This is part 3 of a multi-article series about the Shark Tank collaborative involving NIH and BARDA

Part 1 click here

Part 2 click here

BARDA’S Involvement

Dr Gary Dr Disbrow – Acting Director of the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services – discussed how BARDA supports efforts to develop vaccines, treatments and diagnostics in the Shark Tank initiative.

Medical Countermeasure (MCM) Portal

Health and Human Services Secretary Alex Azar declared a public health emergency on January 31. That same day, BARDA created the Medical Countermeasure (MCM) portal to accept market research and proposals to combat the pandemic. As of May 7, the portal had received over 2700 submissions from stakeholders. BARDA works with interagency partners to prioritize and review the submissions. So far, 1500 participants have presented submissions for the development of vaccines, therapeutics and diagnostics.

They’ve established task forces consisting of experts spanning the U.S. government charged with addressing key challenges and finding solutions, with the goal of prioritizing and aligning MCM development in a transparent manner. Workgroups focus on establishing vaccines, therapeutics and diagnostics. Dr Disbrow cited H1N1, Ebola Virus and Zika Virus as successful examples of similar past endeavors.

BARDA has unique authority to leverage and rapidly expand partnerships. This allows them to push candidates forward through the review, testing and approval phases. They have leveraged $3.5b, provided under the CARES Act, to invest in multiple vaccine, therapeutic and diagnostic candidates. Recently, BARDA’s attention shifted toward antigen and serological testing. They are currently supporting 19 diagnostic products, eight of which have received Emergency Use Authorization (EUA) by the FDA.

Scaling up Testing

Senator Lamar Alexander (R-TN) expects, with over 1000 applications, Shark Tank wouldn’t identify at least a few simple, inexpensive, point of care tests. His primary concern surrounded the manufacture and up-scaling of winners, and what part BARDA would play in that. According to Dr Francis Collins, Director of the NIH, the committee reviewing applications includes experts in business and commercialization. The committee will not invest in a product lacking scalable potential.

Once winners are selected, BARDA will pair smaller businesses with larger business partners for manufacturing and distribution purposes. Dr Disbrow told Senator Alexander to envision a seamless transition. They have done this before and currently have 300 industry partners; they will bring together engineers to assist in the scale-up funded by BARDA. During the initial proposal review process, BARDA would assist with identifying the most promising technology and then coordinate with outside groups to get the work done.

Who is Running this Operation?

Senator Mike Enzi (R-WY) noted that we are “scrambling to catch up, conducting early stage research at the same time as moving products through the advanced development stage.” He inquired as to who’s in charge of the operation. Dr Collins explained that the NIH takes the lead role in early research. Projects are handed off to BARDA when the time comes for advanced development and manufacturing. Dr Disbrow added that BARDA and the NIH have frequently collaborated over the past decade. In particular, BARDA and the NIAID have developed vaccines and therapeutics for some of the greatest threats our nation faces including chemical, biological, radiological and nuclear threats, in addition to pandemic influenza. They “work hand in hand, BARDA is integrated into the ACTIV partnership, everybody is integrated and working across government, sharing info and helping to develop those medical countermeasures.”

Scale of Tests Required

Senator Patty Murray (D-WA) noted experts have stated the U.S. needs five hundred thousand to 5 million tests per day, both now and going forward. She wanted to know if, in order to ensure testing availability, the national strategic plan on testing should include specific numerical targets for testing capacity, supply chain capacity and projections of shortages. Dr Collins replied that this is not his area of expertise. It falls under the responsibilities of the coronavirus task-force and the CDC.

Murray further inquired about whether the plan should detail how to allocate various tests for use in different settings, for example hospitals versus workplaces. Dr Collins noted there are scientific reasons regarding when and where to use certain tests. They are nuanced based on individual state, regional, city or tribal circumstances. Needs differ from one environment to the next, so, in his opinion, the plan should include specific recommendations.

Supply Chain

Senator Tammy Baldwin (D-WI) asked if Doctors Collins and Disbrow to give the committee a summary of the supplies required to administer the new tests, as well as logistics regarding procurement and distribution. Dr Collins explained that each testing platform has differing supply requirements. However, the committees will look at that closely as part of the evaluation process. Many tests may require swabs, but swabs used to sample the front of the nose may be as good as those that go all the way back. He further noted that saliva may be an alternative, in which case, testing might not require swabs at all. He assured Senator Baldwin that committees wouldn’t invest in diagnostic technology without a clear understanding of supply chain requirements. BARDA plays a critical role in supply chain management, as this is a “sweet spot” for them.

Senator Baldwin concluded her questioning by inquiring as to whether it would help the committees to have an understanding of the types of facilities and institutions in need of testing, and when they would need it, in order to identify gaps as well as the tests likely to fill those gaps. Dr Collins expressed that they want to have full sense of needs from multiple institutions, particularly in places that are vulnerable.

During her questioning, Senator Elizabeth Warren (D-MA) circled back to inquire about the process for ensuring the supply chain. Dr Disbrow explained securing the supply chain required public/private partnerships involving cost-sharing measures with the companies involved. “In COVID-19, the government takes the risk for developing these therapeutics, diagnostics and vaccines.”  Throughout development, forward thinking would assess future supply needs.

Defense Production Act

Senator Warren reiterated that the issue isn’t necessarily about innovation or production of new products, so much as the supply chain to support production. If supplies are lacking, new products are useless. She asked whether BARDA takes responsibility for the supply chain. Dr Disbrow explained that BARDA does everything necessary to ensure supply chain and availability of all ancillary supplies required to administer countermeasures, whether therapeutics, vaccines or diagnostic tests.

Senator Warren noted that the U.S. cannot, therefore, “just wait for cotton swabs to roll off the assembly line from the cotton swab factory.” She took the opportunity to make a plug for legislation introduced by Senators Baldwin and Murray that would expedite the production of necessary medical supplies and equipment by having private companies manufacture them through an expansion of President Trump’s limited use of the Defense Production Act.