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PODCAST

The Life Science Rundown

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.

science life sciences

All Episodes

00:52:24

A Playbook for FDA Inspections and Remediation with...

The Life Science Rundown ·

2025/10/16

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 environments and keeping people confident under pressure. He outlines the four-room model for inspection

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00:46:19

Leading Cross-Functional Teams from Concept to...

The Life Science Rundown ·

2025/10/06

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, clinical, scientific affairs, and operations. He brings a rare, holistic view of how leadership,

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00:28:35

Breaking Down FDA’s E21 Draft Guidance: Including...

The Life Science Rundown ·

2025/09/29

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work on technologies to detect pregnancy-acquired cardiovascular disease.Their conversation explores FDA/ICH’s new E21 draft guidance, Inclusion of Pregnant and Breastfeeding Women in Clinical Trials

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00:28:02

Staying Ready for the FDA (When Inspections Are Less...

The Life Science Rundown ·

2025/09/19

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 predictable today—with more variability in inspector experience and a higher likelihood that minor issues

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00:38:00

Building the Next-Gen Lab: AI in a GLP Environment...

The Life Science Rundown ·

2025/09/19

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 fragmented data, manual processes, and costly compliance reviews—and how AI can help orchestrate data,

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00:49:35

How to Build High-Performing Quality Teams with...

The Life Science Rundown ·

2025/09/08

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 quality—and how high-functioning teams go further by protecting a company’s right to compete, preventing

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00:54:16

The 4 Cs of MedTech Leadership with Sean Gallimore

The Life Science Rundown ·

2025/08/18

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 directly impacts growth, culture, and execution.Listeners will learn how to:Pressure-test whether your

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00:51:13

The Power (and Pitfalls) of Real-World Evidence with...

The Life Science Rundown ·

2025/07/28

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 affairs, clinical trials, and RWE analytics to explain why real-world evidence isn’t a replacement for

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00:54:31

Quality Is Not a Cost Center—It’s a Culture (with Dr....

The Life Science Rundown ·

2025/07/15

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 leadership practices. She outlines the difference between good and poor quality costs, explains how to build

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00:44:57

From Cost Center to Value Driver: Rethinking Quality...

The Life Science Rundown ·

2025/07/08

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 illustrates the stakes with a $600 million nationwide OTC-drug recall caused by chemically treated

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00:44:02

Managing Royalties in Biotech, Pharma, and Medtech...

The Life Science Rundown ·

2025/06/09

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 simple once-a-year payment can quickly evolve into a tangled web of tiered rates, stacked IP,

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00:24:23

GMP Compliance in 503B Compounding Pharmacies with...

The Life Science Rundown ·

2025/05/20

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 industry transformation.The conversation reveals how compounders have moved from resistance to acceptance of GMP requirements, though major hurdles persist. For 503B facilities, the primary challenge isn't

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00:41:42

A Smarter Approach to Supplier Quality Audits with...

The Life Science Rundown ·

2025/02/28

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 management and oversight of tens of thousands of suppliers, David advocates for a more strategic approach that balances quality, compliance, and business needs through "exception-based" auditing.Rather than

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00:40:45

Mastering FDA and EMA Regulatory Meetings with Ashley...

The Life Science Rundown ·

2025/02/10

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, Ashley shares expertise on preparing for and executing effective interactions with FDA and EMA.While the FDA and EMA are both considered first-tier regulatory agencies, they handle meetings differently. FDA

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00:38:08

Working with Chinese CROs: Benefits, Risks, and Best...

The Life Science Rundown ·

2025/02/05

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 experience with AstraZeneca and in Chinese biotech—Harri shares first-hand insights on selecting and managing Chinese CRO partnerships while addressing common misconceptions.Chinese CROs have evolved significantly

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00:38:24

The Smart Way to Adopt AI in Clinical Trials and...

The Life Science Rundown ·

2024/11/22

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 on how organizations can effectively adopt AI while maintaining compliance.Discussion points include: Industry Adoption Patterns: Keith contrasts how large pharma companies are establishing AI centers of

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00:39:10

Demystifying AI in Life Sciences Supply Chain with...

The Life Science Rundown ·

2024/11/14

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 adapting to post-COVID realities. Discussion points include: Strategic Implementation Approach: Jen emphasizes the importance of starting with simple, tactical applications before moving to complex strategic

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00:35:28

Streamlining Promotional Reviews in the Life Sciences...

The Life Science Rundown ·

2024/10/25

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 Feedback Challenges: Annalise details how differing team goals, particularly between marketing and regulatory, often lead to bottlenecks, making it essential to streamline feedback and improve claim

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00:27:40

Navigating Supplier Audits in Japan with Derek Wessman

The Life Science Rundown ·

2024/10/17

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 regulatory nuances that impact auditing processes. Discussion points include: Language and Cultural Barriers: Derek explains how the significant language barrier and cultural differences can impact audit efficiency

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00:18:54

Small Lots, Big Risks: Rethinking Statistical...

The Life Science Rundown ·

2024/08/29

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 advantages of more rigorous statistical approaches. Discussion points include: Limitations of Square Root of n + 1: Gary explains why this commonly used method is inadequate for small biopharmaceutical lot

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64 results

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