existed between research and community, between patients and investigators, between all other members of the health sector payers, insurers, employers, purchasers of care, clinicians of all stripes, hospitals and health systems, etc..   00;07;14;22 - 00;07;46;04 So as we've figured out the array of different tools that we should have at our disposal at the quarry and that we encourage others to develop, we want them into some some domains, some buckets, one of which is you've got to fund the practice of engagement. You know, engagement does require resources. When we first set out at the quarry over a decade ago, we heard clearly from investigators, traditional researchers and enthusiasm for getting closer to community.   00;07;46;04 - 00;08;18;17 But we heard clearly that they didn't have support through their institution and that our requirements may be some sort of unfunded mandate. We also heard clearly from patients and communities a likewise enthusiasm and a likewise concern that they didn't have structural support for their engagement and research. And so you've got to you've got to think about how it is that you are going to resource financially the venues, the forums, etc., for communities to come together with investigators.   00;08;18;19 - 00;08;46;24 You've also got to think through what are the facilitators for driving meaningful and effective engagement. So that's creating different tools and resources. And PCORI has many of these available on our website that we encourage others to use. But also as you look at these, you'll see that many of them are community generated themselves. Sometimes the best and most durable solutions are those that bubble up from the participants themselves.   00;08;46;26 - 00;09;12;04 There's also another domain of work that is really this notion of convening that you really need to think through how it is. We can bring people together because there's no substitution for the human touch, there's no substitution for human interaction and thinking through what are the different modalities that we can support people in bridging diverse perspectives in a complex space.   00;09;12;06 - 00;09;44;12 How can we help them see where it is that they may be using different language to say the same thing or the same language to mean different things? Quite common for us to all just talk past each other when we're really driving towards the same goal, but then also thinking through and this is where we've done a lot of work ourselves, thinking through how it is that we can substantively and meaningfully bring our community partners into our work itself, helping us to make better, more responsive decisions to what are the needs of the ground level.   00;09;44;15 - 00;10;12;17 So for Pachauri, for example, that means that we have multi-stakeholder advisory panels, we have application review panels that also are multi-stakeholder, that include investigators and statisticians and clinicians and patients. So really thinking critically about how can we bring people into the fold and have democratization in a sense of our work. Yeah, I really love the way you've laid that out in buckets.   00;10;12;17 - 00;10;58;00 It makes the Pickering's work crystal clear. But I do want to give our listeners a better sense of of why patient centered outcomes matter so much and how that then improves the quality of research. Do you have any success stories or anything that illustrates how enhanced patient engagement tangibly influenced the outcome of research? Yeah, for sure. I mean, let's start with the theoretical model, and it's really that as we create these opportunities for meaningful engagement, again, that word meaningful being so important, that is reflective of the community, it will serve to influence research, to be patient centered, to be relevant, to be useful, which will in turn help to make the research in the forthcoming   00;10;58;00 - 00;11;33;28 evidence understandable to and accessible to the public. And when people see themselves and their priorities reflected, it helps to establish the trust of and acceptability of the findings, which will also help to foster the successful uptake and use of research results and if you go through the course portfolio, you'll see lots of examples of this. And there's one that's actually quite recent where I can say that we're quite honored to see the announcement just this week of an organization called The Accelerated Cure, and they focus on multiple sclerosis.   00;11;34;00 - 00;12;00;10 They've received engagement award funding from a quarry to help really build capacity within their organization, in their community to understand how they can be partners more fully in comparative clinical effectiveness research, how they can identify what are the outcomes that should be measured, that are meaningful and relevant to them, and how to construct the questions that are meaningful to them.   00;12;00;13 - 00;12;27;29 They'd also received early BigQuery funding to support their people powered research network. And so all of these activities together they brought together, they needed together and they recently received it was announced this week over $4 million award from the Congressionally directed medical research program to continue to study different approaches. Online technology facilitated approaches to addressing fatigue and multiple sclerosis.   00;12;28;02 - 00;12;53;13 So it's a very granular example, but also how when we do work through our own funding mechanisms here, of course it can cascade out in many ways that benefit the broader system. Likewise, we've supported awards to, for example, the Bladder Cancer Action Network, where they again started off with engagement funding. Again, that resourcing to identify what matters to them in their community.   00;12;53;16 - 00;13;17;23 And we saw that translate forward into the quarry funded comparative clinical effectiveness research looking at interventions for bladder cancer. So those are just two two crisp examples of how this can all come together and advance in a way that is meaningful and responsive to community. I get that you want patients to have a seat at the research table right from the beginning.   00;13;17;23 - 00;13;44;04 Preferably tell us what's hard about that and then also tell us where the big opportunities and getting it right lie. Yeah, I mean, one of the first and foremost is really finding who are those activated, engaged patients who are ready and able to sit at the table. And oftentimes, I think it's not necessarily as hard as some people may perceive.   00;13;44;04 - 00;14;20;23 One of the best things that we've heard from many folks is to look within their own community, to look in their own backyard and figure out who are their neighbors, who are who are those organizations and individuals that are geographically proximal to them and do that hard work of the cold call of the picking up the phone, of going to where patients are going to, where people who are addressing the condition you're interested in, going to them and approaching them with some humility and with the open heart and the open mind.   00;14;20;23 - 00;14;44;28 Unknown We've seen that be actually a strikingly successful approach over a long period of time for initiating the relationship. Likewise, there are also national and international organizations that represent patients, and they're always worth reaching out to and identifying who are folks that may be within the organization or within their broader networks that are interested in this topic as well.   00;14;45;01 - 00;15;17;17 Again, that's initiating the relationship. Then you have to focus on developing and sustaining the relationship, and that comes through a lot of baseline principles that we previously articulated in what we referred to as our engagement rubric. It's about identifying what's your core learning agenda, How do you learn from each other? Because each party around the table brings important expertise, important lens, important perspective that give a holistic picture of what happens in American health care.   00;15;17;19 - 00;15;42;11 How is it that you will foster trust? And again, we all know that trust is based on that mix of deeds, matching words. And so it's everybody coming together in a forthright and transparent manner that fosters trust. And it's about reciprocity as well, making sure that each side is returning to each other and in bidirectional dialog and bidirectional exchange.   00;15;42;14 - 00;16;08;16 And so these are all factors that that support us and support the research partnership coming together. You know, what we talk about here a lot is technology and how it gets applied to life science research. What is bakery's approach to deciding what technologies to leverage and when and how? Well, in a lot of ways this a research funders are deciding when and where and how happens at the applicant level.   00;16;08;16 - 00;16;47;25 And so it's really the applicant teams that are coming to us with evidence based approaches that are in practice either for engaging a community or for addressing care. And so as a funder, of course, we work with our application review teams to ensure that the evidence underlying those approaches is valid. It's robust, but we see a lot of creative approaches on that engagement side, and I think there was no more clear example of how technology can be facilitative of engagement then the recent pandemic.   00;16;47;27 - 00;17;27;20 We saw so many creative approaches for fostering and nurturing connectivity and connection and for fostering and nurturing relationships with so many novel approaches, whether it was, I think, of often of a brilliant researcher out of New England, Sherman Naji, who did some really fabulous work using photo voice method for engaging African immigrant communities during the time of social distancing, we looked at some of the creative approaches to using engagement methods through some standard platforms that we're all used to now, whether it be teams or Zoom or so on.   00;17;27;23 - 00;17;59;22 We also see some of these approaches moving over into the care questions that are arising in the work periphery fund. So now let's shift over to some of the some of the clinical effectiveness research. There was a project that we funded several years back that was with a really great investigator, author Michael Constantino, and it was looking at different approaches for helping to match patients with therapies.   00;17;59;25 - 00;18;24;00 So if we think about the mental health crisis in this country and we think about the DA of providers, of clinicians in mental health and we think about what we've all probably seen in in our own lives or our lives of our loved ones, of how there's the challenge in finding a therapist that really meshes with you because, you know, mental health care is such a personal close thing.   00;18;24;00 - 00;18;50;16 You really got to find the right person that can help you. What this project did was it looked at a novel app that allows patients to put in what are the things that they value most out of their care, what are the outcomes that are most important and meaningful to them? And it facilitates them finding available therapists that match with their care preferences and their preferred outcomes and have really fabulous evidence.   00;18;50;16 - 00;19;11;00 And I'm really delighted that the team came to us for an award to implement this evidence and further clinical settings, and we're continuing to see some great results for this one. And I'd encourage folks to take a look at it on our website. Great. We'll definitely put that website in the show notes and make sure everybody has access to that so they can check it out.   00;19;11;02 - 00;19;35;05 Obviously, new technology, new tech capabilities seems to be coming along faster, more frequently. What are some of the technology advancements that intrigued you the most or stand to have the biggest possible impact on your work? Boy, that's another great question, Mike. I mean, you're just with a bunch of them today. You know, I think we're going to talk about technology advances.   00;19;35;05 - 00;20;00;28 I mean, let's just put it on the table. It's front and center of everybody right now. And that's that's the burgeoning use of artificial intelligence and large language models. And I think like most, it's an area that we continue to be intrigued by and that we're taking a long, hard look at how it can be used robustly. And, you know, we're taking the long, hard look at it, because this, of course, is clinical research.   00;20;00;28 - 00;20;33;20 And we want to make sure that the application of new technologies such as Iot get it right. So one of the first steps that we've done is we've actually started offering through our Methods Research program. That's a funding track that we have that supports the improvement of the actual underlying methodology for conducting research. We started issuing funding to support our understanding in the field to understanding of how these tools may be deployed within the clinical research enterprise.   00;20;33;20 - 00;20;58;06 And so we have a growing portfolio over there that I think is really going to yield a lot of excellent information and good guidance not only for PCORI but for the broader research enterprise in terms of how to appropriately deploy novel tools at the right moment to the right ends. Do you worry any about AI being potentially overhyped or over promising?   00;20;58;06 - 00;21;18;04 I mean, how do you kind of keep a measure on what's realistic to expect and what's not? Yeah, I mean, that's that's that's a great question. You know, and that's one of the things that I think we're all going to struggle with a bit. You know, there's a lot of interest, a lot of enthusiasm for AI. Certainly there is a lot of investment in the space.   00;21;18;04 - 00;21;49;11 And certainly like everyone else, we look forward to seeing how this continues to evolve, shape up and roll out. For now, we're continuing to be just laser focused on that core message, message and that core mission of ours of funding comparative clinical effectiveness research that really aligns with community preferences. And so while these tools may prove to be effective facilitators of comparative clinical effectiveness research, we remain focused on the questions that matter to communities.   00;21;49;11 - 00;22;28;06 What are the things that people are wrestling with? Well, it's right there in your title, Disseminate, and nothing good happens here if patients and other stakeholders aren't reached and educated. So how do you make sure people and health care providers get the results of research so that it can actually be used in clinical care? Yeah, I mean, we've all heard that data point over the years that it's a 17 year gap from bench to bedside, as they say that from the time that new evidence hits the streets to the time that it is commonly accepted in practice at 17 years, which I think we all agree is way, way, way, way, way too long for   00;22;28;06 - 00;22;51;14 us to be getting new information into the hands of those that need it and to get it into into play. Yeah, it's uninspiring. It is uninspiring, is putting it very, very diplomatically simply. But we can do better. And so we're trying we're trying a bunch of different approaches here at Quarry. Some of them were directed in our authorizing line.   00;22;51;14 - 00;23;19;06 I give actually a lot of credit to Congress in this aspect to have the foresight to task us, to challenge us with 90 days from the completion of our research and our acceptance of the findings to getting the evidence out there for the public 90 days. So as soon as we have accepted the final research report from every project that we find, we get that evidence up there as a publicly facing abstracts.   00;23;19;06 - 00;23;44;05 So people know, so people know within 90 days and we have that full research report, that full accounting for what happened in the research we funded up on our website within a year. That's the entirety of the of the scientific legacy of that project. That's great, but that's not enough. It's not enough to rest on that. It's not enough to rest on publication in the peer reviewed journals, which are a fabulous resource for clinicians.   00;23;44;07 - 00;24;14;27 So we've come up with additional mechanisms, one of which is, of course, like I was talking about earlier, relative to funding engagement, funding dissemination. So we've created funding opportunities for both the investigators that we funded as well as for interested communities to seek support to disseminate the core funded evidence to their community through a mode, through a language, through in a context that makes sense to their community.   00;24;14;29 - 00;24;40;11 I mean, we as one organization cannot be everything to everyone. We cannot know how to speak to everyone in the way that is most resonant to them. And we're honored that we have community partners coming forward that say, yes, we see ourselves in this evidence and we want to share it more broadly. But as any of us with an email inbox understand and Mike, I'm sure you understand this too, that email inbox is just growing and growing and growing.   00;24;40;11 - 00;25;03;19 And so simply disseminating and resting on that isn't necessarily enough. We're all just bombarded with information all day, so there needs to be a little bit more intentionality. Yeah, that's actually where I was going. The challenge of what we're talking about here, especially on the health care provider side, you know, based on other folks we've interviewed on the podcast has been that these providers there nose to the grindstone, busy.   00;25;03;19 - 00;25;26;07 So how can you even know or measure whether they're taking the time to digest research conclusions, much less pass that information on to patients? boy. That's right. That's right. You know, and this is actually where some of my some of our background comes into play as well as I think about the sad, exact message that I used to hear from family physicians back when I was with the American Academy.   00;25;26;07 - 00;25;55;29 I think about also what I heard frequently as a question from state legislators back when I was with the national conference. Folks want to understand how this has worked in other places so that way they can assess what are the implementation risks. And it's not necessarily a financial risk or a health and safety risk. It's a risk to taking their notes away from that grindstone that they are on.   00;25;56;02 - 00;26;21;04 So, you know, states want to know what other states have implemented this. Clinicians and systems want to know what other systems have implemented this. How did it look in their practice? And well, somebody's got to make the first move. You know, when we have high quality evidence that's not only dissemination worthy, but implementation ready, we do actually have opportunities to fund the uptake of evidence here at the Corry.   00;26;21;05 - 00;27;11;11 I mentioned earlier the award to Michael Cosentino for therapist matching. We've had a range of other awards to implement high quality evidence in additional clinical settings. And so that's where we start to go from beyond the more controlled clinical research setting to understanding how do we approach adaptation with fidelity to the evidence. So thinking through, what are some of those learnings from implementation science that we blend with the evidence itself and then apply an implementation practice When we talk about and think about the effect of data sharing and just that information flying back and forth in a more fluent manner so that we can speed learnings in research, it feels like a key element.   00;27;11;11 - 00;27;47;24 There is incentives for few people do anything unless they're incentivized to do it. What incentives are working or might work to help further encourage data sharing? Yeah, that's a great question. I mean that that's been one of the really sticky wickets, I think for the health system overall and not just in the US, but I think more broadly globally is that we have competing incentive systems and it really does require a broader, more fulsome conversation I think across the different participants within the health sector.   00;27;47;24 - 00;28;22;20 It's it's not just health systems hanging on to data, it's not just researchers in academia or elsewhere hanging on to data. It's not patients understandably concerned about how their data may be used. It's not individual clinical sites concerned about their data. It's everybody concerned about that. And so how do we foster conversations that can help us understand what would be the incentives that could actually bring folks to bring more data to the table in a more facilitated and accountable approach?   00;28;22;23 - 00;29;03;09 One of the things that we have tried here at PCORI is we did develop a large distributed data network. So we have been supporting for several years an initiative called P Cornet Patient-centered Outcomes Research Network. It's again a distributed data network that consists of several self-defined clinical research networks. So these are networks of systems and sites that have decided on their own to come together in partnership to work on data sharing through a common data model to support clinical research.   00;29;03;11 - 00;29;36;09 And in true bakery fashion, we require that they also have very robust patient and community engagement. So that way what we're doing is we're bringing together a somewhat novel incentive structure where we are bringing researchers, health systems and patients and communities and clinicians to the table together to think about data, use the context for data use, and to also give them a large degree of autonomy over when and when not to participate in any particular project.   00;29;36;11 - 00;29;57;13 Well, I'm sure that Peccary doesn't do all this on its own. I mean, you've already kind of laid out some of the partnerships, you've got some valuable partnerships and collaborations. Can you tell us about some of those, the main ones and kind of what each brings to the mission? Yeah, well, you're never going to hear an engagement guy talk about a main partnership versus some other partnership.   00;29;57;16 - 00;30;21;17 Who's your favorite Exactly? I mean, you know, everyone brings something really unique and valuable to the table and some may kind of roll their eyes. And Craig, don't say that. But really, when you dig in with folks, man, that's one of the things that I got to tell you, Mike, I just love about this job is getting to see this country and see this system through different eyes each and every day.   00;30;21;21 - 00;30;42;26 And so, you know, I think about organizations and individuals that we work with that bring that patient lens. And that really is the true north for us. How do we orient everything towards outcomes that are meaningful to patients and families and carers? But I also think about clinicians of all stripes, whether they are primary care docs, subspecialty physicians, nurses and so on.   00;30;43;02 - 00;31;12;12 Everybody brings a unique aspect and lens. Likewise with health systems, whether they're for profit or nonprofit or public, whether they're religiously affiliated, whether they're rural or urban. We think, think about the employers. You know, I often think that employers as purchasers of health benefits are one of the often overlooked critical components of the American health care system. I mean, 155 million of us, the most meaningful moment in our journey with the health system is probably open enrollment.   00;31;12;15 - 00;31;39;06 We think about the insurers and they bring a valuable lens as well in terms of the financing and the conduct of care in the system. And so it's really that blend of all of those perspectives that really gives us that criticality. And that's where we find that that value. And so I always encourage folks to think about who you have at the table, but also take a step back and ask each other who is not at the table, you know, who is not at the table.   00;31;39;06 - 00;32;02;14 That can bring an important perspective that will help round out our understanding and maybe help us figure out where are, again, those sticky wickets that we need to get past. Well, let's take a technology provider like the Oracles of the world. One, what can it do better or how can it bring maximum effect to a partnership like yours of a truly wants to improve health care and play a role in that?   00;32;02;16 - 00;32;26;19 Yeah. Yeah. Well, I would say that private partner like Oracle plays a very important role and has a very unique perspective from several of those lenses that I just mentioned. And if we think back to earlier in the conversation when I was talking about everybody brings a unique perspective that's informed by multiple areas in which they've lived and they've experienced, Oracle is no different.   00;32;26;25 - 00;32;50;03 We think about the corporate footprint that Oracle has as an employer and as a purchaser of health benefits. That's a valuable perspective from my seat and understanding how Oracle is considering its community. I also think about Oracle, as, you know, one of the largest I.T. and data services companies in the country, and that's a very unique and valuable lens.   00;32;50;03 - 00;33;24;20 And there's a techno logical knowhow that I think would be of benefit to anyone in research and thinking through what are the partnerships that may emerge there that also encourage Oracle to think about, again, who's not at your table presently as you're on this journey in better understanding and better supporting the improvement of health care in the United States and perhaps even globally, who are those partners that would help support on individual projects as well as enterprise wide and to keep that open door and keep that open seat at the table.   00;33;24;22 - 00;33;53;06 I'm going to ask you a loaded question just to see how diplomatic you are. You describe the health care system and you and you talk about the many, many players and components of it and the stakeholders. Is health care too decentralized within the health system? We approach it as it is as it presently exists, and recognize that people are approaching it with good faith and good cheer.   00;33;53;09 - 00;34;18;23 I truly believe that. I think also they will especially do so when you center your work around the patient. I think, again, the the way that we have health care arranged in this country as a system or probably more accurately, a non system, 56, you know, semi sovereign jurisdictions, each doing it their own way with a federal policy overlay.   00;34;18;26 - 00;34;38;04 It's not that it's too fragmented, it's that we just need to be thinking of what are the bridges that we can build between and amongst each other. And that's hard work. It's incredibly complex. And I think that's why some people may may back away for it. They may sometimes criticize me as being too Pollyannish about it. But I do think that people want to come together.   00;34;38;04 - 00;35;03;18 They want to come together and have their experience recognized, their experience honored, and their experience bridged to that experience of others. So that way they can move forward together. And I think so long as we continue to to work together and try and find those partnerships and those relationships, the better off the system will be and the better off we'll be able to provide patient care.   00;35;03;20 - 00;35;50;19 Well, now I'm really going to unleash your inner Pollyanna, because whether it's possible right now or not, describe what the perfect world of aligning research patients and providers around research outcomes looks like to. Yeah, well, to me, you know, I think that when you can have ongoing longitudinal relationships, that's a key word here, relationships where there is an open door and an open pathway for community to come forward with their concerns, with their dilemmas, where They are having challenges to researchers that are accustomed to working with community and are engaging of community, and where a funder is ready to support that partnership.   00;35;50;21 - 00;36;19;12 And when the applications are rigorous to fund those applications to support a deeper understanding the human condition and scientific knowledge in medical care, the better off will be. To me, I think there is real opportunity for this country to continue to move forward on that pipeline where the ideas and the questions are not borne of the ivory tower, but they're born of the real experience of people living their lives day to day.   00;36;19;14 - 00;36;44;22 We've got listeners, fortunately, that kind of run the gamut all across your stakeholder spectrum. So before we go, what's the most important message you would like for them to hear and hopefully remember? Well, in the spirit of what I just offered, where it is, you know, the notion of evidence needs, if we want to say it that way, the dilemmas that people are facing, The Corey's doors open.   00;36;44;24 - 00;37;06;26 I want to learn those questions. We want to learn what those questions are, what those needs are, what those concerns are. So I hope that people will take this whole conversation as a conversation, as an opportunity to reach out to us, you know, to let us know that they are there, that they're interested. We would love to have them involved and engaged in our work.   00;37;06;29 - 00;37;27;00 We'd love to have them involved and engaged in the work that we fund. We'd love to have them using evidence that we have funded. So please, you know, for all of the listeners out there in podcast land, give us a holler. Get in touch with us. We want to hear from you. Yeah, well, if they do want to learn more about Pachauri or you, what's the best way for them to do that?   00;37;27;03 - 00;37;54;11 Yeah, well, I think that's always important to add. You know, our website is really easy. So Pachauri taught PKO or I talk now if you really want to drill it on the website a little bit, there's the tab on there that says Engage with US. And that's an invitation. That is an open invitation, and you'll find links in there and descriptions and information about all the different ways that you can come and be a part of this work that we do.   00;37;54;14 - 00;38;12;19 You can also reach out to me directly. Greg Martin It's a plain enough name. Our emails are just G. Martin at the Corey talk. Feel free to give me a holler. Great. We got it. And we appreciate that. And for our listeners, don't forget to subscribe to Research and action. Obviously, one of the smarter podcasts out there, as you just heard.   00;38;12;21 - 00;38;42;00 And if you want to learn more about how Oracle can accelerate your own life sciences research, just go to Oracle dot com slash life dash sciences and we'll see you next time on Research in Action.

