 |
| 7:45 AM – 8:30 AM |
Breakfast & Registration |
|
| Welcome and Introduction |
|
| 8:30 AM – 8:55 AM |
Anthony J. Sinskey
Professor of Biology; Faculty Director, Center for Biomedical Innovation, Massachusetts Institute of Technology
view bio |
|
| Keynote Presentation |
|
| 8:55 AM – 9:40 AM |
The Kymriah® Story – Developing and Commercializing the First CAR-T Product
Arvind Natarajan
Head, Program Management Office and Strategy, Cell and Gene Technical Development and Manufacturing, Novartis
view bio | view abstract |
|
| Regulatory Perspective |
|
| 9:40 AM – 10:20 AM |
Regulatory Considerations for Cellular and Gene Therapy Products
Bharat H. Joshi
Staff Scientist, Tumor Vaccines and Biotechnology Branch, Division of Cellular and Gene Therapies,
Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration
view bio | view abstract |
|
| 10:20 AM – 10:40 AM |
Refreshment Break |
|
| Session 1: Development & Commercialization of Cell Therapy Products |
|
| |
Session Chair: Jacqueline Wolfrum CBI, MIT
view bio |
|
| 10:45 AM – 11:15 AM |
Fifteen Years of Driving CARs at MSKCC
Isabelle Rivière
Director, Michael G. Harris Cell Therapy and Cell Engineering Facility, Laboratory Member, Molecular Pharmacology Program Attending Geneticist, Department of Medicine, Memorial Sloan Kettering Cancer Center
view bio | view abstract |
|
| 11:15 AM – 11:45 AM |
Commercializing Tissue Engineered Cartilage: Technology and Regulatory Approval Strategy Case Study
Stephen Kennedy
Executive Vice President and Chief Operating Officer, Histogenics
view bio | view abstract |
|
| 11:45 AM – 12:15 PM |
An Exploration of the Potential to Platform Different Cell and Gene Therapies
Chris Ballas
Senior Director, Process Development and Commercialization, WuXi AppTec
view bio | view abstract |
|
| 12:15 PM – 1:15 PM |
Lunch: Posters Available for Viewing |
|
| 1:15 PM – 1:45 PM |
Path to Exploring Cell Therapy in Conventional Biopharma
Someet Narang
Senior Scientist, MedImmune
view bio | view abstract |
|
| 1:45 PM – 2:15 PM |
Introducing the Standards Coordinating Body: How it Will Advance the Field
Richard McFarland
Secretary, Standards Coordinating Body
view bio | view abstract |
|
| Session 2: Development & Commercialization of Gene Therapy Products |
|
| |
Session Chair: James C. Leung CBI, MIT
view bio |
|
| 2:20 PM – 2:50 PM |
Manufacturing Challenges in Gene Therapy for DMD
Alvaro Amorrortu
Chief Operating Officer, Solid Biosciences
view bio | view abstract |
|
| 2:50 PM – 3:25 PM |
Considerations and Challenges When Establishing a New Manufacturing Facility
Lance Weed
Vice President Operations, uniQure
view bio | view abstract |
|
| 3:25 PM – 3:45 PM |
Refreshment Break: Posters Available for Viewing |
|
| 3:45 PM – 4:15 PM |
Intensifying Transient Transfection Production in HEK293 Cells to Expand Recombinant AAV Manufacturing Capacity
Chia Chu
Principal Scientist, Bioprocessing Research and Development, Pfizer
view bio | view abstract |
|
| 4:15 PM – 4:45 PM |
Considerations for the Manufacture of Viral Gene Transfer Vectors
Richard O. Snyder
Chief Scientific Officer, Brammer Bio
view bio | view abstract |
|
| 4:45 PM – 5:25 PM |
Panel Discussion: Cell & Gene Therapy Commercialization |
| |
Moderator:
Geoffrey Hodge
Chief Scientific Officer, Unum Therapeutics
view bio
Panelists:
Robert Deans
Chief Technology Officer, BlueRock Therapeutics
view bio
Arvind Natarajan
Head, Program Management Office and Strategy, Cell and Gene Technical Development and Manufacturing, Novartis
view bio
Isabelle Rivière
Director, Michael G. Harris Cell Therapy and Cell Engineering Facility, Laboratory Member, Molecular Pharmacology Program Attending Geneticist, Department of Medicine, Memorial Sloan Kettering Cancer Center
view bio
J. Fraser Wright
Principal, Wright Biologics Consulting
view bio
|
|
| Closing Remarks |
|
| 5:25 PM – 5:30 PM |
Stacy L. Springs
Executive Director, BioMAN & CAACB; Senior Director of Programs, Center for Biomedical Innovation, Massachusetts Institute of Technology; Associate Institute Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
view bio |
|
| 5:30 PM – 7:00 PM |
Networking Reception & Poster Competition |
|
