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Compound Approval / Submission

NCEA Request Form

In vitro screening assays

In vivo Animal Model Evaluation

Medicinal Chemistry

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Submitting Compounds

In order to begin participating in the NIAID Antiviral Screening Program, a potential supplier needs to complete an Antiviral Non Clinical Evaluation Agreement (NCEA) Request Form.  The NCEA is a legal document between NIAID and the supplier’s institution. The document protects the supplier from violations of confidentiality. NIAID personnel will work with the supplier on assessing the needs vs. available resources. Once a NCEA is executed, NIAID personnel will send a Compound Submission Form (CSF) template via email. The supplier will complete the CSF and return to NIAID via email. NIAID will evaluate the CSF and send a follow-up via email containing the approval status and a PDF of the CSF attached.

Once an approved CSF is received, the supplier can start working with their assigned AACF contact and AACF repository personnel (provided by Southern Research Institute). Every supplier is assigned an AACF contact and a supplier identification number. All correspondence should go through the AACF contact and the supplier ID number used for identification.  Compounds should be submitted through the AACF contact with the approved CSF. The compounds will then be evaluated based on criteria such as structural novelty and similarity to known, active antiviral agents as well as the rationale for submission, program priorities, and budgeted capacities in the antiviral screens requested.  As a general policy, the program is searching for novel therapeutic agents and compounds should be submitted to enter in vitro assays with follow-up in vivo screening, if appropriate activity criteria are met.  If a compound is not expected to be active in vitro (e.g. immunomodulators), the supplier may request direct in vivo screening with all appropriate supporting information.


Official Submission Procedures

  1. If you are interested in participating in the NIAID Antiviral Screening Program, please complete the Antiviral Non Clinical Evaluation Agreement (NCEA) Request Form and return to via email Dr. Christopher Tseng, the NIAID Project Officer for the program, at ctseng@niaid.nih.gov. The NCEA must be properly executed prior to participating in the program.
  1. During the NCEA process, Dr. Christopher Tseng will discuss with the supplier their sample needs and screening offered.
  1. After the NCEA is executed, NIAID personnel will send a Compound Submission Form (CSF) template to be filled out by the supplier and returned via email to the NIAID for approval.
  1. NIAID will follow-up with an email notification listing the approval status and PDF attachment of the approved CSF. In the email notification, it will list the AACF contact who will provide the next steps for sample submission.
  1. Upon receiving an approved CSF from the NIAID, the Supplier’s AACF contact in consultation with other AACF medicinal chemists and the NIAID committees established to evaluate priorities for antiviral screening will ensure that candidate compounds are appropriate for screening in the assays requested and have not been previously submitted, and will then relay to the Supplier, compounds that are acceptable for submission.
  1. The supplier will receive information for how much is needed per sample/aliquot, where to send the samples and ARB number assignment for all compounds on approved CSF via email from the AACF contact / AACF repository. The supplier should submit samples of each compound to be screened in vials, preferably of 1 dram size with screw caps; vials will be provided to Supplier, if requested.  All shipments should contains vials clearly labeled with a Supplier compound identification number or code, assigned ARB number and accompanied by the appropriate CSF. Help in compound submission (e.g., assistance in weighing/packaging samples, shipping expenses) may be available upon request. Only compounds with approved Compound Submission Forms should be sent into the AACF repository.
  1. The AACF repository will acknowledge receipt of compounds, schedule them for testing, and report data to Supplier as received from the screening facility.

 

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