For the past 18 months companies have been confused and frustrated by the shifting USG policies regarding the development of therapeutics as part of the COVID-19 response. BARDA was back and forth as parts of the BAA were suspended, unsuspended, and resuspended. The American rescue Plan legislation was passed about six months ago and although it included funds for therapeutic development but nothing was done. Until now. Well, it is time to get all those white paper and proposals dusted off and ready for resubmission. Recently $3.2 billion was made available to NIAID for the development of anti-virals for therapeutic use and also post-exposure prophylaxis. Details are below, but the money will be used to support discovery, clinical trials, and manufacturing. Some funding will undoubtedly be used for programs already supported by NIAID but there sill be a lot of opportunity for new candidates too. In particular, $1.2 billion will be used to establish a network of Antiviral Drug Discovery Centers that will fund work well beyond coronaviruses. If you want to spend more time on research and less on contract administration, EverGlade can help. First by getting the proposal together and then after the award by providing compliant contract administration services including project coordination and reporting as well as financial reporting. Here are the details of this exciting new program:
-
NIH will evaluate, prioritize and advance antiviral candidates to Phase 2 clinical trials, using current and expanded contract resources and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early stage development with sponsors and guide candidates along development paths.
-
$300M+million research and lab support
-
$1B for preclinical and clinical evaluation
-
$700M for development and manufacturing through NIAID and BARDA.
-
Up to $1.2B to support the creation of collaborative drug discovery groups called Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern
-
The basic research centers initially will target SARS-CoV-2 and other betacoronaviruses
-
Will expand to target other viruses with pandemic potential, such as paramyxoviruses, bunyaviruses, togaviruses, filoviruses, picornaviruses, and flaviviruses
-
The Funding Opportunity Announcement will be posted on AViDD site when available.
