Accelerated development is exposing the risks of siloed clinical and manufacturing teams.
From protocol design and site selection to formulation strategy, supply planning, regulatory submissions, and commercialization readiness, decisions made in one area can have significant downstream implications in the other. Yet many sponsors continue to approach clinical and manufacturing activities as separate workstreams connected only at key milestones.
In this on-demand webinar, experts from both the clinical and manufacturing sides of drug development explore where these interdependencies are most often overlooked, how misalignment can accumulate throughout development, and why some of the most significant risks emerge not within individual functions, but at the intersection between them. Through real-world examples and cross-functional perspectives, viewers will gain a deeper understanding of how clinical and manufacturing decisions influence one another and what sponsors should consider when evaluating how their development programs are structured.
In this webinar we explore:
- How well your clinical and manufacturing teams understand one another's priorities and how those perspectives shape the same development program.
- Where seemingly independent decisions may be creating hidden downstream risks elsewhere in your development program.
- Whether your current development model supports the growing interdependence between clinical and manufacturing functions.
- If your partners provide the integrated expertise needed to anticipate challenges before they become costly delays.
Speaker Details
Jason Parks
Executive Director, Biotech Operations
Melanie Owen
Executive Director, Portfolio Delivery Lead
Richard Dennett
Senior CMC Regulatory Strategy Director
Kaitlyn Huff
Senior Director, Regulatory Strategy
Mari Halen
Director, CMC Portfolio Management
Barb Simpson
Director, Transportation Center of Excellence
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