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The Life Science Rundown

The FDA Group
FDA
Artificial Intelligence
Quality Culture
Quality Management System
Regulatory Affairs
Data Governance
Cost Of Quality
Quality Systems
FDA Inspections 2025
Data Integrity
ISPE
Quality
Real World Evidence
Royalties
Patient Safety
AI In Regulatory Review
Leadership
Regulatory Compliance
Artificial Intelligence In Medicine
EMA

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 monthlyEpisodes77Founded6 years ago
Number of ListenersCategories
ScienceLife Sciences

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Artwork for The Life Science Rundown

Latest Episodes

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 d... more

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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

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Recent Guests

Yeime Martich
Quality/compliance professional with 25 years in pharma; computer systems engineer focused on inspection readiness
Unspecified in transcript
Episode: TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
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

Host

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

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Talking Points

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TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
Q: What does inspection readiness as a competitive advantage look like in practice?
A state of confidence and speed, not perfection; minimally compliant processes that can be executed reliably with the ability to explain the rationale behind each requirement and its impact on patient safety.
TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
Q: Why do most life science organizations still treat inspection readiness as reactive rather than strategic?
Because inspections are viewed as an event tied to regulators' schedules rather than an ongoing health check of the quality system; the aim should be to embed readiness into daily operations so the system is always in control.
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.

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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?

These podcasts share a similar audience with The Life Science Rundown:

1. FDA Watch
2. BioCentury This Week
3. Up First from NPR
4. The Daily
5. Business Of Biotech

How many episodes of The Life Science Rundown are there?

The Life Science Rundown launched 6 years ago and published 77 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. Yeime Martich
2. Sneha Saggurthi
3. John Butler
4. AJ Acker
5. Tammy Sarnelli
6. Cary Smithson
7. Nelly Viseux
8. Jackie Klecker

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