MIT

 
MIT CBI
Cell and Gene Therapy Products
 
 

Agenda Day 2: November 19, 2015

Morning Session
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7:30 – 8:10 AM Breakfast
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8:10 – 8:15 AM Introduction
Stacy L. Springs | view bio
Director, Biomanufacturing Program; Executive Director, Consortium on Adventitious Agent Contamination in Biomanufacturing, Center for Biomedical Innovation, MIT
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Keynote Presentations
8:15 – 9:00 AM Gary C. du Moulin | view bio
Associate Professor of Drug Regulatory Affairs, Massachusetts College of Pharmacy and Health Sciences Univeristy
Manufacture of Cell Therapy Products: A Look Back Through 26 Years of Development, Regulatory Challenges and Lessons Learned | view abstract
9:00 – 9:45 AM Denise Gavin | view bio
Chief, Gene Therapy Branch, Division of Cell and Gene Therapy, United States Food and Drug Administration
Transitioning from Late Phase to Commercial Manufacturing of Gene Therapy Products | view abstract
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9:45 – 10:15 AM Break
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Safety and Comparability Issues
  Session Chair: Geoffrey Hodge, Senior Vice President of Operations, Unum Therapeutics
10:15 – 10:45 AM John Duguid | view bio
Director, Process Development, Vericel Corporation
Validation and Implementation of Rapid Microbiological Methods for Cell and Gene Therapy Products | view abstract
10:45 – 11:15 AM Alison Wilson | view bio
Principal Consultant, CellData Services
Risk-Based Approach to Comparability: The Regulatory Expectations | view abstract
11:15 – 11:45 AM Michael Paglia | view bio
Senior Director of Technical Operations, bluebird bio
Autologous Gene Therapy Manufacturing Comparability: Meeting the Challenge Through Process Understanding and Product Characterization | view abstract
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11:45 AM – 12:45 PM Networking Lunch
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Afternoon Session
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Sources of Variability and Cost of Goods
  Session Chair: James Leung, Senior Research Fellow, Center for Biomedical Innovation, MIT
12:45 –1:15 PM Jamie Thurman-Newell | view bio
Principal Investigator – Healthcare Technologies Group, Loughborough University
Analysis of Biological Variation in Blood-based Therapy as a Precursor to Biomanufacturing | view abstract
1:15 – 1:45 PM Mark McCall | view bio
Lecturer, Loughborough University
Understanding Manufacturing Costs in T Cell Production and Distribution | view abstract
1:45 – 2:15 PM J. Fraser Wright | view bio
Co-Founder and Chief Technology Officer, Spark Therapeutics
Development of AAV Vector Product Chemistry, Manufacturing and Controls to Support Clinical Program Advancement | view abstract
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2:15 – 2:30 PM Break
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Investing in Sustainability
  Session Chair: Knut Niss, CMC Team Director, Pharmaceutical Operations & Technology, Biogen
2:30 –3:00 PM Stephen Kennedy | view bio
Chief Technology Officer, Histogenics Corporation
Development of Robust Manufacturing Process Technology: Reliable Delivery of Regenerative Medicine Products or Services to Surgeons and their Patients | view abstract
3:00 – 3:30 PM Rosemarie Hunziker | view bio
Program Director, Tissue Engineering/Regenerative Medicine, Biomaterials, and Implantable Medical Devices, National Institutes of Health / National Institute of Biomedical Imaging and Bioengineering
The Federal Investment in Cell Manufacturing for Regenerative Medicine | view abstract
3:30 – 4:00 PM Bill Lundberg | view bio
Chief Scientific Officer, CRISPR Therapeutics
Translating CRISPR-Cas9 Technology Into Transformative Therapies for Serious Diseases - Manufacturing Considerations | view abstract
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4:00 – 4:15 PM Break
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4:15 – 5:30 PM Panel Discussion: Meeting the Challenges of Manufacturing Cell and Gene Therapy Products
  Moderated by: Jackie Wolfrum, Research Scientist, Research Laboratory of Electronics;
Center for Biomedical Innovation, MIT
  Panelists:
  Gary C. du Moulin | view bio
Associate Professor of Drug Regulatory Affairs, Massachusetts College of Pharmacy and Health Sciences Univeristy
  Michael Paglia | view bio
Senior Director of Technical Operations, bluebird bio
  Anne Plant | view bio
Chief of the Biosystems and Biomaterials Division, and Director of Biological Programs, National Institute of Standards and Technology
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5:30– 6:00 PM Poster Awards and Closing Remarks
  Stacy L. Springs | view bio
Director, Biomanufacturing Program; Executive Director, Consortium on Adventitious Agent Contamination in Biomanufacturing, Center for Biomedical Innovation, MIT

 
 
 
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