ARTICLES BY LOUIS

• Is 2026 The Year We End The "Culture Wars" Between Sponsors And CDMOs?

  1/2/2026

  No two cultures meld perfectly, but between any sponsor and CDMO lies a certain culture of manufacturing outsourcing that both should recognize. Earlier, I wrote that 2025 was the year CDMOs focused on their customer service. Let 2026 be the year sponsors do some introspection. Biotechs and pharma alike should ask: “Does our culture enhance –  or inhibit – the outsourcing experience?”

• Trading Places: 2025 Intensified CDMOs Recruiting Sponsor Talent

  12/27/2025

  CDMOs have valid reasons for it. Professionals on both sides say external development and manufacturing organizations want to be viewed in a better light by sponsors. Recruiting experienced sponsor-side professionals is one step to accomplishing that goal. Not exactly new, but intensified in 2025. And expect more in 2026.

• 2025 Review: Customer Service As Important As Capacity And Capability

  12/24/2025

  At times the predominant concern of biotechs regarding outsourcing development and manufacturing is capacity at CDMOs, at other times matching up capabilities. But throughout 2025, it’s a third “c” – customer service  – that's been a focal point. So what do we mean by customer service?

• 2025 GLP-1 Impacts Tell Us About CDMOs In 2026

  12/15/2025

  When we began covering the nexus between GLP-1 drugs and CDMO capacity, there were two key questions: Could Big Pharma keep up with demand? Would the CDMO market also have capacity to serve the thousands of drug sponsors needing assistance with their non-GLP-1 programs? Those answers in 2025 tell us a lot about our industry heading into 2026.

• 2025 Tariffs Barely Impact Europe's API Supply Chains

  12/1/2025

  When earlier this year the Trump administration began waving the specter of tariffs on drug substances and products entering the U.S., the biopharma world held its breath. European countries, as much as even China, felt the lack of oxygen. Would, for example, global sponsors leave European CDMOs to relocate their API production at contractors in the U.S.? Here's what we uncovered.

• FDA PreCheck Implementation Recommendations

  11/24/2025

  Enthusiasm for the FDA’s PreCheck (documented in part one) is a positive sign. We’re always looking for good ideas from regulatory agencies. But implementation and strategic initiatives to take advantage of this facility-approval regulatory reform will take efforts. Dhaval Rathod, Pharmaceutical Sciences group at Shionogi Inc. (USA), has a prescription for working with the FDA to ensure drug sponsors and CDMOs fully utilize the PreCheck program.

• BioPharma Industry Loves New FDA PreCheck Program

  11/17/2025

  Outsourcing professionals alerted Chief Editor Louis Garguilo to the arms-open reception the industry is giving the FDA's new PreCheck program focused on facility approvals and more frequent but less stressful interactions with the agency. Here's an analysis of the program to help build a domestic infrastructure and speed up drug approvals.

• AI Assesses Passion At CDMOs, But Humans Think Differently

  11/13/2025

  A "part two" on passion? Yes, this time employing AI Agents to do some noodling on the subject to supplement the great insight we got from our Advisory Board (made of sentient beings). We carefully define and dissect the idea of passion at CDMOs as a factor for drug sponsors.

• Is Passion A Criteria For Your CDMO Selection?

  11/10/2025

  With a tinge of trepidation at being thought of as whimsical, I asked our Editorial Advisory Board: Can consideration of a CDMO’s passion play a role in due diligence for selecting a partner? Is there a qualifiable measurement (intuition?) related to a CDMO’s enthusiasm? I was surprised (and relieved) by the, well, passion with which some Board members replied. Here's what they think.

• We're A Virtual Biotech. CDMOs Should Treat Us As A Priority

  11/3/2025

  Chief Editor Louis Garguilo says he's sure some readers will smirk at our headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus where the most financial gain is. That's usually with bigger clients. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.