ARTICLES BY LOUIS GARGUILO
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![GettyImages-526288748-DNA]( "Were We (Are We) Correct About Oligonucleotides?")
Were We (Are We) Correct About Oligonucleotides?11/12/2024In 2023, Chief Editor Louis Garguilo proclaimed it was "the year of oligonucleotides," and 2024 would be an incredible growth year for oligos. How are those proclamations panning out? He takes a detailed look, including the important role in the expected growth played by CDMOs.
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![young businesswoman thinking-GettyImages-1307840993]( "Do You Know Your QMM? Moderna Might Some Day")
Do You Know Your QMM? Moderna Might Some Day6/17/2024Don’t panic if you aren’t familiar with the above acronym, which stands for Quality Management Maturity. Chief Editor Louis Garguilo wasn't – until schooled by Jason Kerr, Regulatory Intelligence Senior Manager, Moderna and Adjunct Professor of Quality Systems, Keck Graduate Institute. QMM, it appears, may very well be in your future.
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![Compliance Regulation Business Technology risk management-GettyImages-1433535736]( "A Spy At Moderna")
A Spy At Moderna5/28/2024Jason Kerr of Moderna is a snoop, a spy, a watcher of all things. More officially, he’s tasked by his employer with monitoring for regulatory changes in the environment. “Some do call it regulatory surveillance,” he says, “Some just regulatory monitoring.” Whichever, you might need to hire a Kerr, too. Here's why.
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![Molecules-GettyImages-1182809201]( "Oligonucleotides Outsourcing In 2024")
Oligonucleotides Outsourcing In 20241/9/20242023, among other potential designations, was the year of oligonucleotides. Accordingly, here’s a question I raised with professionals throughout the year: How do you successfully outsource development and manufacture of an oligo program?
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![Ebola virus-GettyImages-1359497022]( "Oh, Oligonucleotides! Everybody Wants In")
Oh, Oligonucleotides! Everybody Wants In10/23/2023“We’re working on oligonucleotides,” says the bubbling biotech. “We can do oligos!” cries the eager CDMO. So it’s a deal? Hang on, says Tony Sampognaro, Director, CMC Project Management, at oligo-focused Stoke Therapeutics.
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![GettyImages-1298201596]( "Moderna And The Building Of Bridge Facilities")
Moderna And The Building Of Bridge Facilities2/27/2023In August of 2021, relatively overlooked because of other news swirling around our industry, Moderna became the anchor client in a new cleanroom on demand housed in a bridge facility in Massachusetts. In retrospect, it may have legitimized a new era in outsourcing.
Louis Garguilo
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Louis Garguilo is chief editor of Outsourced Pharma, and is considered a leading authority on the art and science of drug development and manufacturing outsourcing. He studied public relations and journalism at Syracuse University (and holds a Master’s in English). His widely read editorials are based on in-depth analysis and interviews with industry executives and professionals. Editorials are written in an engaging and unique style that guide readers through the macro aspects and subtle nuances of outsourcing, and working with contract development and manufacturing organizations (CDMOs). Garguilo also serves as moderator for the various Outsourced Pharma Live webinars held throughout the year.
Prior to joining Outsourced Pharma in 2014, Garguilo spent a decade at a global pharmaceutical contract research, development and manufacturing organization, leaving the industry after attaining the role of vice president, business development and marketing. Additionally, he has served under the governor of New York in the state’s economic development agency, as liaison to the pharmaceutical/biotechnology industry; as chief strategic officer for an e-learning software company; and spent most of the ‘80s and ‘90s in Japan as an educator, author, and communications consultant.