Sessions
Standardising Raw Materials to Reduce Outcome Variability
Arriving at your Cell & Gene Therapy Destination: Navigating the Many Journeys Within the Journey
Building an Effective Supply Chain/Temperature-Controlled Therapeutics
Collection Centers of the Future: Standardisation and Optimising Apheresis for Quality Control
Patient-Centric Development – Supporting Improved Patient Outcomes
Standardising Raw Materials to Reduce Outcome Variability
SPONSORED BY
15:30 Chairperson’s Opening
Dawn Henke, Senior Scientific Program Manager, Standards Coordinating body for Regenerative Medicine
15:35 What Can Be Done To Reduce Variability in Collections for Further Manufacturing?
- Address variably in collections for further manufacturing
- Demonstrate tools to help reducing variability
- Describe practice to help the collection procedure
Joseph (Yossi) Schwartz, Medical Director, Transfusion Medicine Quality Assurance, Mount Sinai Health System
15:50 Picking the Right Partner from Product and Process Development Through Commercialisation
- Qualifying how you choose your raw and starting material provider
- Increase your commercialization success rates through standardized methods, access to a diverse and recallable donor pool, and reduce outcome variability
• Choosing a complete partner for primary source material for research use, pre-clinical evaluation, and clinical GMP compliant cellular products
Cate Dyer, Chief Executive Officer and Founder, StemExpress
16:05 Reducing Risk: Effective Starting Material Supply Chain Strategies That Expand Capacity and Maintain Consistency
Joy Aho, Senior Product Manager, Be The Match BioTherapies
16:20 Current and Future Standard Solutions for Raw Materials
Dawn Henke, Senior Scientific Program Manager, Standards Coordinating body for Regenerative Medicine
16:35 Speaker Q&A and Panel Discussion
Speakers
