SEPTEMBER 20249TECH OUTLOOKor halting of a program could be another appropriate time to facilitate a lessons learned session. The natural inclination can be to stop and move on as quickly as possible but there may still be valuable lessons learned to identify and apply to other programs and projects within that team or across the broader organization. Lessons learned outcomes can be applied to a Cell and Gene Portfolio, for example, a platform within that portfolio, specific programs within that platform, and even across CDMOs. If there are lessons learned that can be applied to a wider audience, it is important to communicate them. Now that many of us are operating in a hybrid office environment it is recommended to take a hybrid approach to collecting lessons learned. Project managers from both the CDMO and sponsor can distribute a template to their respective teams, allowing the individual team members to add lessons learned directly to the template. A follow-up meeting can then be held to brainstorm additional lessons learned. Grouping the items by category can facilitate discussions. Once all the lessons learned from both sides have been collated, a review meeting should be set up to discuss any areas in more depth and answer any remaining questions. Here is a template to collect the lessons learned with some examples:Lessons learned outcomes can be applied to a Cell and Gene Portfolio, for example, a platform within that portfolio, specific programs within that platform, and even across CDMOsWhat went well?What can we do better next time?1Category examples: project management, communication, document review, quality systems, batch record design, shipping, tech transfer package, resources, systems, QC method/instrumentation, interim release, final release, stability studies, method verification, quality events, etc. After all the work done by the CDMO and Sponsor to collect lessons learned it is important to record the action items to follow up on. These should be part of a regular check-in during team meetings. For example, if a gap in procedures was identified it will be important to follow-up on the status of the draft SOP to alleviate that gap. Keep the lessons learned session information visible to refer to and/or for onboarding new members to the team. If possible, share the lessons learned outcomes across the company to facilitate learnings for other teams and to prevent them from making the same mistakes. Whether in early stage, late stage, or commercial-stage development, using a lessons learned tool can help foster collaboration and information-sharing amongst the team to ensure timelines are met and products are safe for patients.
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