Life Science Success

Hosted by Don Davis PhD, MBA

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Episodes

317

Latest episode

Jun 2026

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About the show

On this podcast, you'll find interviews with high-performing successful individuals in Life Sciences. On a weekly basis, we cover their proven methods, principles, strategies, and mindsets to implement new technologies that scale to meet the needs of people in our world.

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60 recent

June 11, 202634 min

Inside the Physician Decisions That Make Oncology Trials Safer & Smarter

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is Simran Padam, MD, APMMC, Executive Director of Medical Affairs at Worldwide Clinical Trials. A physician with 17+ years guiding global studies, she shares insights on medical monitoring, complex oncology and hematology programs, and the clinical judgment behind drug development highlighted in her newsletter, The Medical Monitor’s Desk.00:00 Show Intro and Guest01:49 Simran Career Journey04:22 Why CRO Variety Matters05:48 What Medical Monitors Do08:04 Protocol vs Reality09:43 Physicians Role Evolving11:14 Better Trial Decisions13:31 Newsletter Behind Scenes16:09 LinkedIn Newsletter Reach17:07 From Science to Execution19:18 Therapeutic Specialization21:20 Collaboration Across Teams23:05 Capabilities for Future25:16 Rapid Fire Inspiration32:44 Where to Connect34:09 Podcast Outro

May 1, 202645 min

Transforming Pharma Regulatory Operations with Megha Sinha

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is Megha Sinha. The founder and CEO of Kamet Consulting Group LLC, she brings 17+ years of experience advising global pharma and life sciences on regulatory operations, quality, and large-scale transformation, including senior leadership at PwC solving complex regulatory, supply chain, and lifecycle management challenges.00:00 Show Introduction00:30 Meet Megha Sinha01:18 Engineering Into Life Sciences03:29 First FDA Audit Lessons04:29 PwC Shaping Consulting07:27 Three Career Pivots12:22 Why Found Kamet17:24 Mission And Programs19:27 Global Regulatory Depth24:57 Transformation In Practice30:24 Scaling Team And Tech35:14 Leadership Inspiration Concerns40:48 AI Beyond Automation44:27 Closing And Next Steps

April 14, 202649 min

Breaking Down Silos with Ian Crone: Regulatory Data, IDMP, and AI Readiness in Life Sciences

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is Ian Crone. He is the VP Regulatory strategy and growth at ArisGlobal and a global life sciences leader known for RIM, UDI, IDMP, and data migration expertise, inspiring teams to deliver compliant, client-centric solutions.00:00 Show Intro00:30 Meet Ian Crone01:12 From Lab Bench Up03:07 Regulatory Deja Vu05:15 IDMP Explained07:39 Single Source Truth10:38 Why Migrations Fail14:40 Interpretive Drift Risk15:56 Best of Breed Debate21:27 Compliance Clock Ticking23:59 AI Needs Humans26:00 Why ArisGlobal27:33 Sportify Overlay Approach28:49 Data Cortex XDI31:10 IDMP Data For AI32:31 AI As Experimentation33:54 Leading Under Pressure36:20 Mentorship Lessons37:05 Personal Motivation Story39:23 AI Hype Versus Readiness42:15 Human In The Loop44:42 Breaking Silos Wins47:02 Closing And Next Steps

April 9, 202640 min

Inspection Readiness and Quality Systems with Jennifer Vavala

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is Jennifer Vavala, Founder & Principal at AlignPoint Partners. With more than 27 years in pharma, medical device, and diagnostics leading QA/QC in complex regulated organizations, she focuses on quality systems, inspection readiness, and operational delivery, and developed the Operational Stability Recalibration framework to help leaders rebalance escalating mandates with operating capacity before compliance or delivery risks surface.00:00 Intro00:30 Meet Jennifer Vavala01:39 Microbiology Origins04:13 Capacity Not Capability08:43 Across Regulated Sectors12:25 AlignPoint Partners Mission13:15 Operational Stability Framework18:02 Early Warning Signals19:52 Inspection Readiness Reality23:55 Executives And Regulators32:37 Quality Leadership Future36:15 Inspiration Concerns Excitement39:39 Wrap Up And Where To Connect40:19 Outro

April 2, 202639 min

Dean Erhardt: Pharma Strategy, Distribution & Commercial Growth

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is Dean Erhardt, President and CEO at D2 Solutions. He brings more than 20 years of experience across pharmaceuticals and consumer products, with expertise in support program development, distribution, and specialty product management, and has worked with over 100 pharmaceutical, biotech, and medical device manufacturers as well as many small and midsized organizations on commercial operations, strategy, and national accounts.00:00 Intro00:34 Dean's career: HMO, Cardinal Health, Express Scripts03:00 Founding D2 Solutions in 200804:00 Pricing strategy and middlemen taking 50–70% of revenue08:00 What separates successful commercialization from failure10:00 D2's three pillars: distribution, reimbursement, patient services15:00 Pharmaceutical support programs for specialty medications16:00 D2's digital patient engagement platform in action21:00 Resource challenges for small and mid-sized pharma22:00 Retail deserts and the rise of direct-to-consumer models24:00 National accounts strategy and long-term payer relationships26:00 When to engage D2 and cleaning up commercialization missteps28:00 The prior authorization crisis31:00 Leadership advice: one vision, said a million times32:00 AI, remote surgery, and the future of care34:00 Looming shortage of 3.9 million healthcare workers36:00 Concerns: aging population, lost patients, NIH funding37:00 Technology accelerating drug approvals38:00 Outro

