The Trump administration is launching a project to cut the time and cost of drug development. Teams chosen through a bidding process will receive funding and support for five years. Health Secretary Robert F. Kennedy, Jr. and Advanced Research Projects Agency for Health Director Alicia Jackson will unveil the effort in Austin, Texas, on Wednesday. CMS Administrator Mehmet Oz and FDA Acting Commissioner Kyle Diamantas will attend, too.
How the program would work
The program is called the Simulation-augmented, Real-time Platform Adaptive Seamless Trials, or SURPASS. ARPA-H is developing it and will ask for proposals from teams that include a drug sponsor. Selected teams will test drug candidates using experimental clinical-trial processes, with funding and support from the program over five years.
ARPA-H wants proposals in three technical areas: phaseless trials designed to move faster with fewer patients; real-time analysis of data while a trial is underway, rather than only after it ends; and automation to reduce inefficiencies. Teams will likely include medical centers or other clinical sites, biostatisticians and companies that can predict drug outcomes by computer.
The FDA helped plan the program. “There won't be any surprises for regulators in this,” said program manager Daria Fedyukina. The source says the FDA took part in planning, but doesn't say the agency will select proposals or direct the teams’ work.
Costs, timelines and competition
Developing a drug can take more than a decade and cost around $2 billion, while more than 90% of drug candidates fail, according to HHS. The article says China has become a popular place for drug manufacturers partly because early-stage clinical trials there cost less and move faster. Experts and the biopharmaceutical community largely agree that the United States needs to streamline trial processes to compete.
Fedyukina said the program aims “to develop the tech that is missing and blaze the trail of a new clinical trial paradigm.” She said it will require “blueprints and standards that then can be deployed and used by all other trials in the U.S.” Her remarks describe standards intended for use across other U.S. trials.
Fedyukina said possible savings were hard to quantify. “There is no reason why we cannot target, let's say, a 10x reduction in the cost of clinical development for a drug,” she said. She added, “There's no reason why we cannot cut timeline in half or more.” These figures are targets, not established outcomes.
Related trial infrastructure projects
ARPA-H is also announcing three projects tied to clinical-trial infrastructure. One will establish more trial sites, using AI to speed site activation and prepare sites that haven't held trials before. The effort could give patients living near hospitals that don't currently take part in trials access to experimental drugs.
The other two projects focus on clinical-trial data infrastructure and helping patients with complex cancers use their own data and better navigate the care system. The source describes changes to trial processes, infrastructure and access for some patients. It doesn't describe a transfer of national authority, demographic effects or a role for international institutions in the program.