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Reactions to HHS’s new clinical trial modernization initiative have been mixed. On one hand, biotech and regulatory leaders are on board with a pilot program to speed early trials in hopes of bringing them back to the U.S. But former regulators point to roadblocks in running first-in-human trials that are beyond the scope of FDA Operation TrialBlazer IND reforms alone.
What FDA Operation TrialBlazer IND Reforms Actually Target
“FDA is not the primary source of most delays in early phase clinical trials,” Harpreet Singh, a former division director of oncology at FDA, told BioSpace. The major delays instead occur at the site level, she said. Announced June 22, Operation TrialBlazer is an HHS-wide initiative that seeks to reduce the time from drug identification to Phase 1 trials and expedite early clinical development timelines by as much as a year.
Why the U.S. Is Losing Ground on Trial Volume
“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,” Health Secretary Robert F. Kennedy Jr. said in a prepared statement alongside the pilot’s announcement. In 2010, less than 8% of global clinical trials were run in China; by 2020, the Asian nation had overtaken the U.S. in annual registered trials. China’s National Medical Products Administration has also overtaken the FDA in cancer approvals, greenlighting 94 oncology drugs between 2020 and 2025 compared to the 87 that entered the U.S. market in the same timeframe.
How Competing Countries Outpace FDA Operation TrialBlazer IND Timelines
“There’s no question that we’re losing Phase 1 trials,” Hilary Marston, a principal at Canal Row Advisors and former chief medical officer at the FDA, said during a panel discussion at the BIO International Convention in San Diego last month. For companies considering starting an early-phase trial in Spain, Australia or China versus the U.S., “all three, besides the U.S., are going to come in more quickly, more cost effective and with less administrative burden,” Singh explained.
Cautious Optimism From Former Regulators
Marston said she was “heartened” by the TrialBlazer announcement, but there’s a lot of nuance to weed through. Both she and Singh expressed concerns over whether the FDA’s efforts would be enough to shift the clinical trial landscape. “I still am not fully clear on how HHS will address the major issues,” Singh said.
The Specific FDA Operation TrialBlazer IND Changes Underway
During an FDA town hall session at BIO 2026, acting CBER Director Karim Mikhail highlighted two key elements of the new IND program: a rolling submission process letting companies submit applications piecemeal and receive feedback, and streamlined requirements for the IND submission itself. “If you look at the IND guidances we have, they have not been designed for Phase 1, first-in-human IND submission,” Mikhail said.
Comparing U.S. Requirements to Other Countries
Saol Therapeutics CEO Dave Penake agreed that current IND requirements are cumbersome compared to other nations, particularly 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,” he said.
Improving Pre-IND Access Within FDA Operation TrialBlazer IND
A second step of the initiative is improving the process before an IND is even submitted. Mikhail lamented that sponsors currently only get a single pre-IND meeting with the FDA. “You have this one chance, and one chance only, to be in front of the FDA with all your questions… and that’s a very big, honestly tough position for a CEO,” he said.
Why the U.S. Won’t Match China’s Speed
Marston acknowledged that faster clearance of preclinical and IND-enabling tools could help, but cautioned that China achieves speed partly through investigator-initiated trials and pathways that bypass its Center for Drug Evaluation. “We’re not going to be as fast as China, right? I think we just need to recognize that, but we can get much closer,” Marston said.
Why Site and IRB Issues Matter More Than FDA Operation TrialBlazer IND Changes
At Precision for Medicine, Singh and her team have often placed early-phase trials in Australia or Europe based on client preference, predicated on speed, cost, and high-quality data generation. She attributed the slower pace of entering human drug testing primarily to lengthy site activation timelines, site infrastructure challenges and costs, and institutional review board processes. “Until we take care of the site issues, we’re getting nowhere,” Marston agreed.
A Proposed Single IRB Model
Under TrialBlazer, the agency is considering implementing a single Institutional Review Board model where there would be one IRB of record for all of a program’s sites. “We have really substantial delays associated with just IRBs, and each institution having its own request to the protocol,” Penake said. “I could definitely see how 6 to 12 months could get knocked off here if you just did central IRBs.”
Legal and Institutional Reactions to This Proposed Change
In 2022, the FDA issued a proposed rule to require a single IRB for review of multisite studies conducted under an IND, with certain exceptions, according to Claire Davies, a shareholder at Polsinelli law firm. “The Operation TrialBlazer roadmap appears to contemplate moving that proposal forward, and requiring a single IRB for multi-site studies should reduce duplicative review,” Davies told BioSpace.
Concerns About Institutional Resistance
Heidi Gertner, a partner at Hogan Lovells, agreed the idea addresses a real problem but raised concerns that trial sites may not be eager to cede authority. “Usually, IRBs don’t really want to give up their oversight,” she said, because it involves their institution, employees and processes.
A Whole-of-HHS Effort Beyond FDA Operation TrialBlazer IND
At BIO 2026, acting CDER Director Michael Davis emphasized that FDA is but one piece of the TrialBlazer initiative. “This is really a whole of HHS effort,” Davis said. The multi-department effort also includes NIH’s National Center for Advancing Translational Sciences working to accelerate CRISPR-based therapies for rare diseases, while the National Cancer Institute works with cancer centers to streamline trial activation and improve enrollment.
Internal FDA Awareness and Public Feedback
Davis spoke of an internal FDA town hall where leadership addressed roughly 2,000 staffers, laying out the scope of the problem with visuals showing how clinical trial phases are shifting overseas. FDA leadership is now seeking feedback from staffers and the public. The public comment period for the IND initiative ended July 22, with other TrialBlazer programs remaining open for feedback into August and September.
What This FDA Operation TrialBlazer IND Effort Means for Biotech Going Forward
Given the range of perspectives from former regulators, current FDA leadership, and industry executives, this initiative appears to represent a genuine but partial response to a multifaceted problem. Singh, who reviewed up to 20 IND applications per week during her time at FDA, suggested one additional improvement: giving more autonomy to experienced early phase drug developers rather than having FDA staff line-item review and edit every protocol detail, noting that most FDA physicians haven’t spent time in industry developing drugs themselves.
What to Watch Going Forward
As the public comment periods for various TrialBlazer components close through September, industry observers will likely watch whether the proposed single IRB model gains traction despite institutional resistance, and whether FDA’s streamlined IND requirements meaningfully close the gap with faster, lower-cost jurisdictions like Australia and Spain. Given that experts broadly agree site-level and IRB delays represent the larger bottleneck compared to the FDA’s own review timelines, the ultimate success of FDA Operation TrialBlazer IND reforms may depend as much on addressing institutional infrastructure challenges as on any changes to the agency’s own submission and review processes.
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