Driving Standards to Accelerate Development

Driving Standards to Accelerate Development: Convergence of FDA Perspectives and Industry Needs

All times below listed in ET

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