PODCAST · science
The Life Science Rundown
by The FDA Group
The Life Science Rundown is a podcast for life science professionals hosted by The FDA Group. We dive deep into topics across the RA/QA/Clinical space, covering news, exploring trends, and picking the brains of expert guests.
Episodes
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The Adoption Assumptions Hiding in Your Regulatory Strategy
Can the fastest path to FDA approval end up being the slowest path to market adoption? Holley Proctor Miller, Founder and President of Grey Matter Marketing, has spent more than two decades helping medtech companies get new products adopted, starting with the early days of surgical robotics. She...
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Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success
We're honored to welcome Dr. Robert Califf, two-time Commissioner of Food and Drugs and founding director of the Duke Clinical Research Institute, to The Life Science Rundown. Dr. Califf joins Nick Capman to talk about how GLP-1 therapies could become a true public health success, and what it…
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Is Your Biotech De-Risking or Just Delaying?
What stops a promising platform from becoming an investable company? Kevin Walton, CEO of Baseimmune, has watched this from both sides, first as an investment banker and now running a 23-person biotech through a strategic pivot he led himself. He and Nick Capman get into beachhead decisions, why...
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Reg Ops Has Been Kept in a Box. This Is the Way Out.
As the FDA takes its first steps toward receiving clinical data in real time, what happens to regulatory operations professionals? Carla Griffin, CEO of The Sugar Water Operations Team, argues that reg ops has been kept in too small a box for years and that this shift is the opening to change…
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QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell
How do biotech companies move QA from late-stage gatekeeper into an early, risk-appropriate technical partner? Dr. Andrea Bell, a VP and Global Head of Quality Assurance, breaks down what phase-appropriate quality looks like across the lifecycle and why the barriers to getting there are cultural...
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Managing AI Risk Across Global Quality Systems
How do you manage AI risk across global quality systems while the tools change every week? Julio Salwen, SVP and Chief Quality Officer at MiniMed, brings 35 years in pharma, devices, and diagnostics to a conversation about governance, risk tolerance, and what quality leaders need to learn right...
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The Case for Engaging Regulatory Early
Most companies bring in regulatory expertise when they're ready to file. Leland Keyt, VP of Regulatory Affairs and Quality Assurance at Apreo Health, makes the case that by then you've already absorbed costs you didn't need to, and explains what early regulatory partnership actually looks like in...
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Why Quality and R&D Default to Conflict (and How to Fix It)
Why do quality and R&D fall into adversarial roles even when both are working toward patient safety? Shawn Fuller, who spent 24 years at Surmodics and rose from regulatory manager to VP of Quality, Regulatory and Clinical Affairs, is candid about how both sides create the problem and what it…
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Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
A special one for us: we sat down with Sid Bhatnagar, CEO of ASQ, the American Society for Quality. Sid is an engineer and longtime technology executive who now leads the global body at the center of the quality profession, and he brought a sharp, practical view of how AI is reshaping what...
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Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
Why do so many CAPA systems pass their metrics while the same problems keep coming back? Dan Eagles, a medical device quality VP and longtime CAPA mentor, breaks down where these systems quietly fail and how to rebuild them into tools that actually drive improvement. Dan discusses why the problem...
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TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
Why do life science companies still scramble when an inspection is coming, even when their quality systems are solid on paper? Yeime Martich, a 25-year quality veteran, makes the case that readiness is a logistics and culture problem, not a documentation problem, and that the procedures you wrote...
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What Auditors Are Actually Looking For — and the Psychology Behind How They Find It
Why do audits still trigger panic even at companies with strong quality systems? Sneha Saggurthi — a quality compliance manager and lead auditor in cell therapy — breaks down the gap between being compliant and being audit ready, and shares the psychology, patterns, and logistics that actually...
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Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That
Why are there over 400 phase three oncology programs but only one in dialysis? John Butler, who has spent over 30 years in the kidney disease space, breaks down the regulatory and reimbursement dynamics that have created a surge of innovation in rare kidney diseases while leaving dialysis…
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Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
What does it actually take to navigate global regulatory filings across the FDA, EMA, and PMDA, and why do so many programs stumble despite technically harmonized dossiers? AJ Acker draws on about 30 years of rare disease regulatory experience to break down the real differences between regions…
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Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
What actually changes for regulatory leaders when they move between large pharma and small biotech, and what stays the same? Tammy Sarnelli draws on over 35 years of experience across organizations of every size to break down the real differences in workload, risk tolerance, resource access, and...
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Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations. Cary discusses why…
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Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development. Nelly discusses how she structured a...
