Postponed
Pre-Conference Workshop Day
8:30 am - 11:00 am
Designing and Executing your Cell Therapy Supply Chain Strategy- Everything You Need to Know from Clinical to Commercial
Sanjay Srivastava PhD -
Managing Director for Cell & Gene, Life Sciences,
Accenture
Carlo Guy - Executive Director Supply Chain (Cell & Gene Therapies), .
This workshop will examine the common pitfalls and key fracture points to avoid when designing and executing your supply chain strategy. Drawing practical examples from experience, Sanjay and Carlo will walk you through the key challenges involved with commercialization, the key elements to consider when making critical supply chain decisions and practical workarounds on how to mitigate these challenges.
11:30 am - 12:30 pm
Networking Lunch
11:30 am - 1:30 pm
Challenges of Cell Therapy Manufacturing: Scaling Up Production and Plan Early to Success
2:30 pm - 3:00 pm
Afternoon Coffee and Networking Break
3:00 pm - 5:00 pm
Regulatory Requirements to Commercialize Cell Therapy
Due to the specific nature of the material used for cell therapy, it falls within the regulations not only U.S. FDA current Good Tissue Practices (cGTP), 21 CFR 1271, but also under regulations for pharmaceutical or biologic products: 21 CFR 210 or 21 CFR 211.
The regulatory approach used for specific autologous cell therapies is dictated by their planned clinical use, method of clinical delivery and manufacture.
In this workshop, we will review try to translate translating these understanding into practice.
