Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services office responsible for procurement and development of countermeasures principally against bioterrorism, but also including chemical, nuclear and radiological threats as well as pandemic influenza and emerging diseases.:140 BARDA reports to the Office of the Assistant Secretary for Preparedness and Response and manages Project BioShield.:140 BARDA also procures materials, such as vaccines, for the Strategic National Stockpile, and more broadly is an established interface between the U.S. Government and the biomedical industry.:267 BARDA also manages the governmental inter-agency Public Health Emergency Medical Countermeasures Enterprise, providing coordination across the government in development and deployment of such countermeasures.:267
|Parent agency||Office of the Assistant Secretary for Preparedness and Response|
The Project BioShield Act of 2004 created a way to fund the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as a chemical, biological, radiological, or nuclear attacks. The agency gives funds to pharmaceutical companies to develop these countermeasures. To date, BARDA has helped get 52 products FDA approved.
The office was established in 2006 through the Pandemic and All-Hazards Preparedness Act.:267
Rick A. Bright is currently the Director of BARDA, making him the top-ranking official in the agency. He also serves as the Deputy Assistant Secretary in the Office of the Assistant Secretary for Preparedness and Response (ASPR).
Bright is an adviser to the World Health Organization, which recognizes him as an international subject matter expert on influenza, vaccines and therapeutics development, as well as an adviser to the U.S. Department of Defense. Before joining BARDA, he worked in the biotechnology industry (at Altea Therapeutics and Novavax).
BARDA sets the 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.
- Research and development
- Medical countermeasures
- Antimicrobial drugs
- Therapeutic products
- Non-pharmaceutical medical supplies
- Medical countermeasures
- Stockpiling programs (see below)
- Manufacturing infrastructure
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.
Nerve agents and other chemical weapons are a top priority for fighting CBRN threats. VX gas, which was the nerve agent that reportedly killed the half-brother of North Korean leader Kim Jong-un, is an example. BARDA Is preparing to stockpile an anti-seizure medication called midazolam, developed by Meridian Medical Technologies (a subsidiary of Pfizer), which will be made available in an autoinjector that could treat the effects of nerve agents on the neurological system.
In October 2017 BARDA entered a nine-month $12-million contract with the San Francisco-based biopharmaceutical company Achaogen, sponsoring late-stage development of C-scape, an antibiotic used against resistant bacteria and a potential treatment against bioterrorism chemical agents.
Integrated National Biodefense Medical Countermeasures Portfolio
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 the National Institute of Allergy and Infectious Diseases (NIAID), which also oversees all biodefense activities across the other Institutes of the National Institutes of Health (NIH), and multiple elements of the DoD Chemical and Biological Defense Program.
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 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.
In December 2019, BARDA awarded a $226 million six-year contract to Sanofi Pasteur, a global pharmaceutical company with U.S. headquarters in Bridgewater, New Jersey to increase production capacity for an influenza vaccine. In September 2019, President Donald J. Trump issued an executive order requiring the government to modernize influenza vaccines and technologies in order to improve national health security.
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.
The federal government improved its plan against chemical, biological, radiological and nuclear threats after the 2001 anthrax letters attack, which killed five Americans. It was the worst biological attack in United States history.
The agency also invested in the late stage development of a product called NuThrax developed by Emergent Biosolutions, which makes the other anthrax vaccine, BioThrax. According to Homeland Preparedness News, NuThrax will be able to provide immunity to anthrax after two doses, versus the three doses under the currently stockpiled vaccine (BioThrax).
Medical countermeasure products
|Smallpox||TPOXX (SIGA Technologies)||Procured|
|Botulism||Botulism therapeutic product||Procured|
|Anthrax||Nuthrax (Emergent Biosolutions)||Late stage development and procurement|
|Anthrax||BioThrax (Emergent Biosolutions)||Stockpiled|
|Ebola virus||Ebola therapeutic and Ebola vaccine||Late stage development|
(such as VX)
|Midazolam in an autoinjector (Pfizer subsidiary Meridian Medical Technologies)||In process of preparing to stockpile|
|Mustard gas||In process||Future development|
|Chlorine gas||In process||Future development|
|Improvised nuclear device or dirty bomb||Cytokine products||Procured|
|Burn injuries||Silverlon, a metallic silver-based antimicrobial wound dressing (Argentum Medical)||Stockpiled|
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.
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.
Fujifilm Corporation announced in April 2017 that it would invest $130 million to increase production capacity for its BioCDMO division. The division “focuses on contract development & manufacturing for biologics.” Fujifilm Diosynth Biotechnologies, with help from a BARDA grant, has invested around $93 million to build a production facility in Texas. The facility will include “mammalian cell culture bioreactors” and is planned to open operations at the start of 2018.
In April 2017, Switzerland-based Basilea Pharmaceutica and the Food and Drug Administration reached an agreement regarding two phase 3 clinical studies of an antibiotic developed by Basilea called ceftobiprole. The two clinical studies will examine ceftobiprole for the treatment of “Staphylococcus aureus bacteremia (bloodstream infections) and acute bacterial skin and skin structure infections.” Basilea has a contract with BARDA, which it entered into in 2016 for the clinical phase 3 development of the antibiotic. BARDA provided initial funding of $20 million but could provide up to $100 million over a period of 4–5 years.
In 2017, BARDA signed a three-year $8.1 million contract with InBios International, Inc. of Seattle, Washington to develop a “point-of-care diagnostic test that may be able to determine within 15 minutes whether a patient has been infected with the bacterium that causes anthrax.”
In September 2017, BARDA awarded Velico Medical $15.5 million for development of a technology that uses spray drying of human plasma for transfusions. The current industry standard is to freeze plasma. Frozen plasma can take 40 or more minutes to defrost and deliver. According to Fierce Biotech, “Velico has Spray Dried Plasma technology (SpDPTM) that enables the storage of blood as dry powder, rather than the typical freezing, for subsequent rehydration. It's expected to be useful in hospital emergency rooms, operating suites and intensive care units--as well as in a military or field hospital setting.”
In July 2005, at the hearings before the Committee on Health, Education, Labor, and Pensions, the first CEO and Director of the center, Tara O'Toole, MD, MPH, has pointed to center's role as the "BioDARPA" (i.e. "biomedical DARPA").
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