Cambridge Healthtech Institute ’s Inaugural

Gene Therapy CMC and Manufacturing

20-21 March 2019

 

The vector-based gene therapy industry has undergone rapid advances over the last twelve months and shows no sign of slowing down. The clinical results are beyond encouraging. However, the pressure is now on CMC, analytical, process development and manufacturing department to produce these therapies at scale.  

The Gene Therapy CMC and Bioproduction conference examines the practical challenges facing the production, characterization and quality control of vector-based gene therapies, with dedicated sessions on AAV and lentivirus-based platforms as well as oncolytic viruses, CRISPR and other gene editing therapies. Topics include new and emerging analytical strategies, upcoming regulations and the latest manufacturing strategies for large- and small-scale production.

Preliminary Agenda

Preparing for Commercialization

Luxturna: The Regulatory and CMC Story

Dan Takefman, PhD., Head, Regulatory Affairs, Spark Therapeutics

Scaling-Up and Manufacturing Gene Therapies at Commercial Scale

Marian Bendik, PhD, Site Lead Orth, Gene Therapy Center Austria, Biologics Operating Unit, Technical Operations, Shire

Process Development Strategies: Academic to CMO vs. Integrated

Jean-Philippe Combal, PhD, Co-Founder and CEO, Vivet

Regulatory Strategies

Regulatory Aspects of Manufacturing and Control of Genetically Modified Cells

Matthias Renner, PhD, Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute

CMC and Analytical Strategies

Analytics for AAV-Based Gene Therapy Products

Francis Poulin, PhD, Director, Analytical, Sanofi

Analytical Approaches to Characterize AAV Gene Therapy Products

Christine Le Bec, Head of CMC Analytical, Technology Development, Genethon

CMC Development Strategies for Viral Immunotherapeutics: Keeping the End in Mind

José Manuel Otero, PhD, Senior Vice President, Technical Operations, Turnstone Biologics, Inc.

 

Looking at The AAV Particles from Inside And Outside Using Novel Analytical Tools

Eduard Ayuso, DVM, PhD, Team leader, Innovative Vectorology and Scientific Director Translational Vector Core (CPV), Translational Gene Therapy for Genetic Disorders, Inserm, University of Nantes

Process Development and Scale-Up for Gene Therapies – AAV, Lenti and HSV

Process Development for Gene Therapies

Mercedes Segura, PhD., Director, Next Generation Platforms and Technologies, Bluebird

Process Development Challenges in Gene Therapy Moving from Early Clinical to Late Phase/Commercial

Tarik Senussi, Head of Process Development, Gyroscope Therapeutics

Process Development Approaches to Characterize AAV Gene Therapy Products

Matthias Hebben, PhD, Gene Therapy Technology and CMC Development, Genethon

Lentipro Stable Producer Cells for the Development of Scalable Lentiviral Vector Manufacturing

Ana Sofia Coroadinha, PhD, Head of Lab, Health & Pharma Division, Animal Cell Technology Unit Cell Line Development and Molecular Biotechnology Lab, IBET

Lentiviral Vector Manufacturing - Problem or Not?

Hanna Lesch, PhD, Director, Gene Therapy Unit, Kuopio Center for Gene and Cell Therapy




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 Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com

 

Companies L-Z

Carolyn Cooke

Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com