In 2018, FDA investigators performed 1,346 Drug Quality Inspections, covering 29% of what the agency calls it’s “site catalog.” Of those inspections, the majority (53%) were performed outside of the U.S. Here’s why that’s important, and more insight on these worldwide inspections from a newly issued FDA report.
We’ve been thrust from ruminating around the worth of a generic “human life” towards contemplating starker terms of specific two-year-old children. This thanks to Novartis’ gene-therapy Zolgensma, priced at $2.125 million. However, is this our hoped-for future of gene and cell therapies? The irony of life-saving drugs that financially cancel their celebration at the point of FDA approval?
Recent CDMO marketing extolling “the only end-to-end services" hasn’t been universally well received by the biopharma professionals it is targeting. Might we start questioning how truthful all CDMO marketing is as a result? That wouldn’t be good for the drug development and manufacturing outsourcing industry.
The questions for “make vs. buy" raised by Bristol-Myers Squibb’s Christopher Sinko, SVP and Head of Product Development, are news because of this: Sinko reaffirms for us they remain cemented within the otherwise changing dynamics impacting drug development and manufacturing outsourcing decisions.
Didn’t you get the memo? Actually, the series of memos: Biopharma customers need more HP and analytical support. These two services keep popping up as limiting factors for drug development and manufacturing outsourcing programs. Now another of these memos has been written, by Doug Bakan, Arena Pharmaceuticals’ Executive Vice President, Technical Operations.
According to the CPhI Japan Trend Report 2019, there are some interesting cross currents in the Japan market for innovative medicines. But allow me to also alert Outsourced Pharma readers to a separate trend I’ve been following for a while: The CDMO industry in Japan is on the rise.
Technical operations personnel – “Tech Ops” – can feel like they are running in circles as much as advancing programs forward. To straighten out those loops, Arena Pharmaceuticals relies on Doug Bakan, EVP Technical Operations. But complicating matters for Bakan is that today Arena is an all-outsourcing development and manufacturing organization.
Robert Ward of Eloxx Pharmaceuticals is on his second tour of duty as chief executive officer of an early-stage biotech. That makes him the perfect “real-life” CEO to react to a recent editorial about a “speculative” CEO who says to her colleagues: “We outsource, therefore we exist.” Ward’s initial thought? “Don’t put Descartes before the horse."
I asked Susanne Somerville, leader of the MediLedger Project, and now CEO of Chronicled, for an update on blockchain technology and supply-chain adaption in the biopharma industry. She came back with excited talk of “sub-second drug verification,” and a new "interoperability creating effective channels of communication," including with your CDMOs. Glad I asked.
Take it from an organic chemist, who transitioned from the bench to cross-functional leadership and CMO management at companies such as Amgen, Baxter/Baxalta, Shire, and now ImmunoGen: Outsourcing effectively starts with realizing "the value of establishing consistent internal processes for all activities.” And, he adds, bring a bit of attitude to your service providers.