ARTICLES BY LOUIS

• Outsourcing Everything Is The Biotech Blueprint

  6/15/2026

  “My business model when I took over in 2017 was to outsource everything.” That’s as clear as it gets from a biotech CEO. Amit Kumar cuts to the chase during our conversation centered on the newly announced relationship between his company, Anixa Biosciences, and Cytovance Biologics, a U.S.-based CDMO.

• It's Years Later And We Still Disagree: Free WuXi From The BIOSECURE Act

  6/12/2026

  Through more than a dozen editorials starting in February of 2024, Chief Editor Louis Garguilo has disagreed a most reliable, trusted, and thus utilized global CDMO deserves to be brandished as off-limits to U.S. drug sponsors. Here we are again: WuXi AppTec is included in the Pentagon’s new list of companies said to have ties to the Chinese government and military. Here is Garguilo's update.

• Data Confirms Europe's CDMOs Succeed Despite U.S. Gyrations

  6/11/2026

  Confirming data is now at hand. In 2005, we suggested Europe’s CDMOs couldn’t wait for a political or trade détente vis-à-vis the U.S. If they actively leveraged their reputation for reliability, tariffs would not meaningfully redirect manufacturing to the U.S. Here's an analysis of a GlobalData report on what has transpired.

• AI And Data Pull CDMOs Into Pharma's Commercial Strategy

  6/8/2026

  The distance between external API producers and fill-finish experts, and the commercial apparatus of their pharma customers, has lessened. Commercial evidence now starts its derivation as innovation becomes tangible material, set processes, and then product creation … at external development and manufacturing partners. Jon Williams, CEO, Lumanity, says there's a shift toward integrating development strategy and commercial decision-making earlier in the lifecycle.

• FDA Now A Supply-Chain Complication

  6/1/2026

  Crossing the Rubicon to regulatory-leadership discontinuity; suffering a disunity at the FDA impacting our supply chains. When sponsors begin altering outsourcing relationships and clinical-trial strategies because of uncertainty at the FDA, more supply-chain challenges are created than corrected for. That suggests all of us should take a deep breath. Vigilance and concern are always part of the drug industry. But we need to address the question: How is the FDA impacting development and manufacturing outsourcing?

• A CMC Playbook For Leadership And Hiring

  5/28/2026

  Would you like a shortcut to failure in regulatory CMC? Hire extensively based on what candidates already know. That’s a provocation underlying a number of conversations with senior leaders in regulatory CMC, and it feels especially relevant to outsourcing. With the correct attitude and leadership, learning (yes, on the job) may beat credentials for long-term success.

• Why Is Biopharma Left Out Of The U.S. Infrastructure Conversation?

  5/26/2026

  Investment manager BlackRock gathered powerful investors to discuss along with government officials the nation’s physical and economic backbone. The Infrastructure Summit clarified the biopharma industry including CDMOs are in a battle for investments and infrastructure. Analysis from Chief Editor Louis Garguilo.

• AI Stuck Upstream? It Still Influences Manufacturing Outsourcing

  5/21/2026

  AI may help run and optimize bioreactors at your CDMO. There is pervasive pressure to move manual (and reactive) control to AI-autonomous (predictive systems). You may already select your CDMO partially based on its systematic utilization of AI in its facilities. But at this moment of transition, while the odds are high AI may not fully reside in the manufacturing plant today, it increasingly shapes the decisions determining what and how programs get to that plant.

• Kodak's CEO Leans Into Biopharma Manufacturing – "I'm An Operator"

  5/18/2026

  Kodak’s Eastman Business Park in Rochester was the focus of a recent editorial. But the man leading Kodak’s comeback, Jim Continenza, Chairman and CEO, is a topic unto himself. He’s as animated as any public-company CEO you’ll encounter. And he knows his audience; in his conversation with Chief Editor Louis Garguilo he says Kodak “has always supplied CDMOs and the industry with important chemicals.” Read his vigorous take on domestic manufacturing and other supply-chain topics.

• Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not

  5/14/2026

  Tokyo Institute of Technology. London Business School. ETH Zürich. What do these institutions – and a biotech based in Mulhouse, France – have in common? Matthieu de Kalbermatten, CEO of CellProthera. His international experience adds up to this: Build an internal quality (cGMP) organization; become the master of the processes you create for your therapy, before moving to external help; then select your CDMO carefully – maybe just prior to Phase III.