Supply Chain Planning for Clinical Trials: A Practical Guide

＂Before a new drug is approved for general use, its safety and usefulness has to be demonstrated in a clinical trial, in which the new therapeutic is administered to healthy and diseased volunteers under close medical supervision. These hugely expensive trials depend on a timely and efficient supply of the new drug substance. This is not trivial for the manufacturer, because at that point the drug will not yet have entered a large-scale quality-controlled production regime that is the norm for marketed drugs. Managing the timely supply of pre-production drugs to the various centers involved in a clinical trial while maintaining quality control and accountability is a critical component of every clinical trial that requires specialist knowledge and a dedicated workflow＂--

Ryan Mills, PhD, is Director and Supply Chain Head for Denali Therapeutics, South San Francisco, CA. He has over 15 years of experience in pharmaceutical and biotechnology production, and his background in supply chain planning has involved some of the highest-performing companies in the world.