Biomedical Advanced Research and Development Authority

Requirements setting

BARDA sets for requirements for medical countermeasures in order to reduce the threats of public health emergencies such as pandemic influenza, CBRN threats, and emerging diseases. The requirements tell private industry what is required in order to produce medical countermeasures acceptable for BARDA.

Stakeholders across the federal government and the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) create the requirements. After the requirements are established, they drive BARDA advanced research and development and acquisition. The requirements are created consistent with the planning and prioritization expressed in the HHS PHEMCE Implementation Plan for CBRN Threats.

Pandemic Influenza requirements are defined by strategic objectives established in the "National Strategy for Pandemic Influenza", and the "HHS Pandemic Influenza Plan".

Major initiatives

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:

1. Stockpiled medical countermeasures directly support readiness, as the stockpiled products can help to mitigate the effects of an event or outbreak.
2. 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 influenza 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.

Strategic National Stockpile

The Public Health Security and Bioterrorism Preparedness Act of 2002 directed the Secretary of Health and Human Services to develop and maintain a Strategic National Stockpile (SNS). The mission of the SNS is to provide for the emergency health security of the United States in the event of a terrorist attack or any other public health emergency.

The SNS is the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a small outbreak to a large-scale, multiple-threat emergency. When state, local, tribal, and/or territorial responders request federal assistance to support their response efforts, the stockpile is supposed to ensure that supplies are available when and where needed. The stockpile contains enough vaccines, antimicrobial drugs, therapeutic products, and non-pharmaceutical medical supplies to save thousands of lives in the wake of any type of public health emergency including terrorist attacks whether chemical, biological, radiological, and/or nuclear, as well as pandemic influenza and emerging infectious diseases.

Emergent BioSolutions is a Maryland-based pharmaceutical company that manufactures vaccines and related products for use against common diseases and biological weapons. Emergent manufactures the only FDA licensed vaccine against anthrax disease, called BioThrax, which is recommended by the CDC as a post-exposure prophylactic for anthrax infection.

As part of a $450 million contract with BARDA for the SNS, Emergent also developed the only FDA-licensed botulinum antitoxin, BAT [Botulism Antitoxin Heptavalent] for treating naturally occurring botulism.[v] Canada has also approved BAT.

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.

BARDA sees this innovation mandate as an opportunity to work with their 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.