As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States.  The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than 2,000 to 3,000 new cases each day.

Due to the lack of approved therapeutics, vaccines, and diagnostics for this threat, developing new products and testing products already approved for other uses is a high priority for the U.S. interagency response effort—the Medical Countermeasure (MCM) Task Force.  The Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), is leading this Task Force in partnership with U.S. Department of Defense, Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health.

BARDA is currently looking at the effectiveness of existing countermeasures for similar viruses, as well as potential new responsive technologies, including vaccines, diagnostics, therapeutics, and medical supplies.  BARDA is serving as the sole point of entry for product and technology submissions to ensure there is an expedited process for receipt and review of proposed solutions for 2019-nCoV.  In this capacity, BARDA has released two opportunities to submit potential solutions for the 2019-nCoV response discussed below: (1) the EZ-BAA for 2019-nCoV diagnostics and (2) market research packages for any and all potential products and supplies.  Covington encourages those with technology that could be potentially useful to respond.

HHS Easy Broad Agency Announcement (EZ-BAA)

An EZ-BAA is now open for abstract submissions for development of an in vitro diagnostic for the detection of 2019-nCoV in clinical specimens.  The diagnostic must be developed for use with an existing FDA-cleared molecular platform that is currently widely placed in U.S. healthcare settings, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization within 12 weeks of an award.  The number of available awards is unlimited, and any awards are expected to be less than $750,000.  Additional details and requirements for submissions are available here, and HHS’ statement on the EZ-BAA is available here.  Abstract submissions are due by March 18, 2020 at 5:00 PM EDT.

Market Research Package Submission for Medical Countermeasures (MCMs)

BARDA also created a portal for submission of products or technology for MCM research and development in an effort to cast a wide net for possible responsive technology to 2019-CoV.  The interagency response to support domestic preparedness includes four key prongs: (1) MCM development; (2) healthcare system preparedness; (3) supply chain resilience; and (4) medical surge.  BARDA is interested in submissions that help the Task Force meet these strategic efforts.  Although a non-exhaustive list, BARDA provides in the submission portal that the ideal technologies and products could include the following characteristics:

  • Relevant to the U.S. government 2019-nCoV medical countermeasure research and development efforts and/or Emerging Infectious Disease rapid response capabilities
  • Utilize an already-approved platform, have non-clinical data suggesting efficacy, and/or have significant manufacturing capability
  • Fully owned or licensed by your organization (you have full IP rights and/or freedom to operate)

Categories for submission include vaccines, diagnostics, therapeutics, as well as a broad catch-all category.  The Task Force is looking for submissions to encompass a wide variety of MCM approaches, including approaches that allow for an expedited product development pathway that would lead to earlier recognition and isolation of new cases.  No deadline is included in the MCM portal, however, potential stakeholders are encouraged to submit as soon as possible.

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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch is co-chair of the firm’s Government Contracts practice group. Her practice includes a wide range of contracting issues for large and small businesses in both defense and civilian contracting. Her practice involves advising clients on contract proposal, performance, and compliance questions…

Jennifer Plitsch is co-chair of the firm’s Government Contracts practice group. Her practice includes a wide range of contracting issues for large and small businesses in both defense and civilian contracting. Her practice involves advising clients on contract proposal, performance, and compliance questions as well as transactional and legislative issues. Her practice also includes bid protest and contract claims and appeals litigation before GAO, agency boards and the federal courts. Ms. Plitsch has particular expertise in advising clients in the pharmaceutical and biologics industry. She advises a range of pharmaceutical and biologics manufacturers on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as research and development contracts and grants with various federal agencies. She also has significant experience advising on the requirements of various programs under which vaccine products and biodefense medical countermeasures are procured by the Government.

Photo of Tyler Evans Tyler Evans

Tyler Evans is a partner in the firm’s Washington, D.C. office and a member of the government contracts group.  His practice covers multiple subject-matter areas, including research and development, non-traditional contracting, intellectual property, contract negotiations, flow-down requirements, small business issues, sourcing restrictions, costs…

Tyler Evans is a partner in the firm’s Washington, D.C. office and a member of the government contracts group.  His practice covers multiple subject-matter areas, including research and development, non-traditional contracting, intellectual property, contract negotiations, flow-down requirements, small business issues, sourcing restrictions, costs, and compliance.

Photo of Alexander Hastings Alexander Hastings

Alex Hastings advises clients across a broad range of government contracting issues, including advising clients in transactional matters involving government contractors and assisting defense contractors and pharmaceutical companies in securing and performing government contracts.

Mr. Hastings also advises clients concerning best practices in…

Alex Hastings advises clients across a broad range of government contracting issues, including advising clients in transactional matters involving government contractors and assisting defense contractors and pharmaceutical companies in securing and performing government contracts.

Mr. Hastings also advises clients concerning best practices in e-discovery. He assists in investigations and litigations that involve complex e-discovery issues and has represented clients in matters involving the U.S. Department of Justice, Securities and Exchange Commission and the United States International Trade Commission.

Mr. Hastings’ government contracts experience includes advising clients regarding new developments in regulatory requirements, including the Federal Acquisition Regulation’s (FAR) anti-human trafficking requirements and the FAR and Bayh-Dole Act’s intellectual property provisions. Mr. Hastings also provides due diligence regulatory advice to clients contemplating the acquisition of government contracting entities or assets.

Mr. Hastings’ e-discovery experience includes advising a wide-array of clients on best practices in information governance and document collection and assisting clients develop effective mobile device and document management policies.

Mr. Hastings also maintains an active pro bono practice and routinely writes on issues related to government contracts and e-discovery.