Other programs that exist to support the development of therapeutics for COVID-19 include ACTIV, Tx Operation, JPEO, and I-SPY. You may learn more about other programs by visiting the links provided below.
The APP can link sponsors to resources that may choose to provide a wide range of in-kind support for candidates including project collaboration/ partnerships, resources, capabilities, and expertise across the R&D value chain.
Candidates must meet these in-scope 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
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
Other viruses of pandemic potential within the following Family / Order will be considered:
- Other coronaviridae (e.g., MERS)
- Paramyxoviridae (e.g., Nipha, Hendra)
- Bunyavirales (e.g., Lassa, Junin, Rift Valley Fever Virus, Andes, Sin Nombre, LaCrosse, California encephalitis, Crimean Congo Hemorrhagic Fever)
- Picornaviridae (e.g., EV-D68, EV-A71)
- Filoviridae (e.g., Ebola, Marburg)
- Togaviridae (e.g., Chikungunya, EEE, VEE, WEE)
- Flaviviridae (e.g., Dengue, Zika, West Nile)
All small molecules (e.g., nanoparticles, targeted protein degradation/PROTAC approach, nucleotide/nucleoside analogs) are in-scope for the APP if other in-scope criteria are fulfilled.
No, the APP will not support the discovery or development of monoclonal or polyclonal antibody therapeutics regardless of whether their mechanism is neutralizing or non-neutralizing.
No, the APP will not support efforts to discover/develop host-targeting antivirals.
Candidates will be considered that are currently at the discovery through Phase I/II development. Therapeutic efforts that range from early basic research and discovery-based efforts, such as identification and validation of novel viral targets, to optimization of lead chemical series, clinical proof of concept to phase 1 studies, to late-stage preclinical development and IND-enabling profiling of specific drug candidates.
Eligible sponsors including biopharmaceutical companies, academic or scientific research institutions, and foundations or non-profit organizations that own the development rights for the candidate or therapeutic are welcome to submit.
Sponsors from all countries are eligible to apply.
Yes, a requirement for consideration is that you or your institution own the development rights for the candidate.
No, there is not a deadline for submitting your candidate for consideration. Applications will be reviewed on a rolling basis.
Currently, applications are being reviewed on a rolling basis. After your submission has been reviewed, you will be contacted by an APP representative with an update of your application.
No, completing the APP Submission Form does not guarantee support for current or future studies. Your submission will be reviewed and will go through additional processes to determine if and what support should be provided. Additionally, completing the APP 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.
Sponsors should complete the APP Submission Form to ensure complete and timely review of their application. Sponsors that attempt to submit their candidate for consideration through email or other modes of communication will be provided with the link to the APP Submission Form.
Yes, you can download the sample form (PDF will open in new window) to prepare your responses in advance.
No, you will not be able to edit your responses after you submit them. If you need to update your submission, you will be required to submit a new submission form at this time.
Once you submit your application, you will not be able to change or modify your submission. However, if your application is considered for support, an APP representative may request additional information or data.
No, you are not able to save the progress of your submission. You can prepare your responses in advance by download the sample form (PDF will open in new window).
No, you will need to copy and paste your responses from any documents you prepared in advance into the webform. However, you will be able to upload optional supplemental documents with your submission in a PDF format. Additional information about the acceptable size of the attachments will be provided within the webform.
There is a subset of questions that all sponsors will be required to complete. However, not all questions/ sections are required by all applicants. The requirement to answer some questions will be based on your responses earlier in the form.
No, you will not be able to review the status of your submission. After you submit your application, you will receive a confirmation email that your application has been received. After your submission has been reviewed, you will be contacted by an APP representative with an update of your application.
Yes, you can submit more than one candidate or candidate for consideration. However, you will need to submit separate webforms for each candidate.
Yes, you can request support for a candidate with more than one viral target. However, you will need to submit a new application for every viral target. For example, if your candidate targets both SARS-CoV-2 and Ebolavirus, you will need to complete 2 separate webforms: one webform will be completed with all corresponding answers related to SARS-CoV2 and the other, separate webform will be completed with all corresponding answers for Ebolavirus.
Yes, you will be able to upload optional supplemental documents with your submission in a PDF form. In addition, you must complete all questions that are relevant to your candidate.
The platform that houses your submission is regularly used by the NIH and NIAID to collect and store sensitive data. Submissions to this portal will be kept confidential. Submissions to this portal are encouraged to be at a summary level so that they remain non-proprietary and non-confidential. If further confidentiality is needed, submitters can request a NIAID approved Confidentiality Agreement (CDA) at any time in this process by contacting APPSubmission@nih.gov. 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.
You will be asked to provide personally identifiable information such as your name and contact information. In addition, you will be asked to share information about intellectual property, funding resources and preliminary / unpublished data about your candidate.
No, you cannot submit the CDA template used by your institution. However, you can request a NIAID approved CDA template by contacting APPSubmission@nih.gov. Any edits to the CDA must be made using track changes and agreed upon by NIH before signing.
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. 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).