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The Life Science Rundown

The FDA Group
FDA
Artificial Intelligence
Quality Culture
Regulatory Affairs
Data Governance
Cost Of Quality
Quality Systems
Data Integrity
FDA Inspections 2025
ISPE
Quality
Real World Evidence
Royalties
AI In Regulatory Review
Leadership
Artificial Intelligence In Medicine
EMA
Regulatory Submissions
Regeneron
Biopharmaceutical Industry

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.

PublishesTwice monthlyEpisodes76Founded6 years ago
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Life SciencesScience

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Latest Episodes

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 documenta... more

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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 psych... more

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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... more

YouTube

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 bre... more

YouTube

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Recent Guests

Sneha Saggurthi
Quality Compliance Manager at Cartesian Therapeutics; Lead Auditor
Cartesian Therapeutics
Episode: What Auditors Are Actually Looking For — and the Psychology Behind How They Find It
John Butler
President and CEO of Akebia Therapeutics
Akebia Therapeutics
Episode: Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That
AJ Acker
Industry veteran focused on rare diseases and biotech with approvals across FDA, EMA, and PMDA
Independent/Industry
Episode: Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
Tammy Sarnelli
Senior Vice President of Regulatory Affairs and Clinical Quality at Amylyx Pharmaceuticals
Amylyx Pharmaceuticals
Episode: Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
Cary Smithson
Managing Partner and owner of Leap Ahead Solutions
Leap Ahead Solutions
Episode: Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
Nelly Viseux
Vice President of Cell Therapy, Development, Manufacturing, Supply and Quality at Regeneron
Regeneron
Episode: Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
Jackie Klecker
Executive Vice President and Head of Quality and Development Services at Lifecore Biomedical
Lifecore Biomedical
Episode: Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
Mike Martin
President and CEO of ISPE
ISPE
Episode: Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin
Chris Masterson
Senior Vice President and Chief Quality Officer
Tolmar
Episode: How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson

Host

Nicholas Capman
Host of The Life Science Rundown; The FDA Group

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Talking Points

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Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)
Q: What practical steps can organizations take to shift from reactive to proactive quality?
Invest in people with strong technical expertise, implement regulatory intelligence, optimize the quality management system for data access and KPIs, establish a robust scorecard, and foster a learning culture with psychological safety so issues can be raised and addressed without fear of retribution.
How to Build High-Performing Quality Teams with Marcus Gesner
Q: What should leadership drive to foster a high-performing quality culture?
Leadership should invest in quality outcomes, tie incentives to quality metrics, demonstrate visible support for quality initiatives, and embed quality as a valued service across functions.
How to Build High-Performing Quality Teams with Marcus Gesner
Q: What are the specific outcomes that define high-performance in quality, beyond basic regulatory compliance?
Outcomes include reduced holds and disrupts, improved scrap and yield metrics, smoother design-to-manufacturing transfers, faster time-to-market, and a reliable, consistent supply that supports revenue.
Managing Royalties in Biotech, Pharma, and Medtech with David Marlin
Q: What does the typical implementation process look like and how long does it take?
Implementation follows a standardized, repeatable approach: bring all agreements into the system, load product and sales data, and run parallel royalty calculations to compare against legacy results. The process often requires data cleanup, data mapping between skew numbers and IP, and multiple iterative runs; in practice, three months is a common minimum for a mid-sized rollout, while larger enterprises can take six to nine months, with extreme cases taking longer before full pay-out capability is achieved.
Managing Royalties in Biotech, Pharma, and Medtech with David Marlin
Q: What makes royalties in life sciences so complex?
Royalties involve many variables: different license scopes (therapeutics, diagnostics, research use), multiple jurisdictions with varying patent protections, tiered sales-based rates, and sometimes multiple licensors for a single product. The process also includes advances or minimum guarantees, complex data inputs from contracts, sales, and product data, and the need to reconcile and audit across ERP systems with accurate accruals for the balance sheet.

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Frequently Asked Questions About The Life Science Rundown

What is The Life Science Rundown about and what kind of topics does it cover?

The run focuses on regulatory, quality, clinical development, and operations topics across life sciences, with a steady stream of guests who are senior leaders, regulators, or practitioners. Episodes frequently dissect FDA inspections, regulatory submissions, data governance for submissions, AI in regulatory review, and organizational culture around quality. The conversations balance practical playbooks (remediation, audit readiness, phase-appropriate quality systems) with strategic leadership insights (governance, workforce development, cross-functional alignment). A standout pattern is translating complex regulatory and quality concepts into actionable guidance for teams ranging from small biotechs to large pharma, often illustrated with ... more

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Which podcasts are similar to The Life Science Rundown?

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1. FDA Watch
2. Freakonomics Radio
3. Planet Money
4. Biotech Hangout
5. BioCentury This Week

How many episodes of The Life Science Rundown are there?

The Life Science Rundown launched 6 years ago and published 76 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on The Life Science Rundown?

Recent guests on The Life Science Rundown include:

1. Sneha Saggurthi
2. John Butler
3. AJ Acker
4. Tammy Sarnelli
5. Cary Smithson
6. Nelly Viseux
7. Jackie Klecker
8. Mike Martin

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