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Building and Sustaining a Robust Medical Countermeasures Pipeline

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: 12/6/2013 1:55:00 PM
Category: Medical Countermeasures;

BARDA Industry Day Brings Together Partners to Discuss Future Directions

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

Protecting the nation from chemical, biological, radiological and nuclear (CBRN) threats and pandemic influenza takes critical medical countermeasures. Making these countermeasures available means having a robust pipeline of medical countermeasures in development.

Next generation medical countermeasures start with today’s partnerships and plans. To help strengthen those partnerships and discuss those plans, BARDA brought together over 500 partners from government, industry, academia and other organizations for this year’s BARDA Industry Day, which took place November 12-14, 2013 at the Ronald Reagan Building and International Trade Center. During this event, participants learned about the strategic plans, core services, advanced development priorities, and upcoming procurement priorities that will help maintain this pipeline and shape the next generation of medical countermeasures.

As BARDA Director Robin Robinson, Ph.D. noted during his keynote address, BARDA has built an unprecedented pipeline of medical countermeasures products to protect against CBRN threats and pandemic influenza.

Twelve new medical countermeasures have been delivered to the Strategic National Stockpile since 2009 and twelve more are expected by 2019. BARDA has established this robust pipeline by supporting over 150 candidate products against a wide variety of diseases and other threats. Seven medical countermeasures that BARDA has supported achieved FDA approval in 2012 and 2013, including a rapid point-of-care diagnostic device for influenza and respiratory syncytial virus; cell-based, recombinant-based, and adjuvanted influenza vaccines; a next generation portable ventilator; and antitoxins for anthrax and botulism. BARDA anticipates making a number of new acquisitions under Project BioShield in coming years as products mature to the point that they are ready for inclusion in the Strategic National Stockpile.

Even with these successes, there is still more work to do. During the coming year, BARDA will be looking for products and technologies needed to protect the nation from existing and emerging threats and fill remaining gaps in our preparedness. BARDA will focus on funding development of therapeutics for hemorrhagic fever viruses; thermal burn products; biothreat diagnostics; innovative technologies for administration of medical countermeasures; and antigen-sparing vaccines. As part of its longer term strategy, BARDA is working towards a goal for a broadly protective or universal influenza vaccine.

BARDA presenters outlined the strategy, goals, and R&D areas of interest for FY14 and beyond. BARDA recently released three Broad Agency Announcements (BAA) to invite industry partners to collaborate on developing needed medical countermeasures. BARDA programs will maintain a balanced portfolio for specific and multiple threats while placing a high priority on sustainable life cycle management and improved preparedness against unknown threats.

Participants also learned about the set ofcore services BARDA offers to support product development. BARDA brings a great deal of expertise to its partnerships with industry through its Regulatory and Quality Affairs, Clinical Studies, Manufacturing, Facilities & Engineering, and Analytical Decision Support groups. BARDA has also made substantial investments in infrastructure by establishing the Centers for Innovation in Advanced Development and Manufacturing, a Fill and Finish Manufacturing Network, a Non-Clinical Development Network, and a planned Clinical Studies Network, each of which can provide critical services to medical countermeasure developers. Collectively, these core services provide the infrastructure and critical capabilities needed to produce medical countermeasures, such as vaccines and therapeutics, in support of the BARDA’s advanced research and development programs.

With a record number of attendees this year, BARDA Industry Day continued to be a great way to engage and build public-private partnerships. If you missed it, or just are interested in viewing the presentations, view the slide presentations online. To stay up to date on BARDA and its programs and to receive the announcement for BARDA Industry Day 2014, follow BARDA via RSS.


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