ARTICLES BY LOUIS

• The FDA 483 Heard Round The World

  10/2/2025

  Chief Editor Louis Garguilo writes: "For the first time in more than a decade writing this column, I’ll focus on a specific 483 – actually two – received by a CDMO site. It pains me to do so, for a number of reasons. But the overall industry reaction to this specific FDA issuance compels me to take this on." Read about the 482 heard round the world, and what it means for CDMOs, sponsors, and the FDA.

• Execute Or Decay: Radiopharma's Outsourcing Reality

  10/1/2025

  The radiopharmaceuticals industry is benefiting from increasing investments and a rush of promising innovation. At the same time, it faces a rather spotty outsourcing services and supply infrastructure. The Radiopharmaceutical Blueprint Report calls this the industry’s central paradox, “a multi-billion-dollar wave of investment and commercial validation is colliding with a fragile, underdeveloped infrastructure” of isotope supply, GMP manufacturing, and talent.

• You're In Charge Of Strategic Sourcing? What's That Actually Mean?

  9/22/2025

  Chief Editor Louis Garguilo wraps up his investigation into the real meaning of "strategic" when it comes to supply chains, sourcing, procurement, and outsourcing development and manufacturing to CDMOs. He discovers a series of best practices that turn one-off tactics and isolated decisions into multi-variable and thoughtfully aligned relationships.

• 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.