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The Life Science Rundown

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

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 monthlyEpisodes85Founded6 years ago
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Life SciencesScience

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Latest Episodes

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 beco... more

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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 an... more

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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 a... more

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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 ... more

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Recent Guests

Kevin Walton
CEO of Baseimmune, London-based biotechnology company working on active immunotherapies for fibrosis
Baseimmune
Episode: Is Your Biotech De-Risking or Just Delaying?
Carla Griffin
CEO and Principal Strategist of SWOT (Sugar Water Operations Team)
SWOT (Sugar Water Operations Team)
Episode: Reg Ops Has Been Kept in a Box. This Is the Way Out.
Andrea Bell
Biotechnology executive with 25+ years in quality and CMC
BioNTech (BioNTainer)
Episode: QA Is Not a Gate — It’s a Technical Partner, with Dr. Andrea Bell
Julio Salwen
Chief Quality Officer for the MiniMed Group (spun out from Medtronic)
MiniMed Group
Episode: Managing AI Risk Across Global Quality Systems
Leland Keyt
Vice President of Regulatory Affairs and Quality Assurance at Apreo Health
Apreo Health
Episode: The Case for Engaging Regulatory Early
Shawn Fuller
Former VP of Quality and Regulatory at Surmodics
Surmodics
Episode: Why Quality and R&D Default to Conflict (and How to Fix It)
Sid Bhatnagar
CEO of American Society for Quality (ASQ)
ASQ
Episode: Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
Dan Eagles
Vice President of Quality Assurance for NeuraSignal
NeuraSignal
Episode: Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
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

Hosts

Nicholas Catman
Host of The Life Science Rundown; affiliation: The FDA Group
Nicholas Capman
Host of The Life Science Rundown; affiliation: The FDA Group

Chart Rankings

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Talking Points

Recent interactions between the hosts and their guests.

Is Your Biotech De-Risking or Just Delaying?
Q: Why is time such a critical constraint for these companies, and how do you balance speed with quality when dealing with CROs and CDMOs?
Prioritize high quality and speed, and be willing to invest; interview the people who will work on the project, not just the CRO brand, to ensure execution capability.
Is Your Biotech De-Risking or Just Delaying?
Q: So what would you say are some of the most common obstacles small biotech founders face when translating promising science into a commercially viable product or platform?
Focus is key; founders need to choose a single beachhead, avoid over-scoping, and push for early killer data to validate feasibility and attract larger rounds.
Why Quality and R&D Default to Conflict (and How to Fix It)
Q: How do incentives, timelines, and leadership messaging unintentionally reinforce the perception that speed and innovation compete with quality?
The conversation reveals that quality often ends up at the end of the project timeline, leading to pressure on R&D to meet deadlines and a push-pull dynamic where speed is prioritized over thorough validation, unless teams are guided to include quality input throughout the process.
Why Quality and R&D Default to Conflict (and How to Fix It)
Q: So why do cross-functional teams so quickly fall into role-based identities during regulatory discussions?
Shawn explains that learned behavior accumulates over years of experience, and past experiences with quality roadblocks and R&D deadlines create a default posture that becomes hard to break in new projects unless there is conscious effort to shift toward partnership and shared goals.
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.

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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 show targets life sciences professionals working across RA, QA, and clinical operations, frequently hosting senior leaders and regulators to unpack practical challenges in quality systems, regulatory strategy, and workforce development. Episodes repeatedly surface themes like building quality cultures, AI governance in regulatory processes, data governance for submissions, phase-appropriate quality across development stages, and how to navigate global regulatory landscapes. Notable is the emphasis on actionable frameworks, real-world anecdotes from industry leaders, and a collaborative stance toward regulators and cross-functional teams. The format tends to blend leadership perspectives with hands-on, operational guidance, making it use... 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. SmartLess
3. BioCentury This Week
4. NPR News Now
5. The Daily

How many episodes of The Life Science Rundown are there?

The Life Science Rundown launched 6 years ago and published 85 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. Kevin Walton
2. Carla Griffin
3. Andrea Bell
4. Julio Salwen
5. Leland Keyt
6. Shawn Fuller
7. Sid Bhatnagar
8. Dan Eagles

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