Driving Standards to Accelerate Development: Convergence of FDA Perspectives and Industry Needs
All times below listed in ET
Register for Driving Standards to Accelerate Development
This workshop will be held in collaboration with the National Institute of Standards and Technology (NIST) and the Food and Drug Administration (FDA).
Chairs: Judith Arcidiacono, FDA, Timothy MacLachlan, PhD, Novartis, and Samantha Maragh, PhD, NIST
Session 1 – Standards and the Regulatory Perspective
1:00 – 1:40 p.m.
Overview of Standards and SDOs/Standards Development Entities
Judith Arcidiacono, FDA
Regulatory Perspective on the Use of Standards
Bao-Ngoc Nguyen, PhD, FDA
Session 2 – Standards Development Use Cases
1:40 – 2:15 p.m.
PDA National Standards Body: Cryopreservation
Darius Pillsbury, ValSource
ISO International: Cell Characterization
Sumona Sarkar, PhD, NIST
Break: 2:15 – 2:30 p.m.
Session 3 – Consortia Models and Collaborative Efforts for Developing Standards
2:30 – 3:50 p.m.
Public-Private Partnerships to Advance Measurement Science Underpinning Standards Development
Sheng Lin-Gibson, PhD, NIST
NIST Genome Editing Consortium Update
Samantha Maragh, PhD, NIST
Flow Cytometry Consortium Update
Heba Degheidy, MD, PhD, FDA
Viral Vectors Inter-Lab/Collaboration/VCN Cell Lines
Edward Kwee, PhD, NIST
Session 4 – Standards Coordinating Body Coordination
3:50 – 4:10 p.m.
SCB Coordination
Dawn Henke, PhD, Standards Coordinating Body
Panel Discussion: Developers’ Perspective
4:10 – 4:55 p.m.
Frederic Bushman, PhD, University of Pennsylvania
Carsten Russ, PhD, Novartis Institute of Biomedical Research
Aparna Subramanian, PhD, Kite Pharma
J. Fraser Wright, PhD, Stanford University
Moderated by Timothy MacLachlan, PhD, Novartis, and Anna Kwilas, MD, FDA
Closing Remarks
4:55 – 5:00 p.m.
Judith Arcidiacono, FDA