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Poster Session
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2017 BioMAN Summit

Agenda Day 1 | November 14, 2017

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7:45 AM – 8:30 AM Breakfast & Registration
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Welcome and Introduction
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8:30 AM – 8:55 AM Anthony J. Sinskey
Professor of Biology; Faculty Director, Center for Biomedical Innovation, Massachusetts Institute of Technology
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Keynote Presentation
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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
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Regulatory Perspective
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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
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10:20 AM – 10:40 AM Refreshment Break
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Session 1: Development & Commercialization of Cell Therapy Products
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  Session Chair: Jacqueline Wolfrum CBI, MIT
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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
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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
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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
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12:15 PM – 1:15 PM Lunch: Posters Available for Viewing
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1:15 PM – 1:45 PM Path to Exploring Cell Therapy in Conventional Biopharma
Someet Narang
Senior Scientist, MedImmune
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1:45 PM – 2:15 PM Introducing the Standards Coordinating Body: How it Will Advance the Field
Richard McFarland
Secretary, Standards Coordinating Body
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Session 2: Development & Commercialization of Gene Therapy Products
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  Session Chair: James C. Leung CBI, MIT
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2:00 PM – 2:50 PM Manufacturing Challenges in Gene Therapy for DMD
Alvaro Amorrortu
Chief Operating Officer, Solid Biosciences
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2:50 PM – 3:25 PM Considerations and Challenges When Establishing a New Manufacturing Facility
Lance Weed
Vice President Operations, uniQure
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3:25 PM – 3:45 PM Refreshment Break: Posters Available for Viewing
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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
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4:15 PM – 4:45 PM Considerations for the Manufacture of Viral Gene Transfer Vectors
Richard O. Snyder
Chief Scientifc Officer, Brammer Bio
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4:45 PM – 5:25 PM Panel Discussion: Cell & Gene Therapy Commercialization
 

Moderator:
Geoffrey Hodge
Chief Scientifc Officer, Unum Therapeutics
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Panelists:
Robert Deans
Chief Technology Officer, BlueRock Therapeutics
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Arvind Natarajan
Head, Program Management Office and Strategy, Cell and Gene Technical Development and Manufacturing, Novartis
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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
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J. Fraser Wright

Principal, Wright Biologics Consulting
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Closing Remarks
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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)
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5:30 PM – 7:00 PM Networking Reception & Poster Competition
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bottom line
MIT CBI BioMAN