ARTICLES BY LOUIS
Ending Generic Drug Shortages At Hospitals: A Capitalist Goes Nonprofit
I hope Outsourced Pharma readers will enjoy this editorial with Civica Rx President & CEO Martin VanTrieste, featured in this month’s issue of Life Science Leader magazine. VanTrieste has a business plan that could set the generics industry on a new path of full disclosure of drug-manufacture origin, and direct delivery to the point of patient use. Part 2 of this feature will be released next month, with a direct focus on CDMOs and Civica.
CDER: Continuous Shouldn’t Be Continuously Delayed
The FDA wants continuous processing and manufacturing to move forward. CDER’s even sending emails and writing Impact Stories about the technology. Here’s what three biopharma industry experts — from Merck, BMS, and MIT — think about the pace of adoption.
The New Outsourcers: Amylyx And The Next-Gen Biotechs
Justin Klee and Joshua Cohen were just 21 and 22 when they co-founded Amylyx Pharmaceuticals in 2013, while pursuing undergraduate degrees at Brown University. Today, their insights about drug development and manufacturing outsourcing are nothing short of remarkable.
Biopharma Leaders Need Lengthier Lists For Outsourcing Competency
Essential at biopharma: comprehensive lists and analyses to ensure all aspects of your outsourcing (and internal activities) are thoroughly considered as you chart your path forward. "Think big, think long, and think detailed.” So says one biopharma professional who's done it successfully for decades.
Ranbaxy Revisited: Why We Need To Look Back
The fraud, deception and damage Ranbaxy Laboratories Ltd. of India perpetrated around the world a decade ago in the form of shoddy and dangerous drug manufacturing practices, is legendary. It’s time to look back. Katherine Eban, author of “Bottle of Lies: The Inside Story of the Generics Drug Boom” has provided us the means.
FDA Leads, C-Suite Lags Continuous Manufacturing Acceptance
What happened to the continuous manufacturing (CM) revolution that was barreling down the biopharma turnpike? One measurement of progress is the five FDA-approved drugs utilizing CM. I’ve heard positive dispositions on how the FDA is doing all it can to break down the adoption doors. But there’s a sentiment within the industry CM gets stuck in the C-Suite.
How Important Is Geography To Today’s Outsourcing?
A recent CDMO press release essentially asserted superiority via proximity: Geography as God of outsourcing. I contacted two biopharma executives familiar with the Boston/Cambridge scene for reactions: Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics, and 15-year veteran of Merck; and George Avgerinos, Senior Vice President of Biologics Operations, Fortress Biotechnologies, and 22-year veteran of BASF/Abbott/Abbvie.
New FDA Quality Report – A World Full Of Inspections
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.
Novartis And the Price Of A Child’s Life
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?
“We Do Everything” CDMO Pitch Not Pleasing Everybody
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.