Manufacturing & Regulations Bootcamp Day
Wednesday, November 20
Addressing Manufacturing and Regulatory Challenges to Decrease Time & Cost of Neoantigen Therapeutic Development
09:00 - 16:00
Attendees will learn and discuss:
• Discuss alternative approaches to reduce timeintensive release tests while maintaining safety and appropriate control over product quality
• Review approaches to measure patient-specific product potency
• Define what process validation looks like for a patient-specific product
• Discuss how to address the risk of a patient lot failing release specifications from an ethical standpoint (both during clinical development and in a commercial setting)?
• Overcome viral vector manufacturing challenges
Case-study & Roundtable Agenda
9:00 am Process development: Neoantigen Specific Engineered TCRs
- Christopher Choi Senior Director, Process Development, Kite, a Gilead Company
Synopsis• Assessment of process development hurdles • General strategies to overcome selected process development hurdles • Considerations for phase appropriate CMC development
10:30 am Morning Refreshments & Speed Networking
11:00 am Patient-specific Neoantigen Vaccine Manufacture: Addressing Business Continuity Risk in Early Phase Clinical Development
- Marc Wolfgang VP of Technical Operations, Neon Therapeutics
• Review how to construct the risk profile
• Develop and present the mitigation plan
• Key criteria for execution and reporting
12:30 pm Lunch
1:30 pm Patient-Specific Products: CMC Challenges for Phase 2 Trials and Beyond
- Willem-Jan Krebber COO, ISA Pharmaceuticals
• How to reduce overall process and release times?
• How to approach process validation?
• And…..how to reduce your cost of goods?
2:30 pm Afternoon Refreshments & Networking
3:00 pm Summary and Take-Home Messages
4:00 pm End of Neoantigen Manufacturing & Regulations Bootcamp
Willem-Jan Krebber has over 15 years of experience in the pharmaceutical and biotechnology industry in various roles covering process development, manufacturing and project management. In his current role as Chief Operating Officer he leads all innovation, product development and manufacturing activities within the company. Prior to ISA Pharmaceuticals, he worked at OctoPlus (now Dr. Reddy’s R&D) as CMC Program Manager where he was responsible for managing OctoPlus own product and technology development programs on advanced drug formulations and delivery. Prior to OctoPlus he held various CMC and project management positions at Crucell (now part of Janssen Vaccines & Prevention and Johnson & Johnson) for the development and manufacturing of cell-based products.
Senior Director, Process Development
Kite, a Gilead Company
Dr. Christopher Choi is Senior Director of Process Development, and PD Site Head for Neoantigens at Kite, a Gilead Company. He leads the Vector, T cell and Analytical teams in the development of adoptive cell therapies targeting patient-specific tumor neoantigens. Chris brings 18 years of experience in cell and gene therapy GMP manufacturing, Quality and process development. Prior to joining Kite, Chris served as the inaugural Director of Roswell’s GMP compliant cell manufacturing facility, and served on faculty in the Depts. of Immunotherapy and Laboratory Medicine.
VP of Technical Operations
Marc Wolfgang is the Vice President of Technical Operations at Neon Therapeutics, overseeing manufacture and quality control of neoantigen cancer vaccine and T-cell therapies. Marc has 25 years of biotech/pharma experience, holding various positions in CMC, quality and regulatory affairs at Cerulean Pharma, Momenta Pharmaceuticals, Millennium Pharmaceuticals, Biogen and Boehringer Ingelheim Pharmaceuticals. Marc has a B.S. degree in Biology and a M.S. degree in chemistry. He is the former Chairman of the Nanomedicines Alliance and a former steering committee member for AAPS’s Nanotechnology Focus Group.