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

27 Jan 2022
15:30
SPONSORED BY
StemExpress, LLC
Be The Match BioTherapies

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

Dawn Henke
Senior Technical Program Manager
Standards Coordinating Body
Joseph (Yossi) Schwartz
Medical Director, Transfusion Medicine Quality Assurance
Mount Sinai Health System
Joy Aho
Senior Product Manager
Be The Match BioTherapies
Cate Dyer
Chief Executive Officer & Founder
StemExpress, LLC