Session Details

Quality and Operations Track Session 1 – Emerging Standards in Cell & Gene Therapies
Thursday, May 30, 2019 11:00 AM - 12:15 PM
Room 213
Chair: Sowmya Viswanathan, PhD, University Health Network, Canada


Building the Foundation for Regenerative Medicine Innovation through Standards
Judith Arcidiacono, PhD, FDA, United States

Learning objectives:
•      Define the types of standards that can be utilized in the development and testing of cell and gene therapies
•      Describe how standards developed
•      Describe how standards can be used to support regulatory applications to FDA for cell and gene therapy products

Development of a Cryopreservation Standard to Speed Cell Therapy/Regenerative Medicine Product Development
Brian J. Hawkins, PhD, Pluristyx Inc, United States

Learning objectives:
•      Discuss the role of cryopreservation for cell therapy/regenerative medicine product development
•      Demonstrate how cryopreservation best practices can be incorporated into a cell manufacturing workflow
•      Provide an update on the current ANSI/PDA Cryopreservation Standards Initiative

FACT Accreditation Requirements
Paul Eldridge, UNC Lineberger Advanced Cellular Therapeutics Facility, Chapel Hill, United States