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.
Host
Keith Parent
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