Thursday, July 28, 2016

International Partnership Created To Speed Up Antibiotic Development

Drug-resistant superbugs are on the rise, increasingly rendering a number of drugs useless even for infections that were once easily treated. At the same time, it’s been more than three decades since medical science found a new class of antibiotics, meaning the bugs may be outpacing the drugs. Today, the U.S. government, along with private organizations in the United Kingdom and stateside, announced a partnership intended to accelerate the development of new antibiotics.

The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a partnership between the U.S. Department of Health & Human Services, the Wellcome Trust of London, the AMR Centre of Alderley Park, and the Boston University School of Law that hopes to feed hundreds of millions of dollars in funding toward antibiotics research over the next five years.

I Need A New Drug

A recent data provided by Pew Charitable Trusts, no new class of antibiotics has been discovered since 1984. All antibiotics introduced in the decades since have been updates and improvements on existing classes.

Meanwhile, also per Pew, only 37 antibiotics are currently in the FDA’s drug approval pipeline. Of those, and only about one-third of those are specifically intended to treat the types of drug-resistant infections that are on the rise, including drug-resistant gonorrhea (affecting 243,000 Americans a year); C. difficile infections — sometimes resulting from an overuse of antibiotics — that affect half a million people a year and kill 15,000; and infections that are resistant to a class of antibiotics known as carbapenems.

What Will CARB-X Do?

In the tech world, a few developers working around a folding table in the garage can get millions in startup funding from venture capitalists, but antibiotics require a lot more time and energy just to get to the point where they enter the approval process. Even then, only about 20% of infectious disease drugs that begin this process will ever get the green light from regulators. Thus, pharmaceuticals investors have had little reason to back research into new antibiotics. CARB-X hopes to turn that trend around by turning on the cash spout for this vital drug development.

HHS’s Biomedical Advanced Research and Development Authority (BARDA) will provide up to $250 million in research funding over the next five years, including $30 million the first year of CARB-X. The AMR Centre — located in Cheshire, UK — is pledging to provide upwards of $100 million over the five-year period, including $14 million to start. The National Institutes of Health’s National Institute of Allergy and Infectious Diseases will provide research support, including preclinical research expertise, to CARB-X-supported projects.

CARB-X itself will be headquartered at the Boston University School of Law, with an executive team — made up of experts in the field of drug development — led by health law researcher Kevin Outterson.

Additionally, the Broad Institute of MIT and Harvard will create an antibiotics chemistry hub that product developers can access.

The long-view idea is that funding and shepherding researchers through the rough, early stages of the development and approval process will result in contributions from other private and public funding sources so that these drugs can complete their development and — fingers crossed — be approved and introduced to the market.

“Our hope is that the combination of technical expertise and life science entrepreneurship experience within the CARB-X’s life science accelerators will remove barriers for companies pursuing the development of the next novel drug, diagnostic, or vaccine to combat this public health threat,” said acting BARDA deputy director Joe Larsen, Ph.D. “In the same way BARDA’s investment model has proven successful in advancing countermeasures through late-stage development, we believe this international partnership can identify promising candidates in the early stages of development that may offer treatment options for drug-resistant bacterial infections.”


by Chris Morran via Consumerist

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