Outsourcing, Technology Transfer, and CMO-Client Relationships

A large part of biopharmaceutical companies now rely on outsourcing partners for the development and manufacture of biological drug substance and drug product for clinical studies and commercial supply. The CMC section of a biopharmaceutical project is typically on the time critical path and this can prove a challenge for both the Client (contract giver) and the Contract Manufacturing Organization or CMO (contract acceptor). To ensure a successful collaboration and outcome, client expectations must be aligned with the contracted CMO. A mutual understanding of risk is a prerequisite for designing the right development and manufacturing program. In addition, a sense of “co-ownership” of the project adds value in facilitating a seamless contract execution and completion.

Topics to be covered

• This workshop will discuss the lessons learned from a broad range of biopharmaceutical projects developed successfully by the workshop instructors, who represent both the Client and the CMO sides.
• The focus of the workshop will be on the key elements to develop a partnership between the parties, covering all phases, from the CMO selection activity, technology transfer of processes and test methods, to project execution including production, testing, and delivery of Clinical Trial Materials (CTM).
• Additionally, the workshop will include an interactive case study, offering the participants hands-on experience with different CMO selection, risk assessment and mitigation, as well as vendor management tools developed to facilitate cost effective and successful transfer and development of biopharmaceuticals in partnership between the Client and the CMO.