Life Science Success

Hosted by Don Davis PhD, MBA

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Episodes

319

Latest episode

Jul 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

July 31, 202647 min

Stella Vnook: Building the Precision Oncology Future at Kaida BioPharma!

Send us Fan Mail In this episode of the Life Science Success Podcast my guest is Stella Vnook. Stella is the CEO, Co-Founder, and Executive Board Chair at Kaida BioPharma, where she is advancing precision oncology therapies and bringing her experience as a serial biotech entrepreneur, investor, and life sciences leader to the future of cancer treatment. 00:00 Welcome to the Podcast 00:38 Meet Stella Vnook 01:23 From Big Pharma to Startups 04:58 Thriving as Startup CEO 08:08 Mission Driven by Family 10:27 Hard Lessons in Translation 15:08 Building Kaida BioPharma 18:12 Fundraising in a Tough Market 22:33 De Risking and Milestones 25:03 Faster to Clinic with Rigor 29:12 Women Leading in Biotech 35:47 Precision Medicine Outlook 38:17 Inspiration and Concerns 45:46 How to Connect and Wrap Up

July 16, 202628 min

Dr. Seth Toback on ARMR, Biotech Leadership & Clinical Development Today

Send us Fan Mail In this episode of the Life Science Success Podcast my guest is Dr. Seth Toback. Dr. Toback is the Chief Medical Officer at ARMR and a board-certified physician-scientist with over 20 years of experience leading clinical development and medical affairs across biotech, pharmaceuticals, vaccines, infectious diseases, and respiratory medicine. 00:00 Show Introduction 00:29 Meet Dr Seth Toback 01:28 From Pediatrics to Vaccines 03:11 Pandemic Vaccine Milestones 04:51 Speeding COVID Development 07:04 Leading in Crisis 08:59 ARMR Mission and Opioid Waves 11:00 How the Fentanyl Vaccine Works 12:45 Who Benefits Most 14:12 Human Challenge Trial Design 16:02 Endpoints and Real World Evidence 17:57 Clearing Up Misconceptions 21:21 Risk Disinhibition Concerns 22:27 Defining Success and Impact 24:14 Rapid Fire Fun Questions 26:44 How to Learn More 28:01 Closing and Subscribe

June 11, 202634 min

Inside the Physician Decisions That Make Oncology Trials Safer & Smarter

Send us Fan Mail In 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 Guest 01:49 Simran Career Journey 04:22 Why CRO Variety Matters 05:48 What Medical Monitors Do 08:04 Protocol vs Reality 09:43 Physicians Role Evolving 11:14 Better Trial Decisions 13:31 Newsletter Behind Scenes 16:09 LinkedIn Newsletter Reach 17:07 From Science to Execution 19:18 Therapeutic Specialization 21:20 Collaboration Across Teams 23:05 Capabilities for Future 25:16 Rapid Fire Inspiration 32:44 Where to Connect 34:09 Podcast Outro

May 1, 202645 min

Transforming Pharma Regulatory Operations with Megha Sinha

Send us Fan Mail In 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 Introduction 00:30 Meet Megha Sinha 01:18 Engineering Into Life Sciences 03:29 First FDA Audit Lessons 04:29 PwC Shaping Consulting 07:27 Three Career Pivots 12:22 Why Found Kamet 17:24 Mission And Programs 19:27 Global Regulatory Depth 24:57 Transformation In Practice 30:24 Scaling Team And Tech 35:14 Leadership Inspiration Concerns 40:48 AI Beyond Automation 44:27 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 Mail In 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 Intro 00:30 Meet Ian Crone 01:12 From Lab Bench Up 03:07 Regulatory Deja Vu 05:15 IDMP Explained 07:39 Single Source Truth 10:38 Why Migrations Fail 14:40 Interpretive Drift Risk 15:56 Best of Breed Debate 21:27 Compliance Clock Ticking 23:59 AI Needs Humans 26:00 Why ArisGlobal 27:33 Sportify Overlay Approach 28:49 Data Cortex XDI 31:10 IDMP Data For AI 32:31 AI As Experimentation 33:54 Leading Under Pressure 36:20 Mentorship Lessons 37:05 Personal Motivation Story 39:23 AI Hype Versus Readiness 42:15 Human In The Loop 44:42 Breaking Silos Wins 47:02 Closing And Next Steps

