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The Life Science Rundown

by The FDA Group

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Latest episodes

  • Pharma Tech Transfer Is Knowledge Transfer

    October 26, 2026 · 18 min

    Why does tech transfer remain so hard in pharma , even when every document is neatly in order? Paige Kane, PhD, CPIP, Associate Vice President of Technical Excellence & Transformation at CAI, has spent about 25 years on technology…

  • The Adoption Assumptions Hiding in Your Regulatory Strategy

    October 20, 2026 · 1 hr 4 min

    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…

  • Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success

    October 5, 2026 · 33 min

    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…

  • Is Your Biotech De-Risking or Just Delaying?

    September 18, 2026 · 35 min

    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…

  • Reg Ops Has Been Kept in a Box. This Is the Way Out.

    September 14, 2026 · 24 min

    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…

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  • QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell

    September 1, 2026 · 28 min

    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…

  • Managing AI Risk Across Global Quality Systems

    August 17, 2026 · 32 min

    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…

  • The Case for Engaging Regulatory Early

    August 13, 2026 · 22 min

    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…

  • Why Quality and R&D Default to Conflict (and How to Fix It)

    August 6, 2026 · 30 min

    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…

  • Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar

    July 3, 2026 · 49 min

    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…

  • Why Your CAPA System Isn't Driving Improvement (and How to Fix It)

    June 15, 2026 · 28 min

    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…

  • TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures

    May 18, 2026 · 31 min

    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…

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About the show

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.