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Thermo Fisher Scientific
Cell therapy clinical translation: ensuring speed to clinic while mitigating risk
On-demand webinar
In the race to reach the clinic, it is all too easy to sacrifice robustness for speed.
Need guidance on how to strike the right balance for your unique cell therapy program? Watch the on-demand webinar, where a panel of seasoned subject matter experts spanning process, analytical, and CMC strategy development share guiding principles for positioning your early cell therapy program for clinical success.
The panel also discusses the role of platform processes in accelerating cell therapy development and explores innovations in enabling technology that can reduce costs and clinical translation timeframes.
What you’ll take away:
- Practical advice on addressing challenges associated with successfully translating cell therapy products from discovery to clinical manufacturing
- How to create a robust CMC strategy for your cell therapy program
- Insight into early engagement opportunities with regulators and updated FDA guidance documents
The Presenters
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. 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.