Unlocking allogeneic cell therapy success: downstream strategies for commercialization
Oct
17
2023
On demand

Unlocking allogeneic cell therapy success: downstream strategies for commercialization

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Sponsor
Unlocking allogeneic cell therapy success: downstream strategies for commercialization

Allogeneic cell therapies are on the cusp of a transformative breakthrough, fueled by promising clinical data and compelling long-term trends. As the field advances towards large-scale commercialization, a critical focal point emerges: the optimization of downstream processes. These processes encompass the intricate art of efficient cell harvesting, as well as the seamless orchestration of drug product preparation involving complex steps such as formulation, filling, labeling, and inspection.

This presentation and Q&A will cover lessons learned from commercialized autologous cell therapies, highlight key differences between one-to-one vs. one-to-many cell therapies, and profile automation and closed processing technologies optimized for allogeneic cell therapies.

Attendees will learn:

  • What technologies and techniques can gently and quickly harvest cells
  • How to formulate, fill, label, and inspect doses in short timeframes
  • Which freeze, storage, and handling capabilities are needed for last-mile delivery to treatment centers
John Lee
John Lee
Senior Vice President, Cell Therapy Manufacturing at Center for Breakthrough Medicines

Dr John Lee is an accomplished CAR-T immunobiologist with over 20 years of cancer cell biology expertise spanning small and large molecules, as well as cell-based therapeutics. He possesses more than 15 years of clinical research and cell therapy experience including positions at The Wistar Institute, Janssen Pharmaceuticals, and GlaxoSmithKline. John previously built the Cell Therapy Platform team at Janssen Pharmaceuticals. The group led and supported end-to-end therapy discovery and development across nearly a dozen CAR-T programs, including the recently approved cilta-cel (Carvykti). During his subsequent tenure as Vice President, Head of Oncology Cell Therapy at GlaxoSmithKline, John’s team operated within a heavily matrixed organization to support an array of activities establishing multiple preclinical assets and several clinical-stage lete-cel programs targeting the NY-ESO cancer-testis antigen. John holds a Ph.D from the Brody School of Medicine, an MBA from Penn State University, and a Bachelor's of Science from Indiana University of Pennsylvania

Tatiana Nanda
Tatiana Nanda
Senior Director, Head of Cell Therapy Process Development & Drug Product at The Center for Breakthrough Medicines

Dr Tatiana Nanda has 12+ years of experience in biotherapeutics across MAbs and cell and gene. In her role, Tatiana is responsible for the design and implementation of a diverse and client-focused Cell Therapy and Drug Product service portfolio and the establishment of internal manufacturing platforms. Prior to joining CBM, she was in Janssen, where she led the DP scientific strategy and execution of Oncology and Ocular compounds across multiple modalities, including autologous CAR-Ts and AAV gene therapies. Prior to this, Tatiana worked at GSK in Biopharmaceutical Product Sciences. Tatiana has a BS in Microbiology from the University of Tennessee, an MS in Economics from Moscow State University, and a Ph.D. in Biophysics & Lifesciences from UT/ORNL.

Nikhil Tyagi
Nikhil Tyagi
Director of Cell Therapy Process Development at Center for Breakthrough Medicines

Dr Nikhil Tyagi has 10+ years of experience in tumor microenvironment, immuno-oncology, and cell therapies. Nikhil is currently the Director of Cell Therapy Process Development at CBM and spearheads the development of internal and external client-focused cell therapy programs and initiatives. Prior to joining CBM, he developed process platforms for both autologous and allogeneic cell therapies at various biotech companies. Nikhil holds a Ph.D. in Biochemistry, specializing in tumor-targeted drug delivery, and has extensive experience in the field of cancer biology and cell therapy.