Antiviral Development

Funding announcements and solicitations for the planned activities listed below will be posted on this site when available. Antiviral Program for Pandemics (AAP) has developed a submission process using an online form as a mechanism for developers to submit compound candidates.

Research Resources and Laboratory Support

NIAID will expand support of existing programs, including the BEI Resources Repository, which supplies organisms and reagents to the broad infectious diseases research community, and provide animal models that will be used for antiviral toxicology and efficacy studies. NIH’s Office of Research Infrastructure Programs (ORIP) also will enhance support animal models for evaluating lead drug candidates.

Because SARS-CoV-2 and certain viruses with pandemic potential must be handled in specialized labs designed for high-risk pathogens, NIAID will provide expanded operations support for biocontainment facilities under the APP.

Preclinical Evaluation

NIAID offers preclinical services to ensure antiviral candidates advance quickly to evaluation in human participants. Services include a full suite of preclinical and investigational new drug-enabling (IND-enabling) drug development activities, such as in vitro screening (also available through National Center for Advancing Translational Sciences (NCATS)), animal infection models, in vivo safety, toxicology, and Pharmacokinetics/Pharmacodynamics (PK/PD), medicinal chemistry, formulation and manufacturing for clinical trials. Visit NIAID’s Preclinical Resources for Researchers page for more details, including how to access these services.

Public-Private Partnerships

NIAID will award product development contracts to companies to support the development of promising antiviral candidates (i.e., advanced lead series, optimized leads, or product development candidates) from late-stage preclinical studies through IND-enabling activities and clinical testing. NIAID has issued Broad Agency Announcements for more than 15 years to advance product development of vaccines, therapeutics and diagnostics. These efforts advance candidate products forward into human clinical trials and de-risk candidates for further late-stage development by Biomedical Advanced Research and Development Authority (BARDA) or industry. Funding opportunities will be posted here when available – see an example of a similar funding opportunity.

Clinical Product Manufacturing

The Biomedical Advanced Research and Development Authority (BARDA) part of the HHS Office of the Assistant Secretary for Preparedness and Response, will support the manufacturing of drug candidates for clinical trials and the development of analytical assays needed for drug substance and drug product release.

Clinical Evaluation

In addition to the Public-Private Partnerships described above, NIAID will support Phase 1 clinical trials of promising antiviral candidates to de-risk further development for the private sector and fill the pipeline with potential candidates. NIAID clinical resources include the Phase 1 Clinical Trial Units for Therapeutics, and the Infectious Diseases Clinical Research Consortium (IDCRC), which encompasses the long-standing NIAID Vaccine and Treatment Evaluation Units (VTEU). NIAID will use its extensive clinical trials networks to support select Phase 2 and 3 clinical trials of antiviral candidates for SARS-CoV-2.

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