Coller-Monarez, Susan PhD; Groseclose, Samuel L. DVM, MPH, DACVPM; Kurilla, Michael G. MD, PhD; Berg, Jeremy M. PhD
Threat Characterization and Attribution Branch, Chemical and Biological Defense Division, Science and Technology Directorate, Department of Homeland Security, Alexandria, Virginia (Dr Coller-Monarez); Science and Policy Health Practice, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, Atlanta, Georgia (Mr Groseclose); Office of Biodefense, Research Resources and Translational Research, and Biodefense Product Development, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland (Dr Kurilla); Science Strategy and Planning in the Health Sciences, and Department of Computational and Systems Biology, University of Pittsburgh, Pittsburgh, Pennsylvania (Dr Berg).
Correspondence: Jeremy M. Berg, PhD, Department of Computational and Systems Biology, University of Pittsburgh, 3550 Terrace St, Pittsburgh, PA 15213 ( email@example.com).
The authors declare no conflicts of interest.
Research on preparedness comes within the remit of a number of federal agencies, albeit in different contexts and with different emphases. Among these agencies are the Department of Homeland Security (DHS), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health. Here, we present brief perspectives from representatives from these agencies including their interests and initiatives.
The US Department of Homeland Security Science and Technology Directorate (DHS S&T) has broad responsibilities for federal, state, and local biodefense activities. The 4 essential pillars of the DHS biodefense program are as follows: Threat Awareness, Prevention and Protection, Surveillance and Detection, and Response and Recovery. The DHS S&T has developed a balanced approach across all 4 pillars to ensure our nation has a sustainable, robust biodefense posture.
A foundational element in DHS S&T's preparedness prioritization and decision making stems from the Bioterrorism Risk Assessment (BTRA) program. The BTRA is a comprehensive, probabilistic risk assessment program that integrates the judgments of the intelligence and law enforcement communities (threat), with input from the scientific, medical, and public health communities. The results of the BTRA help identify top risk agents and targets to allow federal, state, and local biodefense partners to prioritize their resources to maximize biodefense preparedness. To support the scientific needs for the BTRA, the DHS S&T relies on 2 DHS-sponsored biological sciences characterization centers at the National Biodefense Analysis and Countermeasures Center and the Biodefense Knowledge Center. These facilities provide scientific data through research and analysis for the BTRA and produce numerous products that inform federal, state, and local chemical and biological defense activities.
Interdiction is a major component of biological terrorism prevention; however, it presents significant challenges much greater than those posed by chemical, radiological, or nuclear hazards. Biological agents by their very nature are self-replicating, so even a trace amount of material obtained in nature or through theft can pose a significant risk to the population. So, while the DHS S&T supports interdiction activities such as the Biological Weapons Convention and implementation of robust biosafety and biosecurity standards for select agent research, it also supports developmental efforts in the areas of reducing further dissemination and exposure of a biological agent should it be successfully released by an adversary. Activities include programs for rapid biodetection in indoor environments to facilitate moving people out of harm's way quickly and to automatically alter building airflow to minimize agent transport into or within a building exposed to biological contaminants.
The DHS S&T has developed a multilayered approach to biosurveillance and detection that establishes a framework to rapidly detect the release of a biological agent, understand who may have been exposed, determine what geographical area may be contaminated, and assess the virulence and viability of the pathogen used in the attack. Technologies supported in this area include environmental detectors, biodiagnostics, and assays that identify specific characteristics of the pathogen to aid in response and recovery.
The DHS S&T has 2 major efforts in the areas of response and recovery. First, the DHS S&T has made significant investments and improvements in bioforensics for biocrime attribution. The DHS S&T has stood up the operational National Bioforensics Analysis Center, which is supported by a cutting-edge bioforensics research and development program. Second, the DHS S&T has established numerous efforts to support bioevent response and restoration at the state and local levels. These plans include, among other elements, population movement decision making and decontamination technologies and guidance.
