ARTICLES BY LOUIS

• Buckle Up. It's A Strategic Drive To Successful Sourcing

  9/15/2025

  Chief Editor Louis Garguilo says we bounce around the word “strategic” like a biopharma basketball. We’ve even got our own league. More professionals in our outsourcing industry include “strategic” in their titles than ever before. Starting with this editorial, he investigates what this exulted approach to working with external partners really means.

• The 15% Tariff: A Modest Jolt Or Deeper Disruption?

  9/12/2025

  Regarding the U.S. / E.U. “agreement” to a blanket 15% tariff on pharmaceuticals entering the former from the latter, Chief Editor Louis Garguilo zeroes in on potential effects of outsourcing active pharmaceutical ingredients (APIs). A 2025 analysis indicates 43% of branded pharmaceutical APIs used in U.S. prescriptions come from the E.U. Learn more about our predicament from a case study and closer look.

• Did Trump Just Create An Antibiotic Supply Chain In The U.S.?

  9/11/2025

  In 2022, we had headlines such as: FDA Declares Nationwide Amoxicillin Shortage. Now three years later a homegrown manufacturer — USAntibiotics of Bristol, Tennessee — says it can cover America’s demand under a new arrangement with two titans of distribution and retail: McKesson and Walmart. The other “titan” in the deal is President Trump. Chief Editor Louis Garguilo takes a nuanced look at this breaking news that again puts drug manufacturing on the front pages.

• Paying For Lots Of Formulation Work At Your CDMO

  9/8/2025

  We’ve investigated the outsourcing of early-to-commercial drug formulation. So how do you pay for all that work? For answers and examples, again Chief Editor Louis Garguilo primarily turns to Dileep Boinipally. He starts with the "usual method of payments" - fee-for-service (FFS), but adds a whole lot of options and strategies.

• What FDA's Complete Response Letters (CRL) Say About Outsourcing

  9/2/2025

  The 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.

• Hybrid. Continuous. Peptide. Manufacturing. Lilly's Put It All Together.

  8/28/2025

  After 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.

• Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection

  8/25/2025

  Consider 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.

• Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

  8/21/2025

  An 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.

• As Billions Of Dollars Pour In, Do CDMO Valuations Matter?

  8/18/2025

  Customers 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. 

• 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.