Cell therapy clinical translation: ensuring speed to clinic while mitigating risk

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

Cell therapy clinical translation: ensuring speed to clinic while mitigating risk

In the race to reach the clinic, it is all too easy to sacrifice robustness for speed. Looking for guidance on how to strike the right balance for your unique cell therapy program?

Join our upcoming webinar during which a panel of seasoned subject matter experts spanning process, analytical, and CMC strategy development will share guiding principles for positioning your early cell therapy program for clinical success. The panel will also discuss the role of platform processes in accelerating cell therapy development and explore recent innovations in enabling technology that can reduce costs and clinical translation timeframes.

Attend this webinar to receive:

Practical advice on addressing challenges associated with successfully translating cell therapy products from discovery to clinical manufacturing, including process scalability, product quality and reproducibility, precise analytics, consistency and reliability of raw materials, and more
Guidance for crafting a robust CMC strategy for your cell therapy program
Early engagement opportunities with regulators and insights from updated industry guidance documents

Shreya Shukla

Manager, Analytical Sciences, Cell Therapy at Thermo Fisher Scientific

Shreya has twenty years of experience in stem cell bioengineering, T cell development, hematopoietic stem cells, allogeneic and autologous cell therapy, immunology, CAR-T and TCR-T cell characterization, and cell therapy preclinical development. Previously, Shreya co-founded Notch Therapeutics, Canada’s first biotechnology company that developed renewable, induced pluripotent stem cell (iPSC)-derived T cell therapies for cancer.

Richard Dennett

Senior CMC Regulatory Strategy Director at Thermo Fisher Scientific

Richard has over 25 years of biopharma industry experience, including extensive CMC regulatory and ‘hands-on’ experience spanning R&D and GMP manufacture for multiple biopharmaceutical products. He previously held wide-ranging CMC regulatory and technical strategic positions at AstraZeneca and Novartis, and was a co-Founder of Eden Biodesign.

Steffany Dunn

Technical Program Design Manager at Thermo Fisher Scientific

Steffany supports the Patheon Translational Services team as the lead proposal writer and subject matter expert directly supporting customer interaction and project development. Her team is focused on the translation of early advanced therapy discoveries toward GMP manufacturing through implementation of standardized processes and analytics.

in 11

Days