For fill finish services at CDMOs, two items high on biopharma executives’ wish list are increased analytical and testing capabilities, and automation to replace manual product-line inspection. However, it appears to the CDMOs that customers are saying, ‘The onus is on you to figure it out … and pay it forward.” Is there a mutually acceptable solution?
Each year, Jamie Dimon’s annual letter to shareholders is considered required reading by folks on Wall Street and elsewhere. Dimon is Chairman and CEO of JP Morgan Chase, the largest of the big four American banks. Reading through his letter this year, I found three areas we might consider directly relevant to Outsourced Pharma readers.
As vivaciously as our board members responded to a question regarding their biggest challenges when contracting fill finish services, CDMOs have now reacted in kind. The reactions come from around the world, including four CEOs of CDMOs. One thing both sides agree: They are operating within an encompassing paradigm shift.
Ours is a responsive Editorial Advisory Board, but no question posed to them elicited the range and rate of response as this one:
In 2005, a couple of guys in Waterford, Ireland, got together and said: “There’s not enough high-potency, high-containment facilities in the world. Why not build one?” While they were at it, they also decided to focus a new facility on developing and producing innovative generics. What could be so easy?
When are “solutions” not solutions? When they don’t solve the problems for which they are intended. In part two of our pre-publication review of “Drugs, Money, And Secret Handshakes,” we start with the incongruous idea that raising prices will help lower prices. And we analyze the role of outsourcing.
“Drugs, Money, and Secret Handshakes” is one hundred power-packed pages from author Robin Feldman, the Arthur J. Goldberg Distinguished Professor of Law at the University of California Hastings. Feldman provided Outsourced Pharma a pre-publication copy of the book. Here’s part one of my review.
Effective government/private-enterprise partnerships; biopharma and CDMOs working collaboratively and internationally on innovative plant-made pharmaceuticals; the advancement of biopharma-CDMO business models. And we can partly thank tobacco plants. Who would have thought?
Tough to admit – after all, editors are supposed to be good at editing – but I didn’t know where to start this narrative. (And don’t murmur, “Try at the beginning,” because you’d be reading ‘till Christmas.)
Imagine you are a virtual biopharma developing a plant-based biopharmaceutical, and you contact the CDMO with the most experience in the field. The CDMO offers its technology/knowhow, to help file an IND, and supply the clinical material and launch quantities. Then it'll assist you in building your own commercial facility in your home market. Sound too good to be true?