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Celebrating 61 FDA Approvals, Licensures, and Clearances for Medical Countermeasures. Supported by BARDA under Novel Public Private Partnerships.
Saving Lives, Protecting Americans.

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BID 2021

Barda Industry Day

November 3-4, 2021 | Virtual Event

PRESENTATION VIDEOS NOW AVAILABLE!
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We Are BARDA

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 of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

Together with our industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats.

picture of lab work

WATCH: FIRESIDE CHAT

with the ASPR, Dawn O'Connell, and BARDA Director, Dr. Gary Disbrow

Hear their vision on how ASPR & BARDA can assist in strengthening our medical countermeasure supply chains, manufacturing capacity and leveraging BARDA's innovation networks to prepare for future threats

The mission of the Biomedical Advanced Research and Development Authority (BARDA) is to develop medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

We accomplish this critical mission through six key activities
BARDA Program Wheel
Core Services

BARDA supports a number of core services to assist the development and production of required products, in a manner that is timely, reliable and cost effective.

Innovation

Government Can Drive Innovation! At BARDA We Seek Innovation in Science…. and in the way we do business! BARDA has a long history of designing and launching innovative programs, to accelerate innovative ideas and deliver promising countermeasures to protect Americans.

Chemical, Biological, Radiological & Nuclear (CBRN)

The Pandemic and All Hazards Preparedness Act (PAHPA) established BARDA as the focal point within HHS for the advanced development of and acquisition of medical countermeasures to protect the American civilian population against CBRN and naturally occurring public health threats.

 

Project Bioshield

Congress seeks to improve our Nation's emergency preparedness with Project BioShield, which provides the government with the ability to further develop, acquire, stockpile, and make available the medical countermeasures needed to protect the U.S. population against a public health threat.

 

Influenza & Emerging Infectious Diseases (IEID)

BARDA uses a comprehensive portfolio approach to develop and acquire a broad array of medical countermeasures for pandemic influenza, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures and to build and sustain their domestic manufacturing infrastructure.

Division of Research, Innovation & Ventures (DRIVe)

DRIVe's mission is to accelerate the development and availability of transformative technologies and approaches to protect Americans from health security threats. DRIVe pushes innovation boundaries to tackle the biggest health security challenges while seeking new ideas and new approaches to prevent and protect against health security threats.

BARDA supports a number of core services to assist the development and production of required products, in a manner that is timely, reliable and cost effective.

Government Can Drive Innovation! At BARDA We Seek Innovation in Science…. and in the way we do business! BARDA has a long history of designing and launching innovative programs, to accelerate innovative ideas and deliver promising countermeasures to protect Americans.

The Pandemic and All Hazards Preparedness Act (PAHPA) established BARDA as the focal point within HHS for the advanced development of and acquisition of medical countermeasures to protect the American civilian population against CBRN and naturally occurring public health threats.

 

Congress seeks to improve our Nation's emergency preparedness with Project BioShield, which provides the government with the ability to further develop, acquire, stockpile, and make available the medical countermeasures needed to protect the U.S. population against a public health threat.

 

BARDA uses a comprehensive portfolio approach to develop and acquire a broad array of medical countermeasures for pandemic influenza, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures and to build and sustain their domestic manufacturing infrastructure.

WE NEED YOU ON OUR TEAM!

Join the fight against COVID-19 and other deadly public health threats by applying today for a job at BARDA.

Request for Information (RFI):

EXPLORE DETAILS OR VIEW THE PDF

BARDA Needs Your Assistance!

Q:
Could your organization help strengthen the industrial supply chain for medical countermeasure (MCM) production, manufacturing, and implementation?
A:
If you answered YES to the above question, please consider submitting a formal response to our Request for Information (RFI)

Biopharmaceutical Manufacturing Partnership (BioMaP) Consortium

RFI Main Image

Type: Sources Sought

Product Service Code: 6505 Drugs and Biologics

Place of Performance: HHS BARDA

To: Prospective Partners & Interested Parties

The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from current and potential biopharmaceutical industry partners. Information collected from this RFI will serve as continued market research for the development of a possible program where BARDA would partner with industry to achieve the pandemic preparedness goals set forth by the U.S. Government (USG).

Background: The Department of Health and Human Services (DHHS) is engaging with other Federal agencies and the White House in a whole-of-Government review, update, and transformation of U.S. bio-preparedness capabilities, as outlined in the White House’s September 2021 report, American Pandemic Preparedness:  Transforming our Capabilities.1 This effort will fundamentally transform the Nation’s biodefense and pandemic readiness and address challenges experienced during the ongoing COVID-19 pandemic. Work is being organized across five pillars: (I) Transforming our Medical Defenses, (II) Ensuring Situational Awareness, (III) Strengthening Public Health Systems, (IV) Building Core Capabilities, and (V) Managing the Mission.

