Breaking down Operation Trailblazer: Rolling INDs, outside expert submission help, and one-trial requirement

In this week’s episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Sara Willa Ernst, reporter, break down HHS’ latest vision for the future: Operation Trailblazer. The report is titled: “HHS Roadmap to Maintaining U.S. Leadership in Early Clinical Research and Development.”“The U.S. is apparently losing its leadership in INDs and early phase research,” Paul said. “Some of it is true and also it does not help that the whole enterprise of cancer research right now is in, if not disarray, then at least a kind of mental and spiritual discombobulation.”Most notable were proposed changes to FDA, including an expedited Investigational New Drug program, which would use expertise outside FDA to help prepare INDs before submission, and a lower threshold—just one high-quality late-stage—for confirmatory evidence, which is already common practice in oncology. Paul checked in with sources about the report after it was released. What he heard with his ear to the ground: It’s unclear whether the plans in the report will amount to policy. “We don't know whether it's going to happen and there is a problem right now in that FDA really took a hit in terms of staffing,” Paul said. “At the moment, there is no permanent FDA commissioner. Having leadership that's deeply destabilizing was really a problem.”“FDA really right now needs to get its house in order or as the industry says, ‘right the ship,’” he continued. “A rudderless FDA for a while there was a step in the wrong direction. So, they're going to have to clean this up and maybe they will. Let's hope they do.“That's what I'm hearing from folks as I call them. But it was important to get [the news] out on paper even though the story certainly has a large number of caveats.”Stories mentioned in this podcast include:The Directors: Directors of two Midwestern cancer centers tell us about the challenging healthcare economics in rural areasTo keep the early clinical trial enterprise in the U.S., HHS pledges to simplify regulatory requirementsJoe Fraumeni, founder of molecular epidemiology, dies at 93Karen Huntsman’s vision gave shape to the Huntsman Cancer InstituteRobert Mayer tells us about pancreatic cancer’s hopeless past as new data shows promiseA transcript of this podcast is available: https://cancerletter.com/podcastc/20260701-operation-trailblazer/