June 4, 2024Episode 1032 min

Advancing clinical research through tech and teamwork

What makes multidisciplinary collaboration the key to health and life sciences research and innovation? What is the impact of bundled, integrated solutions on the patient experience? And how can we invest in what matters most in research while streamlining the entire process? We will learn all that and more in this episode of Research in Action with Frank Baitman, Digital Health, Data, and Technology Executive; and former Chief Information Officer of the US Department of Health and Human Services.   http://www.oracle.com/health http://www.oracle.com/life   -------------------------------------------------------   Episode Transcript:   00;00;00;02 - 00;00;27;22 What makes multidisciplinary collaboration the key to health care innovation? What is the effect of bundled, integrated solutions on the patient experience and how can we invest in what matters most while streamlining the entire process? We'll find all that out and more on Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;27;22 - 00;00;52;08 I'm Mike Stiles. And today our very special guest is Frank Bateman, a digital health data and technology executive. He's currently a senior health IT advisor and was a former chief information officer of the U.S. Department of Health and Human Services. Oracle Life Sciences has an e-book on the next phase of growth for the Life Sciences industry, and Frank was a really valuable resource for that.   00;00;52;08 - 00;01;22;00 He's got a lot of great thoughts on how pharma and biotech are investing in tech to support things like personalized medicine, improved clinical trials and drug safety tracking. That's why we wanted to get him on the podcast. So Frank, thanks so much for joining us. Thanks. It's great to be here, Mike. We appreciate it. Well, we got a lot of ground to cover, but I know you went into corporate strategy in the beginning of your career and through the bulk of your career, but obviously somewhere down the line you started crossing paths with government.   00;01;22;00 - 00;01;42;04 So what did that involve? How did that happen? Well, I've been lucky enough to pursue my interests wherever they took me. I hadn't expected to pursue a career in the life sciences and health care when I started out focused on nuclear arms control. But my interest in technology actually came about from my work on verification measures for a nuclear test ban.   00;01;42;21 - 00;02;09;05 Technology first took me to IBM Research and then under IBM corporate strategy, as you mentioned, when in in corporate, I oversaw the company's ten year outlook. And as a tech company, we saw high performance computing in the life sciences staring us in the face. We needed to be in it. And our chairman at the time, Lou Gerstner, accepted a recommendation that we invest 100 million to launch a business unit focused on the life sciences.   00;02;09;19 - 00;02;36;24 So I love the idea. You were actually serving in the Obama administration. White House Entrepreneur in residence. I love the idea of an entrepreneur in residence because one doesn't quickly equate government with speed, original ideas and innovation. Were you impressed by or frustrated by the speed at which you could bring things to full fruition in government? Impressed? Absolutely frustrated.   00;02;37;00 - 00;03;04;25 Yeah. Our times sometimes there are arcane processes that get in the way of novel solutions, but I always thought that had great admiration for the dedicated dedication the mission demonstrated by civil servants. Doing things differently was really a hallmark of the Obama administration. It wasn't just the Entrepreneur in Residence program you mentioned. Obama appointed the nation's first chief technology officer, the first chief information officer.   00;03;05;06 - 00;03;31;08 He launched the US Digital Service to provide agencies with a different approach to software development. He created challenge that guards as a means for agencies to seek innovations by awarding modest prizes as opposed to large government contracts. It brought new voices to light. I look at our current government a lot, like most governments, it's inherited its structure from the industrial age.   00;03;31;18 - 00;03;58;12 For the most part, it's organized by industry, by vertical. There's an Agriculture Department, energy, health, defense and so on. The congressional appropriations process is what exacerbates the problem in this information age. I really believe that Multi-disc culinary collaboration is what brings about solutions. And I don't have a background in biochemistry, but I worked with biochemists to explore therapies that made effective use in both of our disciplines.   00;03;58;25 - 00;04;23;21 If you think of Tesla for a moment, the company has innovations, it has inventions. But its real success was that of an integrator. It brought together knowhow from battery management, aerodynamics, automobile engineering, software development and legacy. Automakers had been working on these problems in building an EV for years, but their approach failed to deliver a car with mass market appeal.   00;04;24;00 - 00;04;47;06 And I think that's precisely what we need to do in the life sciences now, is bring the disciplines together and organize to solve problems. Now, I think the listeners are starting to see why you're such a fascinating person to have on the show. You've been exposed at high levels to nearly every component of health care, and through most of that you were tasked with being really a futurist and a trend spotter in it.   00;04;47;06 - 00;05;08;17 So just keep my head straight. I'm going to cover things with you in buckets now. The first being what the challenges and opportunities really are in life sciences. Fun fact for our listeners can bring up at their next dinner party. When things get dull, it takes about $2 billion and 10 to 15 years to get a drug to market.   00;05;08;17 - 00;05;30;27 Now, for most people who have gotten used to rapid advancement, getting things they want and need on demand, that sounds absolutely crazy. So can technology kind of change this equation soon? Mike I don't think that's crazy at all, and I really believe that we're on the cusp of change. One of the startups that I worked with, Empower Medicine, is a really great example.   00;05;31;11 - 00;06;04;00 What they're trying to achieve is a complex endeavor. It depends upon bringing together people from different disciplines to work across the universe of stakeholders. And going back to the Tesla example, GM and Ford built highly structured teams in engineering designed propulsion. But Tesla was a software company from the start. So I think the challenge is how do you, as a life sciences company, mimic what Tesla did to bring together the disciplines and focus on the entire process of drug development?   00;06;04;14 - 00;06;33;17 It's almost like if technology isn't the answer, what is? For instance, it's the only way really to capture the volume and sources of adverse events, right? We always look at adverse events and drug discovery thanks to that observation. Technology can do wonders, but it isn't nirvana. I it does great things, but I think it's always important to remember in health care there needs to be a human touch because health care at its core is about people.   00;06;33;28 - 00;07;02;27 Technology is already making waves in clinical trials and there's so much more to come. We're on the early stages witnessing that impact. Things like electronic patient reported outcomes and various sensors are beginning to gather data from patients during trials and during real world use. And this technology facilitates the capture of adverse events actively and passively, leading to just a wealth of data and deeper understanding of therapeutic effects.   00;07;03;19 - 00;07;31;23 This could uncover unexpected drug interactions or shed light and personalize or genomic attributes. Sometimes, though, adverse events are not obvious. And that's that's really another role that technology can play because of its ability to capture so much data, it may find unexpected things to match what's going on in the market. Actually, Oracle just merged its health care and Life sciences organization late last year.   00;07;31;23 - 00;07;55;24 Why do you think those two things are coming together? I know you talk about bringing things together and that's just like one example of it. Yeah, I think that's a really great example. I like to think of health as being all encompassing. The life sciences exist to support health. The same could be said for payors, providers, physicians, health systems, pharmacies, patients, Cros, even employers.   00;07;56;09 - 00;08;24;11 Each has their role to play. The vast majority of companies across the health sector have a mission or model that says something like Patients are the reason we're in business. Well, I'm not questioning it. In fact, I'm pretty confident people are involved, they're sincere. But if serving patients is your mission, I'd ask, when was the last time you took a look at your organization to see if it is optimally designed to address the needs of patients in this information age?   00;08;24;28 - 00;08;54;23 We know that siloed organizations underperform multiple disciplines and experiences are not considered. Information isn't shared in much. The way I spoke about HHS is being a reflection of the health sector by having a research component, by having a regulatory component, by having a provider component. I think that those companies that integrate health disciplines need to step out of their comfort zone in the same way that Oracle combined those pieces.   00;08;55;07 - 00;09;24;18 Now put I want to put that futurist hat on and tell us which innovations you think are going to have the most profound impact. On average, Mike's like me and say the next decade, What do you see coming? So I think it's important to have a framework to think about this. And and I've begun to craft a mind map to identify emerging use cases for AI because it's their adoption that makes real change possible downstream.   00;09;25;01 - 00;09;52;06 The framework that I propose is first, think about what are the emerging use cases where good enough, where is today? Suffices seconds Think about the next hurdle that generative AI crosses. What does that hurdle enable? And third, when you look at the first use cases of health, what are the second order needs that become possible? Things that haven't been able to be addressed.   00;09;52;20 - 00;10;19;05 The good enough example concept deserves an example. There's a startup by the name of Hai Labs that makes use of artificial intelligence, and for disclosure, I'm on the company's board. Hi Labs motto is We clean dirty data to unlock its potential for health care. Heaven knows if you've been around health care, you know about Dirty data. Hai Labs has mastered the capability that it is good enough for health plans.   00;10;19;05 - 00;10;49;18 Who can address incomplete claims, claims data, flawed provider directories, even incomplete clinical data plans. Love the product because it solves the problem they have today. Tomorrow, it might be good enough for clinical studies. It isn't today. And that's the framework I think we ought to be exploring when we think about what is generative. AI's impact on health care, what's possible today, what's good enough, and what's that going to train the large language models to do tomorrow.   00;10;50;05 - 00;11;24;20 Another example I find rather inspiring is a nonprofit by the name of Every Cure, launched by David Feigenbaum. Based on his own experience as a med student, he was diagnosed with Castleman Disease, a cell disorder of the lymph nodes and he nearly died after discovering that a 25 year old drug would block Castleman his pathway. He started every cure which is making use of AI to sort through well-documented commercial therapeutics to discover what might be repurposed.   00;11;25;02 - 00;11;47;27 You just don't know where AI is going to take you. And I think you need to look at the indicators in the marketplace to say, Oh, that's happening now. What possibilities does that create for the future? So the next bucket is personalized medicine. We've also become a culture that's really used to getting catered to from grocery stores, knowing what we usually buy to Netflix, knowing what movies will probably like.   00;11;47;27 - 00;12;12;26 We really gotten used to that. Health conditions are seen by patients as a very personal thing. So what are the remaining roadblocks that we're hitting and delivering? Truly personalized and customized medicine? So I have every confidence in personalized medicine. I have worked around it for years now, and there are things to know about individuals that are cheap and easy to collect.   00;12;12;26 - 00;12;41;08 But there are also things that are really difficult and costly to capture. And for each category, I think we need to be asking ourselves the question, What can I do with this knowledge? If I know something about this individual, can I do something? And personalization powered by digitization. I think a good example for patients with type two diabetes, It's moved quite swiftly because that knowledge is easily captured and it can be turned into coaching and medicines.   00;12;41;19 - 00;13;16;16 But there are many other diseases where personalized option doesn't yet offer a therapeutic advantage. How do you protect health information while also making it widely available and shareable to everyone who needs it? Isn't that another barrier? It is. Ultimately, I think patients need to be in control of their own health records. It's the only viable solution if patients are always wondering whether their data is under someone else's control or someone else is profiting from it or using it in ways they don't agree with, then they're not going to share their data.   00;13;17;01 - 00;13;39;15 So we need to find a mechanism to empower patients to control their data, their health data granularly. We've talked a lot on this show about real world data and real world evidence. Should we be am I overhyping what our would and RW we can lead to? Well, I think electronic health records are full of errors. We all know that.   00;13;39;24 - 00;14;07;29 But the question we should be asking is what's good enough and for what purpose? As more medical doctors are born, digital people coming out of med school in their twenties now have only done medical digital like the tech industry, collaborates on standards and competes on performance. Real world data will get better and generative A.I. will have an effect as well.   00;14;08;11 - 00;14;35;23 So I think we need to look at again, it's an evolution. What's good enough and understand that we're heading in that direction because all of our stakeholders are increasingly doing their their jobs only digitally. So the next bucket would be clinical trials. What can we do from a data collection angle to make clinical research move better, more efficient and faster to work better for the patient?   00;14;36;07 - 00;15;09;00 I was with a startup by the name of Empower Medicine and Mark Lee, the CEO of Empower, has a set of PowerPoint slides that I think do a great job of illustrating. The problem is analog to clinical trial data is a greenhouse. It's purpose built for one study. It's costly and the investment cannot be repurposed. When the study is completed, the well-manicured greenhouse is the most that isn't economically sustainable, nor does it capture evidence that might inform science.   00;15;09;16 - 00;15;36;28 So I'm on a separate note. I think we're missing an opportunity to capture data from populations that are representative of the disease being researched. It's obviously a bit more effort and takes some creative thought. So while there's pressure to enroll patients in studies, the lack of diversity impairs our understanding of the disease. And to your earlier question, it slows down the adoption of personalized medicine.   00;15;37;14 - 00;16;09;00 You know, in all honesty, none of my guests have ever exactly rave about the state of electronic health records. How do you think those issues have to get solved in order to improve clinical trials? Well, Mike, I'm not raving, but ours have come a long way over the past 15 years. Your question is interesting, though, because it focuses on clinical trials and for the most part, providers at the point of care are not focused on clinical trials.   00;16;09;16 - 00;16;44;03 That's pharma's interest. Our challenge ought to be to make electronic health records better for everyone. If we take seriously the opportunity to reimagine clinical trials, why should the data from point of care be separate from the trial data? You could argue it's a historic anomaly akin to our discussion of siloed verticals. I'm not saying there should not be a separate clinical trial system that might manage the trial or produce analytics about the trial, but the data about patients should be captured in the EMR and not through a redundant data entry.   00;16;44;03 - 00;17;04;22 Let me give you an example. I used to forget my wallet or my keys every time I left the house. Now my phone has all of those responsibilities and more. It's become more valuable and I rarely forget it. So I guess the question I have is how do we make our more valuable to all stakeholders? And I think that's something Oracle is really leaning into.   00;17;04;22 - 00;17;37;10 With that acquisition of Cerner. It finds itself with the largest components of that equation, so it can then proceed with solutions that do connect clinical trials to points of care. Do you think an undertaking like that is just an example of common sense? I do, and I suspect that many tech vendors are racing to make this happen. It'll be a while before the evidence is sufficient to enroll patients, but generative AI is ready, suggesting patients for studies based upon our data.   00;17;37;19 - 00;18;05;23 So in some sense, where it's good enough for some purposes now and we can only imagine what it might be around the corner, you know, I think of about how clinical trials could be fundamentally changed. I think about reduction of chaos really by using standards and automation. That's accepted pretty much throughout the industry, which means more digitalization. Am I an idiot thinking that's possible?   00;18;06;23 - 00;18;34;27 I'm not going to say that, Mike, thanks. But I do think your question is a certainty and I'm betting on it. Meaningful digitalization requires a rethink. However, of what we're trying to achieve and what the necessary steps are along the way. So doing unneeded steps faster won't have much of an effect. Amazon didn't just give you a shopping cart for your goods.   00;18;35;12 - 00;19;02;18 They changed the shopping experience by providing suggestions for accessories, storing your payment information, delivery preferences, and giving you reviews of those products. We need to be thoughtful about how do we change the process rather than speeding up the unnecessary stage gates along the way. It's all about simplification with a focus on the patient. I don't mean that as a platitude.   00;19;02;18 - 00;19;27;13 Every drug company, as I said, talks about its work in terms of the patient, but it's about understanding the patient's preferences and prioritizing them. I love that. Well, when you said, you know, doing unnecessary things, unnecessary steps faster doesn't get us anywhere, that's very smart. You touched on it, but AI and drug development specifically is kind of its own bucket.   00;19;27;13 - 00;20;04;07 How is pharmaceutical research and development about to be transformed because of a I mean, what roles does it play in getting these drugs to market faster so they can help people sooner? So the mind map that I mentioned I think is informing second order outcomes. And using this framework, I've begun to focus on a few areas. First is clinical research asking the question how does clinical research change when generative AI solutions become good enough to enable patients to provide raw, real world data from digital health devices?   00;20;04;18 - 00;20;32;02 Will that make it easier to recruit patients? And then there's another question what responsibilities the sponsors have when those devices deliver worrying evidence. The second area that I've been thinking about, the second order outcomes is the patient experience. It's never fun to be a patient, but in the current environment you need to be a bookkeeper, an administrator, a note taker, a risk manager, a data interpreter and an advocate.   00;20;32;12 - 00;20;58;27 There are impressive A.I. solutions to each of these challenges that I've seen in development now. So the question we ought to pose is what happens to the patient experience when these solutions are bundled and integrated with one another? And does that amount to a virtual concierge? Since it weaves data across providers, labs, pharmacies, payers and tech stacks, the patient wins.   00;20;59;10 - 00;21;24;22 But I've come to wonder which health sector is when and which lose. Are there any ethics or security concerns that's unique to applying AI to health care? Certainly we've heard the criticisms about, you know, well, AI scrapes the web and turns out not everything on the Internet is true. So, you know, is there any kind of danger of bad data being pulled in and applied by A.I.?   00;21;25;08 - 00;21;44;26 There are tons of concerns and there are think tanks out there publishing reports on these. But the truth is, the genie can't be put back into the bottle. A number of companies have put forward thoughtful ethics guidelines, particularly from the tech sector. But we can't allow the rules to vary from company to company, and we can't depend upon self-policing.   00;21;44;26 - 00;22;09;22 The stakes are just too high. Instead, we need Congress to act in established guardrails that allow the AI industry to grow without causing harm to individuals. Congress largely ignored privacy over the past couple of decades, while the rest of the world moved ahead on that front. We shouldn't allow this to happen again because A.I. arguably poses a much greater risk.   00;22;10;07 - 00;22;35;03 When states are forced to act, we end up with a patchwork of rules that are easy to circumvent. Yeah, you brought up a really good point that, you know, while our focus is on medicine and pharma and clinical research and patients, government and business does enter the picture, how are the pharma companies responding to things like the U.S. Inflation Reduction Act and the price pressures that they're facing?   00;22;35;15 - 00;23;03;05 Well, I can't speak for the pharma companies. I do observe their attempt to prevent it from going into effect, the price pressures, the controls. But I think ultimately we need to get to a point where there is meaningful digitization to allow a rethink of what we're trying to achieve so we can streamline processes. You mentioned about how other countries jumped on the regulation of AI so much sooner than we did.   00;23;03;26 - 00;23;34;11 What are the drug costs and medical procedure cost disparities between the United States and seemingly the rest of the world? I mean, it seems like our costs are always so infinitely higher. They are. And as an American, I've got to say, I can't explain it and I am frustrated by it. And I'm frustrated when seniors or people who don't have resources can't get the medicines that they need because they're being gouged.   00;23;35;08 - 00;24;01;10 Pharmaceutical companies who are charging two and a half to three times what they charge in Western developed nations in Europe. I really do think there needs to be a rethink of the way pharma does its business to streamline it and take unnecessary steps out of the process that could reduce the costs of drug development. Yeah, and a lot of that cost in our system isn't even directly healing patients.   00;24;01;10 - 00;24;30;20 It's administrative costs. It's inefficiencies in everything from staffing to supplies and other verticals and other businesses. Those are areas where tech is really being aggressively applied to get to those efficiencies. And you're saying maybe health care is playing catch up? I think it is. You know, there are two sectors that are laggards in adopting technology globally and it isn't just in the U.S. it's government and it's health care.   00;24;31;02 - 00;24;56;19 Health care has gotten on the bandwagon, particularly in certain sectors like pharma. Every sector in health care needs to do this, though, because the economics of health care are not sustainable, as in other industries. Health care writ large needs to ask what's best for the patient and determine what's the most efficient way of getting there. Delivering that those who employ the greatest creativity will serve both patients and shareholders interests.   00;24;57;02 - 00;25;25;11 So, you know, as I think about what a pharmaceutical company looks like today, or I think about what a payer looks like today, I think the question I have is, is there something outside of your sector that you could do that would deliver value to patients and better outcomes? If there is, why are you doing it? Are you happy with the degree to which research data is being shared?   00;25;25;20 - 00;25;54;15 Currently? Let me suggest that we ask the question just a little differently. Could we improve the sharing of research data? And without a doubt, the answer is yes. What if we think out of the box here and we empower patients, as I said earlier, to make the decision, perhaps all informed consent going forward could include a question where the patient consents to release anonymized data not only for the sponsor, but for all of science, for all researchers.   00;25;54;28 - 00;26;21;16 Putting on my privacy hat, I think it's fair to say that we all expect to have control over our personal health records, and we need to empower patients to make these decisions. And I suspect there are enough examples of this now. I suspect that when patients are asked, will you make your personal information, your health records available to science for future generations, the answer is almost always going to be yes.   00;26;21;28 - 00;26;47;16 Yeah, I agree with you. Turns out not everyone's a nice guy like Frank here. Cybercrime is real. Health care organizations, particularly have been in the news lately for all the wrong reasons. Oracle's Larry Ellison and Seema Verma just wrote about it and the Wall Street Journal. Is that a winnable fight? It feels like we're getting to a place where everyone's just accepting that there is no security and we're just going to have to live with it.   00;26;48;03 - 00;27;09;19 I think it comes down to how you define winnable. I hate to tease that out, but there will be cyber attacks and there will be breaches. You can't stop them entirely, but you can sure cut down on your risk profile. Companies who are diligent can dramatically reduce the risk of appearing on the front page of the Wall Street Journal as opposed to the Opinion Page.   00;27;10;00 - 00;27;50;28 There's no silver bullet, though, and it's unlikely that proprietary technologies can beat attackers, especially when nation states are involved in the attack. When I was in government, I got a close up look at the industry, the health care industry and cybersecurity. We were in the early days of creating industry specific communities. In particular, we launched the health ISAC, which means information sharing and Analysis Center in 2010, and it immediately provided a view into breaches, a view that enabled others across the health sector to shut down the vulnerabilities that were successfully used to attack someone else.   00;27;51;20 - 00;28;15;20 In many instances, it wasn't the technology that failed us. It was social engineering that led to the breach. So expound on that. The difference between, well, obviously technology can do what it can do and that it has its shortcomings. But what do you mean? It was social engineering that failed us. Usually attackers will find a vulnerability. It could be a helpdesk.   00;28;15;29 - 00;28;44;15 It could be someone in an accounting office that has access to the system. They'll call and they'll sound serious. They may even have gotten some personal information from someone else to pretend that they're that person and doing that, they will change a password. They will gain access to a system. So it isn't the technology that failed. It's that there were other access points to the technology that someone socially engineered.   00;28;44;26 - 00;29;04;27 So humans are fool able. Oh yeah, we are not you and I, of course. But you know, other humans are. I hold in my hand the last bucket, which is if I were in charge of everything. If you were in charge of everything in the many components of health care, they would listen to you and follow your recommendations.   00;29;04;27 - 00;29;30;29 What would those recommendations be? As we sit here today, in 2024, I can dream, can't I? Make sure you can. I'm putting I'm making you head of HHS now. I guess my suggestion is what I call threading the needle. By that I mean laying out a business process that begins with life sciences research and ends with providing life saving therapies to patients.   00;29;31;14 - 00;29;59;13 And then ask yourself, how can we invest in what matters while streamlining the entire process? Because there are just too many stakeholders, too many people taking a profit, too many unnecessary steps in a process that, as I said, was designed during the industrial age and isn't needed anymore. Technology can play a crucial role, but so too will company culture, expertise and perhaps most importantly, stakeholder engagement.   00;29;59;29 - 00;30;32;18 Everyone has to be on board for changes, these kind of structural changes to succeed. Does this mean bringing back some aspects of clinical research into pharma away from crows? I don't know. Maybe. Does it involve making use of hours for real world data? I think certainly perhaps it involves personalized medicine and genomic testing would make it unaffordable. But in a world of value based care, is there a way to use the outcomes to pay for the entire therapy?   00;30;32;28 - 00;31;11;22 I think it's quite likely that generative AI is going to change the health sector, making it more efficient, less bureaucratic, better integrated around delivering value. So I think those companies that don't act could very well find themselves with a consequential decision down the road. However, companies that pursue a strategy that really rethinks with the patients in the center and delivering therapies and the science behind doing so, I think will see their benefits to not only their bottom line, but they'll provide the best care that they say they want to provide by focusing on the patient.   00;31;12;17 - 00;31;33;20 It's really great advice that should probably be heeded. Frank It's been great. Again, thanks so much for being with us. I'm sure our listeners may want to follow you or find out more. What's the best way for them to do that? Well, I'm currently on a social media hiatus, and for you, I do avoid it. But certainly anyone can follow me or connect to me on LinkedIn.   00;31;33;28 - 00;32;05;25 Okay, great. And for our listeners, if you want this level of smart all the time, go ahead and subscribe to the show right now. And if you want to learn more about how Oracle can accelerate your own life sciences research, just go to Oracle dot com slash life dash sciences and we'll see you next time.

