Cambridge Healthtech Institute ’s 4th Annual

Gene Therapy CMC and Analytics

Regulation and Analysis of Vector-Based Gene Therapies

August 26-27, 2020

 

CHI’s Cell Therapy Manufacturing meeting examines the practical challenges in manufacturing autologous and allogenic cell therapies at scale, with dedicated sessions on cell processing, scalability, next-generation production technologies, automation, closed systems, supply chain, and facility design. The meeting will feature extensive sessions on autologous and allogeneic production platforms, including CAR Ts, NK cells, TCRs, TILs, and IPSCs at scale.

Preliminary Agenda

REGULATION STANDARDS AND CMC

USP Standards Development Activities to Support Gene Therapies

Jim Richardson, PhD, Senior Science and Standards Liaison, Global Biologics, United States Pharmacopeia

CMC Regulatory Challenges for CAR T and AAV Modalities

Allen Callaway, PhD, Associate Director, Global CMC Regulatory Affairs, Janssen R&D

ANALYTICS AND CHARACTERIZATION

Analytical Assay Development in Gene Editing

Bo Yan, PhD, Senior Scientist, Beam Therapeutics

Using Infectivity Assays as a Surrogate for Potency Assessment of Viral Vectors

Marina Feschenko, PhD, Director, Analytical Development- Gene Therapy/Biologics, Biogen

A Reporter Gene Potency Assay Development for a Clinical Gene Therapy Product

Hsin-Wei Liao, PhD, Scientist, Sanofi

Development of Orthogonal Analytical Assays for AAV Vector Characterization

Jeremy Johnston, PhD, Group Leader, Analytical, AskBio

Developing a Novel and Sensitive Capillary Electrophoresis Method for the Analysis of AAV Product Purity

Jeehae Park, PhD, Scientist, Sanofi

Novel Method for Quantitation of Empty/Full AAV Vector

Zhu Pirot, PhD, Director, Analytical Development, Sangamo

Detection and Quantitation of Subvisible Particles in AAV Vector Drug Products

Julie Wei, PhD, Associate Director, Analytical Development, Ultragenyz

The Role of “Big Data” and Process Analytical Technologies in Viral Vector Manufacture

Damian Marshall, PhD, Director, New Technologies, Cell & Gene Therapy Catapult UK

Characterization to Support Clone Selection in AAV-Based Gene Therapy Development

Xiaoying Jin, PhD, Senior Principal Scientist, Sanofi Biologics Development




For more details on the conference, please contact:
Daniel Barry
Senior Conference Director
Cambridge Healthtech Institute

Phone: (+1) 781-247-6266
Email: dbarry@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z
Carolyn Cooke
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com



Premier Sponsors:

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