ARTICLES BY LOUIS

• How Do We Categorize CDMOs?

  2/24/2025

  Are we on the same page? Do we need to be? That is, how do we differ on what might seem like the mundane defining of CDMOs as small, medium, or large? Some readers have been asking. How might this determination be relative and important to individual sponsors? Our Advisory Board members weigh in.

• CDMOs Bet Big On Asia Expansion. Can Trump Reverse The Tide?

  2/20/2025

  Facility investments by CDMOs continue to be magnetized to Asia. Recent examples abound. Chief Editor Louis Garguilo details some of those, and discusses whether, for example, a President Trump-intensified focus on increasing manufacturing in the U.S. can change this. Will your outsourcing in 2025 change direction? The answer may surprise you.

• Stop Hiring Now! Stay Virtual

  2/17/2025

  Robert Discordia, Co-Founder, President and CEO, EQUULUS Therapeutics, knows that to advance early-stage development assets most economically, biotechs should (a) stay within their virtual model, and (b) base that outsourcing strategy on initial business objectives. Here are his dos and don'ts.

• They Said What? Unexpected Insights Into CDMO Selection

  2/10/2025

  An assortment of conversations with experienced biopharma executives have generated some surprising commentary about CDMO selection. Chief Editor Louis Garguilo puts those insights together in this editorial. They include selection preparation/responsibilities, and some interesting CDMO behaviors of late.

• Regulatory-CMC: A Core Practice For Successful CDMO Partnerships

  2/6/2025

  Regulatory-CMC is the denominator through the career of Sai Prathyusha Bhamidipati, currently at Moderna. Regulatory-CMC focuses on ensuring compliance with regulations regarding the production and quality control of your pharmaceutical products. Bhamidipati explains the importance for the practice of which when dealing with CDMOs.

• Training Specifically For Tech Transfer Skills Does Exist

  2/3/2025

  Professionals in our development and manufacturing outsourcing ecosystem are worried about inadequate training – in-house at their biotechs, and at their CDMOs. A main concern is a lack of sufficiently trained personnel to perform the various technology transfers to keep our industry running efficiently.

• From JP Morgan: CDMOs Have A Change Of Heart

  1/29/2025

  CDMOs seem determined to do two things more strategically and with a greater focus: build on what they do best (instead of spreading across services); and differentiate themselves by a devotion to customer service. Part two from JPM25.

• An Outsourcing Vibe At JP Morgan 25

  1/28/2025

  The JP Morgan Healthcare conference has never been a venue for directed discussion on outsourcing. That’s not to say such discussions aren’t held. This year, Kurt Nielsen co-hosted an evening devoted to the topic. Nielsen, a veteran outsourcing-industry executive, shares his initial thoughts on the vibe this year.

• How Biotech Academy In Rome Is Reshaping Workforce Readiness

  1/27/2025

  As the biotech industry continues to evolve, a growing gap in workforce readiness has emerged, driven by insufficient training for both new graduates and experienced professionals transitioning to advanced bioprocessing. Biotech Academy in Rome's Leonardo Sibilio addresses this challenge.

• The Intelligent CDMO: A Vision With Agentic AI

  1/20/2025

  Agentic AI is the next artificial-intelligence iteration for the biopharma industry. It propels prediction to autonomous decision-making. It can usher in transformative efficiencies to CDMOs. If you've day-dreamed of more effective external-support, this may be a ticket to that destination.