May 22, 2024Episode 932 min

How Innovation is Redefining Health and Life Sciences

Why is the confluence of healthcare and life sciences happening? What are the two biggest mistakes of technology in healthcare? And how can research insights be embedded into every care decision? We will find out all that and more with our guest Dr. David Feinberg, a medical professional and healthcare industry executive and current Chairman of Oracle Health.   http://www.oracle.com/health http://www.oracle.com/life    --------------------------------------------------------   Episode Transcript:   00;00;00;02 - 00;00;27;22 What makes multidisciplinary collaboration the key to health care innovation? What is the effect of bundled, integrated solutions on the patient experience and how can we invest in what matters most while streamlining the entire process? We'll find all that out and more on this episode of Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;27;22 - 00;00;52;08 I'm Mike Stiles. And today our very special guest is Frank Bateman, a digital health data and technology executive. He's currently a senior advisor to Oakland's De Silva and Phillips and was a former chief information officer of the U.S. Department of Health and Human Services. Oracle Life Sciences has an e-book coming on the next phase of growth for the Life Sciences industry, and Frank was a really valuable resource for that.   00;00;52;08 - 00;01;22;00 He's got a lot of great thoughts on how pharma and biotech are investing in tech to support things like personalized medicine, improved clinical trials and drug safety tracking. That's why we wanted to get him on the podcast. So Frank, thanks so much for joining us. Thanks. It's great to be here, Mike. We appreciate it. Well, we got a lot of ground to cover, but I know you went into corporate strategy in the beginning of your career and through the bulk of your career, but obviously somewhere down the line you started crossing paths with government.   00;01;22;00 - 00;01;42;04 So what did that involve? How did that happen? Well, I've been lucky enough to pursue my interests wherever they took me. I hadn't expected to pursue a career in the life sciences and health care when I started out focused on nuclear arms control. But my interest in technology actually came about from my work on verification measures for a nuclear test ban.   00;01;42;21 - 00;02;09;05 Technology first took me to IBM Research and then under IBM corporate strategy, as you mentioned, when in in corporate, I oversaw the company's ten year outlook. And as a tech company, we saw high performance computing in the life sciences staring us in the face. We needed to be in it. And our chairman at the time, Lou Gerstner, accepted a recommendation that we invest 100 million to launch a business unit focused on the life sciences.   00;02;09;19 - 00;02;36;24 So I love the idea. You were actually serving in the Obama administration. White House Entrepreneur in residence. I love the idea of an entrepreneur in residence because one doesn't quickly equate government with speed, original ideas and innovation. Were you impressed by or frustrated by the speed at which you could bring things to full fruition in government? Impressed? Absolutely frustrated.   00;02;37;00 - 00;03;04;25 Yeah. Our times sometimes there are arcane processes that get in the way of novel solutions, but I always thought that had great admiration for the dedicated dedication the mission demonstrated by civil servants. Doing things differently was really a hallmark of the Obama administration. It wasn't just the Entrepreneur in Residence program you mentioned. Obama appointed the nation's first chief technology officer, the first chief information officer.   00;03;05;06 - 00;03;31;08 He launched the US Digital Service to provide agencies with a different approach to software development. He created challenge that guards as a means for agencies to seek innovations by awarding modest prizes as opposed to large government contracts. It brought new voices to light. I look at our current government a lot, like most governments, it's inherited its structure from the industrial age.   00;03;31;18 - 00;03;58;12 For the most part, it's organized by industry, by vertical. There's an Agriculture Department, energy, health, defense and so on. The congressional appropriations process is what exacerbates the problem in this information age. I really believe that Multi-disc culinary collaboration is what brings about solutions. And I don't have a background in biochemistry, but I worked with biochemists to explore therapies that made effective use in both of our disciplines.   00;03;58;25 - 00;04;23;21 If you think of Tesla for a moment, the company has innovations, it has inventions. But its real success was that of an integrator. It brought together knowhow from battery management, aerodynamics, automobile engineering, software development and legacy. Automakers had been working on these problems in building an EV for years, but their approach failed to deliver a car with mass market appeal.   00;04;24;00 - 00;04;47;06 And I think that's precisely what we need to do in the life sciences now, is bring the disciplines together and organize to solve problems. Now, I think the listeners are starting to see why you're such a fascinating person to have on the show. You've been exposed at high levels to nearly every component of health care, and through most of that you were tasked with being really a futurist and a trend spotter in it.   00;04;47;06 - 00;05;08;17 So just keep my head straight. I'm going to cover things with you in buckets now. The first being what the challenges and opportunities really are in life sciences. Fun fact for our listeners can bring up at their next dinner party. When things get dull, it takes about $2 billion and 10 to 15 years to get a drug to market.   00;05;08;17 - 00;05;30;27 Now, for most people who have gotten used to rapid advancement, getting things they want and need on demand, that sounds absolutely crazy. So can technology kind of change this equation soon? Mike I don't think that's crazy at all, and I really believe that we're on the cusp of change. One of the startups that I worked with, Empower Medicine, is a really great example.   00;05;31;11 - 00;06;04;00 What they're trying to achieve is a complex endeavor. It depends upon bringing together people from different disciplines to work across the universe of stakeholders. And going back to the Tesla example, GM and Ford built highly structured teams in engineering designed propulsion. But Tesla was a software company from the start. So I think the challenge is how do you, as a life sciences company, mimic what Tesla did to bring together the disciplines and focus on the entire process of drug development?   00;06;04;14 - 00;06;33;17 It's almost like if technology isn't the answer, what is? For instance, it's the only way really to capture the volume and sources of adverse events, right? We always look at adverse events and drug discovery thanks to that observation. Technology can do wonders, but it isn't nirvana. I it does great things, but I think it's always important to remember in health care there needs to be a human touch because health care at its core is about people.   00;06;33;28 - 00;07;02;27 Technology is already making waves in clinical trials and there's so much more to come. We're on the early stages witnessing that impact. Things like electronic patient reported outcomes and various sensors are beginning to gather data from patients during trials and during real world use. And this technology facilitates the capture of adverse events actively and passively, leading to just a wealth of data and deeper understanding of therapeutic effects.   00;07;03;19 - 00;07;31;23 This could uncover unexpected drug interactions or shed light and personalize or genomic attributes. Sometimes, though, adverse events are not obvious. And that's that's really another role that technology can play because of its ability to capture so much data, it may find unexpected things to match what's going on in the market. Actually, Oracle just merged its health care and Life sciences organization late last year.   00;07;31;23 - 00;07;55;24 Why do you think those two things are coming together? I know you talk about bringing things together and that's just like one example of it. Yeah, I think that's a really great example. I like to think of health as being all encompassing. The life sciences exist to support health. The same could be said for payors, providers, physicians, health systems, pharmacies, patients, Cros, even employers.   00;07;56;09 - 00;08;24;11 Each has their role to play. The vast majority of companies across the health sector have a mission or model that says something like Patients are the reason we're in business. Well, I'm not questioning it. In fact, I'm pretty confident people are involved, they're sincere. But if serving patients is your mission, I'd ask, when was the last time you took a look at your organization to see if it is optimally designed to address the needs of patients in this information age?   00;08;24;28 - 00;08;54;23 We know that siloed organizations underperform multiple disciplines and experiences are not considered. Information isn't shared in much. The way I spoke about HHS is being a reflection of the health sector by having a research component, by having a regulatory component, by having a provider component. I think that those companies that integrate health disciplines need to step out of their comfort zone in the same way that Oracle combined those pieces.   00;08;55;07 - 00;09;24;18 Now put I want to put that futurist hat on and tell us which innovations you think are going to have the most profound impact. On average, Mike's like me and say the next decade, What do you see coming? So I think it's important to have a framework to think about this. And and I've begun to craft a mind map to identify emerging use cases for AI because it's their adoption that makes real change possible downstream.   00;09;25;01 - 00;09;52;06 The framework that I propose is first, think about what are the emerging use cases where good enough, where is today? Suffices seconds Think about the next hurdle that generative AI crosses. What does that hurdle enable? And third, when you look at the first use cases of health, what are the second order needs that become possible? Things that haven't been able to be addressed.   00;09;52;20 - 00;10;19;05 The good enough example concept deserves an example. There's a startup by the name of Hai Labs that makes use of artificial intelligence, and for disclosure, I'm on the company's board. Hi Labs motto is We clean dirty data to unlock its potential for health care. Heaven knows if you've been around health care, you know about Dirty data. Hai Labs has mastered the capability that it is good enough for health plans.   00;10;19;05 - 00;10;49;18 Who can address incomplete claims, claims data, flawed provider directories, even incomplete clinical data plans. Love the product because it solves the problem they have today. Tomorrow, it might be good enough for clinical studies. It isn't today. And that's the framework I think we ought to be exploring when we think about what is generative. AI's impact on health care, what's possible today, what's good enough, and what's that going to train the large language models to do tomorrow.   00;10;50;05 - 00;11;24;20 Another example I find rather inspiring is a nonprofit by the name of Every Cure, launched by David Feigenbaum. Based on his own experience as a med student, he was diagnosed with Castleman Disease, a cell disorder of the lymph nodes and he nearly died after discovering that a 25 year old drug would block Castleman his pathway. He started every cure which is making use of AI to sort through well-documented commercial therapeutics to discover what might be repurposed.   00;11;25;02 - 00;11;47;27 You just don't know where AI is going to take you. And I think you need to look at the indicators in the marketplace to say, Oh, that's happening now. What possibilities does that create for the future? So the next bucket is personalized medicine. We've also become a culture that's really used to getting catered to from grocery stores, knowing what we usually buy to Netflix, knowing what movies will probably like.   00;11;47;27 - 00;12;12;26 We really gotten used to that. Health conditions are seen by patients as a very personal thing. So what are the remaining roadblocks that we're hitting and delivering? Truly personalized and customized medicine? So I have every confidence in personalized medicine. I have worked around it for years now, and there are things to know about individuals that are cheap and easy to collect.   00;12;12;26 - 00;12;41;08 But there are also things that are really difficult and costly to capture. And for each category, I think we need to be asking ourselves the question, What can I do with this knowledge? If I know something about this individual, can I do something? And personalization powered by digitization. I think a good example for patients with type two diabetes, It's moved quite swiftly because that knowledge is easily captured and it can be turned into coaching and medicines.   00;12;41;19 - 00;13;16;16 But there are many other diseases where personalized option doesn't yet offer a therapeutic advantage. How do you protect health information while also making it widely available and shareable to everyone who needs it? Isn't that another barrier? It is. Ultimately, I think patients need to be in control of their own health records. It's the only viable solution if patients are always wondering whether their data is under someone else's control or someone else is profiting from it or using it in ways they don't agree with, then they're not going to share their data.   00;13;17;01 - 00;13;39;15 So we need to find a mechanism to empower patients to control their data, their health data granularly. We've talked a lot on this show about real world data and real world evidence. Should we be am I overhyping what our would and RW we can lead to? Well, I think electronic health records are full of errors. We all know that.   00;13;39;24 - 00;14;07;29 But the question we should be asking is what's good enough and for what purpose? As more medical doctors are born, digital people coming out of med school in their twenties now have only done medical digital like the tech industry, collaborates on standards and competes on performance. Real world data will get better and generative A.I. will have an effect as well.   00;14;08;11 - 00;14;35;23 So I think we need to look at again, it's an evolution. What's good enough and understand that we're heading in that direction because all of our stakeholders are increasingly doing their their jobs only digitally. So the next bucket would be clinical trials. What can we do from a data collection angle to make clinical research move better, more efficient and faster to work better for the patient?   00;14;36;07 - 00;15;09;00 I was with a startup by the name of Empower Medicine and Mark Lee, the CEO of Empower, has a set of PowerPoint slides that I think do a great job of illustrating. The problem is analog to clinical trial data is a greenhouse. It's purpose built for one study. It's costly and the investment cannot be repurposed. When the study is completed, the well-manicured greenhouse is the most that isn't economically sustainable, nor does it capture evidence that might inform science.   00;15;09;16 - 00;15;36;28 So I'm on a separate note. I think we're missing an opportunity to capture data from populations that are representative of the disease being researched. It's obviously a bit more effort and takes some creative thought. So while there's pressure to enroll patients in studies, the lack of diversity impairs our understanding of the disease. And to your earlier question, it slows down the adoption of personalized medicine.   00;15;37;14 - 00;16;09;00 You know, in all honesty, none of my guests have ever exactly rave about the state of electronic health records. How do you think those issues have to get solved in order to improve clinical trials? Well, Mike, I'm not raving, but ours have come a long way over the past 15 years. Your question is interesting, though, because it focuses on clinical trials and for the most part, providers at the point of care are not focused on clinical trials.   00;16;09;16 - 00;16;44;03 That's pharma's interest. Our challenge ought to be to make electronic health records better for everyone. If we take seriously the opportunity to reimagine clinical trials, why should the data from point of care be separate from the trial data? You could argue it's a historic anomaly akin to our discussion of siloed verticals. I'm not saying there should not be a separate clinical trial system that might manage the trial or produce analytics about the trial, but the data about patients should be captured in the EMR and not through a redundant data entry.   00;16;44;03 - 00;17;04;22 Let me give you an example. I used to forget my wallet or my keys every time I left the house. Now my phone has all of those responsibilities and more. It's become more valuable and I rarely forget it. So I guess the question I have is how do we make our more valuable to all stakeholders? And I think that's something Oracle is really leaning into.   00;17;04;22 - 00;17;37;10 With that acquisition of Cerner. It finds itself with the largest components of that equation, so it can then proceed with solutions that do connect clinical trials to points of care. Do you think an undertaking like that is just an example of common sense? I do, and I suspect that many tech vendors are racing to make this happen. It'll be a while before the evidence is sufficient to enroll patients, but generative AI is ready, suggesting patients for studies based upon our data.   00;17;37;19 - 00;18;05;23 So in some sense, where it's good enough for some purposes now and we can only imagine what it might be around the corner, you know, I think of about how clinical trials could be fundamentally changed. I think about reduction of chaos really by using standards and automation. That's accepted pretty much throughout the industry, which means more digitalization. Am I an idiot thinking that's possible?   00;18;06;23 - 00;18;34;27 I'm not going to say that, Mike, thanks. But I do think your question is a certainty and I'm betting on it. Meaningful digitalization requires a rethink. However, of what we're trying to achieve and what the necessary steps are along the way. So doing unneeded steps faster won't have much of an effect. Amazon didn't just give you a shopping cart for your goods.   00;18;35;12 - 00;19;02;18 They changed the shopping experience by providing suggestions for accessories, storing your payment information, delivery preferences, and giving you reviews of those products. We need to be thoughtful about how do we change the process rather than speeding up the unnecessary stage gates along the way. It's all about simplification with a focus on the patient. I don't mean that as a platitude.   00;19;02;18 - 00;19;27;13 Every drug company, as I said, talks about its work in terms of the patient, but it's about understanding the patient's preferences and prioritizing them. I love that. Well, when you said, you know, doing unnecessary things, unnecessary steps faster doesn't get us anywhere, that's very smart. You touched on it, but AI and drug development specifically is kind of its own bucket.   00;19;27;13 - 00;20;04;07 How is pharmaceutical research and development about to be transformed because of a I mean, what roles does it play in getting these drugs to market faster so they can help people sooner? So the mind map that I mentioned I think is informing second order outcomes. And using this framework, I've begun to focus on a few areas. First is clinical research asking the question how does clinical research change when generative AI solutions become good enough to enable patients to provide raw, real world data from digital health devices?   00;20;04;18 - 00;20;32;02 Will that make it easier to recruit patients? And then there's another question what responsibilities the sponsors have when those devices deliver worrying evidence. The second area that I've been thinking about, the second order outcomes is the patient experience. It's never fun to be a patient, but in the current environment you need to be a bookkeeper, an administrator, a note taker, a risk manager, a data interpreter and an advocate.   00;20;32;12 - 00;20;58;27 There are impressive A.I. solutions to each of these challenges that I've seen in development now. So the question we ought to pose is what happens to the patient experience when these solutions are bundled and integrated with one another? And does that amount to a virtual concierge? Since it weaves data across providers, labs, pharmacies, payers and tech stacks, the patient wins.   00;20;59;10 - 00;21;24;22 But I've come to wonder which health sector is when and which lose. Are there any ethics or security concerns that's unique to applying AI to health care? Certainly we've heard the criticisms about, you know, well, AI scrapes the web and turns out not everything on the Internet is true. So, you know, is there any kind of danger of bad data being pulled in and applied by A.I.?   00;21;25;08 - 00;21;44;26 There are tons of concerns and there are think tanks out there publishing reports on these. But the truth is, the genie can't be put back into the bottle. A number of companies have put forward thoughtful ethics guidelines, particularly from the tech sector. But we can't allow the rules to vary from company to company, and we can't depend upon self-policing.   00;21;44;26 - 00;22;09;22 The stakes are just too high. Instead, we need Congress to act in established guardrails that allow the AI industry to grow without causing harm to individuals. Congress largely ignored privacy over the past couple of decades, while the rest of the world moved ahead on that front. We shouldn't allow this to happen again because A.I. arguably poses a much greater risk.   00;22;10;07 - 00;22;35;03 When states are forced to act, we end up with a patchwork of rules that are easy to circumvent. Yeah, you brought up a really good point that, you know, while our focus is on medicine and pharma and clinical research and patients, government and business does enter the picture, how are the pharma companies responding to things like the U.S. Inflation Reduction Act and the price pressures that they're facing?   00;22;35;15 - 00;23;03;05 Well, I can't speak for the pharma companies. I do observe their attempt to prevent it from going into effect, the price pressures, the controls. But I think ultimately we need to get to a point where there is meaningful digitization to allow a rethink of what we're trying to achieve so we can streamline processes. You mentioned about how other countries jumped on the regulation of AI so much sooner than we did.   00;23;03;26 - 00;23;34;11 What are the drug costs and medical procedure cost disparities between the United States and seemingly the rest of the world? I mean, it seems like our costs are always so infinitely higher. They are. And as an American, I've got to say, I can't explain it and I am frustrated by it. And I'm frustrated when seniors or people who don't have resources can't get the medicines that they need because they're being gouged.   00;23;35;08 - 00;24;01;10 Pharmaceutical companies who are charging two and a half to three times what they charge in Western developed nations in Europe. I really do think there needs to be a rethink of the way pharma does its business to streamline it and take unnecessary steps out of the process that could reduce the costs of drug development. Yeah, and a lot of that cost in our system isn't even directly healing patients.   00;24;01;10 - 00;24;30;20 It's administrative costs. It's inefficiencies in everything from staffing to supplies and other verticals and other businesses. Those are areas where tech is really being aggressively applied to get to those efficiencies. And you're saying maybe health care is playing catch up? I think it is. You know, there are two sectors that are laggards in adopting technology globally and it isn't just in the U.S. it's government and it's health care.   00;24;31;02 - 00;24;56;19 Health care has gotten on the bandwagon, particularly in certain sectors like pharma. Every sector in health care needs to do this, though, because the economics of health care are not sustainable, as in other industries. Health care writ large needs to ask what's best for the patient and determine what's the most efficient way of getting there. Delivering that those who employ the greatest creativity will serve both patients and shareholders interests.   00;24;57;02 - 00;25;25;11 So, you know, as I think about what a pharmaceutical company looks like today, or I think about what a payer looks like today, I think the question I have is, is there something outside of your sector that you could do that would deliver value to patients and better outcomes? If there is, why are you doing it? Are you happy with the degree to which research data is being shared?   00;25;25;20 - 00;25;54;15 Currently? Let me suggest that we ask the question just a little differently. Could we improve the sharing of research data? And without a doubt, the answer is yes. What if we think out of the box here and we empower patients, as I said earlier, to make the decision, perhaps all informed consent going forward could include a question where the patient consents to release anonymized data not only for the sponsor, but for all of science, for all researchers.   00;25;54;28 - 00;26;21;16 Putting on my privacy hat, I think it's fair to say that we all expect to have control over our personal health records, and we need to empower patients to make these decisions. And I suspect there are enough examples of this now. I suspect that when patients are asked, will you make your personal information, your health records available to science for future generations, the answer is almost always going to be yes.   00;26;21;28 - 00;26;47;16 Yeah, I agree with you. Turns out not everyone's a nice guy like Frank here. Cybercrime is real. Health care organizations, particularly have been in the news lately for all the wrong reasons. Oracle's Larry Ellison and Seema Verma just wrote about it and the Wall Street Journal. Is that a winnable fight? It feels like we're getting to a place where everyone's just accepting that there is no security and we're just going to have to live with it.   00;26;48;03 - 00;27;09;19 I think it comes down to how you define winnable. I hate to tease that out, but there will be cyber attacks and there will be breaches. You can't stop them entirely, but you can sure cut down on your risk profile. Companies who are diligent can dramatically reduce the risk of appearing on the front page of the Wall Street Journal as opposed to the Opinion Page.   00;27;10;00 - 00;27;50;28 There's no silver bullet, though, and it's unlikely that proprietary technologies can beat attackers, especially when nation states are involved in the attack. When I was in government, I got a close up look at the industry, the health care industry and cybersecurity. We were in the early days of creating industry specific communities. In particular, we launched the health ISAC, which means information sharing and Analysis Center in 2010, and it immediately provided a view into breaches, a view that enabled others across the health sector to shut down the vulnerabilities that were successfully used to attack someone else.   00;27;51;20 - 00;28;15;20 In many instances, it wasn't the technology that failed us. It was social engineering that led to the breach. So expound on that. The difference between, well, obviously technology can do what it can do and that it has its shortcomings. But what do you mean? It was social engineering that failed us. Usually attackers will find a vulnerability. It could be a helpdesk.   00;28;15;29 - 00;28;44;15 It could be someone in an accounting office that has access to the system. They'll call and they'll sound serious. They may even have gotten some personal information from someone else to pretend that they're that person and doing that, they will change a password. They will gain access to a system. So it isn't the technology that failed. It's that there were other access points to the technology that someone socially engineered.   00;28;44;26 - 00;29;04;27 So humans are fool able. Oh yeah, we are not you and I, of course. But you know, other humans are. I hold in my hand the last bucket, which is if I were in charge of everything. If you were in charge of everything in the many components of health care, they would listen to you and follow your recommendations.   00;29;04;27 - 00;29;30;29 What would those recommendations be? As we sit here today, in 2024, I can dream, can't I? Make sure you can. I'm putting I'm making you head of HHS now. I guess my suggestion is what I call threading the needle. By that I mean laying out a business process that begins with life sciences research and ends with providing life saving therapies to patients.   00;29;31;14 - 00;29;59;13 And then ask yourself, how can we invest in what matters while streamlining the entire process? Because there are just too many stakeholders, too many people taking a profit, too many unnecessary steps in a process that, as I said, was designed during the industrial age and isn't needed anymore. Technology can play a crucial role, but so too will company culture, expertise and perhaps most importantly, stakeholder engagement.   00;29;59;29 - 00;30;32;18 Everyone has to be on board for changes, these kind of structural changes to succeed. Does this mean bringing back some aspects of clinical research into pharma away from crows? I don't know. Maybe. Does it involve making use of hours for real world data? I think certainly perhaps it involves personalized medicine and genomic testing would make it unaffordable. But in a world of value based care, is there a way to use the outcomes to pay for the entire therapy?   00;30;32;28 - 00;31;11;22 I think it's quite likely that generative AI is going to change the health sector, making it more efficient, less bureaucratic, better integrated around delivering value. So I think those companies that don't act could very well find themselves with a consequential decision down the road. However, companies that pursue a strategy that really rethinks with the patients in the center and delivering therapies and the science behind doing so, I think will see their benefits to not only their bottom line, but they'll provide the best care that they say they want to provide by focusing on the patient.   00;31;12;17 - 00;31;33;20 It's really great advice that should probably be heeded. Frank It's been great. Again, thanks so much for being with us. I'm sure our listeners may want to follow you or find out more. What's the best way for them to do that? Well, I'm currently on a social media hiatus, and for you, I do avoid it. But certainly anyone can follow me or connect to me on LinkedIn.   00;31;33;28 - 00;32;05;25 Okay, great. And for our listeners, if you want this level of smart all the time, go ahead and subscribe to the show right now. And if you want to learn more about how Oracle can accelerate your own life sciences research, just go to Oracle dot com slash life dash sciences and we'll see you next time.

