Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
BARDA manages the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases.
Contents
Requirements Setting
Medical countermeasure requirements in BARDA provide a solid foundation for establishing advanced development and acquisition programs that support the overarching ASPR mission of reducing the adverse health effects of public health emergencies, including those caused by pandemic influenza, CBRN threat agents and emerging diseases. These requirements are critical to establishing programs to meet our preparedness goals. They also create incentives for industry participation and shape the market for countermeasure products.
Requirements for medical countermeasures for CBRN threats are defined with input from stakeholders across the federal government within the structure of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). Once established, these requirements drive BARDA advanced development and acquisition programs, as well as research, development, and acquisition efforts in HHS. CBRN medical countermeasure requirements are consistent with the planning and prioritization expressed in the HHS PHEMCE Implementation Plan for CBRN Threats.[1]
Pandemic Influenza requirements are defined by strategic objectives established in the National Strategy for Pandemic Influenza[2] and the HHS Pandemic Influenza Plan.[3]
Advanced Research and Development
From its inception, BARDA has been committed to creating a robust and dynamic pipeline of medical countermeasures through advanced development of new and improved medical countermeasures. The goal of medical countermeasure development is to provide multiple product candidates in each program to both account for attrition in medical countermeasure development and to establish multi-product/multi-manufacturer portfolios for sustainability and redundancy.
BARDA medical countermeasures include vaccines, antimicrobial drugs, therapeutic products, diagnostics and non-pharmaceutical medical supplies and devices for public health medical emergencies including chemical, biological, radiological, and nuclear threats, pandemic influenza and emerging infectious diseases. BARDA currently has three programs dedicated to overseeing the advanced development of these medical countermeasures: Chemical, Biological, Radiological, and Nuclear (CBRN); pandemic influenza; and emerging infectious diseases. BARDA’s Influenza and Emerging Diseases Division is in the planning phase for its Emerging Infectious disease program. This program will, when stood up, support the advanced development of vaccine, therapeutic and diagnostic medical countermeasures that address emerging disease threats.
Integrated National Biodefense Medical Countermeasures Portfolio
Integrated National Biodefense Medical Countermeasure Portfolio “One-Portfolio Approach.” The Department of Defense (DoD) and HHS each identify medical countermeasure requirements to address their different missions and focus. DoD’s focus is on protecting the armed forces prior to exposure, whereas HHS’s focus is on response to threats to the civilian population after exposure in a CBRN event. However, there are areas of common requirements or interest where medical countermeasure candidates, resources and information can be appropriately shared to maximize opportunities for success in the development of medical countermeasures for the highest priority threats. BARDA, in partnership with other HHS and DoD partners, is leading an Integrated National Biodefense Medical Countermeasure Portfolio to leverage resources and programs across the agencies that develop and acquire CBRN medical countermeasures to more effectively address the broad range of common threats and requirements. Members of this Integrated Portfolio include BARDA, biodefense programs in NIAID and other Institutes of NIH, and multiple elements of the DoD Chemical and Biological Defense Program
Stockpiling Programs
The Pandemic and All Hazards Preparedness Act (PAHPA) established BARDA as the focal point within HHS for the advanced development and acquisition of medical countermeasures to protect the American civilian population against Chemical, Biological, Radiological, and Nuclear (CBRN) and naturally occurring threats to public health.
BARDA’s stockpiling efforts are focused on building reserves of critical countermeasures as they emerge from Advanced Development. Stockpiling contributes to preparedness in two ways:
- Stockpiled medical countermeasures directly support readiness, as the stockpiled products can help to mitigate the effects of an event or outbreak.
- Establishment of the stockpile helps to ready suppliers to meet the increased demands that an event will bring about, becoming practiced in the production and delivery of products.
BARDA’s acquisitions for the stockpile are not one-time events, complete upon the approval/licensure of a product. Rather, programs are structured to include incremental milestone acquisitions during late stage development, to make available products still in development that may increase preparedness in an event, pending Emergency Use Authorization. Furthermore, we aim to establish stockpiling milestones to address long term commitments post-licensure.
CBRN Stockpiling Programs
In FY 2004, Congress appropriated $5.6 billion to the Project BioShield Special Reserve Fund (SRF) to support the Project BioShield goal of acquiring CBRN medical countermeasures over a 10-year period. BARDA has used these funds to support major acquisition programs leading to procurement of medical countermeasures against top priority threats.
Pandemic Infleunza Stockpiling Programs
Using funds from the Pandemic Influenza Emergency Supplemental Fund, BARDA is leading the nation toward the vaccine and antiviral stockpile goals for preparedness for pandemic influenza.
Manufacturing and Infrastructure Building
Ensuring the availability of medical countermeasures for public health emergencies is central to BARDA’s mission. This includes ensuring that manufacturing infrastructure is sufficient to support the production of required products, in a manner that is timely, reliable and cost effective.
BARDA is taking several approaches to bringing online the necessary infrastructure for medical countermeasure manufacturing. We are supporting the construction of new facilities as well as retrofitting existing facilities for maximal capacity and flexibility. We are also exploring the use of multiproduct manufacturing facilities to provide flexibility and surge capacity. So that we are able to rapidly provide countermeasures in the dosage forms required for use in the field, we are establishing a network of formulation/fill-finish manufacturers for emergency production and distribution. BARDA is also exploring the creation of centers of excellence for the development and production of non-commercial products, with assistance from industry partners.
Advancing Innovation
The Pandemic and All Hazards Preparedness Act (PAHPA) charges BARDA to support innovation to reduce the time and cost of medical countermeasures and product advanced research and development. This is to be accomplished through development of technologies that assist the advanced development of countermeasures, investment in research tools and technologies, and research to promote strategic initiatives including rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.
We see this innovation mandate as an opportunity to work with our partners (including NIH, DoD, CDC, industry, and academia) to create new ways to “make medical countermeasure better.” Examples of this approach to innovation could include the development of animal models to support efficacy testing, immune modulation and other broad-spectrum approaches, immunity assessment, and analytical (potency) assays.
An example of innovation from the Pandemic Influenza program is BARDA’s Mix and Match study, assessing various combinations of antigens and adjuvants to obtain a more robust immune response. BARDA plans to support similar initiatives, leveraging technology platforms and products from multiple companies. PAHPA provided an important “antitrust” authority that is used to facilitate cooperation among companies for whom such cooperation would otherwise be difficult to accomplish.
BARDA’s Strategic Science Team helps bring innovation to our programs. This team is the focal point for discussions with the creators of new technologies, ideas, and products. Together with the program managers, they seek ways to integrate innovative science into the development and production of medical countermeasures.
References
- ↑ HHS PHEMCE Strategy and Implementation Plan
- ↑ National Strategy for Pandemic Influenza
- ↑ HHS Pandemic Influenza Plan
