Public Health Emergency - Leading a Nation Prepared
Today the Biomedical Advanced Research and Development Authority (BARDA), in collaboration with our colleagues at the National Institutes of Allergy and Infectious Disease (NIAID) released a Funding Opportunity Announcement to establish the Combating Antibiotic Resistant Bacteria (CARB) Biopharmaceutical Accelerator. The Accelerator represents a novel public private partnership that will support research and development to accelerate candidate products (drugs, vaccines, and diagnostics) into clinical development.
Infections with bacteria that are resistant to existing antibiotics kill 23,000 Americans per year and cost the U.S. healthcare system an estimated $2B annually. Penicillin-resistant bacteria were first identified in 1947, just four years after mass production of the drug began, and over the last several decades, resistance has emerged to every class of marketed antibiotic. Bacteria resistant to one of the last drugs to treat certain types of hospital acquired infections are now widespread and transmission of this resistance factor between bacteria has been observed, further raising concern.
Many observers are concerned that the current pipeline of candidate antimicrobial products is insufficient to counter the threat of antimicrobial resistance. Compared with other drug product classes, the pipeline is far from robust. For example, as of May 2015, there are 28 antibiotics in Phase II/III clinical development (Pew Charitable Trusts 2015). To put that in perspective, in March of 2015 there were over 500 candidates in Phase II/III clinical development for oncology indications (HemOnc today 2015).
To rectify this shortfall, we need to spur innovation and investment in new antimicrobial products to repopulate the early development pipeline. In 2014 United States released it National Strategy to Combat Antibiotic Resistant Bacteria. The National Strategy calls for BARDA to form new public private partnerships to incentivize antibacterial drug development. Specifically, it calls for BARDA to establish a Biopharmaceutical Incubator/Accelerator to expand the current insufficient pipeline of antibacterial drug candidates.
Through this funding announcement, BARDA and NIAID will identify and select an existing Industry, non-profit organization, incubator or life science accelerator to lead this effort and leverage Industry experience performing the functions of an accelerator. The Accelerator will fund research and development (R&D) activities to help progress candidate products from the proof-of-concept stage through pre-clinical development. Candidates that graduate from the Accelerator will be better positioned for follow on R&D investment and clinical development.
There are various Accelerator models in the marketplace. The Accelerator will be a non-equity accelerator that provides non-dilutive funding to product developers for R&D activities and enables the product developers to retain full ownership and control of their company. The Accelerator will be focusing only on antibacterial products.
The Accelerator that will focus on 1) funding development of antimicrobial products to further enhance the pipeline, 2) offering a suite of capabilities to rapidly shuttle successful product candidates through early development, 3) providing business and drug development guidance, and 4) decreasing the risks and barriers that impact further R&D investment by pharmaceutical companies, private investors and government partners.
The FOA can be found at: EP-IDS-16-001
Interested parties should plan on attending a Pre-Application workshop on March 3, 2016 from 3:00PM – 5:00PM EST at the Hubert H. Humphrey Building, in the Auditorium, located at 200 Independence Ave SW, Washington, DC 20201.
For this program to be successful, BARDA needs your help! BARDA looks forward to engaging the antibacterial community through another novel public private partnership and re-inventing how government is able to partner with industry to address the urgent problem of antimicrobial resistance.
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