April 30, 2024Episode 836 min

Exploring New Frontiers in Pharma: Mindsets, Data, AI, and Oracle

How can shifting mindsets fuel the next wave of innovation in the pharmaceutical and life sciences industry? In what ways can we ensure the vast amounts of health data are utilized securely and effectively to foster groundbreaking medical advancements? And how is Oracle's new Health Data Intelligence poised to transform the industry in an unprecedented manner? You'll learn all that and more with our guest Michael Fronstin, Vice President and Chief Commercial Officer at Oracle Life Sciences, who has worked across nearly every area of the industry from positions at Merck to J&J to Kantar Health and now at Oracle.   --------------------------------------------------------   Episode Transcript:   00;00;00;04 - 00;00;26;25 In what ways do the mindsets in the pharma industry need to change? How can we make sure massive amounts of health data is applied to practical effect? And how might Oracle's new Health Data Intelligence platform be an unprecedented game changer? We'll find all that out and more on Research in Action. Hello, welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;26;25 - 00;00;49;15 I'm Mike Stiles. And today we've got a guest who's been a veteran in the life sciences industry and who knows Oracle Life Sciences quite intimately because the guest is Michael Fronstin, vice president and chief commercial officer at Oracle Life Sciences. He's worked across nearly every area of life sciences, from positions at Merck to J&J to Kantar Health and now at Oracle.   00;00;49;15 - 00;01;11;25 So, Michael, thanks for being here. Thanks, Mike. Happy to be here and thank you so much for hosting this session. Really appreciate it. Great. Well, you know, you're the perfect person to talk to about what I want to talk about, which is changing people's minds and changing how we even approach and think about life sciences. So you've got that to look forward to.   00;01;11;25 - 00;01;34;28 But first, let's learn a little bit more about you. How did your interests and opportunities in life take you down the path that led you to where you are now? Yeah, thanks for that question. That's that's a great question to start out with. I'll tell you that as human beings, we all have something going on in terms of health care, whether it's impacting ourselves or friends or family, everyone's going through something.   00;01;34;28 - 00;01;56;25 At some point. You just don't know what the magnitude is or how long lasting, right? So having patience and empathy is so important. And of course myself, I've gone through things and unfortunately starting at a very early age of 12, I lost my best friend to the brain cancer and from the time I was 12 to the time I was 21, unfortunately, I lost a lot of people to different health ailments.   00;01;57;11 - 00;02;17;10 I guess, climaxing with losing my father when I was 21 years old. During that time, I always thought about health care and how it was impacting the people around me and wondering what could I do? And I felt pretty helpless, to be honest with you during those times, because some young boy don't there and there really wasn't anything I can do.   00;02;17;10 - 00;02;35;01 But as I got older and I went into college, I realized I could make a difference in health care. And that was going to be the industry that I was going to focus on. So I went into social sciences, became a sociologist with a business math background, and went to graduate school for an MBA in health care arbitration.   00;02;35;10 - 00;02;56;07 And that's when really things opened up to me where I started saying, okay, what aspect do I like? Where can I make a scalable impact? And I ended up joining Humana A down in Florida for a year or so, realizing that I can make a difference there and get people enrolled, help them get claims processed and paid. And from there my career took off.   00;02;56;07 - 00;03;21;02 I end up going to Merck, carried the bag and really experience the in office experience back in the days of the early nineties in terms of what patients were experiencing, seeing doctors who were really, really good and so much good at diagnosing patients and treating them in a time where most of the chronic conditions didn't have treatments available and new ones were coming out.   00;03;21;16 - 00;03;53;06 And I'll tell you, it was pretty exciting during these times being at Merck and seeing all these innovations. But I'll tell you, during that time I was really able to focus on one therapeutic area and it wasn't very scalable. It wasn't really having the impact it wanted. And it wasn't until I came to the consulting side of the business, you know, working with dozens of customers and maybe hundreds of brands over the past 20 plus years where I really felt like maybe a direct and indirect impact on people's lives around the globe.   00;03;53;28 - 00;04;16;02 So that's that brings me to today. And now I'm with Oracle Life Sciences, where I feel like it's even bigger and broader and better. So I'm excited about the present. I'm excited about the future. Yeah. You mentioned you kept repeating a phrase that kind of struck stuck with me, which is that you wanted to make a difference. Is that hard to do in the health care space?   00;04;16;02 - 00;04;39;12 I mean, have you been gratified by your ability to do that or has it always been a push and pull? Oh, interesting question. Definitely a push. And so, you know, sometimes you can you can make decisions and get them executed very quickly. Other times, it takes a while to do. You know, you have regulatory bodies that you have to deal with different types of payers around the world.   00;04;39;22 - 00;05;04;19 Decisions are always made quickly. And if it's the right decision because of various reasons, whether it's bureaucracy or internal or external, or you need to generate real world evidence modeling or even publications, we have more than 2000, maybe 3000 publications, and you develop the evidence, you submit the publication. It could take, you know, six months, a year, two years to get it published right?   00;05;04;19 - 00;05;24;14 So things just take time, unfortunately. But yeah, you can make a difference. I feel like I've made a difference. I feel pretty gratified about what I've done. And in the areas of the impact that I've made. So and a lot of it is just make an impact within your world and hoping that you can expand it beyond to make a broader impact.   00;05;24;14 - 00;05;59;11 You were at Kantar Health for like 17 years or so. How did what Kantar does align with Oracle Life Sciences and the idea behind just leveraging technology to benefit customers and partners? I'm actually coming on 19 years since we think about it and you mention it. So when I step back and think about my time at Bert or Change in Merck and the broader industry, life science clients need to accomplish three things in order to get their compound, whether new or existing compound, really the new compounds into the hands of the appropriate patients.   00;05;59;11 - 00;06;24;18 They need to get their drugs approved right by some regulatory authority. They need to get them reimbursed and they need to have a strong launch to drive awareness. Otherwise no one's going to prescribe it or patients. People aren't going to request it, right. So those three things need to need to occur. Kanter Health is really focused on the second and third in terms of the research services and expertise.   00;06;25;00 - 00;07;10;02 So the types of people are. Kanter Help are methodologies, social scientists like epidemiologists, psycho nutrition, these these are the folks that know how to design and conduct research, how to consult on the research from a Real-World evidence perspective and driving insights, evidence from a commercial planning perspective, prioritization, things like that. Where is the Oracle Life Sciences group? The other side of the group is really all about technology and applications predominantly focused on driving clinical trials for regulatory approval, of course, and in the area of pharmacovigilance during those trials and tracking them when those products are in the real world.   00;07;10;06 - 00;07;38;08 Right. Post-marketing authorization. So when you bring these two groups together and these types of people together, the technology, the medical intelligence, the scientific, methodological experience of the cancer health folks, have you got the best of all worlds, right? Technology, data experience combined. You take these wraparound services with the technology in and now our clients are able to see a much higher level of value, if you will.   00;07;38;23 - 00;08;02;25 Well, you've actually been anything but shy in the past about saying how the mindsets in the pharma industry really need to change. So what is the current mindset? And in what ways is it limiting? I'll tell you, the health care industry, including life sciences, has always been a little bit of a laggard in terms of of our movement.   00;08;03;11 - 00;08;30;15 Part of that issue is that we we operate in silos, right? And even within our life science clients or customers, the different cross-functional teams don't always come together. They don't know each other. Sometimes they buy the same data, right? So the inefficiencies of spending more budget than they need to, we're not leveraging the same data for different purposes, and we really need to break down the silos.   00;08;30;29 - 00;08;53;15 I think that from a mindset perspective, individuals on every side of the business really need to step back and pick up their heads and look around, see the big picture, understand where are we going? The data is critically important. Big data was becoming the buzzword ten, 15 years ago, but no one really knew what that B meant. Well, now it's here.   00;08;53;22 - 00;09;14;06 We could do something with big data, right? Is sort of on the fringe. Some people are using it, some people aren't, there hasn't. So this is a time where you could either bury your head in the sand because you don't understand it or you're afraid of it, or you can lean in and figure it out. And if you don't lean in, you're going to be left behind.   00;09;14;06 - 00;09;45;01 So I think we need to break down the silos. People need to step back and see the big picture. And I think they need to take risks and and lean in and it Oracle, that's what we're doing. We're committed to helping, you know, through creating open ecosystems, to breaking down barriers across teams, using our teams. And, you know, hopefully everybody will wind up picking your head up and looking at the big picture and caring more about collaboration and how these things can improve so that innovation moves forward faster.   00;09;45;17 - 00;10;06;25 Is that a realistic ask? I mean, I assume researchers are very busy with their heads down working on what they're working on. Can they can they expand and broaden their view? They have that luxury, Absolutely. It's like anything else, you just have to make the time. You got to take the time to make the time, invest the time to figure it out.   00;10;06;25 - 00;10;26;26 It's not easy. And I'm not saying it's easy by any means, but it's worth it to do. And I remember when I was a rep with Merck, you know, moving to Pennsylvania, the Home Office, the analysis, one of my problems that you get there and if you want pieces of advice when you get there, keep your head up.   00;10;27;13 - 00;10;51;11 And I said, I'm always positive. He said, that's not what he said. Look around, understand what's around you, incorporate it, immerse yourself in things you don't understand. You know, be comfortable being uncomfortable and again, new job, new new house placeholders. How do we find the time, how to figure it out? Right. And I see the people around me and our clients.   00;10;51;11 - 00;11;18;18 I see the people around me at Oracle Life Sciences. The ones who are doing that are the ones that are being most successful. Yeah, I love that. Get, get comfortable being uncomfortable. That's not something people dive into, as is uncomfortableness. But, you know, I don't care if it's industry, politics or even favorite flavor of ice cream. Getting anyone these days to change their mind or change their mindset is really hard.   00;11;18;18 - 00;11;49;09 So getting an industry to collectively think differently, that can't be easy. So what do you see as the biggest challenges to that? And is it that there needs to be some driving force for that? And is that the role Oracle's trying to play? Yeah, it's not easy for sure. All right. So some of the biggest challenges are really the cultures that are existing within and across the industry where people are so busy, right?   00;11;49;11 - 00;12;16;11 They're not set up to work. Cross-functionally The siloed nature that's that's occurring across our industry, even in between clinical care and clinical research, there are gaps. So I think all these different places are causing, you know, challenges in terms of making a difference, getting immersed and taking those risks. People aren't always rewarded for taking risks. So let's say it happens.   00;12;16;11 - 00;12;40;29 Let's say there's a shift in mindset and we're thinking more about leading with knowledge and information and looking at that big picture. What opportunities does that present for both the industry and for me when I get sick? Yeah, no, that's a great question as well. So for the industry, I think we'll be able to actually bring compounds to the to the marketplace more quickly.   00;12;41;10 - 00;13;30;00 Right. For you as an individual or us as individuals, all of us will be able to have more options, both clinical research as a care option. Right? Right now, only 3% of eligible patients participate in a clinical trial. Right. If we're able to take information and put it back in the electronic health record or h.r. System so that doctors can look at it at the point of care and make decisions whether it's about what is your care that they want to prescribe or it's about how are these products impacting you as a patient from a pharmacovigilance or really a tolerability or safety perspective, they're able to adjust very quickly right there on the fly, right?   00;13;30;00 - 00;13;51;29 They'll have more data at their fingertips, as we put it in. And that also could be recruiting patients into clinical trials. Right. So they don't know what's the inclusion exclusion criteria. Look it up. So how can you at their fingertips and knowing that this patient can just walk in the door for these patients scheduled to walk in this week, they're eligible.   00;13;52;00 - 00;14;12;02 Let me make sure that I talk to them about that so that they have other options that will help them get well. Yeah, So it's a good payoff. Your answer to this can be Mike, why don't you just mind your own business, but ask Oracle recently combined their Oracle Health and their Oracle Life Sciences divisions. Why did they do that?   00;14;12;11 - 00;14;37;06 Well, I'll tell you, I won't tell you to mind your own business. This is sort of the the biggest payoff I think we're seeing is movement that we've seen in health care. So the acquisition of Cerner by Oracle was just enormous. And it Cerner, these are your cancer health group is part of it really also was a big deal, right?   00;14;37;12 - 00;15;06;10 Because now we can take what's happening in health, in the clinic, in the hospital, in the offices and combine it with life sciences. Everybody has the same goal, which is to save lives or to increase quality of life of patients. But both of these groups, the hospital systems around the world and the life science companies around the world, they're not connected, right?   00;15;06;10 - 00;15;40;22 They want to be connected. They want to intersect, but they're working in silos, trying to influence each other when they both have the same goals, which is to save lives or help people. And now with Oracle Health and Oracle Life Sciences being under not only the same umbrella of Oracle, but under the same leadership in terms of team of firms, we're able to break down the silos so that we're able to share the appropriate data and information in an open equal ecosystem in bi directional way.   00;15;41;11 - 00;16;09;04 And while these two groups are deeply intertwined, yet this distinct, if you will, there are innovations there that we're looking at that will help everybody that some of the migrations celebrate recruitment, sharing of data, point of care decisions, things of that nature. So it's about turning data into information, that information into insights with some kind of open, intelligent, cloud based platform.   00;16;09;27 - 00;16;39;24 There is the problem, though, of drowning in data, but starving for insight that's applicable to so many businesses across so many industries. How would the ecosystem that you just described keep life sciences customers from drowning in data that is never used for practical effect? They're absolutely drowning in data. There are more data sources existing secondary data sources in the industry and across the world today.   00;16;40;05 - 00;17;12;02 The majority of these like probably 98% of them are not unified, they're not connected, and interoperability is lacking. Credit card companies figured it out a long time ago when healthcare has and we're starting to get there. Training unified platform of data Health data intelligence platform is what we call it in Oracle, backed by the Oracle cloud infrastructure. So you have data that's very sensitive sovereignty of nations, you're using it.   00;17;13;04 - 00;17;58;11 And of course OCI, Oracle Cloud Infrastructure affords the opportunity for security and speed and all these other benefits. So the more of tokenization we could do to connect the charged with other h.r. Claims with patient reported outcomes survey. The more we can do that in standardized ways with the right governance will help our clients sort through this sea of information so that we can and will help them, of course, you know, focus on what's important, you know, and use A.I. to define the trends in predictive analysis, what predicts better or worse outcomes.   00;17;59;01 - 00;18;21;22 So it's going to take time. We're getting there. We're already making a lot of progress, but I think that's now how we're going to help our clients get there. Well, I did ask about the obstacles of changing overall mindsets, but what are the remaining obstacles to actually building and implementing this eco system that you're talking about? Are there remaining tech obstacles?   00;18;21;22 - 00;18;50;01 Are there privacy issues? I mean, what's what's there that's making this a tough job? Not only we drowning in data, we're drowning in obstacles like that. So certainly you know, that's an obstacle of legalities around the world. Cultural changes and mindsets. Like we mentioned, there's governance. Who owns the data? We get data right to the data technology. Then we go back to that for a second.   00;18;50;11 - 00;19;13;28 You know, how do we connect from one system to the other? I do believe there's still 300 EHR systems out there. The interoperability, governance image. I mean, we're just not sure about. Also, we got to kick them off one at a time. And you know what we're doing at Oracle and Oracle Life Sciences is we're partnering with a lot of different organizing that's out there.   00;19;14;06 - 00;19;50;17 You might have seen our partnerships with the video code here. Johnson Labs, from algorithms, Perspectives. We're partnering with a lot of other organizations to help chip away at these obstacles and get to this ecosystem that we're talking about, where everybody wants. Yeah, you know, when you when you list those obstacles, one thing that's not there is resistance by patients, because I think most of us, you know, it's kind of a joke amongst everybody how every time you go to the doctor, you fill out the same forms again and again and again and again.   00;19;50;27 - 00;20;14;15 Clearly, there's not any kind of centralized clearinghouse for data on me as a patient. And I think most of the public kind of What's that? What's your view on meeting patient expectations where that's concerned? You know, isn't that the most important thing right of the whole conversation is putting the patient at the center of meeting their expectations. Okay.   00;20;14;15 - 00;20;41;03 There are a couple of countries where this is already occurring with the patients. The is all in one place. The patient just pulls up their app and they go and it doesn't matter which doctor or hospital you're walking into or what country they're visiting when they're traveling, they have their medical records in their pocket. One of the articles of issues is around privacy, and you might have mentioned this.   00;20;41;16 - 00;21;12;16 So in the US we have hip in Europe yard and this is trying to protect the patient for the right reasons. But we have to and we have to work within these systems to make sure we're able to operate together for the patients. There's nothing more annoying walking at your doctor's office and filling out the same or complaint or consent form or insurance form or whatever it is, you know, and it's certainly something that we need to do.   00;21;13;04 - 00;21;46;07 I think from a cohort perspective, the older populations and I'm not sure where that likes it's at 40 or 50 or 60, I think they're a little bit more protective and reticent about their privacy and their information. Whereas I see the younger generations, they're like, it makes sense to share it all the time. I wanted out less concerned about privacy, and maybe it's because of how they've grown up with the apps, social media, you know, everything's out there, you know?   00;21;46;08 - 00;22;09;17 So I think the trend is here and the tide is turning. You know, we have to find ways to continue to meet the patients and people where they are. Well, I'm sticking with that patient theme. There's how patients are involved or not in research. And we are hearing more about patient centered outcomes in research. It's another kind of mind shift that needs to happen.   00;22;09;17 - 00;22;35;04 How are we moving toward that where we're listening to the patient more and involving them more in clinical research than we used to? And that's that's the next great question. You threw that statistic out there that what, there's like 30% participation? I mean, there's clearly an issue. Yeah, Yeah, for sure. So patient reporting outcomes are typically subjective nature, right?   00;22;35;04 - 00;23;06;29 So by developing different instruments and scales that derive or predict something in might predict undiagnosed insomnia or anxiety, depression might predict of control of asthma, things of that nature. But there's typically surveys that have been validated through different types of behavioral science, a cognitive interviewing techniques, things of that nature, and then putting them out there. Right. And there's pros and there's observables, which are caregivers, right?   00;23;06;29 - 00;23;33;29 So someone caring for an adult relative, they're scales like that around caregiver burden, these sorts of things. And I'll tell you that the FDA has made a concerted effort to focus on patient focused drug development, and they've put these guidelines out there in terms of what they expect as websites companies are going through their clinical trial or clinical development programs.   00;23;34;00 - 00;24;01;17 Right. So I think that was a really great step to say not only open to this, we want it, we expect it. Right. So we've seen some of that, too. Now get your question. How do you do it right. Well, you can go with it. You charge it claims and look at information about the patient. But you also need to go directly to the patient and get their voice so you can do qualitative types of exercises.   00;24;02;04 - 00;24;22;21 For us at Oracle, I think this live of voices two trials where we go out to cohorts of patients who are eligible and we run through issue friendly terms the inclusion exclusion criteria. What do you think? Would you participate or not? What do we need to change here? And there's a whole bunch of other things to expose them to.   00;24;23;04 - 00;24;46;07 And then they tell us just no way, and this is impacting them. Phone calls of various clinical trials that our clients are working on, and they're taking it back to the EMA, the FDA, and say, here's the patient's voice and this is why we're making the decisions so that we're representing what these patients want in our trials. And often it's different.   00;24;46;23 - 00;25;13;08 So that that's one way We're also seeing more decentralized clinical trials. So over the past four years, with all the challenges of leaving one out and going to a site DCT decentralize, some trials have really accelerated in terms of the volume of trials. So so no longer just a patient have to drive an hour or 4 hours or however far to a site.   00;25;13;21 - 00;25;41;10 Now you bring the trial to them. You bring the phlebotomists to their house, you send them the wearable technologies or whatever it is they might need. So you're meeting the patients where they are so that you could increase participation and be more efficient, more productive, and really get it done in a better way. And the last thing I might mention is some natural history of disease registries.   00;25;41;21 - 00;26;07;25 These are registries that occur usually before the product goes into phase two or phase three clinical trial. And this is where you really start to understand what is the natural history of the disease. Most important, rare diseases where it could take years and years to get a count out in development compounded through or me to diagnose the patients.   00;26;08;04 - 00;26;33;01 And it takes too long to do that. So understanding the natural history of disease is critical. Right now we're running a global registry called Guardian, which is in Gauci Disease type two and Type three, and this registry is the Guardian Registry Registries one. We're collecting patient and caregiver information. We're actually developing a new approach and a new ops or so.   00;26;33;01 - 00;27;04;27 We'll have the patients voice. There are no products indicated for type two or Type three. So all the information is being fed back to the clients who have compounds in development for consideration in their clinical trials. And we're working with the International Gaucher Alliance, which is the global patient advocacy group on this registry. So it's a great partnership and it's getting that patient's voice, you know, where it needs to be, which is in the hands of of the compound development.   00;27;04;27 - 00;27;29;14 You mentioned A.I., you touched on that a little bit at AEI has certainly become part of the conversation, thinking about how it is or has the potential to impact therapeutic research and development. What, in your view, is and isn't overhyped about A.I. and the different stages of research and getting drugs to market so much? I make a lot of a lot of hype.   00;27;29;20 - 00;28;10;01 But also there's there's a lot of there's a lot of sizzle and there's a lot of sauce, right this. So you have to look for it and find it. So reading articles about organizations like Genentech and Janssen who are doing what's called Lab in the Loop, right. And a lot of a lot of life science, pharma companies and biotechs are doing this now where they're doing a and they're crossing their existing and other contacts with biological databases to uncover where might there be a match where some combination of a compound or multiple compounds could actually influence some disease?   00;28;10;01 - 00;28;47;05 Right. And then they tested they put it back in. So that's one area where we're seeing a lot of activity with with a for sure, critical trial designs, just looking at feasibility and protocol optimization and to understand where are the patients, how we are and how they're helping with patient recruitment. Where is indentify sites identifying the patients and incorporating dashboards back at the sites to help doctors identify and quickly recruit those eligible patients, or at least to have the conversations to see if they're interested.   00;28;47;14 - 00;29;28;22 Understand diversity of disease using various databases that have social determinants of health to make sure that we're diverse. Once the FDA is draft guidances, which which looked at everything from social determinants and ethnicity to co-morbidities, other demographics, transplantation, patients, etc., etc., etc. real world evidence teams are using it for their literature reviews. Unfortunately, sometimes they come across hallucinations or some false references, you know, show up and therefore you're always going to need this human collaboration to make sure your data is reliable.   00;29;29;03 - 00;29;55;07 And I'd say the last thing my head is pharmacovigilance, where we can go into existing databases, e charts, claims, both structured or unstructured notes, I should say, you know, and pull out information to identify patients who are having issues and report it in some sort of rapid or real time reporting and not wait. So out a major issue?   00;29;55;19 - 00;30;18;15 Well, since the listeners have been interested enough to still be listening, let's reward them by diving deeper into some of those specific technologies for clinical trials. What is Oracle's role in helping with randomization and trial supply management, which I think is also known as interact of response technology? Again, the work being done to that to get to therapeutic breakthroughs faster.   00;30;18;27 - 00;31;04;00 Yeah. Or TSM randomization, trial or supply management and ERP. It used to be called priority and now it's our TSM. This is an area where we've been playing for a long time. Continue to look at our tools for our clients so that they're able to do things that are quicker, faster, more efficiently. And certainly we've invested in a number of new people around the organization in our data product team, which is made up of some phenomenal engineers, you know, and they're investing we're investing significantly in our technologies to bring it to the next level and clients are responding appropriately, which is which is great.   00;31;04;03 - 00;31;30;08 And it's in a scenario where it's going to help clinical trials more quickly and more efficiently. So amazing things are happening. But, you know, I'm never satisfied. So I'm always curious about what the future could hold. I mean, we already touched on A.I., but what trends and technologies are you seeing out on the horizon that are most likely to bring us the kind of health care revolution that we think is possible?   00;31;31;11 - 00;31;55;06 Well, we've talked about some of them, this change in thinking culture for sure. Some of the policy and privacy types of things that we need to to get through. But this is what's not only on the horizon, but is here, right? It's here right now. I'm excited about the things that we're doing with Oracle Life Sciences to get there faster.   00;31;55;18 - 00;32;30;27 You're combining the data, our medical intelligence for our clients, just seeing it all in one place so that our customers are able to leverage it in a way, giving back to a future for physicians to close that gap between clinical research and clinical care. I think that's what I'm most excited about, I suppose. Oracle recently, very recently announced Oracle Health Data Intelligence, which is being called an open intelligence ecosystem or innovation.   00;32;31;09 - 00;32;57;21 Talk about what is that and how that helps life sciences. And researchers love to do so. So first of all, the Oracle Health Data Intelligence platform, it's open. It's open to anyone, meaning that anybody could tap into it, regardless of what industry, what part of the health care industry or working life sciences, whichever system, electronic health record system you're you're using.   00;32;58;06 - 00;33;32;24 So it's really flexible from that perspective that anybody can tap into it. And the data is research ready, meaning it's usable, right? We're form forming it, we're standardizing, and we're harmonizing it in a way that you can go and do the research that you need to do and get the insights and generate the evidence that you need. And this will help in such a tremendous way with the challenges that I mentioned earlier, breaking down silos, connecting disparate data sources, being structured and data that's now usable.   00;33;32;24 - 00;33;59;14 Right? That is that is not usable currently and it's in many formats. So customers will be able to or anyone really can tap into usable data sets from thousands of sources. So that's the other thing anyone can participate, contribute data. We're going to pull in data from a number of different places and again, turn that data into information and that information into insights and that insight those insights into evidence.   00;33;59;26 - 00;34;23;25 So and this will include longitudinal health data, real world data. I didn't define real world data, so real world data is basically any data that is not clinical trial data. It's in the real world, right? So you see that the care that's occurring within the physician's office or hospital that's not part of a clinical trial is considered real world data.   00;34;23;25 - 00;34;48;01 So that's longitudinal health data, electronic health records, patient registries, whether it's natural history or safety, product registries, all that is considered real world data. And all of that will be part of the health data intelligence platform. And this is an API driven ecosystem, which means anyone could access it. As I mentioned before, whether you use an Oracle clinical application or not.   00;34;48;27 - 00;35;16;18 And you can rest assured knowing it's running securely and safely on the Oracle Cloud infrastructure and as you know, OCI Oracle cloud infrastructure, not only is it safe and secure, but it's a military grade infrastructure and it's being used by the Department of Defense. So you could trust it is reliable, scalable, and it's getting the job done. And the health data intelligence platform, as you know, we have it, we're building it, improving.   00;35;16;18 - 00;35;36;17 This is really a big part of our future here in Oracle Life Sciences at Oracle and quite frankly, in the broader industry. Well, great. You know, I got my answers. Thanks for being our guest today, Michael. We'll be watching those, watching for those shifting mindsets and the changes coming to life sciences. Certainly, Oracle seems to be leading the way in that area.   00;35;36;28 - 00;35;53;25 If our listeners want to learn more, though, about what Oracle's initiatives are or if they want to get in touch with you, is there a way for them to do that? You know, first, my thanks for having me on. I really enjoyed the conversation and pretty good and a couple tough questions in there. So thank you for that to join it.   00;35;54;04 - 00;36;20;28 Everyone is welcome to go to my page and connect with me. I try to post relevant things on occasion. So Michael from set of enforcing the Oracle dot com and find the Oracle Health Sub page of the Oracle Life Sciences of the Explosive Alexa Science Stage Armageddon Sounds good. That got it. Thanks again, Michael. And to our listeners, we don't want you to miss any episodes of research and action.   00;36;20;28 - 00;36;49;01 So please subscribe to the show. And if you want to learn more about how Oracle can accelerate your own life sciences research, you can just go to Oracle dot com slash life dash sciences and we'll see you next time.

