Public Health Emergency - Leading a Nation Prepared
Because drug-resistant infections complicate the medical response in chemical, biological, radiological or nuclear emergencies, BARDA devised a three-prong approach to advance promising new antibacterial products from the bench to the bedside. The goal is to protect health, save lives, and enhance national security and global health preparedness. On part of the approach is CARB-X, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator. CARB-X was created to help address the threat of antibiotic resistance that will complicate any public health emergency. CARB-X is one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antibacterial products to help address the threat of antibiotic resistance.
Antibiotics are a fundamental part of modern medicine, but their effectiveness is diminishing. Bacteria are increasingly becoming resistant to those treatments. CDC estimates that drug-resistant bacterial infections affect 2 million people and kill 23,000 people in the U.S. each year at a financial cost of $20-35 billion. BARDA’s role in national security is to protect our nation by supporting the development of products that will either prevent harm from exposure to some of the greatest threats to health or help those who are infected make a full recovery as quickly as possible.
At the same time, major drug companies have cut back or pulled out of antibiotic research and development. Over the last several decades there has been a continual withdrawal of pharmaceutical companies engaged in developing new antibiotics. In 1990, there were at least 18 large pharmaceutical companies actively developing antibiotics. Today there are four. This has left much of the discovery work to small companies with no product on the market limited budgets and R&D capacity.
In the private sector, start-up companies with innovative ideas can turn to venture capitalists, or accelerators, who provide the necessary funding for the research and development and business savvy to turn the ideas into successful products. CARB-X is another partner serving this function for companies with innovative and promising solutions to antibiotic resistance.
CARB-X partners are promoting innovation and could provide hundreds of millions of dollars over the first five years to increase the number of antibiotics in the drug-development pipeline. This early in development, the vast majority of products – 80 percent or more – fail for a variety of reasons. To minimize that risk, CARB-X provides more than non-dilutive funding for these products; CARB-X also provides the business support and drug development expertise the companies, including start-ups, need to increase their odds of success. That way at least two products reach clinical trial.
BARDA and NIAID founded CARB-X with funding partner Wellcome Trust of London, life science accelerators including the California Life Sciences Institute and Massachusetts Biotechnology Council, and strategic alliance partner AMR Centre in the United Kingdom. Boston University serves as the lead institution for CARB-X. RTI International and the Broad Institute of MIT and Harvard have joined the partnership with RTI providing technical and research support services and Broad conducting early antibiotic discovery.
CARB-X’s board, including renowned experts in the field, thoroughly vetted 168 proposals and selected 11 projects to be powered by CARB-X that represent truly exciting early stage research. Three of them could become the first in new classes of antibiotics, and four are innovative non-traditional products. Some of the projects also take new approaches, known as mechanisms of action, to target and kill bacteria. All of the potential new medicines in this first round target Gram-negative bacteria prioritized by the U.S. Centers for Disease Control and Prevention and the World Health Organization.
CARB-X will continue to add products, up to 20, to the portfolio. The larger development portfolio of products - more than a company normally can take on - means the chances of getting innovative products into clinical testing within five years are higher than normal.
The end goal of CARB-X is to move promising antibiotic candidates through earlier stages of research and development, so that they merit private or public investment to advance to approval by the U.S. Food and Drug Administration and/or the Medicines and Healthcare products Regulatory Agency of the United Kingdom.
In 2017, CARB-X will seek new partners - funders and accelerators who want to join the team as they “Xccelerate global antibacterial innovation.” Watch for these opportunities.
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