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| 8:15 AM – 915 AM |
Registration & Breakfast |
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| Welcome, Introduction, and Framing of the Summit |
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| 9:15 AM – 9:35 AM |
Anthony J. Sinskey
Professor of Biology; Faculty Director, MIT Center for Biomedical Innovation
view bio |
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| Keynote Presentation |
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Morning Chair: Stacy L. Springs, MIT CBI, view bio |
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| 9:35 AM – 10:05 AM |
FDA Perspectives on the Advancement of Cell and Gene Therapies
Celia M. Witten
Deputy Director, Center for Biologics Evaluation and Research, United States Food and Drug Administration
view bio | view abstract |
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| Session 1: Advances in ATMP Bioprocessing |
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| 10:05 AM – 10:35 AM |
Hopes & Challenges to Make Advanced Therapy Medicinal Products Sustainable in the Long Run
René Labatut
Vice President, Head of Biologics Technology Innovation Strategy, Sanofi
view bio | view abstract |
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| 10:35 AM – 11:00 AM |
Refreshment Break |
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| 11:00 AM – 11: 40 AM |
iPSC Derived Therapeutics – Development Boundaries and Next Generation Toolkits
Robert Deans
Chief of Innovation, BlueRock Therapeutics
view bio | view abstract |
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| Panel Discussion on Sustainability in ATMP Manufacturing |
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11:40 AM – 12:30 PM |
Moderated by:
Sadik Kassim, Chief Technology Officer, Vor Biopharma view bio
Panelists:
Robert Deans, Chief of Innovation, BlueRock Therapeutics view bio
René Labatut, Vice President, Head of Biologics Technology Innovation Strategy, Sanofi view bio
Christopher Leidel, Head of Acoustic Strategy, Gene Editing and Novel Modalities, MilliporeSigma view bio
Jerome Ritz, Executive Director, Connell and O’Reilly Cell Manipulation Core Facility, Dana-Farber Cancer Institute view bio
Celia M. Witten, Deputy Director, Center for Biologics Evaluation and Research, United States Food and Drug Administration view bio |
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| 12:30 PM – 1:30 PM |
Lunch |
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| Session 1: Advances in ATMP Bioprocessing (continued) |
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Afternoon Chair: Paul W. Barone, MIT CBI view bio |
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| 1:30 PM – 2:00 PM |
Strategic Process Development for AAV Gene Therapies
John Maga
Senior Director, Process Sciences, Purification Process Development, BioMarin
view bio | view abstract |
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| 2:00 PM – 2:30 PM |
Bioprocessing Opportunities for the Next Generation of Immuno-Oncology Targeted Cell Therapies
Sadik H. Kassim
Chief Technology Officer, Vor Biopharma
view bio | view abstract |
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| 2:30 PM – 3:00 PM |
Rethinking Process Development Strategy to Support Commercialization of Viral Vectors
Jessica Tate
Principal Investigator, Science & Technology, Pharma Services, Viral Vector Services, Thermo Fisher Scientific
view bio | view abstract |
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| 3:00 PM – 3:25 PM |
Refreshment Break |
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| Session 2: New ATMP Analytics |
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| 3:25 PM – 4:10 PM |
Advancing Product Analytics for Cell Therapies
Chelsea Qiong Xue
Head of Analytical Development for Cell Therapies, Takeda
view bio | view abstract |
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| 4:10 PM – 4:40 PM |
Rapid, Real Time Quantification of Lentivirus Particles Using Antibody-Based Detection on the Virus Counter® 3100
Maya Fuerstenau-Sharp
Manager of Segment Marketing, Regenerative Medicine, Sartorius Stedim
view bio | view abstract |
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| 4:40 PM – 5:10 PM |
Measuring Biophysical Properties of Single Cells and Particles with High Precision
Scott Manalis
Andrew and Erna Viterbi Professor of Biological Engineering, MIT Koch Institute for Integrative Cancer Research
view bio | view abstract |
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| Day 1 Closing Remarks |
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| 5:10 PM – 5:30 PM |
SMART CAMP: A New MIT Initiative
Stacy L. Springs
Executive Director, Biomanufacturing Initiatives; Senior Director of Programs, MIT Center for Biomedical Innovation
view bio | view abstract |
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| 5:30 PM – 8:00 PM |
Networking Reception & Poster Session |
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