April 16, 202434 min

Unlocking Innovation Through Public, Private, and Academic Partnerships

What are the best ways to set up public, private, and academic clinical research partnerships? How do we get these public-private partnerships (PPP) to work most effectively? And who should be in charge of what in multistakeholder research collaborations? We will get those answers in more in this episode of Research in Action with our guests Rob King, President and CEO of FHI Clinical; and Dr. Kristen Lewis, Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH.   ---------------------------------------------------------   Episode Transcript:   00;00;00;01 - 00;00;22;22 What are the best ways to set up public-private clinical research projects? Where does and should the money for such research come from and who should be in charge of what? We'll get those answers and more on this episode of Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.   00;00;22;22 - 00;00;50;05 I'm Mike Stiles. And today we're just trying to outdo ourselves by talking to not one, but two very interesting people. First is Rob King, president and CEO of FHI Clinical. FHI uses Oracle's clinical trial software for their clinical operations and partner with public entities like PATH, which brings me to Dr. Kristen Lewis, who is Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH.   00;00;50;26 - 00;01;29;23 I could go through what each of these organizations do just to hear myself talk, But why do that when I have both of you here? So, Rob, tell us what FHI Clinical does. Yeah, I think Mike, so clinical in a contract, they were actually for profit and hearing of a large nonprofit called F8 had three ethically and while we are for profit empathy, our mission is to address unmet research needs and maximum social impact pouring into development of medical treatment around the world.   00;01;30;04 - 00;01;58;20 While we work globally, we tend to focus on the low and middle income country on the whole pharma and biotech client are also include nonprofits and government. Empathy. Well with biotech receive public funding and path having him be one of our client. Appreciate Kristen being here arguing that four years ago and I'm currently the CEO and I'm happy to be here.   00;01;58;20 - 00;02;22;19 Well great. Kristen what about PATH? Yeah, thanks for the introduction, Mike. It's a pleasure to speak with you and Rob today and have the opportunity to contribute to this discussion. So most people listening to this podcast may not be familiar with PATH. We're a nonprofit global public health organization with approximately 1600 employees worldwide. Our headquarters are in Seattle, Washington, and we have offices across the African and Asian continents and Europe.   00;02;22;19 - 00;02;53;00 Some of the locations we have offices in include Kenya, Ethiopia, Senegal, Uganda, Zambia, India, Vietnam, Ukraine. And I could go on, but I'll I'll hold hold it there. Our mission is to advance health equity through innovation and partnerships. We do this with the help of local and global partners by generating evidence, advancing innovation and strengthening local capacity to improve health in countries and communities that are experiencing disproportionate burdens of disease and barriers to well-being, specifically in low and middle income countries.   00;02;53;11 - 00;03;26;01 This includes working in over 70 countries across the African, Asian, Latin American, European and North American regions. Within Paths Center for Vaccine Innovation and Access, we drive the mission of achieving health equity using a three-pronged approach, including developing, facilitating and implementing global market and policy solutions to ensure sustainable supply and equitable access to vaccines. Supporting country led efforts to advance national health equity priorities, and to strengthen immunization system resilience and driving innovation and technological advances.   00;03;26;01 - 00;03;50;20 To accelerate and optimize access to vaccines. Now, this last point is where my work is focus. Thus, during today's discussion, I'll be speaking with the lens of developing vaccines for disease indications benefiting low and middle income countries, and the importance of public private partnerships in achieving that goal. And just to note, you'll note a common thread there in the introductions from both Rob and myself, and that's the low and middle income country focus.   00;03;50;20 - 00;04;15;17 And I think that you'll start to hear some commonalities come into play as we go further into this session. Great. Well, I think what I want to get into here is kind of what you talked about is the value of public private partnerships in clinical research. Rob, give me the honest first reaction that a lot of private companies have when it is suggested that they partner with a public or a government organization.   00;04;15;17 - 00;04;45;18 Is that something that they jump at with open arms or is there any hesitancy? How does that go down? You know, with recently reading an article about one of the first public private partnerships and it was how mail really hit home, like, you know, for most of our listener, what most people won't be familiar with are the initiative around vaccination for diseases like polio and Spanish flu, MENA and rubella.   00;04;46;00 - 00;05;33;19 And we tend to have short memories. And they and the devastating impact they've had on society prior to vaccination and treatment options or with also that treatment developed over HIV and AIDS and then most recently the COVID pandemic. So with that said, you know, private companies maintain the shy away from what we call the triple P public private partnership in the funding limitations that my, you know, government based funding required a lot of compliance when the whole myriad of regulations and public kind of activity may have restricting how and where or how and when fund your, you know, without experience are now horsepower in the public private partnership.   00;05;34;07 - 00;06;09;21 It creates see private companies to engage and may see growth for example will not serve as a prime contractor on government funding work because when you're in the accounting and you're when the regulatory compliance and you'll only see those of normal commercial contracts, therefore they can turn them and be overly burdensome for those companies to pay. And public private partnerships, you have to have an operational model that meets the unique need of that partnership.   00;06;10;03 - 00;06;36;15 And at the end of the day, you really can't you can't get value for society that public private partnerships have contributed to. And Kristen, from the nonprofit or public side, what what is the benefit of partnering with private companies? Yeah, that's a great question. And I think to answer that, I'd first like to highlight some of the major successes when these partnerships have come together.   00;06;37;04 - 00;07;05;23 PATH has played through public private partnerships. PATH has played a critical role in some of immunizations, created successes over the past 30 years in lmics low and middle income countries. This includes developing the world's first malaria vaccine, which has now reached more than 2 million children, eliminating meningitis epidemics in Africa following introduction of the A4 backed vaccine protecting over 300 million children from Japanese encephalitis, vaccinating millions of girls against HPV.   00;07;06;06 - 00;07;33;20 And I could go on. But those are some some highlights. Path has not achieved these accomplishments in isolation. These successes have been catalyzed via public private partnerships models, and they're examples of which the private sector alone may not have been interested in developing these indications. These vaccine indications for low and middle income country use due to financing or budget considerations or constraints or some of the points that Rob made earlier.   00;07;34;00 - 00;08;03;13 However, with partnerships between PATH and private entities, including finance mechanisms for rollout and use of the vaccines in the regions following development, we've been able to champion development and introduction of vaccines that might not usually have generated sufficient interest for the investment that's required for full development. So in a nutshell, public private partnerships are the bread and butter of our work and integral to the goal of achieving improvements in global public health among populations facing economic challenges worldwide.   00;08;03;24 - 00;08;43;19 Well, so it feels like these partnerships would automatically create multiple stakeholders. So, Rob, how hard is it to make sure that the goals and priorities are aligned amongst all these people and stay aligned? First, I think I have a, you know, expectation and the goals are higher for public private partnership and for commercial initiative. You know, eight you public five, there is an expectation that you're going to achieve the goal or outcome and you're held accountable for how those on her spent.   00;08;44;11 - 00;09;27;10 You're not accountable to a or stockholder, but general public. And you know, public funds are unlimited and there are every dollar may account for whatever goal they're trying to achieve. And we're spending public funds a buying or accounting of how this on her being spent and her limitation on this on and how there may not be extra funds or reserve goes back to if those funds start to run low and usually the public entity defines the impact and the work that has to be completed in ensuring that the funding is in place.   00;09;28;01 - 00;09;53;24 And they then tracking the work that the private company may have contractually in their you mean clear terms on what's being delivered and the restrictions that may or may not be around the funding for that deliverable. So I you agree that saying, though, priorities are paramount because of the fact that we're accountable to the end of the day, to the general public.   00;09;54;09 - 00;10;29;01 And Kristen, is there anything on the public or nonprofit side that's done to kind of make sure that projects aren't subjected to red tape or bureaucracies? I mean, I guess there's always going to be some of that, but to the extent that would might slow things down. Yeah, it's a great question, an interesting and insightful one. So Path we work as a clinical development partner and hold sponsor sponsor roles to implement clinical trials and generate evidence to support vaccine licensure, W.H.O., Prequalification and decision making for vaccine Introduction.   00;10;29;11 - 00;10;51;09 And our work spans the entire vaccine development and delivery lifecycle. And with this broad set of objectives, in order to achieve the aforementioned successes, we have worked with the same urgencies and efficiencies as our private counterparts. From a private lens, there seems to be a perception that the public sector does not come with the same development pressures as the private sector.   00;10;51;19 - 00;11;22;13 In other words, there seems to be a perception that the public sector works slow due to many policies or rules or paperwork, or is generally lacking a sense of urgency, if you will. Now, I don't have that experience working in government, so I can't comment on that side of things. However, in my experience working in vaccine development with a non governmental nonprofit for the majority of my career as well as a few years working for a for profit entity, I can comment that the intensity of work at a nonprofit has been similar to the intensity at a private entity.   00;11;22;26 - 00;11;46;09 While the root of the development pressures may be slightly different. The goal is to develop products as efficiently as possible, while also retaining high quality remain in both sectors. For private entities, I believe the term may be, quote, time as money and quote as a driving consideration. While for my work in the nonprofit space, what drives us is, quote, time is lives, unquote.   00;11;46;14 - 00;12;17;20 And that is really the driving consideration. But regardless of those driving considerations, there's still urgency and sense that we need to be as efficient as possible and ensure that we aren't were removing blockages, red tape, bureaucracy as much as possible. So, Kristen, I'm curious, just from your point of view, when the pandemic came down, that was an entirely different animal in terms and the need to get something done and get something done rapidly.   00;12;17;25 - 00;12;48;23 Just how different a process was that? Yes. So I wouldn't say that the process was necessarily different between the public and private side. I would say that we did things across both sectors in a a new way. So the COVID pandemic really brought home how there are many similarities between the public and the private sectors. Not everything differs according to operating model.   00;12;49;01 - 00;13;14;16 In fact, during the pandemic, the global public health and product development safe spaces, regardless of the type of sector, were going through the same waves of initial shock and uncertainty and how to continue the trials during the very initial stages of the pandemic considerations in terms of the risk benefit tradeoffs of operating non-covid interventional trials during that time, and depending on the type of trial availability of remote technologies and a product's importance to saving lives.   00;13;14;27 - 00;13;38;24 We had to take into consideration different ways and methods for making sure that those Non-covid interventional trials were completed. We also were involved with needing to identify new ways of getting the work done, which included catalyzing a more definitive shift towards identification of local partners that were in close proximity to the trial locations for ease and trial oversight and management.   00;13;38;24 - 00;14;04;12 Implementing remote solution for activities such as source, document verification, remote training, remote site assessments and other types of remote activities, identifying how to get supplies or equipment to the sites ahead of study. Start with supply chains being disrupted and finally determining how to maintain the trials and keep them running once up and going while continuing to deliver with with high quality and ensuring participant safety.   00;14;04;24 - 00;14;30;10 So from Passent, given our work is primarily focused in low and middle income countries, many of the challenges faced in the private sector high income market were further exacerbated due to the relatively slower adoption or uptake of technology surgical clinical trial advances. And this experience was important as it pushed for adoption of technologies that had been previously questioned due to fear of loss of data or other concerns, as with other areas of our lives.   00;14;30;11 - 00;14;56;28 COVID really helped to push the envelope in terms of finding new efficiencies and ways of getting things done. Rob When a partnership like this comes together, I guess this goes along with the expectation setting side that you touched on earlier. How are the roles and responsibilities assigned? I say that in the triple P or public private partnership it really different in that respect as compared to commercial partnership.   00;14;57;25 - 00;15;41;11 You know, the earlier the public finds an objective and a private is to execute that. Now the public entity may only outsource part of the work because they already have the skills and knowledge and the resources themselves. And then they will only outsource the pieces that they can't do themselves. But I think the main thing to keep in mind when a public private partnership is that the public entity, a steward of the public interest and liability and accountability for that public interest lies with them regardless of whether they outsource or not to a private company.   00;15;41;11 - 00;16;05;12 So I feel bad for Kristin and the pressure that they have on them as a public entity compared to myself and her private empathy, where I don't necessarily feel the same pressure we have. Some people might think that the role of public funding is just to get the project more money. You know, we tell you what we need, you go get it for us, and that's your role.   00;16;05;12 - 00;16;28;04 How true or not true is that, Kristin? Yeah. You point out an important consideration for pairing public funding with private resources. There is the potential that private entities may believe that we, the nonprofit, will help bring in key funder resources to augment a development program regardless of their development goals, in alignment with the use of the product in low and middle income countries.   00;16;28;13 - 00;16;54;25 However, in order to mitigate the potential for this misalignment within PATH, we focus on partnering with private entities. When there's clear alignment between Path's mission and the mission of the private entity. Additionally, this alignment has to be in writing agreed to via contract. It includes global access agreements for product availability and use. And so in summary, my experience has been that it's not true that the goal of public funding is to get the project more money.   00;16;54;25 - 00;17;16;10 The goal of public funding is to achieve an outcome that might not otherwise be achievable, given lack of private interest without the public funding to come in and co-fund an objective that benefits low and middle income countries. So we've got public and private represented on this episode with the two of you. What we don't have is someone representing the academic side.   00;17;16;10 - 00;17;45;27 Rob, do you have any thoughts on the role that that third leg of the stool plays or should play? Yeah, you know, there are academic institutions that also have private public anything in and out where I have a lot of admiration for the role of peer academia, Both public and private institutions rely on academia being a catalyst for innovation and providing health very specific areas of research.   00;17;46;24 - 00;18;13;00 There are a lot of academics out there. They're doing very research and I never know when that point of time in in hand. So at every level we rely on our advisory or academic consultant to keep us informed on very specific events or therapeutic topics. And this plays into whether the research into them or not that we intend to do.   00;18;13;10 - 00;18;51;08 And there's a large portion of investigator and key opinion leaders involved in research actually come from academia. On the flip side, academia also relies on public private partnership to bring their ideas into the research environment because they lack the funding to paint the vision or the technical knowledge on how to bring that idea to the next step. You know, I think the example that perhaps a lot of people have heard of are the bar industry days and Loreal, which is the Biomedical Advanced Research and Development Authority.   00;18;51;24 - 00;19;35;13 They host annually this event where people come in for ideas, for collaboration in partnership with US funding, and so they have it. So for them, the novel idea that aligns with the interests of the US government and they get the opportunity to collaborate with other companies that can bring that into fruition as well with funding behind it. So I think there are a lot of opportunities out there for academics to bring the right into fruition, but we have a great job of sort of pulling them in the right direction.   00;19;35;28 - 00;19;58;14 Kristen, I have to tell you, as a as a layperson, I kind of picture this three way partnership, and the first thing that comes to mind is that's a lot of cooks in the kitchen. So it's kind of amazing to me that anything gets done or gets done in kind of a timely manner. What are the essential ingredients of a truly successful collaboration in your mind?   00;19;58;26 - 00;20;34;24 Yeah, it's a very good point. And I will add on to Rob's comments regarding academia that academia is a very important partner in this setup. Academia generally is part of these partnerships. And so there are I would, as you put it, a lot of cooks in the kitchen when we're bringing these projects together. And the short answer and how we make these successful is to never underestimate the value of careful pre-planning and preparation and setting up the partnerships, including mission alignment, alignment in the partners scopes of work and roles and responsibilities.   00;20;34;25 - 00;21;11;19 I think Rob alluded to that earlier. And the Seven Seas of collaborations jump to mind, clarity of purpose, concurrency of mission strategy and values, creation of value, connection with purpose and people, communication between partners, continually learning or a growth mindset and commitment to the partnership. In addition, it's also important to lay a solid foundation underlying all of that of respect, trust and finding a balance between humility and confidence across the partners to make sure that everybody is partnering fairly and with trust and in good faith.   00;21;12;01 - 00;21;37;07 Yeah, you know, I don't want to start a fight, but who is largely responsible for big innovations in clinical health? I think the public gets the impression there are private scientists huddled together in one lab, and then government scientists huddle together in another lab, probably in D.C. That's not really the way it is, is it, Rob? I mean, how are the big, impactful innovations truly getting developed?   00;21;37;17 - 00;22;07;29 Yeah, I'm one I answer that question in the obvious here. I mean, there when we all work together and leverage the strength of all of our partners. I honestly do think that commercial or private things are faster innovation, but they have a feel and reward system. They're always our innovation, a profit making endeavor. I mean, why not? You have a good eye and you want to be recognized and rewarded for it.   00;22;08;12 - 00;22;36;24 But bringing innovation in areas where the opportunity for regular recognition and reward is not so great. And that's where public private partnership come into play. You know, as a global community, it's in our interest to innovate in low reward scenarios because the knock on effect is that the problem is not spread and that it allows a particular community to or region to prosper.   00;22;37;13 - 00;23;00;15 And so therefore, if people prosper, they're less likely to mean in the future and we can maximize their contribution for the greater good. Yeah, but Rob, when it comes to public health, people do seem to put the bulk of that responsibility on government. Like people didn't demand an answer to COVID from Pfizer. They demanded it from the White House.   00;23;00;15 - 00;23;29;27 So is that fair? I think fair and yet a moral issue that we can do a whole nother podcast around. So, yeah, but, you know, human empathy and theoretically the government are there to serve the public and the public good through taxation and donations. We expect the instinct to step up when the need arises. You know, the public can't hold a private company like Pfizer accountable in a crisis.   00;23;30;13 - 00;23;58;14 And then the obvious thing here is they hold the public entity responsible. The only problem is we pan who fund our public entity with a little support if possible, or we lose the funding that's already there with a whole myriad of special interests. We don't leave a whole lot left in crisis. We're also very bad at funding the future, whether it's for crisis or innovation.   00;23;58;27 - 00;24;25;25 We're not people that really think ahead, sometimes have public empathy, have to scramble to reallocate funds, and they usually can't staff up or get resources in place quick enough. And they turn to commercial companies that really have no restriction on growth and simply eat the money and make it happen. Rob What's the most gratifying thing that's come from working with Path from your perspective?   00;24;26;17 - 00;24;57;14 Well, I'll make this short with Sweet. We know toward the beginning of our path and we'll have similar missions now. Path being a public entity, hailing here for the greater good and not really for a reward or profit. Who? I don't know. But I feel I feel better about myself and my company associating and working with Light Path.   00;24;58;00 - 00;25;22;15 And Kristen, what keeps you bought into the whole public private partnership model? Well, it's it's that it's a factor that the model is effective in bringing new life saving interventions to low and middle income countries. So for me, it's the advancement of the public health mission and being able to efficiently facilitate implementation of health interventions for low and middle income income countries that wouldn't otherwise be available.   00;25;22;16 - 00;25;42;26 It's the ability to have a true impact to save lives. And this partnership model is is critical in making that happen. Yeah, but it can't all be gumdrops and rainbows. So what are some of the challenges as or wish list items that you both feel still kind of need to be addressed when it comes to the partnerships around clinical research?   00;25;42;26 - 00;26;18;16 First Rob, then Kristen how I think we can do a better job of building trust and sharing intelligence even in public private partnership. There in Singapore. If trust and holding on the information that can be of mutual benefit. And I personally would like to break down some of the barriers, you know, a key concept in public private partnership in the best value and in most cases that require public entity get like three quotes for some of activity or contract.   00;26;19;02 - 00;26;44;17 And then you have to justify why you can go with it. So we all know that paper is not always better, and I would like to see us define value in more ways than just cost. Also think they're alive and healthy. It can be shared around best practices of Kristin and I belong to a group that's publicly funded that share best practices.   00;26;45;07 - 00;27;25;20 But you know that sharing of best practice has been limited with sort of all that culture of caution. So I'd like to see more sharing and the assumption of positive impact on our party. And I think we held out a lot during the COVID pandemic, and I applaud that. I hadn't felt the call center for a large government project, and we had to do it time and when I reached out to a technology company to help me fill up that call center, the question was, how much are you going to pay me or what kind of, yeah, how quickly you need it.   00;27;26;12 - 00;28;06;15 And then we literally are without contract, without much, especially around term. And they phone up in record time and we work the other stuff out on the back end to mutual benefit. And I know that we can't always do that, but it shows you what possible. And Kristen, what gets your goat? Yeah, I guess there's two points that jump to mind in the first is that we have some more work to do and in terms of sustainable capacity development to ensure that the ground that we gain in facilitating research in low and middle income countries continues to be built without the loss of human or material resources that are built out for trials.   00;28;06;27 - 00;28;26;16 How do we do a better job of sustaining capacity that's been built following the completion of a trial or a set of trials at sites that we've invested in? That's an area that many folks are putting thought into these days, But I think we have yet to identify a solution to that. And I think that's that's something that we can do, do better at.   00;28;26;16 - 00;28;56;00 And I know we will. It's it's a work in progress. And then the second thing is the concept of equitable partnerships that needs additional consideration and support. And I think back to Rob's comment about assuming positive intent and working in good faith, there's a focus now on on transferring leadership and ownership of much of our clinical development work to the regions that are participating in the work so that they're really co-creating and co owning the development work in the development space.   00;28;56;08 - 00;29;17;00 While COVID helped to catalyze that shift, there's still some more push that we need to do within the global public health and development community to make this shift really, really be adopted and occur. And we have a bit of a way to go in terms of fully embracing the models that are led out of the regions that our products serve.   00;29;17;16 - 00;29;38;27 And I believe that the public private model and partnership is an area where we can help to facilitate this in the future. You know, I'd probably be remiss if I didn't ask about the role that you see technology playing and being maybe that fourth partner in clinical trials. Rob, I know you use Oracle's clinical trial Solutions. What does that bring to the table?   00;29;38;27 - 00;30;25;07 So I think, you know, you're in the COVID pandemic. Technology was really a shining star and allowed some things that we probably couldn't done earlier by embracing technology that people were perhaps hesitant to use before. So I think that certainly around Oracle, we were able to use many of the Oracle platform during the COVID pandemic. I think my favorite story, and people probably heard it before, I apologize to anyone hearing me repeat, is that I think how clinical it have at home, even you're a platform without join and so joined right before the pandemic and you're all now on my whiteboard.   00;30;25;16 - 00;30;50;07 My ideal platform for data collection analysis and sharing with other and a former colleague of mine who we recently joined Oracle dropped by the office and we were hanging out my office and he looked at my whiteboard and he said, What's the Oracle Product Development Plan doing on your whiteboard? I said, Well, that's not the Oracle product development plan, that's my plan.   00;30;50;18 - 00;31;21;25 And he said, Well, that exactly met what we're doing right now. And that was in of our use of clinical one. And, you know, just hearing differently, you know, what I had in mind and what the Oracle developer had in mind were the same. I don't think anybody with smart irony when they coming in the gene at that time drove innovation and all the partners on that, and it came at just the right time.   00;31;22;12 - 00;31;53;20 And Kristin, are you surprised by or frustrated by the technology capabilities that are available for your endeavors and what you're trying to get done today? Yeah, I'm excited for trial platforms in low and middle income countries to have the chance to further adopt technologies that have been utilized in other regions. I would say there's been some reluctance in adoption of the technologies that have been commonly utilized in high income country settings for some time, but that COVID has really catalyzed adoption of many of those.   00;31;54;22 - 00;32;16;19 There has also been some backsliding in use of those technologies since COVID. The urgency of the COVID vaccine development cycle more or less ended. And so what I'm excited for is that there was a push during COVID. We've seen it work in the past and that there's the potential for continued adoption of these solutions, such as these saucy diaries Pro ET cetera.   00;32;16;28 - 00;32;44;20 As we work through the challenges with implementation of those technologies outside of high income country settings. So there's there's a little bit of work to do in terms of adoption. But I think we're we're getting there and I'm excited to see the field further embrace those technologies. Well, it's great to hear about partnerships like this and what's increasingly becoming an accepted model for how we can get better results for people faster and for more people.   00;32;45;00 - 00;33;08;13 A lot of our listeners may want to learn more about what you've been talking about and what you do. So do each of you have a way they can do that or even contact you? How about you? Rob Yeah, so feel free to reach out to me quote unquote dot com. And I'm also only in and happy to sort of brainstorm with anybody.   00;33;08;21 - 00;33;39;20 We sort of can move the idea of public private partnership even farther and Kristen yeah our websites available WW w path dawg and it provides additional information on path and what we do and I'm also on LinkedIn then can be reached via that platform Perfect well if you want to see how Oracle is accelerating life sciences research and how it might be able to do that for your work as well, check out Oracle.com/lifesciences   00;33;40;00 - 00;33;58;18 Also be sure to subscribe to this show and we'll be back next time for Research in Action.

