Creating a CMC Playbook for a Cell and Gene Therapy Company
Clarkston Consulting recently partnered with a cell and gene therapy client on a CMC playbook. Read a synopsis of the project below or download the full case study.
Download the CMC Playbook for a Cell and Gene Therapy Company Case Study Here
A cell and gene therapy company engaged Clarkston’s operations experts to create a Chemistry, Manufacturing, and Controls (CMC) playbook and work with stakeholders on any necessary revisions. Beyond the CMC playbook, the project was to create and accelerate the adoption of the “Client’s Way” for technical operations. Employees new to the client organization, early in their career, and in unfamiliar roles, coupled with new technology, added complexity to project management.
To ensure product candidate milestones and business objectives would be met, the CMC playbook provided clarification for the CMC teams, functional areas, and individuals involved in each team. How the CMC teams (Core, CMC, CMC sub-team) interacted with each other was refined, with decision-making authority and the escalation and governance at all levels clearly identified. This was necessary to ensure the client’s standard ways of working for CMC were formally documented – instead of each resource leveraging the process they knew from their former companies.
The CMC playbook was created as the guiding document that Technical Operations would use for all product candidates, ensuring consistent execution across platforms and serving as a training document for new product managers and new Technical Operations employees. The playbook became the standard way of working and included topics such as drug lifecycle, documents for decision-making (Target Candidate Profile, Target Product Profile, Quality Target Product Profile), timeline generation with phase deliverables, program teams, governance, team member roles and responsibilities, and functional areas.
Supporting teams or forums were included to ensure the authority and purpose of these types of teams/groups were documented for understanding. Available tools were included to ensure consistent use vs. individuals creating new ones due to not being aware of them. A local dictionary or glossary of terms was also included in the CMC playbook to establish a baseline to improve communication and understanding, especially for terms that had different definitions or ones that were unique to the client.
The CMC playbook featured process best practices, such as how programs were named, charter requirements, RAID log, and meeting execution. Business topics were also included to ensure a consistent understanding of requirements. For example, supplier management and selection were featured due to multiple different functional areas leading the process at different stages of the product lifecycle. Risks and decisions are now documented making periodic project updates, using templates to deliver the information with an appropriate level of detail for management and leadership.
The CMC playbook provided a single reference for how Technical Operations executed its assigned responsibilities. The playbook will continue to evolve to include stage gate reviews with acceptable risk to project timeline or science, and when product candidates transfer from research to development and lastly to commercial operations.
Download the CMC Playbook for a Cell and Gene Therapy Company case study, and learn more about our Cell and Gene Therapy Consulting Services by contacting us below.
Contributions from Linda Plumley
