The Life Science Rundown

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 will take to get there: affordability, equitable access, trustworthy information, and responsible regu...

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 most preclinical teams run their experiments in the wrong order, how to keep a distributed team aligned...

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 that. Carla and Nick Capman get into why the hardest adjustment is professional rather than technical, how...

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 rather than procedural. Andrea and Nick get into the real cost of late QA involvement, how risk-based r...

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 now. Julio and Nick get into why building for the auditor is the wrong instinct, how to introduce AI whe...

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 practice. Leland and Nick get into why risk tolerance is the thing that catches scaling co...

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 takes to break the pattern. Shawn and Nick get into the learned behavior behind the roadblock stereotyp...

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...