The Life Science Rundown

The FDA Group's Nick Capman speaks with Marcus Gesner, Vice President of Global Quality at embecta. With more than two decades of leadership experience at companies including Boston Scientific, Olymp…

The FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical de…

The FDA Group’s Nick Capman sits down with Dr. Manfred Stapff—physician, author, and founder of Candid Advisory Inc., a consultancy specializing in real-world evidence and clinical development—for a …

The FDA Group's Nick Capman sits down with Dr. Kimberly Garko, Chief Technical Officer and 25-year life science veteran, for a deep dive into one of the most misunderstood concepts in the industry: t…

Nick Capman talks with Marcia Baroni—a microbiologist with 27 years in global pharma-quality leadership—about reframing quality from a controllable expense to a strategic asset.

Baroni contrasts “bad…

Nicholas Capman of The FDA Group welcomes David Marlin, Co-Founder and CEO of Metacomet Systems, to explore the often-overlooked complexities of royalty management in life sciences.

Drawing from his e…

Nicholas Capman of The FDA Group welcomes David Festa, Director of Corporate Quality at Thermo Fisher Scientific, to explore whether pharmaceutical and medical device companies are auditing suppliers…

Nicholas Capman of The FDA Group welcomes Ashley Preston, SVP of Global Regulatory Affairs & Quality Assurance at BlossomHill Therapeutics, to discuss the critical elements of successful regulatory a…

Nicholas Capman, CEO of The FDA Group, welcomes Harri Järveläinen, an independent consultant specializing in non-clinical and regulatory affairs, to discuss the realities of working with Chinese Cont…

The FDA Group's Nicholas Capman welcomes Keith Parent, CEO of Court Square Group and RegDocs365, to discuss practical approaches to implementing AI in clinical trials and regulatory operations. With …

The FDA Group's Nicholas Capman welcomes Jen Chew, Vice President of Solutions and Consulting at Bristlecone, to discuss how life sciences companies can effectively implement AI in their supply chain…

The FDA Group's Nicholas Capman welcomes Annalise Ludtke, Senior Manager of Marketing and Communications at Vodori. They explore the essential steps and challenges involved in bringing compliant mark…

The FDA Group's Nick Capman sits down with Derek Wessman, a consultant based in Japan, to discuss the intricacies of conducting supplier audits in the Japanese life sciences industry. They explore th…

The FDA Group's Nick Capman sits down with pharmaceutical scientist and consultant Gary Ritchie to discuss the intricacies of statistical sampling in biopharmaceuticals.

They explore the limitations…

The FDA Group's Nick Capman sits down with quality management consultant Kimberly Wallbank to discuss the challenges and best practices of implementing effective quality metrics in the life sciences …

The FDA Group's Nick Capman sits down with Matt Lowe, Chief Strategy Officer at MasterControl, to discuss the opportunities and challenges of implementing AI in the life sciences industry.

Discussion…

The FDA Group's Nick Capman sits down with Eric Busenburg, President of Euro-American Worldwide Logistics, where he oversees GMP storage and international shipping solutions for life science manufact…

The FDA Group's ⁠Nick Capman⁠ sits down with ⁠Aaron Snyder⁠, the Vice President of Quality Assurance at Allotex, where he oversees the development and implementation of quality systems for medical de…

The FDA Group's Nick Capman sits down with Tagg McGurrin, who most recently served as the President and Chief Business Officer (COO/CFO) at Neumentum, Inc., where he led corporate strategy, capital m…