| Morning Session |
 |
| 7:30 – 8:00 AM |
Registration & Breakfast |
|
| 8:00 – 8:15 AM |
Welcome and Introduction
Anthony J. Sinskey | view bio
Faculty Director, Center for Biomedical Innovation; Professor of Microbiology, Department of Biology, MIT |
| |
Summit Objectives
Stacy L. Springs | view bio
Director, Biomanufacturing Program; Executive Director, Consortium on Adventitious Agent Contamination in Biomanufacturing, Center for Biomedical Innovation, MIT |
| |
Jackie Wolfrum | view bio
Research Scientist, Research Laboratory of Electronics; Center for Biomedical Innovation, MIT |
|
|
Keynote Presentations |
| 8:15 – 9:00 AM |
Bruce Levine | view bio
Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania
The Creation of Synthetic Immunity: Chimeric Antigen Receptor T Cells for Relapsed/Refractory Cancers | view abstract |
| 9:00 – 9:45 AM |
David Williams | view bio
Professor of Healthcare Engineering, Loughborough University
Manufacturing Challenges for Cell and Gene Therapies | view abstract |
|
| 9:45 – 10:00 AM |
Break |
|
|
Cell Therapy Manufacturing: Translation from Bench to Bedside |
| |
Session Chair: Geoffrey Hodge, Senior Vice President of Operations, Unum Therapeutics |
| 10:00 – 10:30 AM |
Myriam Armant | view bio
Director, TransLab, Boston Children’s Hospital
Sustainable Development of Cell & Gene Therapy: Perspective from an Academic Translational Lab | view abstract |
| 10:30 – 11:00 AM |
Jerome Ritz | view bio
Executive Director, Connell O’Reilly Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Brigham and Women’s Hospital
cGMP Cell Manufacturing at Academic Medical Centers | view abstract |
| 11:00 – 11:30 AM |
Eileen Higham | view bio
Associate Director/Product Development Team Leader - Adoptive Cellular Therapy, MedImmune
Leveraging CMC Capabilities with Biologics to Deliver Novel Cellular Therapies | view abstract |
| 11:30 AM – 12:00 PM |
Knut Niss | view bio
CMC Team Director, Pharmaceutical Operations & Technology, Biogen
Successful Cell Therapy Manufacturing: Think Big! | view abstract |
|
| 12:00 - 1:00 PM |
Networking Lunch & Poster Session |
|
| Afternoon Session |
|
|
Challenges for Scalable and Sustainable Manufacturing |
| |
Session Chair: Stephen Kennedy, Chief Technology Officer, Histogenics Corporation |
| 1:00 – 1:30 PM |
Chris Ballas | view bio
Associate Director, Gene Mediated Cell Therapies, WuXi Apptec
The Rise of Gene Therapy: Managing the Practical Challenges of Success in a CAR-T Product Case Study | view abstract |
| 1:30 – 2:00 PM |
Michael Washabaugh | view bio
Senior Director of Research and Development, MedImmune
Manufacturing Challenges for Viral-Vectored Vaccine & Gene-Therapy Products | view abstract |
| 2:00 – 2:30 PM |
Martha Rook | view bio
Director, Stem Cell Bioprocessing Group, EMD Millipore
Scalable Manufacturing Solutions for T Cell and MSC Cell Therapy Products | view abstract |
| 2:30 – 3:00 PM |
Brian Hawkins | view bio
Senior Application Scientist, BioLife Solutions
Biopreservation Challenges in Cell Therapy Manufacturing | view abstract |
|
| 3:00 – 3:15 PM |
Break |
|
|
Characterization Challenges and Analytical Methods |
| |
Session Chair: Knut Niss, CMC Team Director, Pharmaceutical Operations & Technology, Biogen |
| 3:15 – 3:45 PM |
Anne Plant | view bio
Chief of the Biosystems and Biomaterials Division, and Director of Biological Programs, National Institute of Standards and Technology
Measurement Challenges for Cell Therapies | view abstract |
| 3:45 – 4:15 PM |
Dominic Clarke | view bio
Global Product Manager for Cellular Therapy and Bioprocessing, Charter Medical
Addressing the Risks: Particulates, Extractables & Leachables in Cell Therapy | view abstract |
| 4:15 – 4:45 PM |
Joseph Hughes | view bio
Vice President, Technology Development and Chief Scientist, WuXi AppTec
Challenges for QC Testing of Cell and Gene Therapy Products: Technical and Logistical Issues | view abstract |
| 4:45 – 5:15 PM |
Sadik Kassim | view bio
Associate Director, Cell & Gene Therapies Unit, Novartis
Toward Safer and More Effective CART Therapies | view abstract |
|
| 5:15 – 5:20 PM |
Closing Remarks |
| |
Stacy L. Springs | view bio
Director, Biomanufacturing Program; Executive Director, Consortium on Adventitious Agent Contamination in Biomanufacturing, Center for Biomedical Innovation, MIT |
|
| 5:20 – 6:30 PM |
Poster Session & Networking Reception |
