KYMRIAH^TM was the first CAR T product to receive FDA approval. Our keynote speaker will share details about Novartis’ path to achieving this milestone as well as thoughts about the future of these exciting products.

Keynote presented by:

• Spencer Fisk, Vice President & Global Head, Cell & Gene Technical Development & Manufacturing, Novartis
  

A wide range of cell therapy products that utilize various cell sources and target unmet medical need are currently under development. Speakers in this Summit will discuss their technologies and how they solve the unique manufacturing challenges posed by the different cell types and characteristics of the target patient populations. Presenters will also examine which critical aspects of manufacturing cell therapies are common and cross-cutting.

Featuring presentations by:

• Chris Ballas, Senior Director, Process Development, WuXi AppTec
• Stephen Kennedy, Executive Vice President and Chief Operating Officer, Histogenics
• Isabelle Rivière, Director, Michael G. Harris Cell Therapy and Cell Engineering Laboratory, Memorial Sloan Kettering Cancer Center
• Greg Russotti, Vice President, Technical Operations, Celgene
• Austin Thiel, Senior Principal Scientist, Semma Therapeutics

Gene therapy manufacturers can draw on some of the experiences from vaccine manufacturing; however, they also face unique technical challenges. The exploding interest in gene therapies has stressed manufacturing capacity and capability in new ways. Our speakers will address the difficulties that must be overcome to ensure continued advances in this class of therapies.

Featuring presentations by:

• Alvaro Amorrotu, Chief Operating Officer, Solid BioSciences
• Chia Chu, Senior Scientist, ImmunoPharmacology, Pfizer
• Richard Snyder, Chief Scientifc Officer, Brammer Bio
• Lance Weed, Vice President, Operations, uniQure

In order to successfully commercialize cell and gene therapies, manufactures must develop new technologies that will adequately characterize these new drugs. Existing manufacturing platforms were developed for proteins and monoclonal antibodies and are not optimized for these products – especially autologous therapies that are produced for a single patient. Speakers in this session will explore innovative approaches to analytics and manufacturing unit operations and platforms that will enable successful commercialization.

Featuring presentations by:

• Jon Chen, Single-cell Evangelist, IsoPlexis
• Jeffrey Kennedy, Process Manager, Cell & Gene Therapy, GlaxoSmithKline
• Debra Meyer, Associate Research Fellow, Pfizer
• Julie Murrell, Head of Cell Therapy Manufacturing, MilliporeSigma
• David O'Dowd, Associate Director, Biomedical Solutions, Draper
• Krystyn Van Vliet, Professor, Massachusetts Institute of Technology

Manufacturers must demonstrate that their cell and gene therapy products are safe and effective. In this session, regulators from the US and Europe will discuss the regulatory frameworks for these new products, as well as key areas where manufacturers will face the greatest challenges because of their unique characteristics. Additional development of enabling standards and adaptation of best manufacturing practices toward product safety will also be considered.

Featuring presentations by:

• Eli Kraus, Scientific Director, Amgen
• Veronika Jekerle, Quality Specialist, European Medicines Agency
• Bharat Joshi, Staff Scientist, Tumor Vaccines & Biotechnology Branch, United States Food and Drug Administration/Center for Biologics Evaluation and Research/Office of Tissues and Advanced Therapies/Division of Cellular and Gene Therapies
• Richard McFarland, Secretary, Standards Coordinating Body