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| 7:45 AM – 8:30 AM |
Breakfast |
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| Introduction |
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| 8:30 AM – 8:35 AM |
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 |
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| Opening Remarks |
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| 8:35 AM – 8:45 AM |
Jennifer Griffin
Vice President, Industry Programs and Relations, Massachusetts Life Sciences Center
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| Session 3: Regulations and Manufacturing Practices to Ensure Product Safety |
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Session Chair: Stacy Springs CBI, MIT |
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| 8:50 AM – 9:40 AM |
Regulatory and Scientific Considerations to Developing Cell and Gene Therapies - A Perspective from the European Medicines Agency
Veronika Jekerle
Quality Specialist and ATMP Topic Lead for Quality, Specialised Scientific Disciplines Department, European Medicines Agency
view bio | view abstract |
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| 9:40 AM – 10:15 AM |
Making Cell Therapy Process Changes: Why, How and When
Gregory Russotti
Vice President, Cell Therapy Development and Operations, Celgene
view bio | view abstract |
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| 10:15 AM – 10:35 AM |
Refreshment Break |
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| 10:35 AM – 11:05 AM |
Managing Challenges to Supply Autologous Gene Therapies
Jeff Kennedy
Process Manager, Cell and Gene Therapy Validation and Lifecycle Management, GlaxoSmithKline
view bio | view abstract |
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| 11:05 AM – 11:35 AM |
Adventitious Agent Control Strategy Considerations
Nigel Pheasey
Principal Scientist, Process Development, Amgen
view bio | view abstract |
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| 11:35 AM – 12:05 PM |
The CAACB Virus Contamination in Biomanufacturing Project - Practical Lessons for Current and Emerging Biotherapeutic Products
James Leung
Senior Research Fellow, Center for Biomedical Innovation, Massachusetts Institute of Technology
view bio | view abstract |
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| 12:05 PM – 1:05 PM |
Lunch |
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| Academic Poster Awards |
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| 1:05 PM – 1:20 PM |
Presented by:
John Frenz, President, CAASS
view bio
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 |
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| Session 4: Technologies and Approaches to Enable Commercialization |
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Session Chair: James C. Leung CBI, MIT
view bio |
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| 1:25 PM – 1:55 PM |
Development Perspectives in Advancing Pluripotent Stem Cell Therapeutics
Robert Deans
Chief Technology Officer, BlueRock Therapeutics
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| 1:55 PM – 2:25 PM |
Semma Therapeutics – Developing Disruptive Therapies to Cure Insulin-Dependent Diabetes
Austin Thiel
Senior Principal Scientist, Semma Therapeutics
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| 2:25 PM – 2:55 PM |
Analytical Challenges for Characterization of a Complex Allogeneic CAR T Product
Debra Meyer
Associate Research Fellow, Pfizer
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| 2:55 PM – 3:15 PM |
Refreshment Break |
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| 3:15 PM – 3:45 PM |
Single T-cell Functional Response Biomarkers to Accelerate Decisions in CAR-T and Checkpoint Based Cancer Immunotherapies
Jon Chen
Single-cell Evangelist, IsoPlexis
view bio | view abstract |
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| 3:45 PM – 4:15 PM |
Needles in the Haystack: Label-free, Biophysical Attributes Enabling Cell Therapy
Krystyn Van Vliet
Associate Provost; Professor, Departments of Materials Science and Engineering and Biological Engineering, Massachusetts Institute of Technology
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| 4:15 PM – 4:45 PM |
Distributed CAR-T Manufacturing to Maximize Market
David O'Dowd
Associate Director, Draper
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| 4:45 PM – 5:15 PM |
Challenges in Cell Therapy Manufacturing are Opportunities for Industrializing Production Systems
Julie Murrell
Head of Cell Therapy Manufacturing, MilliporeSigma
view bio | view abstract |
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| Closing Remarks |
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| 5:15 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 |
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