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U.S. Department of Health and Human Services


Planning to Keep the Nation Safe

Author: Adam Clark, Ph.D., Division of Strategic Science and Technology Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness & Response
Published Date: 9/16/2013 1:48:00 PM
Category: Medical Countermeasures;

How Sound Science, Strong Partnerships and Advance Planning Promote Next Generation Medical Countermeasures

Author: Adam Clark, Ph.D., Division of Strategic Science and Technology Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness & Response

How do we make a universal flu vaccine? How can we get more vaccines sooner, so that we can save more lives in an emergency? Or develop a robust domestic medical countermeasure (MCM) manufacturing infrastructure? How can we advance therapeutics for hemorrhagic fever viruses? Or innovate and create timely and accurate biothreat diagnostics? These are just a few of the tough questions that the Biomedical Advanced Research and Development Authority (BARDA) is tackling with its partners.

Keeping the nation safe from a wide range of threats – from radiological and chemical nerve agents to infectious disease threats such as pandemic influenza, anthrax, or other emerging diseases – will take three things: sound science, strong partnerships and advance planning. BARDA convened the Broad Agency Announcement (BAA) Pre-Proposal Conference to facilitate those three crucial elements of success. The conference brought together over 200 professionals representing more than 150 companies who were eager to learn about the changes that are taking place in BARDA’s advanced development program.  If you are interested in learning more about the conference, the slides and meeting materials are available online.

The three BAAs that make up the core of BARDA’s advanced development program are dedicated to the Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures, the Advanced Development of Medical Countermeasures for Pandemic Influenza, and the development of Science and Technology Platforms Applied to Medical Countermeasures (Innovations). Using these BAAs, BARDA encourages the development of a robust medical countermeasures pipeline and it supports the development of MCMs for specific threats as well as platform technologies that enhance capabilities for development and manufacturing of MCMs.

BARDA relies on its partners to help develop and sustain this pipeline of medical countermeasures. During the conference, BARDA outlined its model for public-private partnerships with industry to achieve these goals. BARDA supports public-private partnerships through the Centers for Advanced Development and Manufacturing and the Non-Clinical Development Network. In addition, BARDA is in the process of establishing the Finish Manufacturing Network and the Clinical Studies Network.

In the next funding cycle, BARDA will emphasize filling gaps such as therapeutics for hemorrhagic fever viruses, thermal burn products, biothreat diagnostics, innovative technologies for the administration of medical countermeasures, vaccine strategies that include antigen-sparing, and a broad-acting or universal influenza vaccine. BARDA also will focus on a number of overarching challenges, including potential threats from bioterrorism; needs of special populations such as children, elderly, or immunocompromised individuals; product sustainability; and effective management of rising life cycle maintenance costs associated with stockpiling MCMs.

BARDA has a history of working with its partners to face tough challenges and create success. In the last year, a BARDA-supported influenza vaccine made with novel technology achieved FDA licensure. It has supported the first drug for the treatment of anthrax through the FDA licensure. BARDA formed a new kind of public-private partnership to develop drugs to combat bioterrorism and antibiotic resistance simultaneously. In addition to these projects, BARDA also supports funding for proof-of-concept studies for the development of a small molecule to protect DNA from damage after exposure to high levels of radiation and it also supports the advancement of broad spectrum antibiotics. BARDA is even working with its partners on a more effective skin grafting technique that could help patients heal more effectively following a radiological or nuclear event. And these are only a few of the innovations that BARDA is helping to make a reality.

Just think of what the next year will bring.


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