The Life Science Rundown

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 leadership requires. Sid and Nick get into why AI pressure now comes from boards and investors rather than th...

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 statement is where most CAPAs go wrong, how teams back-engineer root cause analysis to match a fix the...

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 may be creating more audit risk than you realize. Yeime discusses why "minimally compliant"...

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 determine inspection outcomes. Sneha discusses how auditors think and prioritize, why logistics matter mo...

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 patients behind, and what it would take to change that. John discusses how FDA clarity on endpoints transforme...

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 and the strategies that drive successful multi-regional approvals. AJ discusses why ICH compliance doesn&...

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 culture. Tammy discusses how organizational silos create friction in large companies, why limited resou...

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 data governance has become urgent across three fronts — structured submissions, cross-functional inter...

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 100-person CMC organization at Regeneron to balance innovation with operational execution, why documenti...

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 Vice President of Quality and Development Services at Lifecore Biomedical , about how sponsors and CDMO...

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 engineering, operations, and manufacturing leadership, Mike shares his perspective on why the industry is enter...

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 the biopharmaceutical industry. A microbiologist by training with more than 35 years of BioPharma leader...

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 global regulatory strategy for small- and large-molecule programs from Phase 1 through launch....

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 should be preparing for now. Maria draws on two decades of leadership across nonprofit, government...

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 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection environm...

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 pharmaceuticals, medical devices, and diagnostics, Marwan has held senior roles in R&D, regulatory...

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 innovation—including work on technologies to detect pregnancy-acquired cardiovascular disease. Their conversation explore...

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 readiness across multiple sites while leading global quality teams. Jeff shares why inspections feel less...

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 build the next generation of labs. Catherine explains the biggest challenges labs face today—like...

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 organization truly high-performing. Marcus shares why compliance is only the baseline “entry fee” for...

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 leadership—the 4 Cs: Strategic Clarity, Capabilities, Compliance, and Connectedness—and how each one dir...

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 decisions, and public understanding of evidence. Dr. Stapff draws on decades of experience across medical a...

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 strategic investment—and how companies can embed that mindset into their culture, systems, and leade...

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 controls, oversight) and explains why the latter pay for themselves in resilience and brand value. She...

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, pharma, and medical device firms struggle to manage licensing agreements as they scale. What starts as a simp...