WS22.1 – People, Process, Product to Make Clinical Supply a Strategic Role in R&D

Clinical supply chain (CSC) has been viewed as a purely tactical “fulfillment” center—the last link in the chain rather than a seat at the head of the table. As we navigate the complex R&D landscape of 2026, characterized by high-cost biologics, accelerated timelines, and personalized medicine, this “reactive” model is no longer sustainable. This intensive workshop provides a blueprint for transforming CSC into a strategic engine that drives clinical program success and informs R&D decision-making from Phase I through to commercial launch. Through the tripartite lens of People, Process, and Product, we will dismantle the silos that separate supply teams from Clinical Operations and Regulatory Affairs. Participants will learn how to transition their teams from “kit-movers” to “program-architects” by leveraging advanced data analytics and fostering a culture of cross-functional leadership. We will examine how optimizing the “Process” (integrated demand forecasting) and the “Product” (early-stage CMC-Supply alignment) can drastically reduce R&D burn rates and increase speed-to-market.