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.
Latest Episode
How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson (09.12.2025)
Previous Episodes
- From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo
- How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva
- A Playbook for FDA Inspections and Remediation with Jeff Hines
- Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah
- Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim
- Staying Ready for the FDA (When Inspections Are Less Predictable)
- Building the Next-Gen Lab: AI in a GLP Environment with Catherine Lunardi
- How to Build High-Performing Quality Teams with Marcus Gesner
- The 4 Cs of MedTech Leadership with Sean Gallimore
- The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff
- Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)
- From Cost Center to Value Driver: Rethinking Quality in the Life Sciences with Marcia Baroni
- Managing Royalties in Biotech, Pharma, and Medtech with David Marlin
- GMP Compliance in 503B Compounding Pharmacies with Jesse Gillikan
- A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa
- Mastering FDA and EMA Regulatory Meetings with Ashley Preston
- Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
- The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent
- Demystifying AI in Life Sciences Supply Chain with Jennifer Chew
- Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke
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