In support of National Preparedness Month, ICF International invited expert panelists from the U.S. Food and Drug Administration (FDA) and the National Institute of Allergies and Infectious Diseases (NIAID) to discuss their organizations’ particular roles in U.S. government-wide efforts to support planning and preparedness for major event-based U.S. public health threats. These include menaces such as bioterrorism, consequences of a natural disaster like last year’s nuclear accident in Japan, or infectious disease outbreaks similar to the 2009 influenza pandemic.
In addition to the U.S. Federal agencies that prepare for a pandemic, chemical, biological, radiological, or nuclear event that could result in mass casualties, other prominent agencies play a key role in biothreat reduction. Two of these major organizations include the National Institutes of Health’s (NIH) NIAID and the FDA, both whom have an instrumental role in preparations and efforts critical to minimizing the resulting consequences of any such occurring event.
This panel discussion provided a better understanding of:
- The programs at these agencies that support biothreat preparedness and the role biomedical research and product development play in threat reduction
- The evolution of interagency coordination surrounding threat risk assessment, biosurveillance monitoring, response planning, and emergency response activities
- How the FDA and NIAID each contribute to this process through their activities and how they are addressing current challenges faced in assessment and deployment of medical countermeasures to address potential bio-threats events
Download the presentation slides to learn more.
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DirectorMCMi PHSAT, FDA, Office of the Commissioner, Office of Counterterrorism and Emerging Threats (OCET)
Alan Liss has more than 25 years of experience in the areas of vaccines, biologics, and pharmaceutical product development. He has held a variety of industrial and academic appointments, authored more than 60 scientific publications, and presented lectures nationally and internationally. His work on furthering the development of medical countermeasures includes helping to set up the Regulatory and Quality Affairs Division of the Biomedical Advanced Research and Development Authority Division (BARDA) under the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).
Dr. Liss has a B.S. in Genetics from the University of California, Berkeley and a Ph.D. in Microbiology and Immunology from the University of Rochester School of Medicine.
Acting Director for the Radiation Nuclear Countermeasure ProgramNational Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
Bert Maidment provides scientific and program leadership to the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Allergy, Immunology and Transplantation Radiation Nuclear Countermeasure Program (RNCP) team for the research and development of medical countermeasures to increase survival and mitigate injuries due to radiation exposure. The program goals are to identify therapeutic and biodosimetry candidates, evaluate lead therapeutic candidates for safety and efficacy, and collaborate with industry to obtain licensure for the radiation/nuclear terrorism indication.
Dr. Maidment manages the RNCP staff and coordinates with representatives of other government agencies to design and implement research and development projects to complete regulatory submissions that support U.S. Food and Drug Administration (FDA) approvals for products for the Strategic National Stockpile.
Medical OfficerOffice of Counterterrorism and Emerging Threats (OCET), U.S. Food and Drug Administration (FDA)
Aysha Akhtar is a neurologist and medical officer at the Office of Counterterrorism and Emerging Threats (OCET) of the U.S. Food and Drug Administration (FDA). She serves as the lead OCET liaison for biosurveillance activities and is co-chair of the joint FDA-Centers for Disease Control (CDC) led Medical Countermeasure Surveillance Action Team, which supports and facilitates a coordinated strategic plan for monitoring the safety and performance of medical countermeasures used during public health emergencies.
Dr. Akhtar serves as a co-chair of the Pediatric and Maternal Public Health and Security Action Team (PHSAT). She is also a member of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Pediatric and Obstetrics Integrated Program Team (IPT), whose goals are to facilitate the development, acquisition, deployment, and utilization of medical countermeasures (MCM) for use in pediatric and maternal populations.
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