Discovery Research From The Editor

  1. 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.

  2. 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?

  3. 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.

  4. 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.

  5. 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.

  6. Can A Biotech Create A CDMO Market? 5/11/2026

    Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.

  7. Why A Cell Therapy CEO Waited Until Phase III To Outsource 4/16/2026

    Sometimes, you have to go it alone. For a while, at least. The mantra across biotech has long been clear: engage your CDMO early, and let those experts guide you into manufacturing. Matthieu de Kalbermatten, CEO of CellProthera, a regenerative cell-therapy developer, begs to differ.

  8. Forget Tech Transfer. You Need A Cognitive Connection 4/13/2026

    Cognitive transfer is a concept widely studied in psychology. Today it has growing relevance within our industry’s ever-increasing technology transfers, which have been understood in the main as moving development/manufacturing processes/technologies from one stage, one location, or one organization – as when utilizing CDMOs – to another. Time now to zero in on the communicating of tacit or implicit knowledge, i.e., knowledge or experience difficult to extract through data or written explanation. This is where cognitive transfer enters our portal. Here's an analysis.

  9. In Palm Beach The Focus Is On Biotech (Not President Trump) 4/9/2026

    “When I came to Florida,” James Sapirstein says, “I was leaving New Jersey because of tax reasons.” That was 2018. Timing is everything, they say. Sapirstein’s relocation placed him ahead of a broadening and intensifying migration trend – including he believes, a new biotechnology settlement. This is not news to readers – Miami alone seems perennially in the headlines. “Economics drives investors,” Sapirstein says, and Sapirstein is committed spearheading “a new kind of biotech cluster."

  10. Does Biotech Need More Government Funding — Or A New Business Model? 3/30/2026

    Should government financing appreciably recede – whether through policy shifts, budget pressures, or ideological bent – what would happen to the biotech business model? To ascertain such a question, first we must look at the fundamentals of the existing model, and then understand investors (and service providers) better.