March 19, 2024Episode 636 min

Advancing scientific discovery with patient-led research

How can patients and their families become more integral in the clinical research process? How can patient-led research become more accepted in the scientific community? How are inspiring groups forging new, collaborative paths for science and medicine, and reshaping how medical research is conducted?  We will tackle those questions and much more in this episode with Amy Dockser Marcus, a Pulitzer Prize-winning journalist and author of the recently published book, "We the Scientists: How a daring team of parents and doctors forged a new path for medicine." Amy is a veteran reporter at the Wall Street Journal and won her Pulitzer Prize for Beat Reporting in 2005 for her series of stories about cancer survivors and the social, economic, and health challenges they faced living with the disease. She has covered science and health at the Journal for years, and she also earned a Masters of Bioethics from Harvard Medical School.  -------------------------------------------------------- Episode Transcript: 00;00;00;00 - 00;00;24;19  How can patients and their families become the centers of research? What is open science and who are citizen scientists? We'll explore those questions and more on this episode of Research and Action in the lead in. Hello and welcome back to Research and Action, brought to you by Oracle Life Sciences. I'm your host, Mike Stiles, and our guest is Amy.     00;00;24;19 - 00;00;48;22  Dr. Marcus That's right, that Amy Marcus, the Pulitzer Prize winning journalist, reporter at the Wall Street Journal, a Pulitzer Prize, was won for her series of stories in 2005 about cancer survivors and the social and financial challenges of living with cancer. Her beat, as you would imagine, has long been science and health. And she holds a master's of bioethics from Harvard Medical School, and she's an author.     00;00;48;22 - 00;01;04;26  Her book is We The Scientists How a Daring Team of Parents and Doctors Forged a New Path for Medicine. So this should be interesting as we talk about collaborative, open science and the rise of citizen scientists and patient led research. So thanks for being with us, Amy.     00;01;05;01 - 00;01;06;22  I'm happy to speak with you today.     00;01;06;22 - 00;01;26;29  Great to have you. In your new book, you take readers through some really, frankly, heart wrenching experiences that patients and their families have gone through with a rare and devastating disease called Niemann-pick. Hopefully I'm pronouncing that correctly. Tell us about the book and that disease and what fascinated you about this story.     00;01;27;14 - 00;02;01;21  The origin of the book really is a personal story, which is my mother got diagnosed with a rare type of cancer. And when I tried to do research on her behalf, I started to learn how challenging it is to develop drugs for rare diseases. After she passed away, I took some time off from the Journal. I had a research grant from the Robert Wood Johnson Foundation and I started traveling around the country looking to see if there were new models that might accelerate drug discovery.     00;02;01;29 - 00;02;25;21  And during the course of that research, I was introduced to a group of parents whose children have this rare and fatal genetic disorder, NIEMANN-PICK type C disease. It's a cholesterol metabolism disorder, so the cholesterol doesn't get out of the lysosome and that compartment in the cell and it starts to build up and it causes all kinds of problems.     00;02;25;21 - 00;02;52;12  And the children eventually lose the ability to walk and to talk and to feed themselves. But the parents that I met wanted to do something novel. They had found a group of scientists and researchers and clinicians and even some policymakers in the government that wanted to work together as partners and to see if they could accelerate the search for a cure or an effective therapy for an epic disease.     00;02;52;19 - 00;02;58;11  And they let me follow along during the course of that partnership for over ten years.     00;02;58;24 - 00;03;05;24  That's amazing that you got that kind of insight. And what did you learn over the course of that ten years?     00;03;06;22 - 00;03;34;15  Well, I was really interested in how they saw the production of science in a different way. They all wanted to try to save or extend the children's lives The disagreements lay in. How do you go about prioritizing drugs? What amount of risk is a patient or a patient's family willing to take compared to the level of risk that a doctor or scientist wants the patients to take?     00;03;34;15 - 00;03;54;14  These sorts of tensions arose, I think, in part because they were modeling a new method of where the patients expertise was considered as valuable or even at the center of this of this project. And that's not usually how it is.     00;03;54;14 - 00;04;09;09  But that's rare, right? I mean, in our in the culture of our health care system, it's not really common that the patients input or the patients families input is invited at all.     00;04;09;19 - 00;04;34;11  Yeah, I think that that you're right about that. I mean, the traditional way of setting things up is that the scientists devise the hypotheses and they then construct trials in conjunction with clinicians and sometimes with pharmaceutical companies, of course. But in this particular collaboration that I was describing, the drug was not in the hands of a pharmaceutical company.     00;04;34;11 - 00;04;59;06  It was widely available. And so the partnership was truly about, you know, going to be conducted at the NIH. And therefore it gave the parent and the families, I think, more leeway to do this experimental idea. What if we all recognized each other's expertise? What if we all saw each other as equal partners? What if we got to weigh in?     00;04;59;13 - 00;05;20;24  Not in once. You've already set up the clinical trial, but at the very, very outset, when you're simply going through the scientific literature to come up with potential compounds, when you're thinking about what might work, when you're trying to prioritize what to do first, second and third, all of those things where patients don't always have a voice. But in this case they really did.     00;05;21;07 - 00;05;43;16  You know, we just had Hilary Hannah Ho on the show. She's secretary general of the Research Data Alliance, and we talked about open science and open data and how important all that is to getting the scientific breakthroughs that will actually help people and get to those breakthroughs faster. But open science can kind of be polarizing. There's some confusion around what exactly it means.     00;05;43;23 - 00;05;48;14  How would you define or describe open science and citizen scientists?     00;05;48;27 - 00;06;34;22  Yeah, I think that's a really good point, that there isn't one sort of accepted name and that there are many names and people use different phrases when they're thinking about different things. For me, I used the term patient LED research and I often use the term citizen science. And what I meant by that was, again, what we've been talking about from the outset, which is a recognition that the patient, the patient experience should be at the center of everything, a recognition that the patient and the families are experts, that they have the ability not only to be beneficiaries of scientific knowledge, but also creators of scientific knowledge.     00;06;34;27 - 00;06;46;15  And to me, that shift the idea that you can be a creator of scientific knowledge is the fundamental one that needs to happen if we're going to really reach the goals that I think we all want to reach.     00;06;46;29 - 00;07;11;10  So here's something we highlighted in your book. Quoting here Science is inherently a social enterprise. Yet too often scientists operate behind closed doors, removed from the very people they intend to help. That's struck me as kind of a mike drop statement with a lot of truth to it. But did the pandemic change anything? Was the work still removed from those patients on ventilators and ICU?     00;07;11;20 - 00;07;52;04  So I do make a point in the book to draw some parallels between the various patient led research movement experiences that I describe and the COVID 19 pandemic, and in particular the group of patients that call themselves long COVID patients, where they're suffering symptoms for many, many months. I argue that COVID allowed us in real time to to recognize that anyone can be an expert and that now that is something that it was easier to see during the pandemic because there was a novel virus, there weren't established experts yet.     00;07;52;14 - 00;08;25;28  And so while doctors and scientists and the government were scrambling to try to help patients, I think they also saw themselves for the first time as part of this effort to understand the disease. Together, there wasn't already an understanding of COVID 19. And so what I say in the book is that we can draw from from that experience and sort of take that part of it forward where we say patients should be at the center of things.     00;08;26;06 - 00;09;07;01  Patients are experts. Patients are able to identify things that many scientists or doctors didn't have time to recognize because they were they had to focus on trying to save lives and, you know, working in a vacuum at that point. So there also was a sense of urgency. Like one of the things that I was struck by during the pandemic as a as a science reporter was that scientists were able to put their papers online right away on these websites before it had gone through the full peer review process because it was recognized is so essential to get this information out there as quickly as possible.     00;09;07;09 - 00;09;29;16  And everyone understood that maybe there were going to be some mistakes. It wasn't fully vetted, but it was out there. Not only was it publicly available to the doctors and scientists who are also studying it, it was publicly available to patients and people who are simply interested. And long COVID patients organized themselves, did research on themselves, and they also published their papers on these websites.     00;09;29;16 - 00;09;43;22  I think those types of models where patient researchers can be contributors and can benefit from the information to fuel their own research, I think that should move forward and is it shouldn't be just a relic of the COVID 19 pandemic.     00;09;44;07 - 00;10;05;03  But what isn't there a risk of chaos a little bit? Because we're always told, hey, whatever condition you have, don't go Googling it on the Internet. You'll just go down a rabbit hole and, you know, worry about all these conditions that you may or may not have. So what is the risk of, like you said, mistakes and wrong information being published?     00;10;05;13 - 00;10;27;11  Well, even the traditional peer review process in science publishes papers that turn out to have mistakes in them. Papers are retracted all the time. And there is a well-known phenomenon that peer reviewed papers sometimes the results can't be replicated. I mean, that's the problem for science. I don't think that's a problem just for having patient researchers get involved.     00;10;27;28 - 00;10;54;27  I also think that the advice not to Google something is both old fashioned at this point and probably unrealistic given that almost all of us are connected in some way through the Internet. My sort of idea, rather, is that let's use the Internet and other methods to become better partners. Let's share good quality information online that people have access to.     00;10;55;06 - 00;11;20;20  Let's form partnerships where we can collaborate, where among experts, the people that I was talking to and interviewing and spending time with the parents, they weren't saying, Hey, we're trying to go it alone. We know everything. No, the opposite. What they were saying is we have very relevant and valuable information. We are experts because we live with this disease and we know what level of risk we're willing to tolerate.     00;11;20;20 - 00;11;43;28  And we do our own research. But we need partners who can also help us fill the gaps where we don't have knowledge. We want to collaborate with scientists, we want to collaborate with clinicians treating our children. We want to collaborate with government scientists who have access to data and and robots and things that we're not going to have in lab equipment that we don't have access to.     00;11;44;06 - 00;12;02;19  So no one's saying, go down a rabbit hole by yourself. What people are arguing is let's find ways to pool information, and by pooling everyone's information, we can sort through more quickly what's good, what we think is good, but might turn out not to be good later. And what can benefit all of us.     00;12;03;04 - 00;12;20;02  Yeah, and from a technology standpoint, gathering that data and organizing it and working with it is becoming more possible than ever. COVID should have scared our health system out of its mind. Did it? And is that leading to any systemic changes in science and health?     00;12;20;15 - 00;12;46;19  Well, I'd like to focus on what my book was focusing on, which is can a group of patient activists and scientists and clinicians and government policymakers working together make changes to the system? And I think the answer is yes. You can make changes to the system. The patient researchers that I was talking to and the families I was talking to, they built on activist patient work that had gone before.     00;12;46;19 - 00;13;10;06  And there have been responses in the past. HIV activists were able to influence the FDA to pass the accelerated approval rule that now allows drugs to be approved more quickly. And I think that, you know, compassionate use program that FDA has the patients in my family, the patients in my book and the families benefited from that as well.     00;13;10;17 - 00;13;48;01  So there have been changes along the way. But I think what my book is arguing for, and I think this message came out of the COVID 19 pandemic as well, is that even with all the changes that have been made in the past, the patient experience is still not at the heart of the system. And I think that's the message that all of these families are saying put the patient experience at the heart of things, and then you will see that the system, when you configure the system around the patient centric experience, you'll see that it will work in a different way and an I think, a better way.     00;13;48;02 - 00;13;50;02  But we need to run that experiment.     00;13;50;17 - 00;14;12;20  So we mentioned the concept of citizen scientists. That's what we've been talking about. These are people that pursue what they pursue, driven by mostly love and urgency for their kids, which is just a whole different level of motivation than most researchers have. I think you have a few stories about, you know, people like Chris and Hugh Hempel and and some others that went through this experience.     00;14;13;02 - 00;14;34;21  I want to make a point here that I think also is really important for people to understand who are listening to this. The parents in my book and you know, you cited Chris and Hugh, they were definitely among the pioneers who did this. And there was Phil and Andrea Morella, and there were also Darrel and Mark Poppea who are who are part of this, too.     00;14;34;21 - 00;14;57;29  And many, many other parents. I mean, the Parseghian Research Foundation and the National Niemann-pick Disease Foundation, all family driven. The people who are doing this. Yes, they are driven by their love of their children. They are driven by a sense of urgency. But they're not going to the FDA and saying, Hey, please pass and approve a drug because we love our children.     00;14;58;05 - 00;15;24;05  Please pass and approve a drug based on our emotion. No, not at all. They want to give effective drugs to their children. What they are saying is we are creating scientific knowledge and we think that that should be part of this approval process, that should be part of the drug development process. I just want to give some examples that I cite in the book where the parents were creators of scientific knowledge.     00;15;24;24 - 00;16;07;11  You had parents who read the scientific literature, published scientific literature, called up. The scientists interviewed the scientists came up with hypotheses themselves that they proposed to scientists, contributed to the two scientific experiments, coauthored papers that were published in the peer reviewed scientific literature. You know, went to the NIH regularly to have meetings where they helped contribute to assessing and prioritizing which compounds should go first in terms of advancing them into clinical trials, contributed their thoughts on the risk benefit analysis in devising the clinical trials.     00;16;07;22 - 00;16;34;28  One of the parents went to an FDA sponsored workshop for how to file an orphan drug designation, which is part of the approval process and the long process to getting approval for rare disease drugs. And went to the workshop, participated in the workshop, presented scientific data to the regulators, met with the regulators, and earned an orphan drug designation for one of the compound Cyclodextrin that got moved forward.     00;16;35;07 - 00;16;46;24  So yeah, they have a sense of urgency and yes, they love their children and want to save their lives, but they're producing real scientific knowledge and I really hope that that people take that message away from reading the book.     00;16;47;10 - 00;17;08;15  So those are great examples of exactly what citizen scientists do that sets them apart from just patients who are not doing that level of research, that depth of research. You talk about Chris Austin and the book, and I'm going to read another quick excerpt here, The Promise of Genetics to Deliver new interventions, new drugs and new treatments for patients is not going to happen.     00;17;08;15 - 00;17;27;28  Chris told his boss, unless there's some way to get through the valley of death. Francis gave Chris a green light to pursue his vision. So the boss in that excerpt is former National Institutes of Health director Francis Collins. What is the Valley of Death and Chris's role in citizen led research?     00;17;28;06 - 00;17;54;21  Great. No, that's a great question. So Chris Austin is a Harvard Medical School trained neurologist, also with a background in genetics who worked at pharmaceutical companies as well, and then found his way to the niche where he worked for Dr. Collins and became also a director of one of the institutes at NIH called Ed Katz, the National Center for Advancing Translational Science.     00;17;55;06 - 00;18;23;29  And one of the sort of green lights he got from Dr. Collins was to set up a lab that would have robots that were sort of at the same type of robots that pharmaceutical companies have that would work around the clock and could rapidly screen drugs to try to find compounds that might work for diseases. And what Chris Austin's idea was is that let's screen these vast libraries.     00;18;24;04 - 00;18;50;06  Let's find some drugs that might be promising, and let's also find patient partners. Let's find scientist partners, and let's then try to take all this data and move it forward together. One of the hypotheses that Chris Austin said he had as a scientist was can drug development go faster if patients and families are part of that process from the very beginning?     00;18;50;18 - 00;19;17;02  And one of the things that Chris Austin was trying to get around is this valley of death, which is this, you know, where compounds kind of go to die. You have a great idea as a scientist. But how do you get that idea from the bench to the clinic and to a patient's bedside? And the Valley of Death is just all the various obstacles that end up making it hard to develop a drug.     00;19;17;13 - 00;19;39;21  Some of it can be scientific. You know, you test it in a in a mouse or an animal, you test it in the lab and it turns out to be toxic for the cells or the amount of drug that you need to give to a person is so high it's not realistic or a drug company decides they want they don't want to put any money into it anymore or it gets or a drug company gets bought and they don't want to pursue it anymore.     00;19;39;21 - 00;20;02;08  And there's a million things that happen in the Valley of Death. But Chris Austin's vision was if we can involve patients and families as partners, along with scientists and drug developers and government officials from the beginning, maybe we can get things out of the Valley of Death, or maybe we can fail faster and find the successful compounds more quickly.     00;20;02;25 - 00;20;22;23  Yeah, a big takeaway from your book is the need to build bridges between science and citizens. But and we talked touched on this a little bit. You can't sacrifice scientific rigor or safety. So what are the challenges to building these bridges? What's holding that process back, especially when it does come to drug discovery and clinical trials?     00;20;23;09 - 00;20;47;05  So I think that there is a variety of issues that make it challenging to build bridges. For one thing, there's often a tension between, you know, people who are sick or are advocating on behalf of people who are sick, who really want to focus on the here and now. They they really need something to help their loved one right now.     00;20;47;19 - 00;21;22;19  And often, you know, clinical trials are an experiment. And when you enroll in a clinical trial, you're told this is not designed for the benefit of you. This is designed to benefit future patients. And therefore, it's not a treatment and it's not the equivalent of clinical care. And that can be a source of frustration and tension. And often also when research crews are doing research, they weigh the risk benefit assessment of moving drugs forward differently than people who are trying to you know, solve a problem now.     00;21;23;00 - 00;21;48;14  So I think that and that came up in this partnership in my book. It came up in this partnership in my book a lot. And yet I think each side was able to get a sense of what the points were, what the what the tensions were. But again, in my opinion, one of the ways that they overcame this divide was by both sides saying patient centric medicine is the way to go.     00;21;48;15 - 00;22;16;29  Patient centric science is the way to go. There are ways to collect data in a rigorous manner that can both benefit patients now and also not stop you from insights that will lead to benefits in the future. There are ways to come to terms with that. Some people have a higher acceptance of risk than others. I mean, we see movement towards that already right now.     00;22;17;01 - 00;22;23;01  I think that one of the messages of my book is to try to accelerate that even further.     00;22;23;25 - 00;22;37;19  Well, to that point, you say in the book, government and agencies like the FDA and NIH have a vested interest in helping these science and citizen partnerships succeed. Do they understand that? And what role should government be playing to move this forward?     00;22;38;01 - 00;22;57;01  Well, government is not one person. You know, so but I think that the book shows that there are people in the government who were partners with the patients and the families and the scientists and the clinicians. I mean, this whole book is about a partnership. And Chris Austin, although he's no longer in the government, he left the government.     00;22;57;10 - 00;23;28;05  He was in the government at the time, and he was a partner with these people. So I think that the government has shown in the book that, you know, and outside of my book, obviously interest in investing in new ways to do science, interest in investing in new ways to accelerate science, the government is supposed to represent the interests of the people, and the people's interest is in being healthy and in and trying to find solutions for drugs.     00;23;28;14 - 00;23;56;15  So in the book, I do talk about how the patients and the families in my book were able to directly talk to FDA regulators. Some of the parents went to workshops that the FDA was sponsoring. They had conversations with FDA regulators. I think those types of workshops are really novel and they really are fruitful because they allow the families and the patients to really think like scientists and to produce science as they can and should do.     00;23;56;16 - 00;24;21;16  They want to produce science. And I think also one of the messages that Chris Austin gave at representing the NIH was that the NIH is here to be your partner, and we're open to coming up with novel ways of accelerating science. So I think that there's there's openness to doing this, but of course, always more can be done.     00;24;21;17 - 00;24;51;16  I mean, patients have a sense of urgency, and that's the message that they bring to the government all the time. I mean, in the book, I, I describe FDA advisory committee hearings that are held when the FDA isn't sure about the data and they want to have a public hearing about it. And many of the parents and families showed up and gave testimony not just about their thoughts and their opinions, but about the data that they had gathered, the science that they were generating, that they wanted to share with the FDA and be heard.     00;24;52;00 - 00;25;16;13  What role does Rules Framework's guidelines play and what we're talking about here? I think you even your former advisor, was part of a group of scientists that worked on this framework. And the platform for patient led research, I think was spearheaded by that advisor, former advisor and a group of scientists. What's the infrastructure that needs to be put in place for this to work?     00;25;17;08 - 00;25;46;03  So, yes, So the advisor that you were referring to, Effie Diana was my advisor in my bioethics program and she does a lot of pioneering research on patient led research movements. And she and a group of collaborators, scientists and, and social scientists and clinicians and, and policymakers got together and tried to devise what they called a new social contract.     00;25;46;13 - 00;26;14;17  What they argued is, is that patient led research is a novel form of research that doesn't fit into the traditional regulatory standards that have guided, you know, clinical trials and human subjects research up until now. And that's because the traditional methods of regulation are based on the idea that scientists are going to be leading the research and doctors are going to be leading the research.     00;26;14;26 - 00;26;42;04  And that still is the traditional model. And they usually are leading the research. And in those cases, they often have more information and more power than the traditional patient or human subject. So Effie and her collaborators weren't arguing. We're arguing that the traditional rules should be thrown out because obviously patients do need protection and human subject research does need regulatory guidance.     00;26;42;11 - 00;27;17;26  But what she and the others were saying is let's also think about these new ways of doing research and how we can get scientists and clinicians to accept the results. That patient led research arrives at. And one of the ways she and the others said is let's come up with ways that patient researchers can seek ethical guidance. Let's put tools online that they can use so that they can devise experiments in ways that approach the rigor that traditional scientific experience experiments do.     00;27;18;06 - 00;27;52;04  Let's generate research that's of benefit to the people now, but also can be useful in guiding treatments in the future. Let's make a path towards publishing their data in peer reviewed journals. Let's make them part of the peer review process. I mean, you do have journals now that have patient researchers participating in peer review of scientific papers. And you have groups like Pachauri that ask scientists and patients to collaborate together on experiments.     00;27;52;13 - 00;28;24;24  So I think I think what she and the others were getting at is the current contract that we have may still be fine in certain circumstances, but isn't set up to address this new kind of research that's being done. And if we want it to be generalizable, scientific knowledge, which is always the gold standard, then we need to work together to help all of the partners to do better research that meets the standards that we can all except.     00;28;25;09 - 00;28;40;27  When you kind of make the promise of patient led research obvious. But, you know, how many times do we see things with great promise get tied up in knots? Is a paradigm shift likely? And if so, how long of a runway is that going to need?     00;28;41;15 - 00;29;01;11  I mean, I don't know how long it's going to take, but if there is a message in my book, if there is a message from the people that I focused on in my book, I mean, they've been working together for more than ten years. They've made a lot of progress, but they're not where they want to be yet.     00;29;01;20 - 00;29;23;29  So that's a long time. And I think that they want to go faster. I think the message of long COVID patients is we need to go faster. I think the message of HIV activists and breast cancer activists and disability activists is we need to go faster. And I don't think that you need to change a paradigm in a day.     00;29;24;12 - 00;29;53;19  Paradigms, by definition, take time to change, and they involve a lot of debate and discussion, dissension. And that's what happens in a society. People have different, different views. But I think what we're getting at here as a society is that patients need to be at the center of any paradigm that exists and that if everyone works together towards that goal, they may not agree how to get to that.     00;29;53;24 - 00;30;14;21  They may have different ideas on how to ensure that the science is rigorous and works. But if they keep this notion always at the center that the purpose is, is patient centered science, then I do think that you can end up with a paradigm that works better for more people.     00;30;15;16 - 00;30;27;10  One of the chapters in your book is Cathedral of Science, and in it a professor at Harvard. Had you read the story Cathedral by Raymond Carver. Why did they have you read that? And how does that relate to what we've been talking about?     00;30;28;04 - 00;30;55;26  Yeah, I mean, I say in the book that when we were told to read Cathedral by Raymond Carver, I was really surprised because usually in in my bioethics classes when we talk about stories and narrative bioethics, many of them involve sort of cases drawn from real life and cathedrals, really a quiet story that involves a married couple that seems to be drifting apart.     00;30;56;06 - 00;31;16;24  And the wife invites a friend who happens to be a blind man to come and stay with her and her husband. And the husband's a little bit jealous of the relationship that this person has with his wife and he doesn't really know what to say to him. And the wife goes to sleep and leaves these two men alone watching TV together.     00;31;17;00 - 00;31;38;19  And they start to watch a program about the building of a cathedral. And the narrator says to the blind man, Have you ever seen a cathedral? Do you know how to build a cathedral? And the blind man says, Let's draw one together. And the two of them construct a cathedral together. The man places his hand on the husband's hand, and they draw that cathedral.     00;31;38;27 - 00;32;01;23  And at the end of creating this cathedral, it's the blind man who says, Let's put some people inside, inside the cathedral. What's a cathedral without people? And I thought about this story all the time as I was spending time with the families and the scientists, because so many of the scientists were products of the Cathy trial of science.     00;32;01;23 - 00;32;34;13  They were the products of the best medical schools. They worked at the NIH. They I mean, they they really were, you know, part of this edifice that's been constructed and that has benefited so many people. And one of the things I kept thinking about is how do we put more people in this cathedral? I mean, that's really one of the messages that came through in this partnership that the parents and families and scientists and doctors and government officials were constructing a cathedral without people isn't really what you're looking for.     00;32;34;20 - 00;32;52;05  You're you're looking to use the power of science and research to help people. That's should be the goal of everything. And that's really the message I took from this story, that it touched me in just such a fundamental way. And it wasn't even a story about science.     00;32;53;27 - 00;32;57;18  As literature often does. That inspires us in many different ways.     00;32;57;21 - 00;32;58;20  Absolutely.     00;32;58;27 - 00;33;20;02  What did I miss? I mean, what is it that our listeners should know that you cover in the book that's important for them to know or some way that they can help or participate in this kind of effort? Or is there something that a follow up book might cover, something that you think needs additional exploration?     00;33;20;11 - 00;33;53;25  Well, I mean, I think that the message of the book is that we can all be scientists, right? I mean, it's in the title. We, the scientists, and I chose a title that echoes We the People, because I wanted people to think about the fact that what works best is a partnership. What works best is when we all come together and try to bring our different visions forward and to come up with something that will benefit all of us.     00;33;54;07 - 00;34;15;25  I think, you know, one of the things that I was struck by during during the research, not only for this book, but also when I, you know, covering health and science as a reporter is that all of us really are patients. We're either patients now or we were in the past or we will be in the future, or we love people who are patients.     00;34;16;04 - 00;34;50;28  We're advocates for those people, even if we're a doctor or a scientist, we're often on the other side of the table either trying to advocate for people we love or because we're patients. And so I think we all have a vested interest in creating a system that works well for all of us that remembers that we need treatments and that we that we need science and that all of us are experts in our own lives and that we can do research in a way that can contribute to advancing health and wellness for us all.     00;34;50;29 - 00;34;56;00  So I feel like that's the message that I hope is the takeaway of the book.     00;34;56;12 - 00;35;03;10  Well, I'm pretty sure there are listeners who are interested in the book and getting it or getting in touch with you. How can they do that?     00;35;04;00 - 00;35;26;00  So there are a variety of ways to get in touch with me. My email is publicly available. It's Amy Marcus at WSJ dot com. I'm on Twitter at Amy D Marcus. You can go into the bookstore and get the book, you know, in person, or you can order it online. You can get it from bookshop. You can get it from Powells.     00;35;26;00 - 00;35;32;18  You can get it from Amazon, Barnes and Noble. I mean, they're, you know, any, any, any place online. You can order the book.     00;35;32;26 - 00;36;03;05  Great. We appreciate that. And we want to thank you for being faithful listeners to Oracle Life Sciences, Research and Action. As always, we invite you to subscribe so you don't miss a single episode. And also maybe tell your friends and colleagues about the show as well. And we'll be back next time with more research and action.

