TECH OUTLOOK 8SEPTEMBER 2024IN MY OPINIONFACILITATING A LESSONS LEARNED SESSION WITH YOUR CMO By Yvonne Ware, Associate Director, CMC, BioNTechSponsors invest significant time and money managing Contract Development and Manufacturing Organizations (CDMOs) to ensure seamless delivery of cGMP materials and products with particular attention to safety, quality, and on-time delivery. To protect that investment, it is important to periodically assess project performance for any lessons learned that can be applied to current and future projects with CDMOs employed by the company. A lessons learned session can be utilized to document what is working well while also looking to improve upon any areas where things could have gone better. Whether a program is in early or late-stage clinical development or commercial-stage manufacturing, there are many benefits to facilitating a lessons learned session in partnership with your external manufacturers. Determining when to gather lessons learned can depend on how a particular program is performing. If it has been going relatively smoothly it may be good to reflect after certain major milestones, such as the completion of a tech transfer, before starting clinical manufacturing, or at the end of a clinical manufacturing campaign. If the program encounters significant issues, whether technical or operational, it might be a good time to hit pause and work together with the CDMO to identify immediate areas for improvement. It may seem counterintuitive but even completion Yvonne Ware
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