De-Risking the Early Phase Clinical Trial Supply Chain

Keith Parent, CEO of Court Square Group, discusses De-Risking the Early Phase Clinical Trial Supply Chain with Jim Kernan, CEO of PRONAV Clinical, a 40-year veteran of the pharmaceutical industry. Their conversation focuses on early-phase clinical supply chains, highlighting the shift from linear to multi-nodal supply chains in biotech. Jim explains the role of the Qualified Person (QP) in ensuring GMP compliance and data management, emphasizing the importance of secure data handling. They also discuss the complexities of cold chain logistics, particularly the challenges of maintaining -80°C temperatures for biologics, and the validation of labeling processes for ultra-low temperature products. Jim mentions the Clinical Bridge initiative to share knowledge and experiences with emerging biotech and pharma companies.Driving the Business of Science is the podcast for clinical operations, IT, and business managers in the pharma, biotech, and medical device world.Bringing new products to market takes more than just great science. From R&D and clinical to regulatory and approval life science leaders require fit-for-purpose technology, processes, and partners at step.In the Driving the Business of Science podcast leaders from across the life science industry share real-world experiences and practical insights that will impact your business.Join host Keith Parent, serial life science CEO, as business leaders share experiences and insights on emerging challenges in the life science market.