Since its creation in 2006, the Biomedical Advanced Research and Development Authority has funded the development of medical countermeasures for pandemic influenza, anthrax, smallpox, Ebola virus disease, Zika virus, and, of course, COVID-19.  In just the last year, BARDA has made more than 35 new awards to partners, assisted its partners in achieving 20 FDA approvals of their products, and launched Project NextGen, a $5 billion program it leads alongside the National Institute of Allergy and Infectious Diseases to accelerate the development of COVID-19 vaccines and treatments through public-private collaborations.  

On November 30, BARDA announced its latest plans for Project NextGen, releasing new solicitations for project proposals for the development of next generation COVID-19 vaccines, therapeutics, and enabling technologies.

The three new solicitations – detailed below – were announced through the Rapid Response Partnership Vehicle (RRPV), a consortium that supports BARDA in its objective to develop medical technology to address future pandemic or other biological threats.  All offerors must be members of the RRPV consortium at the time they submit their proposals.  Proposals are due in early January 2024.

Additionally, BARDA also announced a new Area of Interest (AOI) through its Division of Research, Innovation, and Ventures (DRIVe) Agnostic Diagnostics program.  The new AOI focuses on bringing metagenomic next-generation sequencing to routine clinical labs and point-of-care settings through innovation in sequencing hardware, sample preparation, or bioinformatics.

1. Enabling Technology – Decentralized Trial – Home Focus (proposals due January 10, 2024)

BARDA requests project proposals to conduct a study designed to assess potential correlates of protection using immunogenicity data correlated to symptomatic COVID-19 following vaccination with an FDA licensed/authorized COVID-19 vaccine. 

To be eligible, awardees must have a successful history of conducting clinical trials for medical countermeasures.  BARDA expects the period of performance to begin in February 2024.

2. NextGen Vaccinations: Phase 2B Clinical Trial Execution (proposals due January 10, 2024)

BARDA is seeking to partner with developers and other organizations to advance the clinical development of next-generation COVID-19 vaccines into a Phase 2b clinical trial.  BARDA will support development by providing planning and regulatory support as needed.

In order to be eligible, awardees must have (1) a successful history of developing, cGMP manufacturing, release testing, and conducting clinical trials for vaccines and (2) an active or complete Phase 1 clinical trial Next-Generation COVID-19 Vaccine, with unblinded safety and immunogenicity data to support a Phase 2b trial.  BARDA expects the period of performance to begin in the second quarter of fiscal year 2024.

3. COVID-19 Monoclonal Antibody Therapeutics for PrEP (proposals due January 19, 2024)

Finally, BARDA seeks partnerships with developers and other organizations to advance the clinical development of next-generation therapeutics for COVID-19.  Awardees would be responsible for developing of COVID-19 monoclonal antibody therapeutics (single or combination products), with a primary indication of PrEP.

To be eligible, awardees must have a demonstrated successful history of developing, cGMP manufacturing, release testing, and conducting clinical trials for therapeutics and/or vaccines.  BARDA expects performance to begin on the date of contract award.

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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She…

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
    the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.

Photo of Catherine Wettach Catherine Wettach

Catherine Wettach is an associate in the firm’s Washington, DC office. She is a member of the Government Contracts and White Collar Defense and Investigation Practice Groups.