ARTICLES BY LOUIS

• A (Partial) Vindication For Wuxi AppTec … And Global Outsourcing

  10/22/2025

  Chief Editor Louis Garguilo believes WuXi AppTec should take this as a dose of vindication. Even a partial victory. Supporters persuaded the Senate to NOT include WuXi in the BIOSECURE Act. Here’s an analysis of this current situation that can affect anyone outsourcing drug development and manufacturing.

• Italy A Quiet Outsourcing Standout For Drug Manufacturing?

  10/20/2025

  Italians, the quiet ones? Perhaps. The relative attention Italy collects in our industry is not commensurate with the substantial development and manufacturing outsourcing that takes place in this European nation. Coming out of COVID a few years ago, Italy is now the largest CDMO market in Europe, ahead of Germany’s ~$3 billion, and France’s $2.49 billion. 

• Will It Not Die? The BIOSECURE Act Back With Iterations

  10/17/2025

  Chief Editor Louis Garguilo describes this as "Act VI, in which the antagonist reenters the stage." The stage is the U.S. Senate, and the antagonist is again the BIOSECURE Act. Earlier this month, the Senate included a new version of the legislation – again as an add on to a National Defense Authorization Act (NDAA). 

• The Key To Outsourcing Is Timing-lines, Not Timelines

  10/16/2025

  The Rolling Stones sang, “Time is on my side.” Nary a biotech would agree. Brent Powell, a process chemist who started his career at a CDMO, knows a few reasons for this, and how to make the strategic change in your thinking from timelines to timing-lines.

• Outsourcing: You Own It, They Earn It

  10/15/2025

  “Well, of course they’ll charge you, one way or another,” says Scott Jeffers, CTO of GenSight Biologics, describing what happens when your CDMO decides to move your program from one site to another – even if they initiate the move. Jeffers is a pragmatic, positive biopharma professional with advice for (anticipating and avoiding) challenges with your CDMO. 

• Ivory Tower To CDMO: Can Universities Successfully Outsource Development?

  10/6/2025

  Let’s be honest: for professionals at CDMOs, dealing with university-based clients can feel like trying to run a development campaign through a distortion field. Even when inventors are “spun out” into the “real world” as a biotech, breaking through to the realities of progressing molecules is tricky. Apologies to those who might take offense, but stick with us, this will prove helpful for academia and others to optimize working with CDMOs.

• The FDA 483 Heard Round The World

  10/3/2025

  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 483 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.