Antiviral Program for Pandemics (APP) Submission Form

Middle East Respiratory Syndrome Coronavirus particle envelope proteins immunolabeled with Rabbit HCoV-EMC/2012 primary antibody and Goat anti-Rabbit 10 nm gold particles.

Credit: NIAID

Purpose

The Antiviral Program for Pandemics (APP) seeks to identify virus targeted antiviral candidates in the discovery phase through early clinical trials that target SARS-CoV-2 and other viruses of pandemic potential. The goal is to support candidates by de-risking early stage development and guiding candidates along the development path.

This submission form is for information and planning purposes only and shall not be construed as a solicitation or funding opportunity; a contract, grant, cooperative agreement, or other transaction; or as an obligation on the part of the Federal Government, the NIH, and Biomedical Advanced Research and Development Authority (BARDA) to provide support for any ideas identified in response to it.

Submitting information about a candidate does not guarantee support for current or future studies. Candidates of interest will be contacted by an APP representative to complete additional steps if needed.

You may submit a single candidate with multiple viral targets. However, for each viral target, you will be required to complete a separate submission form.

The APP will only accept submissions for virus targeted antiviral candidates that meet the program criteria listed below.

In-Scope Candidates

Candidates must meet these criteria:

  • Virus targeted antiviral (i.e., acting against viral targets)
  • Developed for RNA viruses of pandemic potential:
    • Family or Order: Coronaviridae including SARS-CoV-2, Paramyxoviridae, Bunyavirales, Picornaviridae, Filoviridae, Togaviridae, and Flaviviridae
  • Small molecules or new modalities (e.g., nucleic acids, peptides, antibody-drug conjugates)
  • Target outpatient use (e.g., oral, intranasal)
  • New chemical or molecular entities (i.e., not re-purposed marketed drugs)
  • Discovery up to early clinical trial ready candidates

Out-of-Scope Candidates

Candidates are out-of-scope if they meet any of the below criteria:

  • Host-directed therapies (therapies that target host proteins) including immunomodulators
  • Neutralizing antibodies or non-neutralizing antibodies
  • Target viruses representing families or orders other than those listed above
  • Administration requiring hospitalization or for inpatient use (e.g., intravenous)
  • Off-label therapeutics that have been approved for other indications

Eligible Sponsors

Eligible sponsors including biopharmaceutical companies, academic or scientific research institutions, and foundations or non-profit organizations that own the development rights for the candidate are welcome to submit. Sponsors from all countries are eligible to apply.

Submission Instructions

Eligible sponsors are requested to fill out the APP Submission Form with all required information about the potential antiviral therapeutic. Incomplete submissions will not be reviewed, however, you may select data not available for specified questions. After your submission, you will receive an email confirmation that your form as been received. If applicable, an APP representative will contact you at the contact information you provide to update you on the status of your submission. In progress submissions cannot be saved and you cannot update or modify your submission once it is completed. However, you may submit a new submission.

To prepare your submission before completing the online form (button below), you can download a sample form (PDF will open in new window). Please note that this document is a copy of the APP Submission Form to help you prepare your submission. You cannot submit this document in lieu of completing the online submission process.

Disclaimer and Confidentiality

You will be required to acknowledge the APP Disclaimer and the Confidentiality Statement once you access the APP Submission Form. For your awareness, the APP Disclaimer and Confidentiality Statement read as follows:

  • APP Disclaimer: This submission form is for information and planning purposes only and shall not be construed as a solicitation or funding opportunity; a contract, grant, cooperative agreement, or other transaction; or as an obligation on the part of the Federal Government, the NIH, BARDA, or other partner agencies to provide support for any ideas identified in response to it. The Federal Government will not reimburse or pay for the preparation of any information submitted, or for the Federal Government’s use of such information. No basis of claims against the U.S. Government shall arise as a result of a response to this submission form or from the Federal Government’s use of such information.
  • Confidentiality Statement: Submissions to this portal are encouraged to be at a summary level so that they remain non-proprietary and non-confidential. Further, federal employees are bound to protect most types of proprietary information in these submissions (see, for example, Exemption 4 of the Freedom of Information Act at 5 U.S.C. § 552(b)(4) and the law on Disclosure of Confidential Information at 18 U.S. Code § 1905). Submissions to this portal will be accessed and reviewed by staff at the National Institutes of Health. At NIH’s discretion, portal submissions may be shared with partner US Govt. agencies (e.g., BARDA) affiliated with the APP.

Submit Antiviral Candidates

Eligible sponsors are requested to fill out the Antiviral Program for Pandemics (AAP) Submission Form. Please remember that in progress submissions cannot be saved and you cannot update or modify your submission once it is completed. However, you may submit a new submission.

Begin the APP Submission Form

Contact Information

For additional information, please see the Frequently Asked Questions (FAQs).

For all other queries including how to complete a Non-Disclosure Agreement, please contact APPSubmission@nih.gov.

Partners

  • United States Department of Health and Human Services (DHHS)
  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Allergy and Infectious Diseases – Division of Microbiology and Infectious Diseases
  • National Institute of Allergy and Infectious Diseases – Division of AIDS
  • National Institutes of Health – Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
  • Biomedical Advanced Research and Development Authority (BARDA)
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