The subject of this Sources Sought are Goal I: Transforming our Medical Defenses and Goal IV: Building Core Capabilities, as they pertain to BARDA’s ongoing effort to expand the industrial supply chain for medical countermeasure (MCM) production, manufacturing, and implementation.2

1White House Office of Science and Technology Policy (OSTP), American Pandemic Preparedness Transforming our Capabilities, September 2021, https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf.

2Gary Disbrow and Ian Watson, “Expanding the domestic public health supply chain is a matter of national security,: STAT, 26 Aug 2021, https://www.statnews.com/2021/08/26/expanding-domestic-public-health-supply-chain-matter-of-national-security/.

To transform and build core capabilities for biodefense, BARDA is contemplating consortia comprised of industry partners across the drug and vaccine manufacturing supply chain, including the manufacturers of required raw materials and consumables as well as suppliers of fill-finish services. The consortia will establish the physical infrastructure, manufacturing platforms, and supply chain capable of producing enough vaccines for the entire United States population within 130 days and the global population within 200 days after its recognition as a potential emerging pandemic threat and expand the ability to domestically produce the therapeutics and vital supplies to halt future pandemics.

BARDA is interested in identifying industry and private-sector partners who may be interested in participating in such consortia, supported by BARDA, that will prepare for and respond to emerging and ongoing pandemic threats focused on developing, establishing, and manufacturing capabilities to handle a broad array of threats. BARDA is interested in establishing and sustaining:

  • Facilities and organizations with experience supplying or manufacturing any of the following:
    • licensed vaccines and antibodies
    • single-use consumables such as sterile packaging, tubing, connectors, assemblies, needles
    • fill-finish services and supplies (e.g., syringes, vials)
    • suppliers of raw materials such as the solvents, reagents, and other materials
    • small-molecule and active pharmaceutical ingredient (APIs) manufacturers
  • Proven vaccine manufacturing platform technologies
  • Trained biomanufacturing workforce
  • Robust supply chain to support large-scale manufacturing
  • contracting/agreement mechanisms

Interested firms are requested to submit company contact information and responses to the following questions relating to the establishment of, and participation in, potential consortia:

  • Brief description (10 pages or less) of company experience and existing infrastructure related to manufacture or supply of any of the aforementioned resources or services; plus additional pages comprising:
  • Discussion/perspective on potential barriers (financial, technological, legal, etc.) to, and/or concerns over, participating in consortia of industry participants to meet the pandemic preparedness and response requirements;
  • Perspective on granting the USG access/rights to USG-funded infrastructure and technologies on a preferential basis (“priority access”) in the event of a declared public health emergency (PHE);
  • Perspective on sustainment of pandemic response capacities and capabilities during non-pandemic or declared PHE’s.

THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY. NO CONSORTIUM OR SOLICITATION CURRENTLY EXISTS. BARDA will use this information to guide decisions and plans regarding establishing domestic biopharmaceutical consortia and to establish a contact list of potential industry participants for future outreach efforts.

Please note that contractors performing advisory and assistance services that support BARDA will have access to any submission under this RFI. Please do not include proprietary information in response to this RFI.

HHS BARDA POC: Peter Wallace, peter.wallace@hhs.gov, 508.498.6676

Closing Date: February 28, 2022

pdf icon Download Full BioMap Consortium RFI

OPPORTUNITIES TO PARTNER WITH BARDA

If you are interested in partnering with the federal government on a COVID-19 medical countermeasure, submit your ideas to a platform that reaches a host of potential federal partners.


LEARN MORE

To spur innovation, BARDA has issued its business-friendly, streamlined Easy Broad Agency Announcement (EZ-BAA) to support a number of new medical countermeasures to fight the COVID-19 outbreak.


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BARDA is investing in an array of medical countermeasures to diagnose, treat, or protect against the 2019 novel coronavirus under the BARDA Broad Agency Announcement (BAA-18-100-SOL-00003).


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Website Refresh - www.medicalcountermeasures.gov is pleased to announce a phased launch of our newly redesigned public website. We are making website improvements to provide a more modern and customer-centric web experience. Over the next several months you will see differences throughout the site while we continue implementing updates. Thank you for your understanding and please let us know if you have any questions: techwatchinbox@hhs.gov