ARTICLES BY LOUIS

• 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.

• RNAi vs. mRNA: Two Therapies, Two CDMO Strategies

  7/1/2025

  The biotech industry is often described in grand dichotomies such as innovator vs. generic, small vs. large molecule, or clinical vs. commercial. These differentiators influence development and manufacturing, CDMO selection and outsourcing strategies. There are also nuanced pairings, such as mRNA vs. RNAi.

• Lonza Bets On Biologics. What's It Mean For You?

  6/26/2025

  It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” including for antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry? 

• Late-Stage Formulation Is A Different Ballgame. Insights From An Allstar

  6/19/2025

  The art and science of late-stage/commercial formulation, compared to early-phase formulation, is a different ballgame, says Dileep Boinipally, currently utilizing CDMOs to advance a pipeline of oral and injectable candidates. He has a stadium full of advice for readers.