April 9, 202640 min

Inspection Readiness and Quality Systems with Jennifer Vavala

Send us Fan Mail In 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 Intro 00:30 Meet Jennifer Vavala 01:39 Microbiology Origins 04:13 Capacity Not Capability 08:43 Across Regulated Sectors 12:25 AlignPoint Partners Mission 13:15 Operational Stability Framework 18:02 Early Warning Signals 19:52 Inspection Readiness Reality 23:55 Executives And Regulators 32:37 Quality Leadership Future 36:15 Inspiration Concerns Excitement 39:39 Wrap Up And Where To Connect 40:19 Outro

April 2, 202639 min

Dean Erhardt: Pharma Strategy, Distribution & Commercial Growth

Send us Fan Mail In 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 Intro 00:34 Dean's career: HMO, Cardinal Health, Express Scripts 03:00 Founding D2 Solutions in 2008 04:00 Pricing strategy and middlemen taking 50–70% of revenue 08:00 What separates successful commercialization from failure 10:00 D2's three pillars: distribution, reimbursement, patient services 15:00 Pharmaceutical support programs for specialty medications 16:00 D2's digital patient engagement platform in action 21:00 Resource challenges for small and mid-sized pharma 22:00 Retail deserts and the rise of direct-to-consumer models 24:00 National accounts strategy and long-term payer relationships 26:00 When to engage D2 and cleaning up commercialization missteps 28:00 The prior authorization crisis 31:00 Leadership advice: one vision, said a million times 32:00 AI, remote surgery, and the future of care 34:00 Looming shortage of 3.9 million healthcare workers 36:00 Concerns: aging population, lost patients, NIH funding 37:00 Technology accelerating drug approvals 38:00 Outro

January 29, 202657 min

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

Send us Fan Mail Jesse 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 Podcast 00:34 Pressing Issues in Pharmaceutical Manufacturing 00:51 Introducing the Experts from Model N 03:08 Understanding International Reference Pricing 04:14 Impact of US Pricing on Global Drug Launches 09:26 Challenges with Pharmacy Benefit Managers 16:29 Domestic Manufacturing Boom in Pharmaceuticals 23:08 AI in Drug Discovery and Personalized Medicine 29:03 Access and Policy Discussion 30:01 Direct to Consumer Pricing 31:32 TrumpRx Overview 33:11 Compliance Challenges 38:30 Pharmaceutical Revenue Management 41:38 AI in Life Sciences 48:35 Future of Life Sciences 50:45 Concerns and Challenges 53:52 Excitement in Current Work 55:54 Conclusion and Final Thoughts

October 20, 202542 min

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

Send us Fan Mail In 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 Podcast 00:37 Meet Troy Fugate: CCO of Compliance Insight 01:09 Troy's Career Journey and FDA Focus 04:10 The Align, Apply, Adapt Framework 04:47 Differentiating Compliance Insight 08:03 The Importance of Clarity in Compliance 17:10 Challenges and Solutions in Compliance 25:38 Human Behavior and Continuous Improvement 34:39 Troy's Inspirations and Concerns 39:07 Final Thoughts and Closing Remarks

October 11, 202543 min

RNA Secrets Unveiled: Byron Purse's Biotech Breakthrough Journey

Send us Fan Mail In 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 Podcast 00:29 Meet Byron Purse: Professor and Co-Founder of AlidaBio 01:05 Byron's Journey into Life Sciences 03:10 From Academia to Entrepreneurship 06:49 Founding AlidaBio: Vision and Mission 08:59 Innovations in RNA Modifications 23:09 Challenges and Successes in Developing the EpiPlex™ Platform 28:44 Leadership and Inspiration 35:00 Concerns and Future Outlook in Life Sciences 43:02 Conclusion and Final Thoughts