A large part of biopharmaceutical companies now rely on outsourcing partners for the development, manufacture, and testing 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 (CMO) and Contract Testing Organization or CTO (Contract Acceptors). To ensure a successful collaboration and outcome, client expectations must be aligned with the Contract Acceptors. A mutual understanding of risk is a prerequisite for designing the right development, manufacturing, and testing programs. 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 Contract Giver and the Contract Acceptor sides.
- The focus of the workshop will be on the key elements to develop a partnership between the parties, covering all phases, from the CxO selection activity, technology transfer of processes and test methods, to 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 Contract Acceptor 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 Contract Giver and the Contract Acceptor.
Who should attend?
This workshop is designed for all persons involved in outsourcing activities -- either your job function is on the receiving side (the CxO) or you are representing the contract giver (the Client). Relevant job functions include: Project Management, Process and Analytical Development, Production / Manufacturing, Sourcing, Procurement, Quality Assurance and Control, Business Development, and Senior Management.
Why should you attend?
Wear the “Hat” of a Big Pharma Sponsor in a safe, educational and entertaining environment, allowing you to explore key outsourcing situations in one day, which normally takes years to develop. Experience how applying Risk Assessment tools supports the different elements of the process, including: Choose the right Contract Acceptor, guide you through the contractual agreement, perform technology transfer and produce a clinical batch of monoclonal antibody, while keeping within budget and time constraints!
0900 - 0915
Instructors & Participants
0915 - 1015
CxO selection process tools:
- Selection process parameters
- CTO vs. CMO with Analytical Testing Services
Introduction to the CMO selection exercise
1015 – 1045
Coffee / Networking / E-mail Break
1045 – 1200
GROUP BREAKOUT AND DISCUSSION I
- CMO selection process (60 min)
Justification of CMO choice / Group presentations (15 min)
1200 – 1330
Lunch / Networking Break
1330 – 1430
Technology transfer and outsourcing tools – Part 1:
- Analytical test methods transfer
Risk assessment and FMEA
1430 – 1500
Coffee / Networking / E-mail Break
1500 – 1615
GROUP BREAKOUT AND DISCUSSION II
- Technology transfer FMEA (30 min)
- Analytical methods transfer interactive exercise (30 min)
Discussion (15 min)
1615 – 1645
CxO performance management tools:
- CxO performance management metrics
1645 – 1700
Participants’ and instructors’ feedback
End of Workshop