Session Details

Quality & Operations Track Session 7 - Synchonizing CMC preparation for commercial approval with regulatroy accelerators
Sunday, September 15, 2019 07:30 AM - 08:30 AM
Ballroom B
With the recent advancements of cellular and gene therapies and available expedited programs, commercializing products using phase 2 study data is now a reality. Synchronizing CMC with clinical program is vital to expediting product development. The maturity of CMC development not only is a key factor of approval but also may influence the Fast Track, Breakthrough and Regeneration Medicine Advanced Therapy (RMAT) designation status. This workshop will discuss strategies of early GMP compliance by Dr. Mo Heidaran, former FDA CMC reviewer and share industry product development and commercialization experiences by Dr. Marianna Sabatino, former Senior Director of process development at Kite Pharma and current Vice President of Cell Product Sciences at Arcellx, Inc. .

Chair:

Yong Fan, MD A2Z Reg Solutions, USA

Speakers:

Chemistry Manufacturing Control Readiness for Expedited Programs
Mohammad Heidaran, PhD, PAREXEL, USA
Learning objectives:
•      Identify Major Manufacturing Challenges for Product Approval
•      Understand Essential Elements and CMC Requirements for the Development and Approval of products with expedited program(s) designations
•      Discuss Possible Prerequisites CMC Requirements for Expedited Programs

The CMC Pressure in Developing Fast Track Product
Marianna Sabatino, MD Arcellx, USA
Learning objectives:
•      Share experience of building CMC while moving product toward BLA
•      Elements to consider in early development to guarantee rapid development
•      Some lessons learnt