Public Health Emergency - Leading a Nation Prepared
Approach provides a pipeline of new drugs rather than a single medical countermeasure
Drugs to combat bioterrorism and antibiotic resistance simultaneously will be developed under a public-private partnership agreement between the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and GlaxoSmithKline of North Carolina. The agreement is the first in which HHS has taken a portfolio approach with a private sector company instead of contracting to develop a single medical countermeasure – a drug, vaccine, diagnostic, or equipment needed in public health emergencies.
“Working as strategic partners with a portfolio approach offers a new way to move forward in developing a robust pipeline of novel antibiotics that address gaps in our nation’s preparedness as well as the evolving threat of antibiotic resistance,” said BARDA Director Robin Robinson, Ph.D.
The agreement is flexible, so drug candidates can be moved in or out of the portfolio, based on the advanced development stage and technical considerations, during joint semi-annual portfolio reviews. The approach balances the business risk for the federal government and GSK. Supporting development of multiple drug candidates simultaneously increases the likelihood that one or more will advance to the level at which the company can apply for U.S. Food and Drug Administration approval of the drug.
These novel antibiotics may become available in the commercial marketplace, which diminishes the federal government’s need to stockpile as much of these medical countermeasures for biodefense. Reducing the need to stockpile drugs reduces taxpayer costs.
BARDA and GSK’s antibiotic group will manage and fund the portfolio initially over 18 months and potentially up to five years. As a cost-share arrangement, HHS will provide $40 million for the 18-month agreement and up to a total of $200 million if the agreement is renewed for the full five years.
The partners will form an oversight committee for the semiannual review that determines which GSK drug candidates should be included in the portfolio and move forward in development. Under the agreement, GSK researchers will conduct safety and toxicology testing, clinical pharmacology studies, clinical studies, and non-clinical studies to support approval to treat illnesses caused by bioterrorism agents like anthrax, plague and tularemia, as well as address antibiotic resistance.
One of the antibiotics to be further developed under this agreement is GSK’944, the first in class of drugs that targets bacterial DNA replication in a unique fashion. GSK has conducted studies in which GSK’944 protected or successfully treated animals suffering from anthrax, plague, or tularemia.
Under the BARDA-funded program, additional data will be generated to support use of GSK’944 for the treatment of anthrax, plague and tularemia. GSK will intends to pursue development of the use of GSK’944 to treat hospital- and community-acquired drug-resistant bacterial infections, thereby addressing public health needs. Additional antibiotic candidates are expected to be incorporated into the program during the first 18 months.
Rather than a standard contract, HHS entered into the agreement with GSK using, for the first time, what is known as other transactional authority (OTA), which was granted under the Pandemic and All Hazards Preparedness Act of 2006. Although not a contract, grant or cooperative agreement, the OTA provides a funding and collaboration vehicle to promote innovation in technology for advanced research and development.
Federal acquisition regulation and certain procurement statutes do not apply to agreements under an OTA. The OTA gives agencies the flexibility necessary to develop agreements tailored to national needs presented in particular scenarios such as biodefense. HHS is one of eight federal agencies authorized to use OTA.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing infrastructure building of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health medical emergencies including chemical, biological, radiological, and nuclear threats, as well as pandemic influenza, and emerging infectious diseases. For additional information, visit http://www.phe.gov/about/barda/Pages/default.aspx.
The partnership with GSK is funded by BARDA’s Broad Spectrum Antimicrobials Program. BARDA is seeking additional proposals for broad-spectrum antimicrobials that could potentially treat or prevent illness due to biological threat agents. Proposals are accepted through the Broad Agency Announcement BARDA-BAA-12-100-SOL-00011 at www.fbo.gov.
For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about partnering with BARDA in public health preparedness visit www.medicalcountermeasures.gov.
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