Reactions to the Department of Health and Human Services’ new clinical trial modernization initiative have been mixed, as biotech and regulatory leaders express support for a pilot program intended to accelerate early trials in the United States, while former regulators highlight challenges beyond the Food and Drug Administration’s control. The responses came after Operation TrialBlazer was announced on June 22, aiming to reduce the time from drug identification to Phase 1 trials by up to a year through changes in the investigational new drug (IND) application process.
“FDA is not the primary source of most delays in early phase clinical trials,” Harpreet Singh, former division director of oncology at FDA, said. She attributed major delays instead to site-level issues. Health Secretary Robert F. Kennedy Jr., in a prepared statement alongside the announcement, said, “America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas.”
Industry experts pointed out that other countries have become more competitive locations for early-phase trials due to speed and lower administrative burdens. Hilary Marston, principal at Canal Row Advisors and former chief medical officer at FDA, said during a panel discussion that “there’s no question that we’re losing Phase 1 trials.” Singh added that companies often choose Spain, Australia or China over the U.S., citing faster processes and lower costs.
At BIO 2026 in San Diego last month, acting Center for Biologics Evaluation and Research Director Karim Mikhail outlined two key elements of FDA’s IND program: launching a rolling submission process so companies can submit applications piecemeal with ongoing feedback; and streamlining IND requirements specifically for Phase 1 submissions. “It’s not like it’s one and done, and we’re finished with streamlining requirements. We will continue to do that,” Mikhail said.
The initiative also seeks solutions beyond IND reform by addressing site activation timelines, infrastructure challenges, costs associated with starting studies at sites, and institutional review board (IRB) processes. Saol Therapeutics CEO Dave Penake said current U.S. requirements are more cumbersome than those in countries like Australia: “There are a lot of non-clinical data that are required in the U.S. before you have your first-in-human dosing that are not required until Phase 2 in some other countries.” The FDA is considering implementing a single IRB model across all sites within a program as part of efforts under TrialBlazer.
Acting Center for Drug Evaluation and Research Director Michael Davis emphasized collaboration across HHS agencies within Operation TrialBlazer during BIO 2026 sessions: “This is really a whole of HHS effort.” Public comments on aspects such as expedited IND pilots were accepted through July 22; additional programs remain open for feedback into August and September.
