President’s advisory group calls for clinical trial changes, incentives for antibiotics R&D


With antibiotic resistance on the rise at a time when Big Pharma has largely vacated the risk-heavy field, the President’s Council of Advisors on Science and Technology (PCAST) is proposing a number of recommendations to lure companies back into the arena and help speed up the development of new antibiotics.

At a July 11 meeting, the council voted to accept a report that endorses a federal plan to address antibiotic-resistant pathogens called superbugs, which cause infections in more than 2 million people and about 23,000 deaths in the U.S. every year, according to the U.S. Centers for Disease Control and Prevention. Most of these infections–including E. coli, salmonella, Shigella and C. difficile–are acquired in healthcare settings, such as hospitals or nursing homes.

One of the areas the report addresses is the clinical development path for new therapeutics. At the meeting, council co-chair Eric Lander said PCAST is recommending a national infrastructure for clinical trials of new antibiotics.

Lander said the challenge with clinical trials is that patients with an antibiotic-resistant infection need to be enrolled immediately, as opposed to other disease areas like cancer.

“So we need to have the most streamlined, efficient clinical trials to decrease the cost to the developer of a new antibiotic, of testing that antibiotic, as safely and effectively as possible,” Lander, president and director of the Broad Institute, said at the meeting.

Lander said an “ongoing, continuous” clinical trial network for experimental antibiotics would be a desirable approach.

PCAST is also calling on the FDA to step up its role in combating antibiotic resistance. Lander said there should be a way to approve an antibiotic for a limited special use based on a focused clinical trial.

With the exception of Roche ($RHHBY), Big Pharma has largely pulled out of antibiotics, given the high costs associated with R&D and relatively low financial reward. Cubist ($CBST), Basilea ​Pharmaceutica ($BSLN) and Otsuka are doing most of the late-stage work in antibiotics right now. To help attract industry to the field, PCAST is advocating economic incentives like federal funding for antibiotics development, similar to how the Biomedical Advanced Research and Development Authority (BARDA) initiatives have spurred interest in drug programs for bioterror threats.

PCAST says it will release its official report within the next few weeks.