Louis Garguilo
ARTICLES BY LOUIS
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9/25/2023
They say biotech taught pharma how to outsource. So what’s someone who has spent 31 years working in Big Pharma know about outsourcing from the vantage point of smaller organizations? A lot, it turns out.
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9/21/2023
“I look from a supply-chain perspective,” says AI / supply-chain expert Tingling Dai, “discovery, development, manufacture ... until we put them into clinical use.” And that involves, he says, “keeping track of multiple stakeholders.”
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9/18/2023
It’s time to get real about artificial intelligence applied specifically to drug development and manufacturing outsourcing; practical supply-chain enhancements to implement right now. Thoughts from an AI supply-chain expert. Part 1.
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9/15/2023
Each year, I present some takeaways to Outsourced Pharma readers from BioPlan's important annual survey on bioprocessing. This year, I notice our noisy nomenclature, and present a chart that indicates CDMOs will keep on keeping on.
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9/11/2023
A global drug development and manufacturing stalwart recently relayed heady outsourcing advice, and tales of what you might call economic woe that provide words of caution to all readers ...
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9/6/2023
Hint: According to long-termed Pfizer supply-chain professional Francis Dumont, it is sterile-fill. Learn about that and much more on working effectively with CDMOs to optimize production.
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8/28/2023
A few months past the culmination of a 31-year career at Pfizer, Francis Dumont has this seminal thought on drug development and manufacturing outsourcing: “I’m tired of the word ‘strategic.’”
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8/21/2023
What do you do when batches are lost at a CDMO, or other negative outcomes arise from your service provider? Here's a real-life example and answer from an experienced biotech CEO. He believes solutions start with relationships on all levels.
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8/14/2023
All outsourced or not, “It's our product," says NervGen CEO Michael Kelly." We have an 'intellectual responsibility' as stewards to make sure we can get this through clinical trials and to patients as quickly as possible.”
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8/9/2023
Form 483 – issued at the conclusion of an FDA inspection – is the perfect example to lend to a universal principle: Whatever is going on at a CDMO that might impact customers should be communicated to those customers. Here's a detailed analysis from industry professionals.