Louis Garguilo

AI Is Not The CMC Revolution You're Looking For The #cell / #gene therapy landscape has reframed innovation from "groundbreaking" discovery to intelligent data and processes management. #AI then becomes less a revolutionary and more efficiency engine. outsourcedpharma.com/doc/ai-is-not-…

According to two professionals, there are two developments in our industry that constitute a seismic change in the way #pharmaceutical #manufacturers are regulated. An Internal Audit Program In Pharmaceutical Quality Operations can help you keep up. outsourcedpharma.com/doc/maximizing…

We cannot delimit our development and manufacturing outsourcing into national components determined by governments. Biopharma organization should select its suppliers with eyes wide open. We are global, and need to stay that way to serve patients. outsourcedpharma.com/doc/a-partial-…

outsourcedpharma.com/doc/a-partial-… WuXi AppTec should take this as a dose of vindication. Even a partial victory. There's been a reverse in not include WuXi in the BIOSECURE Act. But we can only guess how the company feels. WuXi has declined to comment. That's wise. Here's why…

The FDA 483 Heard Round The World outsourcedpharma.com/doc/the-fda-he… For the first time in over a decade writing editorials, I’ve focused on a specific FDA-issued 483 received by a CDMO site. It pains me to do it, but the overall industry reaction to this compels me to take it on.

I believe it’s worth a consideration over your weekend. Both the reality and the symbolism of “Antibiotics Made in America” is indeed powerful, from both a national and industry-specific perspective. outsourcedpharma.com/doc/did-trump-…

...and for the most part, what goes on in the world of drug development and manufacturing supply chains is overshadowed by other national and global news of all kinds. I believe the most important news of this week combines the two categories above.

My job for the past decade-plus has been to report on news and professionals around the world that impact the biopharma supply chain. At times, that work interlaces with much broader happenings in the world. On the other hand ...

It’s rare when a CDMO’s restructuring leads to thoughts about national health policy, and macro economics. But recent news did just that. And No, I am not talking about tariffs. outsourcedpharma.com/doc/why-cdmos-…

@Keith_SNY here’s the easiest way for Mets radio: audacy.com/stations/metsr…

@Keith_SNY Pete in the conversation for gold glove? Early, but he’s been impressive.

@Keith_SNY @Gary_D_Cohn my little league team was named “Amalgamated Joint Board,” but were often called “Amalgamated Junk Board.” A side note: none of us had a clue what an amalgamated joint board was.

@musk_news13 Star. Name him Star.

I agree. It's been a deluge of #AI commentary/analysis. So I humbly present part 2 of my take on Agentic AI (in the #biopharma industry. outsourcedpharma.com/doc/the-intell…

@carlquintanilla re debanking, read Melania Trump’s recent book. Much on the subject within.

#Biopharma now has generative #AI in our employ. Just in time for #AgenticAI to ride in. This iteration could revolutionize our #drugdevelopment and #manufacturing, and impact, for example, #outsourcing decision-making, and #CDMO relationships. #JPM25 outsourcedpharma.com/doc/autonomous…

@elonmusk Just finished a Friedman book (still going in paperback) from 1990. Amazing - nothing (good) has really happened related to gov. bloat! Same issues, only worse.

Milton Friedman was the best

@BretBaier not “where” are those congressional seats still outstanding, “WHY are they still outstanding??”

@JoeSquawk you should have asked @WalterIsaacson if he would be so concerned if @elonmusk was jumping for joy on a stage at a Harris rally.

@JudiciaryGOP Unfortunately, it was a big loss of freedom of speech that gives us this big win. But if in fact it is a big win will only be borne by future behaviors. Don't trust, and verify.

Mark Zuckerberg just admitted three things: 1. Biden-Harris Admin "pressured" Facebook to censor Americans. 2. Facebook censored Americans. 3. Facebook throttled the Hunter Biden laptop story. Big win for free speech.