By Kate Hammeke
As a market researcher, I am frequently asked “What is an unexpected finding from ISR’s research?” This question prompts me to think for a moment — not because of a shortage of unexpected findings that relate to contract manufacturing, of which there are a multitude — because I need to get in the mind-set of the person who has asked the question in order to reveal something they too would find unexpected. This can be a challenge because of my vantage point, which is atop a mountain of data about the dynamics between sponsoring organizations and the contract manufacturers they engage.
The finding that truly struck me by surprise in the past year comes from ISR’s CDMO Outsourcing Models survey. The purpose of this study is to understand how various outsourcing approaches — transactional relationships, preferred provider lists, and strategic partnerships — work for sponsor organizations. In it we asked participants an open-ended question: “In your opinion, what is the most difficult part of outsourcing manufacturing activities?” The write-in responses, in order of frequency, for development-stage manufacturing are: 1) Quality, 2) Timelines, and 3) CMO selection; and for commercial manufacturing, they are: 1) Quality, 2) CMO selection, and 3) Timelines.