Early-Stage Clinical Development: What You Need to Know

All times below listed in ET

Planned by the Commercialization Committee
Co-chairs: Angela Whatley, PhD, BridgeBio,and Debasish Roychowdhury, MD, Partner Therapeutics

Register for Early-Stage Clinical Development

Session 1 – Clinical and CMC Preparations

1:00 – 2:45 p.m.

Defining the Issues: How Early Development Decisions Impact Commercialization
Katy Spink, PhD, Dark Horse Consulting

Non-Clinical Considerations in Early-Stage Development: Animal Model Selection, Assessing Animal Model Toxicity, Predictive Capability
Larry Whiteley, DVM, PhD, Pfizer Inc.

Preparing Your CGT Clinical Protocol to Fit Your TPP
Rafael Amado, MD, Allogene Therapeutics

CMC Considerations: Striking the Balance on Scalability Readiness and Preparation in Early Development
Mo Heidaran, PhD, GC Therapeutics

Panel Q&A moderated by Angela Whatley, PhD, BridgeBio, and Debasish Roychowdhury, MD, Partner Therapeutics

Break: 2:45 – 3:15 p.m.

Session 2 – How to Get into Early-Stage Drug Development

3:15 – 5:00 p.m.

Overview of the Issues: How do People Learn about and Break into the Field?
Peggy Sotiropoulou, PhD, T-Knife Therapeutics

Scope of the Problem: Developing a Skilled and Diverse Workforce
Richard McFarland, MD, PhD, Advanced Regenerative Manufacturing Institute

Partnerships, Innovative Employment Models, and Attracting and Retaining Talent
Julia Chapman, BridgeBio

CDMO Insider: Career Opportunities, Scaling Up Your Product, Understanding Lab-Grade Versus Commercial-Grade Products

Panel Q&A moderated by Angela Whatley, PhD, BridgeBio, and Debasish Roychowdhury, MD, Partner Therapeutics