The Life Science Rundown

Oct 25 2024 47 ep. 33 mins 15
The Life Science Rundown Podcast artwork

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.

  Science
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Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke

Oct 25 2024 35 mins  
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 marketing content to market in a regulated industry. Discussion points include: Bottlenecks and Feedback Challenges: Annalise details how differing team goals, particularly between market

Navigating Supplier Audits in Japan with Derek Wessman

Oct 17 2024 27 mins  
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 the unique challenges and opportunities presented by Japanese suppliers and the cultural and regulatory nuances that impact auditing processes. Discussion points include: Language and Cul

Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma

Aug 29 2024 18 mins  
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 of the square root of n plus one sampling method, particularly for small lot sizes, and the advantages of more rigorous statistical approaches. Discussion points include: Limitatio

Quality Metrics that Matter with Kimberly Wallbank

Aug 19 2024 41 mins  
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 industry. Discussion points include: Quality vs. Quantity in Metrics: Kimberly emphasizes the importance of focusing on meaningful metrics rather than simply tracking throughput. Al

Applying AI in the Life Sciences with MasterControl's Matt Lowe

Jul 15 2024 30 mins  
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 points include: AI Applications in Life Sciences: Matt outlines the broad spectrum of AI applications, from early-stage drug discovery to post-market analysis of customer feedback

Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg

Jul 03 2024 32 mins  
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 manufacturers. They discuss the critical challenges and solutions for storage in the life sciences industry, particularly for manufacturers experiencing rapid growth. Discussion points incl

Building and Leading Effective Quality Assurance Teams with Aaron Snyder

Jun 20 2024 55 mins  
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 devices and pharmaceuticals. They discuss the critical elements of building and leading a successful QA team in the life sciences industry. Discussion points include: Recogniz

The Pharma Startup Playbook: Advice from the Field with Taggart McGurrin

Jun 18 2024 50 mins  
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 markets, corporate financing, accounting, legal, investor relations, and business development. They discuss the critical elements of planning, governance, and capital access necessa

Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman

May 15 2024 28 mins  
The FDA Group's Nick Capman sits down with Adam Foresman, Head of Quality & Regulatory Affairs at VideaHealth, to explore the intersection of AI, machine learning, and diagnostics within the FDA's regulatory environment. Adam brings over 15 years of experience in medical device design, quality management systems, and regulatory affairs, with a recent focus on AI in the

Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck

Apr 30 2024 18 mins  
The FDA Group's Nick Capman sits down with Carlos Yuraszeck, an accomplished leader in biopharmaceutical compliance, operations, and quality assurance, with a specialized focus on driving innovation and efficiency in cell therapy manufacturing. With over two decades of dedicated service in the biopharmaceutical industry, most recently serving as the Head of GMP Manufacturing a