Public Health Emergency - Leading a Nation Prepared
Author: Tyler Merkeley, M.S. MBA, Broad Spectrum Antimicrobials (BSA) Program, Division of CBRN Countermeasures , Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR) Published Date: 6/24/2014 2:45:00 PM
Category: Medical Countermeasures; Public Health Preparedness;
BARDA established a Broad Spectrum Antimicrobials (BSA) Program in April 2010 to develop novel antibacterial and antiviral drugs to treat or prevent diseases caused by biological threats. ASPR and BARDA leadership recognized that new antibiotics are needed immediately to address the increasingly prevalent public health threat of antibiotic resistance, as well as the likelihood that antibiotic resistance will complicate the response to a public health emergency.
The BSA program provides non-dilutive funding to support product development and augments our partners existing capital raised from their investors. For laypeople, this means that BARDA provides funding companies can count on and can add to their own funding to develop a drug. If the drug is approved by the FDA, the company can sell it on the commercial market to treat antibiotic resistant infections. The approved antibiotic would then also be available during a public health emergency, if needed.
BARDA continues to establish public-private partnerships with industry to develop novel antibiotics, and we anticipate a long-term commitment to this market. Through these partnerships, we support concurrent development of candidate products for biodefense and commercial indications based on strategic and funding priorities outlined in our Broad Agency Announcement (BAA).
This strategy helps ensure that novel antibiotics progress through the development pipeline to approval for public health and commercial indications. The approach also increases the likelihood that novel antibiotics will be added to the arsenal of possible treatments available to antibiotic resistant infections. Approval of a drug for a commercial indication also helps establish a human safety database and a warm-base manufacturing capability for the drug should it be needed in a biothreat emergency.
By engaging with BARDA, our industry partners are able to receive funding and expert technical advice from BARDA for clinical studies (Phase 1-3), manufacturing, and regulatory activities. Industry partners are encouraged to visit the BARDA BAA and sign up for a TechWatch meeting with BARDA and other U.S. Government subject matter experts.
In just four years our Broad Spectrum Antimicrobials program, has funded six partnerships through the BARDA BAA and we anticipate funding additional programs using this mechanism in the future.
This post is the third part in our series Combatting Antibiotic Resistance. Next week, our blog post will focus on the specific incentives BARDA is using under the BSA program to revitalize the antibiotic pipeline and engage industryTo stay up to date as new blog posts are published, subscribe to the ASPR Blog on RSS, follow @PHEgov on Twitter or Like us on Facebook.
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