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Agenda Day 2 | December 7, 2016

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8:00 – 8:30 AM Breakfast
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Welcome
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8:30 – 8:35 AM Stacy L. Springs
Director, BioMAN; Executive Director, CAACB, CBI, MIT
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Introductory Remarks
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8:35 – 8:45 AM Travis A. McCready
President & Chief Executive Officer, Massachusetts Life Sciences Center
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Session 3: Challenges and Approaches to Manufacturing the Products of the Future
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  Session Chair, Morning: Jacqueline Wolfrum, Research Scientist, CBI, MIT
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8:45 – 9:15 AM Entrepreneurial Innovation at the Frontier of Health
David Berry

General Partner, Flagship Ventures
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9:15 – 9:45 AM The Impact of the Entry of Biosimilars: Evidence from Europe
Ariel Dora Stern
Assistant Professor of Business Administration, Harvard Business School
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9:45 – 10:15 AM Manufacturing Challenges for Antibody-Drug Conjugates: Past, Present and Future
Nathan C. Ihle
Vice President, CMC Strategy & Management, Seattle Genetics
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10:15 – 10:30 AM Morning Refreshment Break
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10:30 – 11:00 AM Manufacture of Cell and Tissue Therapy Products: Cartilage Regeneration
Stephen Kennedy
Chief Technology Officer, Histogenics
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11:00 – 11:30 AM Paradigm Shift: Perspective of mRNA in Vaccine
René Labatut
Vice President, Technology Innovation, Sanofi Pasteur
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11:30 AM – 12:00 PM Targeted Genome Editing: Overview and Measurement Needs for Cell and Gene Therapies
Samantha Maragh
Leader, Genome Editing Program, NIST
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12:00 – 12:30 PM Global Market Access Manufacturing Considerations for Transformative Products
Aura Mackenzie
Senior Principal, Global Pricing and Product Strategy, Precision for Value
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12:30 – 1:30 PM Lunch
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  Session Chair, Afternoon: Paul W. Barone, Associate Director, BioMAN and CAACB, CBI, MIT
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1:30 – 2:00 PM Engineering Red Blood Cells for Therapeutic Function
Avak Kahvejian
Co-founder and Chief Executive Officer, Rubius Therapeutics
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2:00 – 2:30 PM Human Microbiome Therapeutics
John Aunins
Executive Vice President of Bioprocess & Manufacturing and Chief Technology Officer,
Seres Therapeutics
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2:30 – 3:00 PM Manufacturing Innovation via Public-Private Partnerships: Challenges and Opportunities for Emerging Therapies
Krystyn J. Van Vliet
Professor, Department of Materials Science and Engineering and Department of Biological Engineering; Director of Manufacturing Innovation, MIT Innovation Initiative, MIT
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3:00 – 3:30 PM AAV – Based Gene Therapy: Scalable CMC to Support Clinical Program Advancement
J. Fraser Wright
Co-founder and Chief Technology Officer, Spark Therapeutics
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3:30 – 4:00 PM Toward Commercialization of Exosome Technology
Konstantin Konstantinov
Senior Vice President, Manufacturing & Process Sciences, Codiak BioSciences
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4:00 – 4:15 PM Afternoon Refreshment Break
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Session 4: Panel Discussion – How do we get there from here?
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4:15 – 5:00 PM Moderator:
Charles L. Cooney

Professor Emeritus, Department of Chemical Engineering; Faculty Director Emeritus, Deshpande Center for Technological Innovation, MIT
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Panelists:
John Aunins
Executive Vice President of Bioprocess & Manufacturing and Chief Technology Officer, Seres Therapeutics
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Konstantin Konstantinov
Senior Vice President, Manufacturing & Process Sciences, Codiak BioSciences
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Samantha Maragh
Leader, Genome Editing Program, NIST
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J. Fraser Wright
Co-founder and Chief Technology Officer, Spark Therapeutics
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Closing Remarks
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5:00 – 5:15 PM Stacy L. Springs
Director, BioMAN; Executive Director, CAACB, CBI, MIT
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MIT CBI BioMAN Mass Life