Summary
In this episode of Driving the Business of Science, 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.
Listen on your favorite podcast platforms
iHeart Radio | Apple Podcasts | Spotify | Amazon Music | Buzzsprout
Key Takeaways
Introduction and Overview of Court Square Group
- Keith Parent introduces himself as the CEO of Court Square Group, a managed service firm specializing in IT infrastructure for life science clients, including pharmaceutical, biotech, and medical device companies.
- Keith mentions their system, ARCC, an audit-ready, compliant cloud environment, which can host and manage applications from pre-clinical through manufacturing.
- Keith introduces Jim Kernan, who has a background in clinical trial operations, particularly in early-phase clinical supply across the globe.
- The topic of the podcast is de-risking the early-phase clinical trial supply chain.
Jim Kernan’s Background and Role
- Jim Kernan thanks Keith and mentions his extensive experience in clinical trial operations, focusing on early-phase clinical supply across the US and Europe.
- Jim has 40 years of experience in the pharmaceutical industry, with the last 20 years on the clinical side.
- Jim explains his role in managing data and many other aspects of clinical supply operations.
- Keith emphasizes the importance of understanding the complexities of the life science world, which goes beyond the actual science.
Changes in Clinical Trial Supply Chain
- Jim discusses the evolution from small molecule production to biotech, highlighting the shift from a linear supply chain to a multi-nodal, geographically dispersed one.
- He explains the increased complexity and data generation in the biotech industry, which requires secure and comprehensive data management.
- Jim mentions the importance of real-time data review to ensure timely and safe delivery of clinical trial materials.
- Keith shares his experience of meeting Jim at a conference and learning about the clinical supply chain, particularly in the EU.
The Role of Qualified Person (QP)
- Jim explains the role in the EU of a Qualified Person (QP) in batch certification and supply chain GMP compliance.
- The QP reviews data from various elements of the manufacturing supply chain to ensure compliance with EU GMP regulations.
- Jim describes the QP’s responsibility in traceability and ensuring no hidden gaps in the supply chain.
- Keith inquires about the certification process for QPs, and Jim explains that it is a role specific to the EU and requires additional study beyond the basic science or pharmacy degree.
Navigating EU Complexities with PRONAV Clinical
- Jim discusses how PRONAV Clinical helps navigate EU complexities for emerging biotech and pharma companies.
- He explains the use of a standardized template called PROMAP to manage tasks and documents related to clinical trial materials.
- The template includes traffic lights to indicate the status of tasks and allows direct communication within the system.
- Jim highlights the success of the PROMAP platform, which has become essential for project management and record-keeping.
Challenges in Cold Chain Management
- Keith and Jim discuss the challenges of maintaining cold chain management, particularly for biologics.
- Jim explains the importance of maintaining low temperatures to preserve biological stability and the role of dry ice in transportation.
- He describes the challenges of dry ice sublimation, the impact of pressure variation associated with changes in altitude, and the need to maintain a high concentration of carbon dioxide gas around the dry ice.
- Jim shares an example of a validation process for labeling post-freezing of clinical trial materials, which required special work with the glue on the labels and validation of the labelling process.
The Business of Science and Future Collaborations
- Keith emphasizes the importance of understanding the complexities of the life science world, which scientists often overlook.
- Jim mentions his involvement in a consortium called Clinical Bridge, which aims to share knowledge and experiences with emerging biotech and pharma companies.
- The Clinical Bridge forum will provide video content and online resources to help navigate clinical trial challenges.
- Keith expresses interest in future collaborations and thanks Jim for the insightful discussion.