ARTICLES BY LOUIS

• 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.

• Tech Transfer 2025 – A High-Stakes Game Of Trust

  8/4/2025

  Trust 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.

• Relationship Equity With CDMOs Is Real, Take It From A Packaging Pro

  7/31/2025

  A 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.

• CDMOs Should Stop Stringing Biotechs Along

  7/28/2025

  Biotechs, 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.

• The Biggest Problem At CDMOs Today

  7/21/2025

  A 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. 

• The Mighty CDMOs Producing API

  7/14/2025

  CDMO focused on active pharmaceutical ingredients (APIs) have long been vital components in the supply chain. Today, they are more than your enablers. CDMO have become strategic actors helping to reshape global outsourcing markets. A new report focuses on the new forces raising their importance.

• The FDA Was Darned Near Perfect, Right?

  7/11/2025

  Let's return to minutes before Donald Trump became president in January, to a time when the FDA was near perfect. That’s what one would assume today listening to those up in arms over the agency. Of course, the reality was quite different. Chief Editor Louis Garguilo helps regain perspective.

• Why CDMOs Are Leaving Small Molecules Behind

  7/7/2025

  It’s rare when a CDMO’s restructuring leads to thoughts about national health policy. But as Chief Editor Louis Garguilo wrote his recent editorial on Lonza’s decision to focus heavily on biologics, it brought to mind a government policy that may have contributed to the company’s restructuring. No, it's not tariffs.