ARTICLES BY LOUIS

• Cell And Gene Therapy CDMOs: On The Path To $75 Billion in Services?

  4/30/2026

  Cell and gene therapy (CGT) developers – and thus their service providers – have had their share of ups and downs. But what do the promise and uneven realities of these therapies add up to in the development and manufacturing outsourcing sector? According to a Towards Healthcare report, despite the bumps in the road, in 2025 the global CGT CDMO market grew to $8.2 billion. What of future predictions? Here's a detailed analysis.

• FDA Letters Made Public Are Creating New Risks

  4/23/2026

  There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake.

• A CMC Professional At Sanofi Focuses On Collaborations (And The Right Questions)

  4/20/2026

  Manda Pasarkar, Global Regulatory Affairs, CMC Head, Sanofi, has overseen global, multi-billion-dollar portfolios of products from early development to commercialization. She spoke with Chief Editor Louis Garguilo on her outsourcing strategy and philosophy.

• 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.

• 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.

• 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."

• 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.

• What If The U.S. Government Stopped Funding Biotech?

  3/23/2026

  It sets off a real tension – ideological, economic, even personal. But what would happen if the U.S. government cut direct financial support for “biotechnology research,” leaving it entirely to investors, private and public markets, and bigger pharma? "Our industry’s mind-meld says with no government largesse our biotech industry collapses," writes Chief Editor Louis Garguilo. It's an "outlandish hypothetical," but he asks for a few minutes to go through this. And he has help in making his case.

• The Long Road To U.S. Vaccine Manufacturing

  3/19/2026

  GeoVax CEO David Dodd sings the praises and is grateful for the program-enabling relationships he has in Europe. At the same time, he harbors lingering disappointment. From the outset of its formation, the biotech has desired to work with U.S.-based CDMOs.  But he says he will not give up. “One way or the other,” Dodd says, “GeoVax will have U.S.-based manufacturing.”

• Advising The Biotech C-Suite To Reconsider Quality

  3/16/2026

  “I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”