Louis Garguilo
ARTICLES BY LOUIS
-
![FDA Seal of approval-GettyImages-1977218350]( "What FDA's Complete Response Letters (CRL) Say About Outsourcing")
9/2/2025The FDA embraced "radical transparency” by publishing over 200 complete response letters (CRLs) for drug and biologics applications submitted between 2020 and 2024. Hooray for the FDA; good for drug developers hard at work today. Good for developers, writes Chief Editor Louis Garguilo, because he can identify patterns to help us outsource better.
-
![GettyImages-656926656]( "Hybrid. Continuous. Peptide. Manufacturing. Lilly's Put It All Together.")
8/28/2025After reading part one with Lilly Kinsdale's Lorraine O'Shea, readers want to learn more about that facility’s “hybrid continuous manufacturing for peptides” technology. Chief Editor Louis Garguilo explores that technology with O'Shea, and ties it into thoughts of CDMO facilities as well.
-
![Fairness-GettyImages-2214633591]( "Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection")
8/25/2025Consider these two questions: How do we select a CDMO? How do we select a facility? The second of these should carry as much weight as the first, but unfortunately often does not. Chief Editor Louis Garguilo thinks that should change. He turns to Eli Lilly's ISPE Award Winning facility, and Lorraine O'Shea, Associate Vice President and Plant Manager at Lilly Kinsale, to make the case.
-
![orange plastic tubing-GettyImages-2211338336]( "Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured")
8/21/2025An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.
-
![Analyzing chart-GettyImages-500482196]( "As Billions Of Dollars Pour In, Do CDMO Valuations Matter?")
8/18/2025Customers of a CDMO receiving some of the billions of dollars being invested in CDMOs might be enthusiastic. But large investment into the ownership pool can bring the ripple effects of transition. For some CDMO customers, this positively translates to increased offerings. For others, it introduces complexity and a shift in relationship dynamics.
-
![Worried business people in meeting-GettyImages-2151309416]( "Our Supplier Failed? Heck No, We Failed Our Supplier!")
8/12/2025“We would be in meetings, and someone would disparage a certain CDMO. But one of our leaders would almost always have the opinion that we could make the relationship work. ‘No one is perfect, including us,’ he said.” Outsourcing is an attitude, explains Dan Marasco. Here's the attitude he says you should bring to your external partnerships.
-
![finacial staff meeting-GettyImages-1412797969]( "Tech Transfer 2025 – A High-Stakes Game Of Trust")
8/4/2025Trust us. You'll want to read this editorial from Chief Editor Louis Garguilo, who was (gently) reminded he hadn't visited the subject of tech transfer in a while. He answers the questions both sponsors and CDMOs ask to gain the trust to make a tech transfer work for both sides.
-
![Dan Marasco]( "Relationship Equity With CDMOs Is Real, Take It From A Packaging Pro")
7/31/2025A professional of packaging who has weaved through various positions in Big Pharma says you should understand any points of leverage you have with a CDMO. When leverage is minimal, creating "relationship equity" is key. After a decade interlude, a well-timed follow up conversation with Dan Marasco.
-
![Thumbs up, thumbs down-GettyImages-1399273404]( "CDMOs Should Stop Stringing Biotechs Along")
7/28/2025Biotechs, first working closely with a CDMO’s sales manager, experience subsequent and sudden rejections of their projects. Did some of you just wince? If so, that might be because we are again hearing of a problem with sudden rejections after protracted discussions and even site visits. Part two on what is one of the biggest problems for outsourcing today.
-
![Business men in meeting-GettyImages-2210165491]( "The Biggest Problem At CDMOs Today")
7/21/2025A perennial outsourcing problem has resurfaced, according to industry sources. It is the misalignment at CDMOs between their business development and tech ops or other project-evaluation teams. Sponsors are again encountering situations where CDMO sales/BD show enthusiasm, but later hear the project has been declined.
Louis Garguilo
Click here to e-mail Louis
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.