Mehran Bhatti, CEng, CPSM, Independent ATMP and Biotech Supply Chain Advisor, takes an interesting look at the supply chain challenges that can emerge during clinical development. The analysis highlights how decisions made early in a program—often before supply chain teams are involved—can have significant downstream impacts on manufacturing readiness, quality, and execution.
From Mehran:
Supply chain is not late because of poor planning. It is late by design.
The frameworks that guide early-stage drug development do not include it. The teams building them are focused on the science, the clinical plan, and the IP.
By the time supply chain arrives, the CDMO is already selected. The bill of materials is locked. The manufacturing network is largely set. From preclinical through to late Phase 2 or Phase 3, that gap spans 4 to 9 years.
74% of FDA complete response letters cite quality or manufacturing deficiencies. Up to 40% of those are attributable to CDMO sites specifically. 1 in 17 programs ends entirely due to preventable CMC-related causes.
These are not execution failures. They are the result of decisions made without supply chain input due to the absence of the function at those stages.
I have spent 10+ years in this space, including leading advanced therapy manufacturing readiness and supply network readiness through commercial launch. The pattern is consistent.
There is not much published that consolidates and quantifies this gap in one place. I did the research and attached it below. I would be glad to hear your take.
