Ten years ago, in the wake of the 2001 anthrax attacks, the U.S. government set out on a bold path to improve the country’s preparedness for bioterrorism by developing and stockpiling new drugs and vaccines to protect Americans from health emergencies. Individuals from both political parties – many who had experienced bioterror first hand – worked together to harness the power of innovative science and tackle this national security threat. The ten year initiative was called Project BioShield.
Since then, biotechnology companies have partnered with the government to help fulfill that mission. As a result of support from the Biomedical Advanced Research and Development Authority (BARDA), companies have moved more than 70 medical countermeasure products into advanced development and several more – including vaccines against smallpox and anthrax, and treatments for botulism and radiation exposure – into the government’s Strategic National Stockpile.
A report issued in September 2012 by the Alliance for Biosecurity and MD Becker Partners reflects on the important advancements and progress made over the last decade in medical countermeasures development and identifies core challenges and key recommendations for the future. The report, titled “Medical Countermeasures: A Roundtable Discussion,” includes insights from 16 field experts from industry, government, and Wall Street.
The experts agree that tremendous progress has been made. However, this public-private partnership is at a critical juncture where further funding, research and development are necessary to ensure that progress continues and the U.S. population is protected.
Taking Stock of Success
Congress worked in a bipartisan way to create a viable and diverse industry for medical countermeasures by passing ground breaking legislation that funded medical countermeasure development and procurement and created BARDA – a federal entity whose core mission is to promote the development of medical countermeasures.
In addition to the number of new products in the national stockpile and in advanced development at BARDA, there has also been progress in the development of regulatory pathways to license medical countermeasures. The Food and Drug Administration has notably increased its transparency and interactions with developers of medical countermeasures.
Importantly, some biodefense companies have been able to use the expertise and knowledge gained while developing medical countermeasures to advance other commercial drug candidates.
Demanding Further Progress
The experts conclude that there is a need for strengthened leadership, long term funding, increased transparency, and streamlined contracting in the medical countermeasure enterprise.
For example, the Project Bioshield Special Reserve Fund that supports the advanced development and procurement of medical countermeasures is set to expire in 2013. Without adequate resources and a transparent long term plan, this enterprise is at risk.
While private industry plays a critical role in taking risks to bring new treatments to the market, the U.S. government is sometimes the only customer. In order to meet the national security objectives laid out ten years ago and reaffirmed today, federal leaders must not allow funding shortfalls to erode progress made and prevent future progress.
Given the fiscal challenges and biological threats facing the nation, drive, ownership, and coordination of this enterprise are imperative to its continued success.
A complimentary copy of the full report can be obtained using the following website link: http://mdbpartners.com/medical-countermeasures-report.
For more information on the Alliance for Biosecurity, visit: http://www.allianceforbiosecurity.org/.
Jennifer B. Alton is Vice President of Government Affairs with Bavarian Nordic, Inc.