March 5, 2024Episode 535 min

Bringing clinical research into everyday patient care

How can an extensive collection of real-world data help find more diverse and better participants for clinical trials? How do we create a continuously learning ecosystem that helps bridge the gap between clinical research and clinical care? And what are the biggest challenges to patient record standardization and personalized healthcare? We will learn that and more in this episode with Dr. Lu de Souza, Vice President and Executive Medical Officer of the Learning Health Network, which is a division of Oracle. Dr. de Souza leads a team that seeks to help health organizations integrate clinical research into everyday care. That means addressing clinical discovery cost, time, and patient inequities. She's also a huge advocate for real-world data and bringing technology to bear for true healthcare advancements. Dr. de Souza has years of experience in health informatics and was the most recent CMO of Cerner in North America. She practiced pediatric hospital and emergency medicine until 2020 and has held multiple leadership and teaching positions.  -------------------------------------------------------- Episode Transcript: 00;00;00;01 - 00;00;25;21  How can an extensive collection of real-world data help find diverse participants for clinical trials? Are some organizations already using the concepts of a continuously learning ecosystem. And what are the biggest remaining challenges to patient record standardization and personalized health care? We'll find all that out and more on today's Research in Action episode.     00;00;27;05 - 00;00;47;23  Hello and welcome to Research in Action, brought to you by Oracle Life Sciences. I'm Mike Stiles and our guest today is Dr. Lu de Souza, vice president and executive medical officer of the Learning Health Network, which is a division of Oracle Life Sciences. In a nutshell, Dr. de Souza leads a team that seeks to help health organizations integrate clinical research into everyday care.     00;00;48;03 - 00;01;11;28  That means addressing clinical discovery, cost time and patient inequities. She's also a huge advocate for real-world data, bringing technology to bear for true healthcare advancements. Dr. de Souza has years of experience in health informatics and was the most recent CMO of Cerner in North America. She practiced pediatric hospital and emergency medicine until 2020 and has held multiple leadership and teaching positions.     00;01;12;12 - 00;01;16;03  Dr. de 'Souza, thank you so much for taking the time to be our guest today.     00;01;16;14 - 00;01;20;12  Now Thank you, Mike. It's really a pleasure to be here. And please feel free to call me Lu.     00;01;21;02 - 00;01;29;21  There's a lot of ground to cover here. But first, let's just find out about you. What was the life path that brought you to where you are today and doing what you're doing today?     00;01;30;15 - 00;01;55;05  You know, as you mentioned, I am a pediatrician who focused on taking care of sick kids in the hospital and the emergency department. And I really loved my job. But like many doctors, I felt frustrated by the inefficiencies of health care. And I felt very frustrated with the limitations of time and data that we suffer both of those things are super essential to make the fast decisions that we need to make.     00;01;55;23 - 00;02;16;20  So I started thinking about technology and the role that it could play in solving some of these foundational issues. And also, you know, we always want to see how many more patients we can help. So I felt like the pivot would allow me to take care of patients in a different way, but at higher numbers. It was not easy decision.     00;02;16;20 - 00;02;41;20  It was very hard for me to leave full time pediatrics, so much so that I stubbornly continue to practice for the first ten years that I was full time at Cerner. But at the time that I was considering joining Cerner, my mother's breast cancer was misdiagnosed and that happened because of inequities, fragmentation in care and a lack of standardization that exists today.     00;02;42;00 - 00;03;08;03  Eventually, she turned out okay with that. But these missteps and delays in diagnosis led to a much more aggressive course of treatment and the complications that came with it. But this experience really sealed the deal for me. I felt like there was a lot of work that I could contribute to so that led me to my career in informatics that started with EMR implementations and technology enabled process improvement.     00;03;08;28 - 00;03;30;25  Then ten years later, my cancer warrior mom was diagnosed with a different cancer. This one was rather rare and aggressive, and we quickly found that there was not enough research to support any specific type of treatment for her and that the survival rate for anything that they could try was pretty low. And that was not good enough for her.     00;03;31;07 - 00;03;57;05  She decided to forego treatment and instead focus on having better quality of life for the remainder of the year that she was with us all of nine months. In stories like that, Mike, are super common. Many of our listeners, I'm sure, have gone through something like it and as devastating as it is, these life experiences also help shape us and they bring these opportunities that we hadn't considered.     00;03;57;19 - 00;04;25;17  And sure enough, only a few months after her passing, the Learning Health Network was founded and I was asked to help out and I was immediately drawn to its mission and vision and the impact that it could have in cases like my mom's. So it took a little bit of time to get here. But last year I was able to take on a full time role with Learning Health Network, and I'm just super excited to be a part of this awesome team that brings transformation to research.     00;04;26;07 - 00;04;29;03  Okay. And tell us what the Learning Health Network is.     00;04;29;09 - 00;05;01;06  All right. So I'm going to start with the why and why it was created and paint this picture for for everyone to understand how important this is today. Clinical discovery. So how we get to medicines and treatments and different diagnostics is still a major challenge for life sciences and health care organizations. And because these two sectors of our industry are mostly siloed from one another, it's a very onerous process for patients and providers to participate in clinical trials.     00;05;02;01 - 00;05;27;13  Even myself as a doctor who understands the language of medicine had a really hard time finding out what types of trials were available to my mom, just as an example. So for context here, when we're bringing a new drug to market, it takes approximately 17 years and it costs an average of $2.5 billion. That those are crazy numbers, right?     00;05;27;22 - 00;05;59;13  And the biggest driver of that time and cost is getting to the patients, identifying the right patients, recruiting them and enrolling them into these trials. And about 20% of these clinical trials fail because they cannot recruit enough patients. And overall, only 3% of our population participates in these studies. Of course, 3% of the population cannot be representative of the diversity that we have here in United States or across the globe.     00;06;00;02 - 00;06;30;04  So the Learning Health Network was created to help solve these problems with the concept of these patients are in everyday care, and that's where trials need to go. We need to bring research into everyday practice. The Learning Health Support Network is a partnership between Oracle and health systems that we serve, and these organizations contribute their de-identified data to serve as the fuel for research and clinical discovery.     00;06;30;18 - 00;06;59;09  So this data set is called the Oracle Real World Data, and I'll call it our RWD from now on to to make it easier. And it's one of the largest datasets in the world like this in exchange for that data contribution, which we're immensely grateful for, Oracle provides these organizations the access to the data set so that they conduct they can conduct their own research, and we provide that at no cost.     00;06;59;21 - 00;07;22;05  We also do all of the heavy lifting for them, so it doesn't take any effort on their side to get the data there to make it de-identified and normalized. We do all of that work and then we offer a variety of benefits for them depending on where they are in the course of doing research, whether it's data science or clinical trials and so on.     00;07;22;22 - 00;07;58;05  So the Oracle Real World Data is home of about 108 million active longitudinal records from all over the United States, covering about 2600 facilities. And this membership comes from a variety of organizations. These whole systems can be large, multistate and academic centers all the way down to critical access hospitals. And this combination, this this composition of membership is intentionally done and balanced by us.     00;07;58;05 - 00;08;37;11  So they're very similar in numbers. And that becomes our superpower by having data from such a wide range of facilities and such diverse communities, and means that people who never had access to clinical research near their homes can now be represented in this dataset and represented in a lot of research that gets done. And it also means that this research, a big data set, matches fairly well to the US Census and brings that much needed diversity that we're lacking in clinical trials today, and that helps decrease the the health and research inequities.     00;08;38;01 - 00;09;03;26  How we do this is again, by using the dataset to find the patients. So we find patients that are good matches for trials, and then we find trials that are good matches for those sites and for that community. And the data can also be leveraged like I said before, by organizations to drive or derive clinical insights by using data science and the tools that Oracle provides.     00;09;03;26 - 00;09;05;10  That is us in a nutshell.     00;09;05;28 - 00;09;28;17  I think there's a lot of people listening that would be really surprised to find out the thing that slows down getting new drugs and new treatments to market isn't necessarily like bureaucracy or red tape or lack of scientific knowledge. I think people would be surprised to find out the real problem is being able to find and get people and a diverse group of people to participate in these clinical trials.     00;09;28;17 - 00;09;32;09  So that's probably what adds great value to this dataset, right?     00;09;32;29 - 00;09;54;27  Yeah, I mean, the things that you mentioned definitely are barriers that we have to cross as well. But it was surprising to me as well as I entered into this space. Just as an aside. One of the reasons it's so important for clinical research to be embedded into care is because we people, patients, we trust our health care providers.     00;09;55;10 - 00;10;09;15  You know, these are the people that we listen to and take advice from. So the studies have shown that the majority of patients that enter clinical trials or accept to participate are because those trials were discussed by their providers.     00;10;10;05 - 00;10;15;00  And what's your role in it? What what constitutes a really good week or a month for you?     00;10;15;15 - 00;10;47;21  As the executive medical director, my main responsibility is really to the health system. Members. I have a team, a super awesome team of clinical researchers that ensures these members gain value from their incredible data contribution and also know how to leverage it. We provide programing around them so that they can learn, collaborate, network and so on, and I also lead our clinical research strategy and operations, which is focused on two major components.     00;10;48;03 - 00;11;26;12  One is bringing the funded research opportunities to the members that want to have clinical research research programs, funded opportunities, meaning they come from life sciences organizations and cross, and also helping these organizations that are smaller to become research ready. So these are organizations that don't today have a program or are beginning and they need more support. The second major focus is breaking down the silos that exist today between clinical research and care delivery, and that will help drive the awareness, the efficiencies, the safety.     00;11;26;21 - 00;11;46;12  It will help us improve that patient recruitment into trials and so on. Now, boy, my my day to day changes quite a bit. So a good week or a month is hard to describe, but I would tell you that a really good day is when one of our community, Rural Health Hospitals, is awarded a study that we facilitated.     00;11;46;23 - 00;12;10;29  And because we know that those patients will be represented, that community will be represented in research and they will gain access to cutting edge medical interventions. It feels really good to know that we played a part in that and another really good day is also when our members use this data set to gain insights that lead to positive patient outcomes and that we're blessed to hear about that quite often.     00;12;11;01 - 00;12;19;04  Our Learning Health Network members have published over 500 peer review articles using this data set.     00;12;19;17 - 00;12;32;11  Best case scenario if the Learning Health Network gets its job right, how can that change how health care data, The gathering and use of real world data is used to improve patient outcomes and health care policy?     00;12;32;23 - 00;13;19;26  Yeah, I would just reiterate a couple of things. With the Learning Health Network and its real world data, we'll have real data in real time deriving insights to lead to better care and better outcomes in the continuously learning ecosystem. We'll be able to quickly restudy and improve upon those longstanding medical practices we have today. So the word restudy is really important because we do have a lot of medical practices today that are gold standard and they're based on old research or based on research that didn't include certain populations, didn't include the necessary diversity or, you know, certainly the composition of us as human beings has changed.     00;13;19;26 - 00;13;43;22  So it is very important to ensure that we're still providing the best care and we can use the data for that. And that also will decrease these existing disparities and drive us closer to personalized care. The future also would look like we no longer will take so many years to complete clinical trials because we're going to know where the patients are for specific studies.     00;13;44;01 - 00;14;11;18  We're all going to know what those studies are more important to take to specific communities and patient populations. And and I think that is going to alleviate a lot of that, not just the time, but also the cost, because these costs are, you know, also what driving the cost of medications for our patients or interventions. Let's see, we'll be able to get to a more predictive and prescriptive models of care.     00;14;12;04 - 00;14;37;24  So understanding not just what happens with an individual now and how to take care of that problem, but also understanding what's likely to happen to Mike based on data points that we have on you today and behaviors. And this way we're able to intervene in the product in a proactive way. Imagine being able to predict and prevent a heart attack from happening three years from now.     00;14;38;05 - 00;15;10;24  All of these things are in our reach today. And the good news is that we're not too far from them. In fact, our our member organizations, the ones that are using the the real world data, are already experiencing practice and research transformation. But we certainly need to scale this up, scale this approach, and hopefully we'll get to a point in which the medical community will trust more on approaching research in this way and it becomes more the standard of care of how we discover and apply changes.     00;15;11;11 - 00;15;18;04  And I also think there is going to be a lot of other possibilities of this data set brings that we haven't necessarily conceptualized yet.     00;15;18;23 - 00;15;23;23  So follow up question You mentioned that organizations are already doing this. Can you give us an example or two?     00;15;24;19 - 00;15;50;12  Sure, sure. I'll give you two of my favorite examples, not just because I'm a pediatrician, but also because less than 20% of all U.S. research funding is dedicated to children. This is a highly underrepresented population in research, just by sheer numbers, which means that patient recruitment in trials is even harder. And conducting those trials in the traditional way is much more challenging.     00;15;50;28 - 00;16;24;20  So these two examples come from very proliferates users of real world data. And in these are pediatric hospitals. The first example comes from children's health of Orange County in California, where they have used RWD and machine learning to create what is the first published pediatric readmissions algorithm. So it's an algorithm that gives us a risk of readmissions for patients that were in the hospital or presented to the hospital, and they were able to accomplish that in the matter of months.     00;16;25;03 - 00;16;51;14  They then incorporated this risk score into the clinical workflows. They put it right inside of their Oracle, Cerner EMR, and they saw a 10% decrease in readmissions in the first two years, which is just commendable. You know, it doesn't just improve the quality of of these kids, but in today's healthcare, this change also amounted to $2.7 million in cost avoidance.     00;16;51;28 - 00;17;18;23  Everyone knows how expensive it is for hospitals when a patient is readmitted. The other example is Children's Mercy Hospital. Their research team leverages the rural data for a lot of projects, and this one is really near and dear to me because I worked in the E.R. with children. They looked at adolescents with migraine headaches that were presenting to the emergency department with these headaches and how they were being treated.     00;17;19;03 - 00;17;44;29  And what they found is that 23% of these kids across 180 AEDs were receiving opioids. I want to repeat that because that's really important to us. 23% of these children were repeating were receiving opioids as the first line of treatment, and that is not necessarily the best treatment for them. It is a misuse of the medication. And it's very aggressive.     00;17;44;29 - 00;18;23;20  And, you know, we're having already opioid crisis in this country. So then they they took that learning. They created a new clinical protocol and a clinical decision support tool that they incorporated into their Oracle, Cerner EMR, and were able to decrease the use of opioids for this condition to almost zero in their emergency departments. They had several in Kansas and Kansas City, Missouri, and just like, you know, a true learning health network, they they took this knowledge and the new clinical protocol and they presented that at headache conferences around the country.     00;18;23;20 - 00;18;39;13  And they know and and they're helping improve care for kids everywhere. So as you can see, the Learning Health Network is really a game changer for these organizations. They're now able to do research in a fraction of what it would be a typical research time.     00;18;40;01 - 00;19;07;20  That's really exciting and inspiring because you listen to every opioid addiction horror story and they all start out with an accident or a headache or a quote unquote, legitimate use for opioids that then turned into something worse later. So that's a particularly incredible impact you're having, but I'm assuming it's not that easy. So what are the biggest challenges to making the dreams you just outlined come true for society?     00;19;07;27 - 00;19;35;27  Yeah, you're absolutely right. We come across many barriers. But the cool thing about this team is we we don't find them discouraging. We're truly motivated to look for solutions in innovative ways, and we find partners that can help us as well. One of the biggest challenges of community based research is the lack of resources and infrastructure today that would allow these providers to offer trials and to conduct trials as a care option for their patients.     00;19;37;03 - 00;20;13;25  You have heard this in many other ways from other people of just how burned out providers and clinicians nurses are today. They're overwhelmed by the numbers. They don't have the time and support to then take on something else like research. So we try to overcome that in a few ways. Obviously, as a software company, we're continuously looking for ways that technology can support these gaps, but we also work with outside partners who can provide the actual resources or boots on the ground and expertise for these community providers to do research.     00;20;14;15 - 00;21;01;03  Another challenge is on the data and technology side, and that is that big data requires significant compute power, know it needs specialized tools, and you need specialized training. So it all can sound easy, but it's not easy. Fortunately, Oracle is the leading provider of cloud infrastructure and services. This continuous pursuit that we have for autonomous databases and low or no code applications, I always struggle with saying that these tools, it really lends itself nicely to the work that we're doing with RWD and I think it's going to allow us to challenge the market with the new generations of these data sets and tools.     00;21;02;00 - 00;21;38;13  And then lastly, I want to touch on on cybersecurity, because that is a constant challenge across healthcare and obviously our entire business is data. So we have to be very aware and cognizant and careful of it and again, I think the unique to Oracle is this ability to leverage other data security experiences that Oracle has. So, you know, Oracle has been protecting the data of the financial and banking sectors for many years, and we're able to leverage that and bring that into Oracle Life Sciences as well.     00;21;38;23 - 00;21;46;21  It's it's a level of security and governance to healthcare data that, you know, is really important to have and it feels good to have it.     00;21;47;08 - 00;22;02;10  Well, none of this happens without tech knowledge is that have come onto the scene. So first, let's talk about how far we've come. What is today's state of electronic health records and data analytics where patient care and health care delivery are concerned?     00;22;03;04 - 00;22;28;24  Yes, this is every doctors favorite subject to the notorious electronic health record in the life that I've that I've led for the last 12 years. You know, my as much as the patient records are still fragmented and EMR is are still considered clunky tools, I do think it's important to recognize the progress that we've made and the effect that it's had for us as a society.     00;22;29;08 - 00;22;54;04  You know, most people's records are digitized today. You know, there are many children that are born across the world that will never have a paper record, will have their entire record available electronically. And that means that their data is available to us and it gives us this ability to understand health care like we've never had before. But of course, our industry is challenged.     00;22;54;15 - 00;23;19;25  We still suffer from a lack of standardization in various areas and that makes data extraction and its use challenging in various ways. The way that I think about it, the simplistic way I think about it, is that old ATM cards, you know, remember how they only function in a specific bank and then years later you could use them within a network as long as you went to that particular symbol in the back of your card.     00;23;20;13 - 00;23;39;19  And then now here we are being able to access our banking information and our money everywhere in the world. And when you are anywhere and you swipe that credit card, the transaction is seamless. I mean, it's seconds there and they're doing a lot with those seconds. You know, they're checking, do you have the right funds? Are you the right person?     00;23;39;20 - 00;24;03;22  Because, you know, could this be fraud and then authorize that? So it's very impressive, their journey. And I'm sure that getting there was not easy nor fast. So similar to that. Our struggles with patient records are similar, but we've made good strides in interoperability. I think that right now we have the right direction and the right tools to get there.     00;24;04;13 - 00;24;33;29  And also, you know, we have the experience from from from these other industries that will accelerate our progress. I think, you know, one of the things that impressed me when we joined Oracle is the number of the number and the variety of industries that this company supports and partners with. And I've seen this constant pursuit of working across the verticals, looking for opportunities to learn and collaborate and understanding that we're better, faster together.     00;24;34;09 - 00;24;57;01  That's really important for us in health care because we do have this reputation of wanting to work alone and being difficult to work with. But, you know, when you look back over time, I don't think that we would be as well positioned as we are today with patient safety, for instance, if we hadn't leveraged, you know, the learnings and the experience of the aeronautics industry.     00;24;57;01 - 00;25;09;19  Right? So flight safety and those concepts were applied to to medical safety, and that's really propelled us ahead. And so I'm looking forward to continue to work across these different industries.     00;25;10;02 - 00;25;34;16  Yeah. You know, when I've asked other guests who are engaged in clinical research and recruiting for clinical research, one of the things they seem least impressed with is how spread out varied, disconnected patient records are. What's the ideal state, and can existing tech get us there, or do we need something more or is it more of a policy and bureaucracy problem?     00;25;34;16 - 00;26;10;03  I think the answer is yes. You know, expanding a little bit more on that fragmentation of of record of patient record health it's still, like I said, struggles with standardization and that's the piping and the backbone that supports good technology. So we're talking about standards for health data elements, meaning having the same names, the same codes, the same ontologies, and also standards for quality in health care data is still not universal, which is, which is a big challenge.     00;26;10;04 - 00;26;46;15  So I have this colleague that works in data quality and runs a company in data quality, and he always says, you know, garbage in means garbage out. So when data is not captured appropriately, it's output is harder to use. Another big challenge is getting to a single longitudinal health record, because we do in this country suffer from a lack of a universal patient ID So interoperability is extremely important, but it's still, you know, having some difficulties getting there to a seamless in a seamless way.     00;26;46;26 - 00;27;07;15  But once again, we have made a lot of progress. You know, I think that we're going to be in the place where, you know, you walk into any facility and you can scan your card or maybe you're going to have a chip on your on your arm there. Mike, I don't know. And those health care workers are going to know who you are and they're going to know how to take care of you.     00;27;07;24 - 00;27;32;22  So I do believe that we are going to get there on the policy side and, well, both research and health delivery are super highly regulated and rightfully so. We want them to be, but they're not always congruent. And there's definitely increased recognition that some of the policies, regulations that we have in place are outdated. We have evolved since then and they need to be reconsidered.     00;27;32;22 - 00;27;59;08  And we're seeing movement across federal sectors, like in I like the NIH and the White House to try to help some of these regulatory burdens. So we absolutely fully believe that your observations are right, and this is a great opportunity for us to help break down those those issues. And to me, that's one of the most exciting ways that we can make an impact.     00;28;00;06 - 00;28;21;18  You know, we've talked to several guests over past episodes about personalized medicine. Obviously, we don't get anywhere near personalized medicine without real world data. What are your thoughts about what the true barriers are to personalized medicine? Can we start looking for it and getting excited about it? Or are we still like a Star Trek distance away from it becoming reality?     00;28;22;09 - 00;28;32;15  Well, I funny that you mention Star Trek because I am a big fan and I still do. I still want to be Dr. McCoy with a tricorder. One of these days.     00;28;32;15 - 00;28;35;11  I think we all have dreams.     00;28;35;11 - 00;29;03;17  I always felt that watching sci fi movies is is a great way to imagine what the future can look like, like Judge Dredd and the Flying cars, you know, other industries already applying intelligence and suggestions. There are way ahead of us and these suggestions are derived everyday from everyday interactions right? You are constantly bombarded by ads that relate to a conversation you had with your spouse near a smart home device or via email or a search that you did.     00;29;04;04 - 00;29;32;26  So all of this is possible. It's very personalized, but health care data needs to be very protected. So I do believe we should be able to get there to more general personalized care, and the data is the foundation for that. There are definitely sectors or treatment areas like oncology, immunology, where these advances are already there in place. And we know more about genomics and other omics and we know how to target treatments for those patients.     00;29;33;07 - 00;29;34;29  So we are we're definitely getting there.     00;29;35;10 - 00;29;46;22  And thinking just about the Learning Health Network What do you see as the biggest opportunities for that organization? What does that look like in five years and what does it need to focus on to get there?     00;29;47;07 - 00;30;08;21  So I'll touch on three very important things for us. And I and I think, you know, that the ranking might be different depending on who you ask on our team, but global expansion is definitely a top priority for us. We want our RWD to power research all over the globe. We want to be a part of that movement and we want to facilitate that movement.     00;30;09;08 - 00;30;33;09  Extension of our data set is going to be very important and also with that extension of our platforms and our partnerships, we feel that there are many possibilities here to augment the current research and discovery processes with different types of data. We know that what makes up an individual and an individual's health, you know, only 20% of that is is health care data.     00;30;33;09 - 00;30;54;13  And what we do in hospitals and in practice, 80% of that is is more related to social determinants of health and our behaviors. So there is other data that we need to bring in as well to help that discovery in that personalized care and then leveraging the rural data to support other important initiatives is very important to us.     00;30;54;13 - 00;31;17;19  So rural data can help us leapfrog the current technical abilities that we have. I truly believe in AI and I know that our customers are dying to have that. So is that, you know, the easiest example I can give you that we need real data, real medical data to train AI and to create large language models that are more suited to health care.     00;31;18;03 - 00;31;24;05  And then, of course, we'll continue on our mission to to bring research into everyday practice.     00;31;24;20 - 00;31;45;24  With technology playing an ever increasing role in health care and how we deliver that health care to society. More of the focus does seem to be on landing on what role companies like Oracle can play. So I suppose my question is just that what's the appropriate role for a company like Oracle? What can it best do to shape the future of health care?     00;31;46;18 - 00;32;22;16  Well, I certainly don't want to simplify it. And, you know, I feel like we can we can do a lot here and and really make a big impact. But I feel in its most simplistic way that companies like ours are pivotal in enablement, in innovation. We have all the tools, advanced health care, we have experience to bring from other sectors and success in my mind is is not just being creative in building things that we think are cool tech, but, you know, really partnering and listening and understanding what clinicians and researchers need in solving for the right problems.     00;32;23;00 - 00;32;26;01  So that's how I see us as the conduit to get there.     00;32;26;17 - 00;32;34;18  Are there any really innovative products you're kind of seeing at Oracle that are especially relevant to the work you're doing and the goals that you're pursuing?     00;32;35;06 - 00;33;15;28  Well, I'm not going to lie. I am super excited about AI and how Oracle is applying AI to remove burden from health care. As a physician that suffered burnout in medical practice, this work is extremely important and it's also happening across life sciences, Oracle life sciences. So this is intelligence not only to decrease the huge amount of duplicative work that exists today, but also to be able to digest the overwhelming amount of data that we have in healthcare and provide more guided, guided decision support to clinicians and researchers and overall to improve safety for our patients.     00;33;16;12 - 00;33;54;15  I think that you had a chat with one of my colleagues who was working on the life sciences safety aspects of our work, and we are leveraging AI there to help read through tons of medical records to pick up those essential elements that are needed for Pharmacovigilance. I also wholeheartedly agree that employers, as often as they are today, should be a thing of the past and that health information needs to live in a different layer, needs to be more flexible, more usable for our patients, for our providers, and certainly for health delivery systems.     00;33;54;24 - 00;34;03;00  So Oracle is currently working on that and that's going to have a tremendous impact. And for our for us on the clinical research side as well.     00;34;03;08 - 00;34;17;15  Well, sounds exciting and we will, as they say, be watching that space very closely. Lu, thanks again for being with us. If someone wants to get in touch with you or learn more about your work or what Learning Health Network does. Is there a way they can do that?     00;34;18;02 - 00;34;44;27  Absolutely. You know, we welcome talking to any provider or organization that has EMR data to contribute. If you can contribute our data or health data in exchange for success, we want to talk to you. And this is regardless of whether you are an Oracle customer or not, today our RWD is EMR agnostic. We have data from at least 18 different health records and it's not exclusive.     00;34;44;29 - 00;34;55;07  So you can join multiple networks, but join ours as well. And you can reach out to us at Learning Health Network underscore at Oracle dot com.     00;34;55;16 - 00;35;27;13  Great Well if you are interested in how Oracle can simplify and accelerate your life sciences research, we invite you to check out Oracle dot com slash life dash sciences. Also be sure to subscribe to the show because there's more great insight and episodes ahead and join us next time on Research in Action.

