Antiviral Program for Pandemics (APP)
The APP works toward creating safe and powerful antiviral medications to fight against COVID-19 and other potential pandemic-causing viruses, while also establishing sustainable systems for targeted drug research and development.
Antiviral Program for Pandemics (APP)
We bring our proficiency in drug discovery and development to fill a critical role in the APP, a multi-agency initiative to develop safe and effective oral antivirals. The APP aims to develop treatments for SARS-CoV-2 and to accelerate the development of a portfolio of promising antivirals that can quickly pivot to combat future pandemics.
As part of the APP, we will support early discovery and preclinical development by applying our expertise and cutting-edge resources in a variety of ways, including developing novel assays for viral targets and using high-throughput screening to identify potentially effective compounds. The program launched in 2021 with more than $3 billion in funding from the American Rescue Plan. Having safe and effective oral antiviral candidates ready for deployment in later-stage clinical trials against a newly emergent virus would save lives, reduce serious illness and prevent overwhelming surges in hospitalizations during a viral outbreak or pandemic.
Accelerating Antiviral Development
As part of the APP, NCATS is a key partner alongside the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) in accelerating antiviral development through early discovery and preclinical development. NCATS also coordinates with partners to take candidates into clinical development.
NCATS applies its proficiency in drug discovery and development and its cutting-edge technologies to fill critical needs of the APP, such as target validation; high-throughput screening (HTS) for drug starting points; medicinal chemistry for lead optimization; and preclinical, investigational new drug (IND)-enabling development.
Specific NCATS activities include:
- Novel assay development for viral targets, including Biosafety Level 2 and Biosafety Level 3 assays
- Compound testing to characterize activity across virus families
- HTS of diverse collections of chemical compounds to identify drug development starting points
- Hit-to-lead optimization of promising compounds, from preliminary structure-activity relationship exploration to full-scale medicinal chemistry studies
- Rigorous evaluation of drug metabolism and pharmacokinetic (DMPK) properties, exploratory toxicology to demonstrate initial safety, and validation of efficacy in relevant in vivo systems
- Preparation of comprehensive data packages for inclusion in IND applications to the U.S. Food and Drug Administration
In addition to SARS-CoV-2, NCATS' activities address other viruses within the scope of the APP that represent known threats because of their pandemic potential. The table below shows virus families/orders and examples of viruses that the APP may target.
|Viral Family/Order||Example Viruses|
|Coronaviridae||SARS-CoV, MERS-CoV, SARS-CoV-2|
|Bunyavirales||Rift Valley fever, Hantavirus, Crimean-Congo hemorrhagic fever|
|Flaviviridae||Yellow fever, Dengue, Zika|
Opportunities for Collaboration
We are partnering with extramural scientists and the private sector to advance drug discovery and development programs for oral antiviral candidates. We can collaborate on projects with entry points anywhere along the development pipeline — and with flexible project exit points — to speed discovery and overcome the scientific, technical and enterprise barriers to delivering drug candidates ready for Phase 2 clinical trials in future pandemics. To learn more about partnering with NCATS, please contact firstname.lastname@example.org.
Our OpenData Portal is an open and accessible platform for sharing COVID-19-related drug repurposing data and experiments involving drugs.
National COVID Cohort Collaborative (N3C)
We created and maintain this national resource of clinical and other data to answer critical questions about COVID-19 health outcomes.
With the aim of accelerating translational research across all diseases, we developed research tools, technologies, expertise and collaborative networks that can quickly pivot to address urgent public health issues.