The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.
The FDA is now accepting applications for the first companies and partnered qualified research institutions to participate in its expedited investigational new drug program, dubbed Operation TrialBlazer.
First announced in June, 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. The objective is to speed early trials in hopes of bringing them back to the U.S. FDA officials expanded on the design of the IND pilot program that falls under the broader initiative in a press release Tuesday morning.
“The pilot not only pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA, it also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed,” Acting FDA Commissioner Kyle Diamantas said in a prepared statement.
The IND pilot program will allow drug developers to partner with qualified research institutions (QRI) with the scientific expertise to support efficient development of IND submissions, according to its webpage. These could be academic medical centers or contract research organizations, Center for Drug Evaluation and Research (CDER) director Michael Davis told reporters during a media call Monday evening.
The QRIs selected for the pilot program “will bring specialized and substantial scientific expertise to the IND application preparation process allowing the FDA to review and accept individual components on a rolling review during the pre-IND phase, rather than waiting for all components to begin review,” per Monday’s release.
The goal is to “identify and resolve issues earlier, reduce the risk of clinical holds and make the path to first-in-human trials more predictable,” Karim Mikhail, director of the Center for Biologics Evaluation and Research (CBER), said on the media call.
The pilot will assess whether this process can prevent FDA holds being placed on first-in-human clinical trial protocols during the 30-day IND review.
Between eight and 10 sponsor-QRI pairs are expected to be selected to participate in the initial pilot cohort, the FDA said Monday. The application period will be open until Oct. 30.