January 29, 202657 min

The Future of Pharma Pricing, Access, and Global Market Complexity

Send us Fan MailJesse Mendelsohn and Michael Grosberg from Model N discuss why U.S. pricing complexity is spreading globally, the collapse of the PBM rebate model, what's really driving the pharmaceutical manufacturing boom, and why direct-to-consumer discount programs won't solve America's drug access problem.00:00 Introduction to Life Science Success Podcast00:34 Pressing Issues in Pharmaceutical Manufacturing00:51 Introducing the Experts from Model N03:08 Understanding International Reference Pricing04:14 Impact of US Pricing on Global Drug Launches09:26 Challenges with Pharmacy Benefit Managers16:29 Domestic Manufacturing Boom in Pharmaceuticals23:08 AI in Drug Discovery and Personalized Medicine29:03 Access and Policy Discussion30:01 Direct to Consumer Pricing31:32 TrumpRx Overview33:11 Compliance Challenges38:30 Pharmaceutical Revenue Management41:38 AI in Life Sciences48:35 Future of Life Sciences50:45 Concerns and Challenges53:52 Excitement in Current Work55:54 Conclusion and Final Thoughts

October 20, 202542 min

Align, Apply, Adapt: Building Lasting Compliance with Troy Fugate

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is Troy Fugate. The CCO of Compliance Insight, Inc., Troy brings 30+ years of FDA readiness, GMP, and quality leadership—turning complex requirements into practical, culture-shaping solutions and championing the Align–Apply–Adapt framework used across pharma, cell and gene therapy, and medical devices.00:00 Introduction to Life Science Success Podcast00:37 Meet Troy Fugate: CCO of Compliance Insight01:09 Troy's Career Journey and FDA Focus04:10 The Align, Apply, Adapt Framework04:47 Differentiating Compliance Insight08:03 The Importance of Clarity in Compliance17:10 Challenges and Solutions in Compliance25:38 Human Behavior and Continuous Improvement34:39 Troy's Inspirations and Concerns39:07 Final Thoughts and Closing Remarks

October 11, 202543 min

RNA Secrets Unveiled: Byron Purse's Biotech Breakthrough Journey

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is Byron Purse, co-founder of AlidaBio and professor of chemistry at San Diego State University who is pioneering innovative approaches to studying RNA modifications. Byron brings a wealth of expertise in synthetic and natural nucleic acid modifications, with a passion for advancing biotechnology and human health through his groundbreaking research and entrepreneurial endeavors.00:00 Introduction to Life Science Success Podcast00:29 Meet Byron Purse: Professor and Co-Founder of AlidaBio01:05 Byron's Journey into Life Sciences03:10 From Academia to Entrepreneurship06:49 Founding AlidaBio: Vision and Mission08:59 Innovations in RNA Modifications23:09 Challenges and Successes in Developing the EpiPlex™ Platform28:44 Leadership and Inspiration35:00 Concerns and Future Outlook in Life Sciences43:02 Conclusion and Final Thoughts

September 27, 202548 min

Revolutionizing Addiction Risk: Genetics, Tech, and Hope Unveiled

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is James Piacentino, CEO of Thrive Genetics, Inc., a pioneering digital health startup focused on transforming addiction risk assessment through genetic and behavioral science. James brings a unique blend of entrepreneurial experience, technical expertise, and personal mission to develop innovative solutions that help healthcare providers manage dependency risk with unprecedented precision.00:00 Introduction to Life Science Success Podcast00:46 Upcoming Podcast Announcement01:08 Introducing James Piacentino01:49 James Piacentino's Background in Digital Health03:29 Corporate Experience and Startup Journey06:53 Founding Thrive Genetics08:35 The Impact of Addiction on Families09:19 Thrive Genetics' Approach to Addiction Risk18:43 Partnerships and Technological Advancements21:29 Combining Genetics, Behavior, and AI25:06 The Conservative Approach to AI in Customer Journeys26:12 Balancing Scientific Rigor with Business Models27:09 Adoption and Value Creation in Technology30:54 The Importance of Customer Feedback40:05 Leadership Lessons and Values-Based Leadership43:18 Inspiration and Overcoming Limiting Beliefs45:29 Concerns and Complexities in Today's World46:47 Excitement for the Future47:35 Conclusion and Farewell

September 18, 202554 min

Financial Strategies for Life Science Startups: Insider Secrets Revealed!

Send us Fan MailIn this episode of the Life Science Success Podcast my guest is Josh Yelen, a CPA, MBA, and the Founder & CEO of Function, a strategic financial leadership and bookkeeping services company that supports businesses across various industries, including life sciences. With over two decades of experience in operations, accounting, finance, and sales, Josh is also a co-founder of Venture Forward Capital, where he supports early-stage entrepreneurs in building disruptive companies.00:00 Introduction to Life Science Success Podcast00:40 Join Our Free School Community01:41 Introducing Our Guest: Josh Yelen02:10 Josh Yelen's Professional Journey04:30 The Birth of Venture Forward Capital and Function09:05 Function's Unique Approach to Financial Services14:55 Challenges in Biotech and Pharma20:40 Trends Shaping the Future of Biotech29:19 Firing the Biggest Client and Growing the Business29:46 Innovative Use of AI in Business30:53 Aligning Company Goals with OKRs32:45 The Importance of Focus and Avoiding Distractions36:46 Leadership Advice and Entrepreneurial Challenges39:31 Motivational Videos and Personal Drive45:37 Concerns About AI and the Future of Work50:48 Excitement for the Future and Final Thoughts