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
Quality and Operations Track
Chair: Sowmya Viswanathan, PhD, University Health Network, Canada

Speakers:

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

Sowmya Viswanathan PhD
Affiliate Scientist
University Health Network Cell Therapy Program
Chairman


Judith Arcidiacono MSc
International Regulatory Expert
FDA/CBER
Speaker


Paul Eldridge PhD
Facility Director
UNC Lineberger Advanced Cellular Therapeutics Facility
Speaker


Brian Hawkins PhD
Chief Technology Officer
Pluristyx, Inc
Speaker