2026 - 2027 Training Program for CMC Leaders

"Being a CMC leader for a biosimilar project has been the greatest professional challenge of my life. Not only does it require human qualities to constantly maintain cohesion and support for a multisite and multicultural team with differing individual priorities and backgrounds, but it also demands communication and leadership skills with management, business partners, CMOs, and CROs. Moreover, a problem-solving mindset is essential to manage all sorts of risks and issues, resources, timelines, budget, and to handle the pressure and stress from management. Additionally, one must acquire understanding in all project areas: cell line generation, biosimilarity, cell banking, cell culture, downstream processing, analytics, bioassays, statistics, prevention of viral contamination, viral clearance, drug substance and drug product characteristics, formulation, medical device design and validation, knowledge of CQAs and their degradation mechanisms, safety testings, regulatory standards for clinical trials and MAA/BLA submissions, scale-up & tech transfer, QA and phase-appropriate GMPs, all steps of process validation, supplier QTA reviews, establishment of contracts with CROs and CMOs, organization of source documents, CTD drafting, FDA interactions, preparation for FDA inspections, and CRO and CMO audits, etc.

Due to the obvious multidisciplinary nature of the role, it is inevitable to realize most CMC leaders have gaps of experience in some CMC areas. Based on our past experience, Hervé and I decided to design a 7-month training program for CMC leaders (or equivalent) in biotechnology (from mammalian cells, yeasts or bacteria cultures, for gene & cell therapy, ATMP, biosimilars, antibody or any other large molecules).

Ultimately, as a CMC leader, you are the conductor responsible for assembling all the pieces of the CMC package puzzle at the time of clinical trials and BLA submission, ensuring all the pieces from multiple departments and sites fit and arrive on time, and are compliant. You must become extremely confident in this key role to lead the CMC team in moving the project in the right direction. While it is not expected for the CMC leader to become an expert in all detailed aspects of CMC-related topics, it is imperative to have a correct level of knowledge of CMC-specific sciences, industry best practices, and up-to-date regulatory standards, as well as the proper evaluation of business and regulatory risks to create the best project strategy and long-term plan that will lead to product market approval.

We created the dreamed training for biotech CMC leaders. I hope to see you on-board with us, enjoying the courses and workshops in this 7-month journey together !!! "

- Mylène Talabardon, PhD-