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| 8:00 AM – 9:00 AM |
Breakfast |
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| Welcome Remarks |
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| 9:00 AM – 9:05 AM |
Jacqueline M. Wolfrum
Associate Director, Biomanufacturing Program, MIT Center for Biomedical Innovation
view bio |
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| 9:05 AM – 9:25 AM |
State Investments to Support Biomanufacturing in Massachusetts – From Infrastructure to Innovation
Travis McCready
President and Chief Executive Officer, Massachusetts Life Sciences Center
view bio |
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| Keynote Presentation |
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Morning Chair: Jacqueline M. Wolfrum, MIT CBI, view bio |
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| 9:25 AM – 10:10 AM |
Patient-Customized Oligonucleotides and Genomic Medicine
Timothy Yu
Attending Physician, Division of Genetics and Genomics, Boston Children’s Hospital
view bio | view abstract |
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| Session 3: New Therapies, New Questions |
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| 10:10 AM – 10:40 AM |
Innovative Approaches and Solutions for Commercializing Novel Therapeutics: A Case Study
Arun Tholudur
Executive Director, Process Development, Amgen
view bio | view abstract |
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| 10:40 AM – 10:55 AM |
Continuous Flow Non-Viral Transfection for ex vivo Cell Therapies
Cullen R. Buie
Associate Professor, Mechanical Engineering, Massachusetts Institute of Technology
view bio |
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| 10:55 AM - 11:10 AM |
Refreshment Break |
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| 11:10 AM – 11:40 AM |
Complex New Modalities Require Advanced Biomanufacturing Platforms: The Case for Exosome Biotherapeutics
Phillip Maderia
Head of Manufacturing Operations, Codiak BioSciences
view bio | view abstract |
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| 11:40 AM – 12:10 PM |
Viral Vector-based Heterologous Prime/Boost Immunotherapy Against HLA Class I-Predicted Neoantigens to Drive CD8 T-Cell Responses in Cancer Patients
Vijay Yabannavar
Executive Vice President of Manufacturing and Technical Operations, Gritstone Oncology
view bio | view abstract |
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| 12:10 PM – 12:40 PM |
Single-Cell RNA Sequencing and Functional Assessment of Healthy Donor- and Cancer Patient-Derived T and CAR-T Cell
Demetrios Kalaitzidis
Director, Immuno-Oncology, CRISPR Therapeutics
view bio | view abstract
Konstantinos Karagiannis
Lead Bioinformatics Engineer, CRISPR Therapeutics
view bio | view abstract |
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| 12:40 PM – 1:30 PM |
Lunch |
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| Session 4: Manufacturing Operations and Scalability of ATMPs |
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Session Chair: James C. Leung, MIT CBI, view bio |
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| 1:30 PM – 1:50 PM |
Continuous Perfusion for Scaling Up Lentiviral Vector Production using Transient Transfection and Stable Producer HEK293 Cell Lines
Maurizio Cattaneo
Chief Executive Officer and Founder, Artemis Biosystems
view bio | view abstract |
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| 1:50 PM – 2:10 PM |
Process Control Strategy to Mitigate Contamination Risk of an Aseptic Viral Vector Production Process
Keen Chung
Principal Scientist, Pall Biotech, Pall Corporation
view bio | view abstract |
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| 2:10 PM – 2:30 PM |
Multi-Dimensional Acoustic Standing Wave Technology for Automated Manufacturing of Cell and Gene Therapies
Bart Lipkens
Chief Technology Officer, Gene Editing & Novel Modalities, MilliporeSigma
view bio | view abstract |
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| 2:30 PM – 3:00 PM |
Key Challenges in Translating Cell and Gene Therapies from Development to Clinical Manufacturing
Dominic Clarke
Global Head of Cell Therapy, HemaCare Corporation
view bio | view abstract |
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| 3:00 PM – 3:20 PM |
Refreshment Break |
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| Session 5: Sustainable Patient Access for ATMPs |
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| 3:20 PM – 3:50 PM |
Early Health Technology Assessment of Stem Cell Therapies: Applications for Type 1 Diabetes
Cátia Bandeiras
PhD Graduate in Early Health Technology Assessment of Stem Cell Therapies, MIT Portugal Program in Bioengineering
view bio | view abstract |
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| 3:50 PM – 4:15 PM |
New Cures Require New Pricing Policies
Rena M. Conti
Associate Professor, Department of Markets, Public Policy and Law, Questrom School of Business, Boston University
view bio | view abstract |
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| 4:15 PM – 5:00 PM |
Precision Financing Solutions for Durable, Potentially Curative Cell and Gene Therapies
Karen Katz
Director, FoCUS Program, MIT Center for Biomedical Innovation
view bio | view abstract |
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The Total Direct Age-Specific and Lifetime Costs of Healthcare in Commercially Insured Patients with Sickle Cell Disease
Jonathan Salcedo
PhD Candidate, University of Southern California; Visiting Scholar, FoCUS Program, MIT Center for Biomedical Innovation
view bio | view abstract |
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| Closing Remarks |
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| 5:00 PM – 5:15 PM |
Stacy L. Springs
Executive Director, Biomanufacturing Initiatives; Senior Director of Programs, MIT Center for Biomedical Innovation
view bio |
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