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Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum. In this episode of The Life Science Rundown, host Nick Capman speaks with Jackie Klecker, Executive…
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Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin
The FDA Group's Nick Capman sits down with Mike Martin, President and CEO of ISPE, for a conversation on how the pharmaceutical industry must rethink workforce development amid rapid technological and cultural change. Drawing on nearly four decades of global experience in pharmaceutical...
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How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson
The FDA Group’s Nick Capman sits down with Chris Masterson, Senior Vice President of Quality and Chief Quality Officer at Tolmar, for a wide-ranging conversation about how to create and sustain a quality-centric culture that drives compliance, operational excellence, and long-term resilience in…
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From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo
The FDA Group’s Nick Capman sits down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs & Quality Assurance at SAB Biotherapeutics. With nearly 30 years of experience across Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, Carlos has led...
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How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva
The FDA Group’s Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looking discussion on how regulators are actually using AI today, where the technology is going, and what life science organizations...
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A Playbook for FDA Inspections and Remediation with Jeff Hines
Coruna Medical’s Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement. Drawing from nearly four decades in pharmaceutical quality, including more than…
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Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah
The FDA Group’s Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the life science product development cycle—from concept to commercialization. With nearly 30 years of leadership experience spanning...
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Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim
The FDA Group’s Nick Capman speaks with Regina Atim, PharmD, pharmacist, maternal and perinatal health advocate, and founder of Clinicians Touch Healthcare Solutions. Regina brings deep expertise at the intersection of clinical practice, regulatory strategy, and maternal health…
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Staying Ready for the FDA (When Inspections Are Less Predictable)
The FDA Group’s Nick Capman speaks with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With more than 25 years of pharmaceutical manufacturing experience spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection...
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Building the Next-Gen Lab: AI in a GLP Environment with Catherine Lunardi
The FDA Group's Nick Capman speaks with Catherine Lunardi, Founder and CEO of GenAIz. With nearly a decade leading GenAIz and prior leadership roles at GSK, CGI, and Héma-Québec, Catherine brings a seasoned perspective on how life science organizations can practically and compliantly deploy AI to...
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How to Build High-Performing Quality Teams with Marcus Gesner
The FDA Group's Nick Capman speaks with Marcus Gesner, Vice President of Global Quality at embecta. With more than two decades of leadership experience at companies including Boston Scientific, Olympus, Covidien, JUUL Labs, and others, Marcus brings a unique perspective to what makes a quality...
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The 4 Cs of MedTech Leadership with Sean Gallimore
The FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical devices, diagnostics, CROs, and industrial technology, Sean shares his practical framework for...
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The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff
The FDA Group’s Nick Capman sits down with Dr. Manfred Stapff—physician, author, and founder of Candid Advisory Inc., a consultancy specializing in real-world evidence and clinical development—for a wide-ranging conversation about how real-world data is reshaping drug development, regulatory...
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Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)
The FDA Group's Nick Capman sits down with Dr. Kimberly Garko, Chief Technical Officer and 25-year life science veteran, for a deep dive into one of the most misunderstood concepts in the industry: the cost of quality. Dr. Garko shares why quality should be viewed not as a cost center but as a...
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From Cost Center to Value Driver: Rethinking Quality in the Life Sciences with Marcia Baroni
Nick Capman talks with Marcia Baroni—a microbiologist with 27 years in global pharma-quality leadership—about reframing quality from a controllable expense to a strategic asset. Baroni contrasts “bad-quality” costs (scrap, recalls, deviations) with “good-quality” investments (testing, preventive...
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Managing Royalties in Biotech, Pharma, and Medtech with David Marlin
Nicholas Capman of The FDA Group welcomes David Marlin, Co-Founder and CEO of Metacomet Systems, to explore the often-overlooked complexities of royalty management in life sciences. Drawing from his experience helping over 200 companies automate royalty payouts, David explains how biotech…
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GMP Compliance in 503B Compounding Pharmacies with Jesse Gillikan
Nick Capman talks with Jesse Gillikan, President of cGMP Validation, about the challenges compounding pharmacies face with GMP compliance in 2025. After helping over 100 pharmacies navigate FDA regulations since the 2013 Drug Quality and Security Act, Jesse shares candid insights about this...