February 20, 2024Episode 434 min

Building patient-friendly access to clinical trials

Research reveals that 95% of patients do not participate in clinical trials. How do we find better ways to connect willing and qualified participants to clinical trials? How do we ensure diversity in participant populations? And how can we make access to clinical trials more patient-friendly? We will get those answers and more in this episode with Brandon Li, Co-Founder at Power. Power is a fast-growing startup building a patient-friendly way to get access to clinical trials and is working to increase the diversity in clinical trials. -------------------------------------------------------- Episode Transcript: 00;00;00;03 - 00;00;17;02  Are there better ways to connect willing and qualified participants to clinical trials? How do you ensure diversity in participant populations? And why do 97% of patients not participate in clinical trials? We'll get those answers and more on this episode of Research in Action.     00;00;18;07 - 00;00;19;19  The need to.     00;00;21;14 - 00;00;41;18  Build the Hello and welcome to Research and Action, brought to you by Oracle Life Sciences. I'm Mike Stiles, and our guest today is Brandon Lee, co-founder at Power. Power is building a patient friendly way to get access to clinical trials, and they're working on increasing the diversity in clinical trials. Brandon, thanks for taking the time to be with us today.     00;00;41;28 - 00;00;42;27  Yeah, it's my pleasure.     00;00;44;06 - 00;01;03;27  Great. Well, looking forward to it. And we are going to be talking about some amazing stuff as always. But we also always like to get a feel for the person behind that amazing stuff. So what did you want to be when you grew up and how did you get from there to the field of clinical trials and technology and the kind of things you're doing now?     00;01;04;06 - 00;01;13;12  It depends on how far back you want to go, but I think that through most of my childhood, I probably wanted to be a like a professional trading card game player as.     00;01;16;03 - 00;01;17;28  Are you a Pokemon man or.     00;01;18;11 - 00;01;29;24  It was it was all of the above, right? It was like a Pokemon journey. Then there was like a, you know, journey. Then there was a magic. The Gathering journey. I kind of cycled through all of them, but I ended up landing on magic, I think, for most of it.     00;01;30;15 - 00;01;32;25  Well, check those old cards. You could be a millionaire.     00;01;33;01 - 00;01;39;12  I've been. I've been watching the the price of Charizard skyrocket with a lot of energy. You remember having plenty of money?     00;01;39;23 - 00;01;43;08  Well, great. Yeah, but obviously that's not what you wound up doing full on.     00;01;43;23 - 00;02;12;07  No, not at all. Yeah, I think the kind of journey here was. Well, at some point I became a consumer internet. Consumer marketplace person sometime between my my kind of professional trading card game times and and kind of coming out of college, I started thinking a lot more about consumer tech. So I spent a handful of years just doing things that look a lot like classic consumer marketplace work.     00;02;12;07 - 00;02;33;14  Thumbtack, Airbnb, Zillow, all kinds of kinds of products. And at one point I had a close friend of mine diagnosed with a brain tumor who had to go looking for a clinical trial on her own and, you know, that journey was brutal for her. She did everything that patients basically go and do today, which is backchannel the heck out of every doctor that she knows.     00;02;33;14 - 00;02;55;08  And eventually all roads ended up leading to clinicaltrials.gov. So she spent weeks there trying to figure out, okay, is there a trial that could make sense for me? Eventually, she finds one and the contact information is like the front desk of the hospital. So she's cold calling the hospital. The hospital's routing her internally. She's trying to find a way to get an appointment and eventually she gets in front of a study, she gets in.     00;02;55;08 - 00;03;17;26  And that's what they had a positive readout earlier this year, which is probably the happiest journey somebody could have gone through. But it was through that kind of experience that I realized a few things. The first one is that she can't be the only person out there who is sitting in front of clinicaltrials.gov, sitting in this kind of situation trying to answer the question, are there leading medical researchers that can help me?     00;03;18;13 - 00;03;42;10  And the second thing we realized was, while that journey is way too difficult today, right. Everything from even discovering trials in the first place to evaluating your options to figure out what you could be qualified for, what looks really promising through to even contacting the research sites. So we just put put our heads together and realize, well, I think that we can actually bring a lot from this consumer into that space and hopefully, hopefully help a lot more people in need.     00;03;42;22 - 00;03;48;09  So tell me what power was founded to do the problems that it specifically seeks to solve?     00;03;48;29 - 00;04;14;24  It's pretty straightforward, and I like to look at it through a couple of different lenses. So through the lens of the patient, it's exactly this kind of dream that I just described, right? It's helping individuals find and get access to leading medical researchers that could help them from the perspective of the sites. It's how do you connect with as many patients that are potentially interested in your study but not established at your site?     00;04;14;24 - 00;04;31;25  So maybe you don't have a relationship with them yet, but we help you kind of like widen that catchment area as a site and then as a sponsor. It's well, we give superpowers to your sites and we help elevate the kind of the reach of your studies to the patients that are using our platform. And we have hundreds of thousands of them now.     00;04;31;25 - 00;04;37;05  So plenty of folks on, on the website looking, looking around for trials and trial information.     00;04;37;28 - 00;04;55;04  So the people who want to be in clinical trials would find useful connections to those doing the research. And what's the level of the research world? How is it embracing the platform? Is it eagerly seeking to connect with these people who want to do clinical trials?     00;04;55;20 - 00;05;17;25  I think this this kind of touches on an age old problem, right where everybody I'm sure the kind of guest are. The the audience of your podcasts knows these stats, but we didn't coming in certainly turns out that finding patients to participate in trials is one of the biggest problems in life. Science, R&D, right? 86% of trials being delayed because they couldn't find the patients to participate.     00;05;17;25 - 00;05;46;23  So what we found is that we've had north of a thousand like research sites already, like just sign up to start connecting with our patients from the kind of ground ground up. And that's led to a movement that we can then point to some really interesting data and say things like, Wow, actually turns out that the the the research sites that are using power or connecting with patients like ten times more than if they weren't they weren't using patients.     00;05;46;23 - 00;05;49;19  And that data has been really meaningful for us to see.     00;05;49;19 - 00;06;09;20  Well, is it a database of willing participants that the researchers can go look at and find? Because it seems to me most patients, they are totally taking the guidance of their doctor, you know, and so is the doctor playing a role in connecting these people with these research projects?     00;06;09;20 - 00;06;27;25  There's kind of two things here. The first one is, yeah, we've got a registry where patients sign up and they say, Yeah, admitted registry. The registry experience from the the site's perspective is kind of like a LinkedIn for patients, if you can imagine it. It's like, Oh, there's these patient profiles, they've created a profile. I can see them.     00;06;28;04 - 00;06;51;27  They might have answered some prescreening questions at some point. So I'm starting to paint a picture of, you know, medical history and I can invite them to connect if it makes sense. So there's kind of like this LinkedIn for patients. And then on the other side, there's also, you know, new patients signing up every month. And I think that's where a lot of the impact is, because our view is that the patients that are most recently active and interested are the patients that are most likely to actually take action.     00;06;52;24 - 00;06;59;22  So it's all about new flow of patients in our mind, even more so than the the kind of depth of of the database or the registry.     00;07;00;07 - 00;07;11;17  And then what about that Dr. element? Are doctors aware that this tool is available and are they eager or reluctant to get their patients involved in clinical trials?     00;07;12;04 - 00;07;30;23  One of the most interesting things that we've started to see is that doctors are referring their patients to us, right? We're starting to see that in the data where, you know, maybe when we launched, nobody's doing that. And then a year ago, you know, you got a handful of people and that number has actually doubled like year on year of like the number of doctors that are actively referring patients.     00;07;30;23 - 00;07;55;20  And it turns out doctors are okay, referring patients to clinical trial resources. It turns out they do that all day long anyways, but they actually send patients to clinicaltrials.gov. And if you talk to any doctor about it, they they kind of look at you like sheepishly and and almost kind of confess that they do it because they hate it, they hate clinicaltrials.gov, and they know it's not going to help the patients that they're working with.     00;07;55;20 - 00;08;17;26  And it's going to be a really difficult experience. So one of the things we found is that by building a superior product experience for consumers, for individuals on the Internet to learn about clinical trials, doctors are actually more than happy to send patients to to the website to learn about trials. And that's been, you know, one of the kind of happy byproducts of building the kind of best patient experience possible.     00;08;18;12 - 00;08;26;11  So because doctors weren't exactly in love with clinicaltrials.gov, they knew they would be sending their patients kind of down a frustrating rabbit hole.     00;08;26;12 - 00;08;27;05  Correct.     00;08;27;05 - 00;08;53;07  Now, your friend. Well, you're right in saying that, you know, researchers have a hard time finding participants for clinical trials. Your friend on the flip side was eager to participate in a clinical trial. So what makes her different from a lot of patients who are reluctant to participate? Is it because they don't know about the clinical trials or they're too scared to engage in them?     00;08;53;07 - 00;08;54;23  What's what's your view on that?     00;08;55;05 - 00;09;13;29  Yeah, I think it's actually about evaluation. I think evaluation is a key step. If we think about kind of the journey in three phases, there's like discovery, even learning about clinical trials and seeing the trials in the first place. That's difficult. You know, in clinical trials that is rather hard to do properly. Discovery or even your option search.     00;09;14;10 - 00;09;32;29  Then there's the second stage of evaluation. What could be good for me? What am I actually qualified for, and why should I be excited about this relative to status quo? And then there's the kind of participation experience of connecting with the right sites. Right? But I think that, like the second stage of evaluation is really, really the the kind of one of the missing pieces here.     00;09;32;29 - 00;10;00;15  All three are difficult, but evaluations of missing piece, oftentimes when we speak to patients and we speak to patients every week, the key question is, well, how should I be thinking about this trial relative to my current my current care? And is there a reason to believe that this is really exciting or meaningful and I think it's on are kind of like partners in the life science space to properly lay that out for patients.     00;10;00;15 - 00;10;12;10  What is the driving hypothesis that makes you excited enough to put your your capital behind this, this study? And I think patients are looking for that with probably less of a clinical expert explanation of it, though.     00;10;12;21 - 00;10;26;13  Your friend, you mentioned that the outcome was positive, So I'm assuming she got into a clinical trial. She participated. She was not one that got the placebo. She actually got a new drug that helped.     00;10;26;24 - 00;10;27;05  Correct.     00;10;27;16 - 00;10;40;19  Well, let's talk about a lack of diversity and the things that make clinical trials, not that user friendly for everyone. Why is diversity a hard problem to solve and what makes the reward well worth the effort?     00;10;41;01 - 00;11;01;23  You know, we if we look at the stats, it's pretty obvious that clinical trials aren't representative of the population. I think the kind of problem here, let's sit with the problem and talk about kind of like the root cause here. I think the problem here, the problem with it is that it kind of poses a broader public health challenge.     00;11;02;21 - 00;11;25;22  Let's imagine everything goes well and we end up getting new treatments through there. Phase three in front of the FDA approved and we start launching them, but we haven't properly ran these trials with a diverse group of patients. We don't actually know how some how some treatments might affect different different populations and that's why I call it a public health challenge, right?     00;11;25;22 - 00;11;46;14  Because all of a sudden now something becomes standard of care. But we don't know how it affects East Asian, how it affects East Asians and that's and that's the kind of root cause problem. It's it's not a I think, a performative point that diversity, it's really kind of like a downstream potential public health challenge. So that's why it's so important.     00;11;46;14 - 00;12;07;12  And then I think, B, the question of why is it the way it is today is an interesting one. And I think it has to do with the history of clinical research sites that that we choose to partner with. Typically, you know, you partner with a handful of clinical research sites. Those research sites are tasked with recruiting patients from their existing populations.     00;12;08;06 - 00;12;29;05  And then, you know, the kind of set of patients you end up seeing on the set of patients that those sites have established. And it just so happens that the sites that we typically work with in research have a largely white existing patients and that that that ends up skewing the kind of population because you've got a bit of a sampling bias at that point.     00;12;29;25 - 00;12;47;21  Right. So obviously research is not a one size fits all proposition. That's it's amazing that things have been passed that have not been tested on all types of people, all demographics, different patient sets. There's kind of assumption that, well, if it worked with this group, it's going to work with everybody.     00;12;48;05 - 00;13;09;07  Yeah, yeah. I mean, certainly I think the the approach thus far. But you know, I think the the industry is making incredible strides here in raising awareness of this challenge. And then certainly with the recent FDA guidance starting to lean in more to understanding that, oh yeah, there is a potential health care challenge that comes with this that we need to be solving for.     00;13;09;07 - 00;13;12;03  And that's been very inspirational. Watch.     00;13;12;03 - 00;13;32;10  So you did form power to address all this. What does it do in terms of actively recruiting to solve the diverse party problem? In other words, increasing that pool of minority candidates, people that traditionally have not been participating in clinical trials?     00;13;32;24 - 00;13;57;20  You know, we think of ourselves as a a source of unique patients that are interested in trials, Right. So we we help improve access for patients that may not be currently established at the at the research sites. So when we when we think about our role in diversity, what matters to us the most is, is our source of patients more diverse, right, than the other kind of status quo.     00;13;58;03 - 00;14;23;13  And turns out when you look at our data, 40% of the patients who sign up and are actively participating on our platform are nonwhite. And that's right in line with what the US Census and what you would expect in a in a representative sample of of the US population. So I'm we're excited that we're able to hold true to that mission of improving access and that as a result of improving access, actually being a representative source of patients that are interested in research.     00;14;23;29 - 00;14;39;01  Well, you're tackling a tough space because there's so much regulation and the practices are absolutely entrenched. So what's been the rudest surprise you've encountered in your mission so far or the toughest hurdle you had to overcome?     00;14;39;17 - 00;15;11;16  Not not rude surprise, but I think one of the the challenges that, you know, I think everybody can empathize with is that our research sites are incredible busy, busy and often overburdened. So sometimes what is potentially easiest for the patient isn't easiest for the research site. And when you when you think about solving this problem of improving access, if you haven't also solved the problem at the research sites, at the end of the day, you can't close the loop, right?     00;15;11;18 - 00;15;30;03  You can't kind of make the kind of transaction complete, so to speak. Right? So one of the kind of hurdles that we need to we need to overcome and we're constantly kind of like balancing is the line between what is best and easiest for patients and then what is best and easiest for the researchers that they actually need to connect with.     00;15;30;03 - 00;15;39;17  And it has to be, you know, a little bit of give and take and easy for both, Easy enough for both the they that they both can take action because ultimately if if one of them doesn't take action, nothing happens.     00;15;39;27 - 00;16;03;05  Right. So ease of use is definitely a factor. Trust is probably the other factor we kind of touched on this, but we're used to things like control groups and devices to make sure that bias and inaccuracies don't enter the clinical research picture. It seems like if there's underrepresentation and trials, the best results you're going to get are cloudy at best.     00;16;03;16 - 00;16;42;10  Yeah. Yeah. You know, trust is an interesting one, right? One thing that we've experienced with the patients on our platform is that once they've if they if they're coming through our platform, it's because they're almost predisposed to be interested in research. Right. If you think about the kind of factors that have to be true for somebody to be predisposed to be interested in research, one of the factors is that they've they've probably considered it a little bit and are coming in with a higher baseline level of trust, which is not to say that you don't have to continue to build trust.     00;16;42;10 - 00;16;59;15  As a as a researcher, I think everybody has to continue to build trust and it's easy to erode it, especially in a in a clinical setting. But what we're seeing is that the folks are looking around on our website and poking around and reading about different studies there and and then ultimately choosing to connect with it with a researcher.     00;17;00;05 - 00;17;04;02  It's because they've built up a requisite amount of trust already.     00;17;04;21 - 00;17;22;12  Well, let's say I'm someone with an understudied disease and I really want to participate in a clinical trial. How does someone go about that? I mean, obviously going to power and being registered and in the database, but what are the odds that I would get accepted? What factors come into play?     00;17;22;27 - 00;17;51;22  I mean, I think the kind of standard factors come into play at that point, right? So a patient kind of comes through the journey on the website, finds a trial and connects with a with a study, then I think the standard kind of factors come into play around eligibility. How qualified are we and can we prove our qualification as a part of connecting with the research sites in order to get the research site excited to kind of bring you in and kind of work with you?     00;17;51;22 - 00;18;12;12  Right. So some of that is on us as a platform to help help patients maybe put together what we call a dossier or an application packet that helps them get quickly considered and screened for a study. Part of that is the kind of nature of how the protocol is written, and I really think we can influence and that's okay.     00;18;12;12 - 00;18;17;28  And that's kind of par for the course. And just the way that research is structured, not everybody is qualified for every study.     00;18;18;13 - 00;18;30;24  Well, I was looking over the notes and, you know, one figure really jumped out at me. And, you know, correct me if this figure is wrong, 97% of U.S. patients and providers don't participate in trials.     00;18;31;14 - 00;18;55;27  Yeah, it's something like that. I think roughly 3% of of patients as the stat that I've seen, 3 to 5% of patients participate in trials, which is which is amazing when you think about the kind of opportunity to develop improve visibility of research. Research is such an important part of our system and oftentimes should be considered as a part of the the kind of treatment journey like for for an individual.     00;18;56;01 - 00;19;18;04  And I think that's part of actually solving this and increasing that percentage of want to think about that is like the end goal. Part of solving this, I think, is building a relationship with patients through their treatment journey and helping them understand, okay, I'm at this point and I'm on this, you know, potential treatment path and there are some trials that are available on and make sense right now.     00;19;18;13 - 00;19;33;24  But then there are also some trials that could make sense a year from now based on how these kind of treatments progress and based on how I react to them. And I think part of what we want to do as a platform is build that relationship and help be a part of that that journey in that planning for individuals.     00;19;34;17 - 00;20;05;11  Well, 97% is huge. And you said earlier 86% of clinical trials are delayed because they can't recruit enough patients. Is it that people and providers are not participating because trials are so hard to stand up and run? Or, you know, we've talked to other people before, you know, on the podcast and previous interviews and and a big problem is participants in clinical trials kind of don't really know what they're getting into in terms of the level of monitoring that's needed.     00;20;05;11 - 00;20;19;19  And, you know, it becomes very difficult to incorporate the clinical trial into their lifestyles. And are those some of the issues that are just preventing 97% from leaning into research?     00;20;20;12 - 00;20;43;24  You know, I go back to this evaluation question like, are we are we properly are we properly conveying to patients like the reasons to believe if there's a compelling reason to believe that this is a like the best kind of like path forward, I think that that's is kind of like a like put into context of the burden of, of participation.     00;20;43;24 - 00;21;05;28  And I think oftentimes from the patients experience, all they kind of like get exposed to really is the burden of participation without the, you know, the requisite amount of exposure to, you know, why is this the best path forward for me or the best option available right now? I think about it in terms of balancing these two things.     00;21;06;17 - 00;21;38;22  Yeah, there's an increased ask and burden on behalf of the patients and there's also potentially a really compelling reason why this is exciting. And those two things have to be put into a kind of like proverbial pros and cons list that individuals can kind of trade off as they as they think about about research, but not no, I don't think that's the kind of question of burden is excluding 97% of of patients, I think that there are patients that that will be turned off by the burden.     00;21;38;22 - 00;21;41;01  But I don't think it's 97% of people.     00;21;41;20 - 00;22;06;23  And for the general public, you know, getting excited about research, how do you think the amount of time that it takes to do good and qualified research, you know, and get all the way through to FDA approval? It just seems like it takes years and years and years. So it's it's hard to get excited about something that may not yield results for anyone until well into the future.     00;22;07;08 - 00;22;22;27  I think if you put yourself into the shoes of the individual participating, right, it's it's not typically a question of, okay, like what is the impact ten years from now? I think it's a question of, you know, what am I experiencing in the here and now? Does that make sense?     00;22;23;13 - 00;22;39;23  Yeah, absolutely. Is control of the major clinical trials in the hands of too few facilities and researchers, or do you feel it's pretty much properly democratized? You're seeing a lot of clinical research opportunities available.     00;22;40;09 - 00;23;16;16  Yeah, control is an interesting question, right? So certainly clinical trials are concentrated to a group of providers, sites that are familiar and let's say have a track record of doing research. And I think there are like very reasonable rationales for that. I would even argue, you know, probably okay with that, there's a little bit of concentration, right? Because the kind of bigger a trial gets, the more people that are or the more providers that are participating, the more noise and variance kind of gets introduced and gets introduced to the system.     00;23;16;16 - 00;23;38;20  And that's not always a good thing. Our perspective here is that we do need to increase access, but the way to increase access is not necessarily to get to 100% of providers participating in in every study. I think the way to increase access is actually to help individuals and patients learn about studies that are happening in their in their geography, and they get properly connected with those sites.     00;23;38;29 - 00;24;00;02  And to make that that kind of journey easier, rights for patients have more visibility to what's available and then getting connected with the right person in the city. It doesn't really make sense to have, you know, a hundred providers in Cincinnati doing a doing a study right is just about funneling patients to the to the right locations and improving kind of like access and transparency.     00;24;00;02 - 00;24;00;26  Those opportunities.     00;24;01;17 - 00;24;17;01  Well, you do have primarily a technology product. You're connecting people to clinical trials. Technology is going to play a role in that. But it's not like this is tender, right? Me So what what kind of tech and guidelines does power use to make these connections?     00;24;17;01 - 00;24;38;00  We think of the our, you know, our publicly facing platform and that's that's what most people see when they kind of engage with us as like an Airbnb like interface for individuals who are looking for trial. So it's really on the on the patients side, right? It's like a discovery and evaluation product and we do a bunch of things that are interesting there.     00;24;38;05 - 00;24;59;26  But one of the things we do that's interesting is we actually have one of the best structured data sets on eligibility criteria that is out there and then as a result, we can have patients now start to do their search on the basis of, for example, like their genetic biomarkers, and they can do filtering on genetic biomarkers relative or relevant to their their kind of condition that's not available anywhere, anywhere else.     00;24;59;26 - 00;25;31;04  Right. From a patient facing perspective, that's that level of kind of like of detailed search experience actually makes the discovery and evaluation process way easier on from a patient's perspective. Then on the flip side, you know, let's use that as continue the Airbnb analogy research sites get access to. Well, we like to think of as, you know, like a referral management or a recruitment management platform that they can use to see all the patients that are interested in their trial on our website, on our platform.     00;25;32;14 - 00;25;53;09  So it's kind of a workflow management tool that that sites can use to kind of connect those patients that are on our website and expressing interest in their studies. And then somewhere in between we've got a kind of like matching algorithm. So we're I'm sure everybody who's who's kind of come through here and is working on technology is thinking about ways that you can use A.I. rights to improve workflows.     00;25;53;09 - 00;26;25;05  Our view is that A.I. is an interface is not the end game, but as a as a component to kind of like your tech stack is really compelling. So we're looking at ways to use AI to improve match rates, improve kind of screening qualification, and in doing so, reduce some of the burden on the on the patient side for identifying what could be a good trial, but also reducing burden on the site's perspective and having to screen that these patients from from scratch every single time.     00;26;25;27 - 00;26;38;10  So it sounds like the databases, the processing power required for that would be pretty intensive. Is all of that being run smoothly and securely in the cloud? Is that a hybrid approach? Is it on premises? What do you have?     00;26;38;17 - 00;26;46;12  Yeah, it's all in the cloud and it's not a you know, we're not making our own A.I. models, right? So it's it's not nearly as intense as maybe it sounds.     00;26;46;29 - 00;27;03;24  So it sounds like the proposition is just that there are the ability to run filters and eliminate mismatches to get to good results better. And that a superior, I would assume, to what clinicaltrials.gov have offers.     00;27;04;10 - 00;27;23;18  Oh, yeah, certainly right. For if we're going to both sides of the equation, patients can more quickly figure out what trials they should actually be considering. Right. Like if you if your patient search on clinicaltrials.gov, you get thrown 150 different options that you need to track in a spreadsheet and try to whittle down towards five or ten that are a good fit.     00;27;23;18 - 00;27;39;06  So patients can very quickly do that. It takes them a minute on our platform and then on the researchers side, they can double click into the patient's profile, the medical history, all this kind of stuff in order to quickly make an assessment about whether this patient is qualified enough to kind of come in and screen.     00;27;39;29 - 00;28;08;20  So what we've been talking about is bridging the gap and making the connections between patients and clinical research. And Oracle Life Sciences mission is kind of bridge the gap between clinical research and then clinical care. So kind of in the connecting business as well. But if power is successful and we're running diverse clinical trials, what are your thoughts on how those learnings can then be made actionable in the point of care and patient portals area?     00;28;09;08 - 00;28;37;02  I think that, you know, and this is kind of early in and the way that we're thinking about it, but I think that providers have a really important role here and consideration and the consideration process of clinical trials. And one thing that we would love to to see more is for us to have broken down the barriers for providers to understand and what trials are currently running in their specialty and stay on top of the best options.     00;28;37;02 - 00;29;00;12  Right Today, you know, providers in the community have to stay on top of reams of information. It's really quite a difficult journey for them as well to stay on top of the kind of latest research in their in their category. So one thing we would love to see is for those providers to be able to leverage power to, you know, just stay smart on the kind of latest in a medical research.     00;29;00;17 - 00;29;05;14  That way when they do have a patient comes through, they have the information they need at their fingertips as well.     00;29;06;04 - 00;29;26;29  Are doctors reluctant to give patients? I don't want to say false hope because the hope is genuine, but it's almost like they don't want to get their hopes up by saying, hey, this clinical trial is likely to give you a solution where today we don't have a solution for you.     00;29;27;17 - 00;29;50;09  I think providers are are really the experts at navigating that that conversation. And I don't know any providers who I think misrepresent the the opportunities present in clinical trials. But I think really providers are quite thoughtful about how they present research as an option.     00;29;50;09 - 00;30;08;06  Well, we talked about your tech stack. And when you think about your tech stack and you look over all the tools that you have, is there anything on your wish list or is there anything you know, you touched on I a little bit that you see coming in the future that's going to really kick power up a notch?     00;30;08;26 - 00;30;11;27  Yeah. I mean, if somebody could just solve this medical record thing, I'd be nice.     00;30;13;11 - 00;30;29;07  Well, you've brought up an area of mass chaos, but kind of expand on that. You know, what's what's the problem? Is it just like incoherent, inconsistent, not interconnected methods for keeping medical records for Americans and others?     00;30;29;19 - 00;31;07;23  Yeah, all of the above. Right. And, you know, patients might want to get access to their medical records. How do they get those records? You know, the new clinical trial inevitably is going to want the medical records as well. How do how does the trial get access to those medical records, the kind of like general mosaic of different set ups and different communication norms and different like ways to share the records, I think introduces a lot of inconsistency into the space, which makes it difficult for everybody from providers to researchers to patients, and certainly for the life science companies that are pulling their hair out and looking at everything, trying to figure out is there     00;31;07;25 - 00;31;09;09  is there a good way through this mess?     00;31;09;27 - 00;31;12;25  Turns out a little standardization isn't a bad thing.     00;31;13;02 - 00;31;38;28  No, it could be really helpful. I don't know. You know, I think a little bit of the the kind of banking and finance stuff where Clyde has really solved this inter connectivity problem for our intraoperative interoperability problem for financial services institutions to allow fintech at some point. It'd be nice if somebody does that on the medical record side, and there are a lot of really great teams sprinting at this.     00;31;38;28 - 00;31;47;18  So, you know, I'm I'm cheering them on. Waiting for the day when collecting a medical record is as easy as connecting my bank account to a new app.     00;31;48;10 - 00;32;07;28  Well, if you were to assess where we are today in terms of bringing more participation and diversity into clinical trials and where we might be, say, five years from now, can you change mindsets and the culture around clinical trials in that period of time? Where do you see this going in, say, the next five years?     00;32;08;15 - 00;32;36;24  I think it's it's interesting. I think there's a ton of runway ahead of us for impact. Or let's go back to one of the stats that you brought up. 97% do not participate in trials. 3% do getting 1% more of the kind of population to be excited about research. And depending on research, just 1% increases. The overall the overall participate participation rates of the population by 33%.     00;32;36;24 - 00;32;56;25  That's massive, right? So can we go from 3% to 5% in the next five years, almost doubling the kind of participation rate? That's huge impact, a huge impact on on our industry. It's not yet broad population adoption. And I think that's okay. When you're starting from a small base, you kind of have to stack up the the wins and think about them economies relative terms.     00;32;57;14 - 00;33;03;15  Well, we'll look forward to watching the progress in the space and we'll let you know when that medical records thing gets sort of shorter.     00;33;05;01 - 00;33;05;03  So.     00;33;05;04 - 00;33;15;11  You can be on your way. Well, Brandon, thanks again for being with us today. If someone wants to get in touch with you or learn more about what power does, what's the best way to do that?     00;33;15;20 - 00;33;39;28  Yeah, you know, I think that get in touch with me. I probably shouldn't do this, but my email is Brandon up with power dot com. Feel free to send me an email. Always happy to chat and share. Share what we're up to. And then if you want to take a look at our website, it's it's free and public so it's with power dot com pretty easy to go find and take a look at the kind of experience that we're trying to build for for people who are learning about research.     00;33;40;11 - 00;34;12;22  Fantastic. And we appreciate it. If you are interested in how Oracle can simplify and accelerate your life sciences research, we invite you to check out Oracle dot com slash life sciences and also be sure to subscribe to the show because there's more genius ahead and join us next time on Research and Action.

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