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CMC Forum Summer 2017: Scientific Program
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To view the final program, click here

 

Monday, July 17, 2017
Morning

Analytical Methodologies and Specifications 
Session Chairs: Bruce Thompson, Pfizer, Inc. and Andrew Weiskopf, Biogen 

Measurement Assurance for Regenerative Medicine Advanced Therapies
Anne Plant, National Institute of Standards and Technology (NIST)

Viral Vector Analytical Paradigms, Platforms, and Proposed Specifications
Eric Pastor, Sanofi

Development of Gene Edited Allogeneic CAR T-Cell Therapy
Julianne Smith, Cellectis

Accelerated CMC Development of Regenerative Medical Products
Yoshiaki Maruyama, Pharmaceuticals and Mecial Devices Agency (PMDA)

Afternoon 

Comparability of Cell & Gene Therapy Products
Session Chairs: Paul Husak, Amgen Inc. and Stefanie Pluschkell, Pfizer, Inc. 

Cell Therapy Product Manufacturing Considerations
Mohammad Heidaran, CBER, FDA

GTx and AAV: Advancing Analytical Characterization to Improve Product Understanding, Control, and Comparability Exercises
Herb Runnels, Pfizer, Inc.

Manufacturing, Development, and Comparability Assessments of Cell and Gene Therapy Products for Marketing in Europe
Margarida Menezes-Ferreira, INFARMED

Comparability Studies for Autologous Cell Therapy Processes
Christopher Shen, Kite Pharma


Tuesday, July 18, 2017 
Morning 

Cell & Gene Therapy Manufacturing Strategies 
Session Chairs: Sid Advant, Celgene Corporation and Shian-Jiun Shih, Tessa Therapeutics 

Regulation of Manufacturing Cell and Gene Therapy Products for Use in Phase 1 Clinical Trials
Adrian Gee, Baylor College of Medicine

TBD
Craig Beasley, Juno Therapeutics

Manufacturing Challenges with Cell and Gene Therapy Products: A Health Canada Perspective
Christopher Storbeck, Health Canada

Manufacturing and Commercialization of an Oncolytic Virus Product
Tia Bush, Amgen Inc.

Afternoon 

Raw Materials Sourcing & Supply Chain 
Session Chairs: Kathleen Francissen, Genentech, a Member of the Roche Group, Steven Oh, CBER, FDA and Cindy Riggins, Novartis Pharmaceuticals Corporation 

Standards and Best Practices for Cell, Gene and Tissue-based Therapies 
Rebecca Potts, U.S. Pharmacopeia (USP)

A Life Cycle Approach to Raw Material Qualification for Cell and Gene Therapy Products
Angela Whatley, CBER, FDA

Integrated Supply Chain for Cell Therapy
Bryan Silvey, Kite Pharma





more Calendar

6/10/2019 » 6/12/2019
Cell & Gene Therapy Products 2019

7/15/2019 » 7/16/2019
CMC Strategy Forum North America Summer 2019

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