The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
A few lessons on adaptability, intentional innovation, and empowering teams to navigate scientific uncertainty.
 • The FDA Group
37:59
Consultant Spotlight: What 30+ Years of FDA, Consent Decree, and GMP Work Teaches You About Fixing Real Quality Problems
A conversation with one of our senior consultants, Neal Siegel, PhD, on system-level thinking, consent decree lessons, and what experienced quality…
 • The FDA Group
29:09
Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
How disciplined knowledge transfer, risk management, and communication prevent costly delays as products scale.
 • The FDA Group
35:24
Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin
ISPE’s Mike Martin shares how automation, culture, and lifelong learning are redefining what it means to work in pharma.
 • The FDA Group
42:34
How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson
Tolmar’s Senior Vice President of Quality and Chief Quality Officer shares how teams can embed quality as a lived value—from the executive suite to the…
 • The FDA Group
43:27
From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo
A veteran regulatory strategist, global submission leader, and commercialization advisor walks us through how to navigate the clinic-to-commercial…
 • The FDA Group
48:45
How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva
DIA’s Chief Science & Regulatory Officer explains how FDA and global counterparts are adopting AI for efficiency while preserving scientific rigor…
 • The FDA Group
51:29
A Pressure-Tested Playbook for FDA Inspections and Remediation with Jeff Hines
Coruna Medical's Vice President of Quality shares his 4-room inspection model and how to lead through remediation with composure, clarity, and…
 • The FDA Group
52:24
Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah
DIA Global’s CEO shares how leaders can balance innovation, rigor, and collaboration across R&D, regulatory, and commercial functions to deliver quality…
 • The FDA Group
46:19
Breaking Down E21: Including Pregnant & Breastfeeding Women in Clinical Trials with Regina Atim
How FDA/ICH’s draft E21 guidance shifts sponsors from default exclusion to risk-based inclusion—and what to do next.
 • The FDA Group
28:35
Mentorship Is Leadership (in Quality): How to Pass the Torch Well with Edward Armstrong
Insights from biotech quality executive Edward Armstrong.
 • The FDA Group
48:53
How to Stay Ready for the FDA (When Inspections Are Less Predictable) with Jeff Brenneman
Alora Pharmaceuticals' VP of Global Operations Quality shares how teams can sustain inspection readiness, simplify quality systems, and keep teams…
 • The FDA Group
28:02
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