The Life Science Rundown

Nick Capman talks with Jesse Gillikan, President of cGMP Validation, about the challenges compounding pharmacies face with GMP compliance in 2025. After helping over 100 pharmacies navigate FDA regulations since the 2013 Drug Quality and Security Act, Jesse shares candid insights about this industry transformation. The conversation reveals how compounders have moved from resistance to acceptance o...

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 too frequently and with the right personnel. With over 25 years of experience in quality management and oversight of tens of thousands of suppliers, David advocates for a more strategic approach that...

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 agency meetings. With over 20 years of experience in regulatory affairs and quality assurance, Ashley shares expertise on preparing for and executing effective interactions with FDA and EMA. While t...

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 Contract Research Organizations. With over 20 years in the pharmaceutical industry—including experience with AstraZeneca and in Chinese biotech—Harri shares first-hand insights on selecting and managing Ch...

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 30 years of experience managing infrastructure for life science companies, Keith offers insights on how organizations can effectively adopt AI while maintaining compliance. Discussion points include: I...

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 operations. Jen sheds light on a few practical approaches to AI adoption in an industry still adapting to post-COVID realities. Discussion points include: Strategic Implementation Approach: Jen emphas...

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 marketing and regulator...

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 Cultural Barriers:...

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: Limitations of Square Root...

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. Aligning Metrics w...

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 and adverse ev...

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 include: Understan...

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: Recognizing the Need for Change:...

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 necessary to build a st...

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 dental diagnosti...

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 at the Astellas I...

The FDA Group's Nick Capman sits down with Stephen Poor, a physician-scientist with over 20 years of experience in the industry, mainly with Novartis — currently serving as Novartis's Global Program Clinical Head (Executive Director). They delve into the psychological and professional impacts of organizational changes, particularly focusing on identity and adaptation during times of transi...

The FDA Group's Nick Capman sits down with Nick Klingensmith, a four-time cancer survivor, motivational speaker, and mindset coach. They discuss the challenges of remote work, especially the disconnect between leadership, management, and frontline employees, and how it affects company culture and employee engagement. Key points discussed include: Klingensmith's journey from sales in the te...

The FDA Group's CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries. Discussion points include: The need for a formalized inspection readiness program, especially highlighted by challenges in accessing critical documents like quality manu...

The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance. Discussion points include: The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance. The evolution of TMF str...

The FDA Group's CEO Nick Capman sits down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups. Discussion points include: » Common questions startups have around engaging with the FDA and determining costs and timelines for GMP facility setup and clinical trials. » Recommendations for engaging regulatory experts early and doin...

The FDA Group's CEO Nick Capman, sits down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector. Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise. Discussion points include: » The essence of quality culture being more...

The FDA Group's CEO, Nick Capman, sits down with Jonathan Wacks to discuss ways to minimize the stress associated with FDA inspections. Jonathan is an experienced healthcare industry executive with a proven track record in startups and Fortune 500 companies. He has a strong background in international QA/RA, engineering, and project management, specifically with medical devices, electronic ass...

The FDA Group's CEO Nick Capman, sits down with Sunil Gupta, a seasoned expert in pharmaceutical data, to shed light on the nuances of SDTM (Study Data Tabulation Model) compliance and its pivotal role in clinical trial processes. Sunil brings a wealth of experience from his three decades in the pharmaceutical industry, focusing on areas like SAS programming, submissions, and leveraging new te...

The FDA Group's CEO Nick Capman, sits down with David Marks to discuss the intricacies of Quality culture and QA communication pathways in the life sciences. David is a strategic advisor and experienced executive with a proven track record in establishing global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs across biopharma and CROs. Discussion points...