| |OCTOBER 202319CIOReviewLessons 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 1JUNE - 2023JUNE - 20232FACILITATING A LESSONS LEARNED SESSION WITH YOUR CMO By Yvonne Ware, Associate Director, Manufacturing Operations at 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 or 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 CDMOsYvonne WareCXO INSIGHTSRelated Batch/Method/Stability referenceDate (if applicable)Category1LessonAlln/aCommunicationCDMO and Sponsor open to suggestions, i.e., appropriate level of detail in deviation reportsAllQ4 2022Project managementGantt charts provided by CDMO aided in aligning expectationsWhat can we do better next time?Related Batch/Method/Stability referenceDate (if applicable)Category1LessonRecommend Change to ImplementAlln/aSystemsNeed more process definition early onImplement QbD (quality by design) before Tech TransferBatch 001-003 Q1 2023Batch recordsClearer instructions needed in the batch records to help prevent deviations and save timeUtilize decision trees in batch records for known situation with complexity of path(s) forwardWhat 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. 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: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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