Louis Garguilo
ARTICLES BY LOUIS
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7/8/2019
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.
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6/28/2019
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.
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6/24/2019
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.
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6/14/2019
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.
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6/13/2019
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.
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6/10/2019
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.
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6/3/2019
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.
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5/29/2019
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?
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5/23/2019
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.
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5/16/2019
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.