Anthony Fauci, MD, FIDSA, director of the National Institute of Allergy and Infectious Diseases (NIAID), laid out a comprehensive plan for improving the nation's response to a range of infectious disease threats during the opening plenary presentation at the 48th Annual Meeting of IDSA in Vancouver.
The U.S. experience with the 2009 H1N1 pandemic influenza vaccine and morbidity and mortality data on other infectious diseases help illustrate the need to improve the country's ability to rapidly develop medical countermeasures, including therapeutics, diagnostics, vaccines, and other preventive tools, to protect against public health threats. Dr. Fauci outlined a comprehensive, 6-month review conducted by the Department of Health and Human Services, which called for action in five areas:
- Improving influenza pandemic preparedness through increased surveillance and other steps
- A concept acceleration program to help eliminate chokepoints in the research and development of biomedical products
- A strategic investment fund to support development of products that address unmet public health needs
- Flexible manufacturing and advanced development, including providing additional production capacity to respond quickly to public health threats
- Advancing regulatory science to develop new ways to assess the safety and efficacy of products
"You and I, as members of the infectious disease community, have to play an important role in this, regardless of what you do every day," Dr. Fauci told meeting attendees. "This is not just product development in a vacuum. It is a multi-faceted process that involves the basic researcher at the bench who never sees a patient, the clinical investigator, the clinician, the regulatory agencies, and, importantly, the pharmaceutical industry."
Dr. Fauci also outlined a plan to expand the research focus of the NIAID Clinical Trials Networks to go beyond HIV/AIDS and to include AIDS-related morbidities such as tuberculosis and hepatitis B and C, as well as non-AIDS infectious diseases (using non-AIDS resources) including antimicrobial resistance, influenza, and neglected tropical diseases, among others. The NIAID clinical trial networks have worked "marvelously well" for HIV, Dr. Fauci noted. "Why not expand the clinical capacity for infectious diseases that go beyond HIV? There are so many other infectious diseases that could use a boosted up clinical trials capability."
Dr. Fauci also discussed a current NIAID project to identify barriers that serve as obstacles to clinical research, including issues related to Institutional Review Boards (IRBs), that will produce recommendations intended to improve both the effectiveness and efficiency of research.
Check out the next issue of IDSA News for more 2010 IDSA Annual Meeting coverage. Audio and synchronized speaker slides from sessions are available for purchase online.
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