Money, Money, Money . . . . It’s A Rich Man’s World: Getting Funding for COVID-19-Related Medical Products

While many of us are justifiably focused on the negative aspects of the COVID-19 pandemic, one positive result has been the way in which the life sciences community has answered the call to develop lifesaving medical countermeasures to fight the coronavirus.  In the last 4 months, the Food and Drug Administration has authorized an incredible number of products and others are being studied in clinical trials.¹    Despite the urgent need for these products to come to market, some companies do not have the funding necessary to carry out human clinical trials or to eventually obtain approval or clearance from FDA, and must think of creative ways to raise much needed capital.  One option that we have discussed with our clients is applying for a government grant to fund their efforts.

Anyone who has ever tried to apply for a grant will recognize that the process can be complicated and that often the grants are very specific to a particular population, cause, or disease.  When it comes to funding for COVID-19-related products, the Biomedical Advanced Research Development Authority (BARDA) continues to have the most robust COVID-19 grant program and the one that seems to include broader research opportunities.²   Overall, BARDA received $3.5 billion under the Coronavirus Aid, Relief and Economic Security (CARES) Act to support the manufacturing, production and purchase of COVID-19 vaccines, therapeutics, diagnostics and other medical devices.³ 

Before applying for a grant, manufacturers should carefully review the applicable BARDA Broad Agency Announcement (BAA) and determine whether the technology is at the level of development that would be of interest to BARDA.⁴ The BAA will state the level of technology readiness necessary to qualify for a grant (e.g., and Investigational New Drug Application (IND) submission).  Following that process, it is recommended that companies participate in a pre-submission process by requesting a meeting with BARDA’s TechWatch Program, which has been renamed CoronaWatch, because the program is now only focused on reviewing COVID-19-related submissions.  According to a representative from the TechWatch program, they have received an “unprecedented volume of meeting requests.”⁵  Therefore, CoronaWatch is only granting meetings to “those requests with candidate products or technologies that are determined by [their United States Government (USG)] team to be highly relevant as they may have an immediate impact on the COVID-19 response.”

While the CoronaWatch program has received a large number of requests, companies should still consider participating in this process before submitting a grant application to BARDA.⁶   This process can help determine what will be needed to increase the chances of a successful grant application, considering that preparing a full grant proposal can be costly and time consuming.  During a CoronaWatch meeting manufacturers can receive feedback from USG experts on their technology, discuss techniques and strategies for addressing any technological or regulatory challenges, and have the opportunity to have their submission shared across U.S. Government agencies involved in COVID-19 medical countermeasures research and development.

The timing of a meeting with CoronaWatch will depend on the amount of information the company is able to include when requesting a meeting, as well as the technology readiness level.  If selected for a meeting, a company is asked to participate in a 30-minute webinar, which will require a slide presentation.   It has been our experience that CoronaWatch will review a meeting request within a few days of submission, if it concludes there is sufficient information to proceed to the next step.   However, the likelihood of obtaining a meeting with the CoronaWatch program, or ultimately a COVID-19 grant from BARDA, will clearly depend on whether the company can show that the product can have an “immediate impact on the COVID-19 response.”⁷

After the CoronaWatch meeting, the next step is the submission of a Quad Chart and White Paper to start the formal application process.⁸   The review of the Quad Chart and White Paper can usually take 90-120 days; however, the process may be a lot shorter due to the pandemic.  After BARDA reviews the White Paper, it will inform the company whether it can move to the next step and submit a full proposal.  The proposal review takes on average another 120 days, but funding might be obtained in a shorter period depending on the project.  BARDA is accepting COVID-19 grant applications until October 31, 2020.⁹

AGG Observations

• Before requesting a CoronaWatch meeting, manufacturers need to make sure that they are far enough along in their product development process. For example, if the company is developing a drug to treat or prevent COVID-19, it is recommended that the manufacturer has submitted an IND to FDA before requesting a meeting.
• Participation in the CoronaWatch process can lead to meeting representatives from other federal agencies (e.g., Department of Defense) that may have their own specific grant programs.
• Manufacturers should review BARDA’s current portfolio of COVID-19 products to determine whether their product may fill a potential gap. If there are already similar products in BARDA’s portfolio, it will be important to demonstrate that the product is unique, or is potentially a new and improved version of a product that has already been funded.
• After the CoronaWatch meeting, make sure to incorporate any feedback received during the meeting when preparing the Quad Chart and White Paper. This will increase the company’s potential for a successful formal proposal submission.

[1] For example, as of July 17, 2020, FDA has authorized 184 tests under Emergency Use Authorizations (EUAs) (152 molecular tests, 30 antibody tests, and 2 antigen tests).   See FDA’s Coronavirus (COVID-19) Update:  Daily Roundup July 17, 2020, available at  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-17-2020

[2] https://medicalcountermeasures.gov/App/barda/coronavirus/COVID19.aspx

[3] There are other potential funding opportunities, but we are focusing on BARDA in this Bulletin.

[4] https://www.medicalcountermeasures.gov/trl/integrated-trls/.

[5] https://www.medicalcountermeasures.gov/Request-BARDA-TechWatch-Meeting/.  To date, CoronaWatch has received over 3,600 COVID-19 Techwatch Meeting requests and BARDA has held over 400 meetings with innovative companies.

[6] Companies who have already submitted a White Paper or a full grant proposal to BARDA are not eligible to participate in a CoronaWatch meeting.

[7] BARDA’s current Coronavirus product portfolio is available at, https://medicalcountermeasures.gov/App/barda/coronavirus/COVID19.aspx.

[8] A Quad Chart is a technical document used to briefly describe the invention and project.  It is described as a quad, because it is divided into four quadrants.  A Quart Chart Template is available at https://www.phe.gov/about/amcg/BARDA-BAA/Documents/quad-chart-template.pdf.  The White Paper expands on the information provided in the Quad Chart and provides enough relevant data and details about the proposed project to enable BARDA to evaluate the project and its technical merits.  The White Paper should not exceed 10 pages.  More information on the QUAD Chart and White Paper, is available at https://www.phe.gov/about/amcg/BARDA-BAA/Pages/barda-baa-toolkit.aspx. 

[9] BARDA’s COVID-19 BAA is available at https://beta.sam.gov/opp/7c72ff2e5c514b2faa15765e78294128/view#general.