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A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa
Nicholas Capman of The FDA Group welcomes David Festa, Director of Corporate Quality at Thermo Fisher Scientific, to explore whether pharmaceutical and medical device companies are auditing suppliers too frequently and with the right personnel. With over 25 years of experience in quality…
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Mastering FDA and EMA Regulatory Meetings with Ashley Preston
Nicholas Capman of The FDA Group welcomes Ashley Preston, SVP of Global Regulatory Affairs & Quality Assurance at BlossomHill Therapeutics, to discuss the critical elements of successful regulatory agency meetings. With over 20 years of experience in regulatory affairs and quality assurance…
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Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
Nicholas Capman, CEO of The FDA Group, welcomes Harri Järveläinen, an independent consultant specializing in non-clinical and regulatory affairs, to discuss the realities of working with Chinese Contract Research Organizations. With over 20 years in the pharmaceutical industry—including…
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The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent
The FDA Group's Nicholas Capman welcomes Keith Parent, CEO of Court Square Group and RegDocs365, to discuss practical approaches to implementing AI in clinical trials and regulatory operations. With 30 years of experience managing infrastructure for life science companies, Keith offers insights…
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Demystifying AI in Life Sciences Supply Chain with Jennifer Chew
The FDA Group's Nicholas Capman welcomes Jen Chew, Vice President of Solutions and Consulting at Bristlecone, to discuss how life sciences companies can effectively implement AI in their supply chain operations. Jen sheds light on a few practical approaches to AI adoption in an industry still...
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Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke
The FDA Group's Nicholas Capman welcomes Annalise Ludtke, Senior Manager of Marketing and Communications at Vodori. They explore the essential steps and challenges involved in bringing compliant marketing content to market in a regulated industry. Discussion points include: Bottlenecks and…
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Navigating Supplier Audits in Japan with Derek Wessman
The FDA Group's Nick Capman sits down with Derek Wessman, a consultant based in Japan, to discuss the intricacies of conducting supplier audits in the Japanese life sciences industry. They explore the unique challenges and opportunities presented by Japanese suppliers and the cultural and...
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Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma
The FDA Group's Nick Capman sits down with pharmaceutical scientist and consultant Gary Ritchie to discuss the intricacies of statistical sampling in biopharmaceuticals. They explore the limitations of the square root of n plus one sampling method, particularly for small lot sizes, and the...
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Quality Metrics that Matter with Kimberly Wallbank
The FDA Group's Nick Capman sits down with quality management consultant Kimberly Wallbank to discuss the challenges and best practices of implementing effective quality metrics in the life sciences industry. Discussion points include: Quality vs. Quantity in Metrics: Kimberly emphasizes the...
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Applying AI in the Life Sciences with MasterControl's Matt Lowe
The FDA Group's Nick Capman sits down with Matt Lowe, Chief Strategy Officer at MasterControl, to discuss the opportunities and challenges of implementing AI in the life sciences industry. Discussion points include: AI Applications in Life Sciences: Matt outlines the broad spectrum of AI...
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Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg
The FDA Group's Nick Capman sits down with Eric Busenburg, President of Euro-American Worldwide Logistics, where he oversees GMP storage and international shipping solutions for life science manufacturers. They discuss the critical challenges and solutions for storage in the life sciences…
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Building and Leading Effective Quality Assurance Teams with Aaron Snyder
The FDA Group's Nick Capman sits down with Aaron Snyder, the Vice President of Quality Assurance at Allotex, where he oversees the development and implementation of quality systems for medical devices and pharmaceuticals. They discuss the critical elements of building and leading a successful...
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The Pharma Startup Playbook: Advice from the Field with Taggart McGurrin
The FDA Group's Nick Capman sits down with Tagg McGurrin, who most recently served as the President and Chief Business Officer (COO/CFO) at Neumentum, Inc., where he led corporate strategy, capital markets, corporate financing, accounting, legal, investor relations, and business development. They...
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Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman
The FDA Group's Nick Capman sits down with Adam Foresman, Head of Quality & Regulatory Affairs at VideaHealth, to explore the intersection of AI, machine learning, and diagnostics within the FDA's regulatory environment. Adam brings over 15 years of experience in medical device design, quality...
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Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck
The FDA Group's Nick Capman sits down with Carlos Yuraszeck, an accomplished leader in biopharmaceutical compliance, operations, and quality assurance, with a specialized focus on driving innovation and efficiency in cell therapy manufacturing. With over two decades of dedicated service in the...
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Leading Through Transition: Strategic Insights from Novartis's Front Lines
The FDA Group's Nick Capman sits down with Stephen Poor, a physician-scientist with over 20 years of experience in the industry, mainly with Novartis — currently serving as Novartis's Global Program Clinical Head (Executive Director). They delve into the psychological and professional impacts of...
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Frequently Asked Questions
How many episodes does The Life Science Rundown have?
The Life Science Rundown currently has 74 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
What is The Life Science Rundown about?
The Life Science Rundown is a podcast for life science professionals hosted by The FDA Group. We dive deep into topics across the RA/QA/Clinical space, covering news, exploring trends, and picking the brains of expert guests.
How often does The Life Science Rundown release new episodes?
The Life Science Rundown has 74 episodes. Check the episode list to see recent publication dates and frequency.
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Who hosts The Life Science Rundown?
The Life Science Rundown is created and hosted by The FDA Group.
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