For The Record: How Past Experience Enables Future Success
By Jakob Lange and Shawn James

Years in business, launches and manufacturing capacity are the standard checklist for judging a drug delivery partner.
They prove delivery, but they say little about what a company learned along the way, or how much of that learning reaches the next customer. Jakob Lange and Shawn James look at what sits behind the numbers: how a shift from bespoke devices to modular platforms changed the way knowledge accumulates, which lessons carry across programs and which stay tied to a single molecule or container, and how engineering judgment develops in human factors, regulatory precedent and manufacturing scale-up. They also consider why a partner chosen in clinical development may be a decade-long commitment.
Explore the argument for treating a track record as a foundation rather than a history.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.