COVID-19 R&D support: US (FDA, BARDA, NIAID), Europe (EMA, EC), and globally (BioCentury resource hub)

Dear All,

And now for a change from our usually scheduled content! As you might expect, major agencies in the US (FDA, BARDA, NIAID) and Europe (EMA, EC, national agencies) are actively supporting the global R&D response to COVID-19. In addition, global consortia are appearing and BioCentury has provided both a newsletter on this as well as a well-organized resource hub (link), both free of charge.

In the US:

FDA have FDA have consolidated links to all their COVID-19 resources on to this webpage. The resources here include a Coronavirus Treatment Acceleration Program (CTAP, link) that seeks to use every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. Examples of actions via the CTAP program include 24-h turnaround on protocol review, 3-h turnaround on expanded access requests, and rapid triage of requests for guidance to appropriate FDA staff. In addition, FDA has guidance for trial conduct here.

BARDA have established a special portal on their countermeasures website to collect information about potential products or capabilities that could be utilized as part of this effort. BARDA’s interest includes both diagnostics and therapeutics. Applications submitted to their database are monitored and reviewed by BARDA and its interagency partners at NIH, CDC, DOD, and FDA.

If you think you may have a relevant product requiring support, you are encouraged to reach out to the agencies via the link below. The agencies will get back to you for follow-up as soon as possible. No specific timeline for response is stated: a patient attitude is likely appropriate in the face of what I hope is a substantial volume of submissions.

To submit data on your COVID-19 product: https://www.medicalcountermeasures.gov/app/barda/coronavirus.aspx
General website link: https://medicalcountermeasures.gov/ 

In addition, you are encouraged to review recent changes to BARDA’s Broad Agency Announcement (Amendments 13 and 14), and DRIVe EZ-BAA (Special Instructions), which outline their current Areas of Interest reflecting a focus on SARS-CoV-2 countermeasures, via the following links.

• BAA general information: https://www.medicalcountermeasures.gov/barda/barda-baa/
• BAA Amendment 13 and 14: https://sam.gov/opp/1b46a4169fcb4902b9c4fcbb5bf981f7/view
• EZ-BAA general information: https://drive.hhs.gov/partner.html#ncov
• EZ-BAA Special Instructions: https://sam.gov/opp/b4f7923443a448218d369209723141c5/view

NIAID has a range of resources for support of both basic research and candidate products — see the list below. If further clarification or assistance is required, please reach out to Ann Eakin (Ann.Eakin@nih.gov).

• NIAID recently issued a Notice of Special Interest (NOSI) regarding the Availability of Emergency Competitive Revisions for Research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). This Emergency NOSI is limited to NIAID grantees with active awards who wish to submit a request for a competitive revision to expand the scope of their current award to address SARS-CoV-2/COVID-19. Please see: https://grants.nih.gov/grants/guide/notice-files/NOT-AI-20-034.html
• For those with active NIH funding, administrative supplements can also be submitted at any time through the eRA Commons. Please see: https://grants.nih.gov/grants/guide/pa-files/pa-18-591.html
• The NIAID Partnerships FOA highlights SARS-CoV-2/COVID-19: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-028.html
• Funding opportunities specific to COVID-19 are also available from other NIH Institutes and Centers. Please see the table on this website https://grants.nih.gov/grants/natural_disasters/corona-virus.htm.
• NIAID has many research resources available for investigators. Please see: https://www.niaid.nih.gov/research/resources
• SARS-CoV-19 virus and reagents are available through the NIAID BEI repository. Please see: https://www.beiresources.org/Home.aspx

For those involved in animal care, AAVLD (the American Association of Veterinary Laboratory Diagnosticians) has a useful resource page here. The page covers SARS as well as COVID-19 and provides discussions of pets as fomites, testing of companion animals, and more.

In Europe:

EMA have a response team in place … read more details here: “The aim is to provide advice on regulatory requirements so that any promising medicinal product can be made available as rapidly as possible to patients, initially in the clinical trial setting and then, once authorised, on the market.” In addition, EMA has general guidance for sponsors here and GCP-focused guidance here.

The European Commission (EC) have a variety of programs underway. You can get a good start from this webpage. The Research and Innovation programs include support for Therapeutics, Diagnostics, and Vaccines. In particular, all the European Commission research and innovation calls on Covid-19 are here. Further, take note of these national efforts:

• France has a Covid-19 Flash Call here 
• Germany: BMBF has summarized its work-in-progress here and has a list of active calls here.
• Spain: ISCIII has a call for Expressions of Interest here
• UK: MRC has a COVID-19 Rapid Response Rolling Call here
• [NEW on 20 Apr 2020] The online journal Science|Business has provided a table of additional calls within the EU. Go here to see it.

At a global level:

• Global consortia are now starting to form. BioCentury has provided both a newsletter on this as well as a well-organized resource hub (link), both free of charge. BioCentury is not a sponsor or member of the consortium … the newsletter makes it clear that they fell into it via data-sharing discussions with several of the early members. The consortium is open to new members … see the newsletter for details.
• [new on 21 Apr 2020] Superb webcast from 20 Apr 2020 featuring former FDA commissioners Scott Gottlieb and Mark McClellan is here. This 2-h webinar was an excellent survey of work underway both on the R&D side and on ways to collaborate on rapid evaluation of new products.
• [new on 27 Apr 2020] IDSA (Infectious Diseases Society of America) has an excellent resource hub here. This hub is particularly noteworthy for carrying the society’s most current treatment guidelines.

Stay safe in these difficult times, All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.