ARTICLES BY LOUIS
Lyndra Therapeutics is designing in-house a specialized, continuous and automated manufacturing line to manufacture its new long-acting oral-drug products. Someday, it hopes to export that line to partners around the world. The strategy starts with a basic scientific knowledge that propels an organization to continuous.”
A miniature manmade “star” – with round middle and triangular arms – collapses to fit into a capsule and provides patients an oral drug. The creators of this device-like drug are devoted to manufacturing through continuous manufacturing. Can the company also outsource some of what they've developed internally?
There's a hiring crunch out there, and today drug sponsors are recruiting from inside some of their CDMOs. Is that a good strategy? We'll take a look at both sides of the equation.
Steve Goodman, Vertex Pharmaceuticals has been outsourcing development and manufacturing for years. “I’ve been successful because my approach to managing a CDMO is mostly agnostic to modality,” he says. Here are a few more of his best practices.
Steve Goodman’s new title at Vertex Pharmaceuticals catches the eye: Executive Director, AAV Process Development and Manufacturing. It points us to where our industry is rapidly heading. In fact, we might say Goodman himself has been a leading indicator.
I first described Cosette Pharmaceuticals as an “innovative specialty generics” organization, but President & CEO Apurva Saraf had us questioning all three of those words, and how we use them (or shouldn't) today.
“I have not wanted to go to India or China for most of my API needs, and to the extent possible I do not want to go there for formulations either,” is part of a surprising sentiment from a long-tenured generics outsourcing professional.
When it reaches criticality at your CDMO – like the potential delivery delay of clinical material – it’s "Hypercare" time. That’s the word coined at Alexion Therapeutics for an intensified coordination and managing of activities at CDMOs in crucial moments. Read on: Hypercare might be right for you, too.
Have you sufficiently examined the “life” of your drug development and manufacturing outsourcing? If you rely on outsourcing as an external life force to get you into and through the clinic (and perhaps beyond), how you answer that has never been more important.
We the People of the Outsourcing Industry, in Order to form a more perfect Union, establish Service, ensure Reliability, and secure the Blessings of our system of drug development and manufacturing, establish this Constitution for working with CDMOs. (Preamble to the Outsourcing Constitution)