The CDC has invested in preparedness and response research, informed by legislation—the Pandemic and All-Hazards Preparedness Act of 2006 (Pub L No. 109-417, 2006)—and several key strategies and frameworks ranging from the National Health Security Strategy, Public Health Preparedness Capabilities, and National Strategy for Public Health Preparedness and Response. The Pandemic and All-Hazards Preparedness Act of 2006 tasked the CDC to lead an initiative to identify the existing public health systems knowledge base for preparedness and emergency response and to establish a research agenda that was based on federal, state, local, and tribal public health preparedness priorities. In response, the CDC commissioned an Institute of Medicine report,1 “Research Priorities in Emergency Preparedness and Response for Public Health Systems: A Letter Report,” to delineate a set of near-term research priorities for all-hazards emergency preparedness and response in public health systems that were relevant to the specific expertise resident at schools of public health and related fields. Beginning in 2008, the CDC established Preparedness and Emergency Response Research Centers (PERRCs) to pursue research agendas focused on priority policy and practice issues.2 The PERRCs represent the first federal commitment to public health systems research—defined as “a field of study that examines the organization, financing, and delivery of public health services within communities, and the impact of these services on public health.”3(p180)
In addition to the public health systems research conducted by the PERRCs, in September 2011, the CDC's Office of Public Health Preparedness and Response released its “National Strategic Plan for Public Health Preparedness and Response” to stimulate scientific research and technological innovations and serve as a guide for the CDC, the entire public health system, and its stakeholders to secure the health of our nation. Annually, the Office of Public Health Preparedness and Response leadership engages health security stakeholders internal and external to the CDC to identify priority programmatic and applied research initiatives to support the priority objectives.4
Public health preparedness and response research is challenging due to a number of issues, including the requirement to conduct research during emergency responses to address some key questions. For example, it is only during emergency responses that unique exposures or risk factors may be characterized or system performance for certain capabilities may be accurately measured. In addition, preparedness and response research is typically performed in low-resource settings and involves the investigation of vulnerable populations. The timeliness required for response research challenges our ability to involve affected communities and system partners in the definition of priority research questions and makes it difficult to balance “top-down” (researcher-driven) approaches with “bottom-up” (community-driven) approaches.
Effective preparedness and response requires performance of a broad spectrum of traditional public health functions and capabilities but uniquely requires close collaboration across the health care delivery, public health, emergency management, and public safety sectors. Applied research and program evaluation that address public health preparedness and response is relatively new endeavors—especially when an all-hazards perspective is considered. As such, to date, limited research that addresses public health emergency preparedness capabilities has been completed and there are few examples of successful dissemination and translation to practice. The CDC looks forward to harvesting the work of the PERRCs and other applied research over the next few years to enhance the performance of the public health system and its partners to improve our nation's health security. The CDC will continue to engage our federal partners and the practice community in the assessment of our public health preparedness and response research portfolio to identify the sustainable and scalable initiatives most likely to improve public health practice and population health in the near term. There remains a need to periodically identify gaps in public health preparedness and response research to effectively direct available funding to address key unanswered questions.
The National Institutes of Health has an interest in preparedness research since a timely and effective response to public health emergencies, especially for infectious disease outbreaks, requires effective response planning with the appropriate necessary countermeasures available in sufficient quantities. While each type of event and/or outbreak may be unique, there are sufficient similarities and patterns that permit preparedness planning for such events. Preparedness research involves the combination of activities that occur preevent to develop response plans along with the development of required specific countermeasures needed for such a response as well as the capability and preparation to conduct analyses and evaluations during an event in order to evolve and refine future response plans for similar events. At the same time, addressing nonemergency public health threats and thus lowering the baseline of routine circulating infectious diseases allows for more rapid identification of emerging infectious disease outbreaks due to lower noise (unusual situations can be recognized faster).
The National Institute of Allergy and Infectious Diseases (NIAID) participates in a wide array of federal interagency groups to align research and development programs with recognized threats and to foster coordination with other federal partners to ensure the seamless transition of potential medical countermeasures from concept discovery through to eventual procurement and utilization.
The NIAID supports a wide array of vaccine and therapeutic and diagnostic development efforts to support prevention from and treatment of infectious diseases, particularly those with the propensity to result in outbreaks. It supports these development efforts through a series of targeted funding mechanisms focused on specific phases of the product development pathways. Biomedical applications proceed in an orderly fashion from basic research to translational efforts and finally into product development culminating in a licensed, commercially available product. Specific funding mechanisms have been identified for different stages of development efforts to align objectives and evaluation with the unique requirements for each developmental stage.
At the same time, the NIAID also maintains research and development infrastructure that provides specific capabilities to support research and development efforts when specific gaps (such as scientific, technical, facility, or financial) have been identified. These services have been established to assist and augment research efforts throughout the entire product development pathway; for example, hard-to-obtain reagents have been aggregated within a publicly available repository or access to a technically demanding Food and Drug Administration–required preclinical IND-enabling assays is available. Through this comprehensive program, the NIAID maintains support for biomedical investigations from basic and concept discovery through to clinical proof of principle.
Most important is that NIAID programs and services are available for all infectious disease–related research activities. Rather than attempting to design emergency-specific mechanisms, the NIAID has established a comprehensive infectious disease product development initiative that serves the development of routine infectious disease biomedical interventions while supports US government-wide biodefense efforts and can rapidly respond to emerging public health threats.