Discovery Research From The Editor

1. 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.

2. 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.

3. 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.”

4. 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.”

5. The Jones Act Hurts U.S. Pharmaceutical Manufacturing 3/13/2026

   The Jones Act punishes U.S. pharmaceutical manufacturing. It may have taken a modern-day war, one much involved with the free navigation of commercial shipping, but after more than 100 years navigating a policy of protectionism – and fear of competition – are we are again waiving the Jones Act (for 60 days). Chief Editor Louis Garguilo says let’s not temporarily waive it. Sink the Jones Act forever.

6. With CDMOs Like This, Who Needs Biotechs? 2/7/2026

   The question struck like a thunderbolt, writes Chief Editor Louis Garguilo. “Where are CDMOs going with all this?” asked Edward Ahn, CEO, Medipost, Inc., referring to the remarkable growth of some CDMOs. “When CDMOs aim to offer every service, capability, and the requisite capacities for an entire drug life cycle – from discovery to clinic to commercialization – what’s actually left for a biotech sponsor to do?” A forward discussion on an evolving outsourcing dynamic.

7. At JP Morgan 2026, Few Showed Up For U.S. Manufacturing 2/2/2026

   What may turn out to be an instructive anomaly emerged at at the JP Morgan Healthcare Conference. Across eight roundtable discussions convened by biopharma investment advisors – covering topics such as Avoidable Drug Development Pitfalls and The Emergence of Highly Competitive Chinese and Korean Biotech – the one where nary a soul showed up was titled U.S. Manufacturing. “I don’t quite understand it,” says Ali Pashazadeh, Treehill Partners founder. Here's a close investigation.

8. Is 2026 The Year We End The "Culture Wars" Between Sponsors And CDMOs? 1/2/2026

   No two cultures meld perfectly, but between any sponsor and CDMO lies a certain culture of manufacturing outsourcing that both should recognize. Earlier, I wrote that 2025 was the year CDMOs focused on their customer service. Let 2026 be the year sponsors do some introspection. Biotechs and pharma alike should ask: “Does our culture enhance –  or inhibit – the outsourcing experience?”

9. FDA PreCheck Implementation Recommendations 11/24/2025

   Enthusiasm for the FDA’s PreCheck (documented in part one) is a positive sign. We’re always looking for good ideas from regulatory agencies. But implementation and strategic initiatives to take advantage of this facility-approval regulatory reform will take efforts. Dhaval Rathod, Pharmaceutical Sciences group at Shionogi Inc. (USA), has a prescription for working with the FDA to ensure drug sponsors and CDMOs fully utilize the PreCheck program.

10. BioPharma Industry Loves New FDA PreCheck Program 11/17/2025

    Outsourcing professionals alerted Chief Editor Louis Garguilo to the arms-open reception the industry is giving the FDA's new PreCheck program focused on facility approvals and more frequent but less stressful interactions with the agency. Here's an analysis of the program to help build a domestic infrastructure and speed up drug approvals.