Submission Of Pure Compounds For Testing In The NCI Screens
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The Developmental Therapeutics Program (DTP) operates a tiered anti-cancer compound screening program for the benefit of the general research community with the goal of identifying novel chemical leads and biological mechanisms. The program, which includes the NCI 60-Cell Line Screen and operates at no cost to suppliers of compounds, encourages the submission of synthetic compounds and purified natural products from academic, public and private sources worldwide. Select non-viral biological agents may also be considered for screening by special request (see below). Compounds are accepted for initial 60 cell line screening after review by NCI staff based on defined guidelines. Suppliers generally retain intellectual property rights to their compounds and biological screening data. Compounds can be submitted under the terms of a Confidentiality Agreement with the NCI, which assures that the compound structures and resulting screening data are not publicly disclosed without supplier authorization within the terms of the agreement.
Note: Submission, tracking, storage and distribution of synthetic compounds and purified natural products are administered by the Drug Synthesis and Chemistry Branch .
- Non-viral biological agents are reviewed by individual request by contacting Dr. Raj N. Misra at the Drug Synthesis and Chemistry Branch. Investigators should review the NCI60 assay methodology to confirm that the methods are compatible with evaluation of their agent prior to submitting a request.
- Viral biologics and nanoparticle formulations are not accepted into the program.
- Natural products extracts are reviewed by individual request by contacting the Natural Products Branch.
Registration Test Request Structure Selection Compound Submission
Suppliers are required to complete a one-time registration through the DTP Compound Submission Application web page prior to requesting screening. During registration, suppliers will create a User ID and password. Requests for screening of a compound are executed through the same secure DTP Compound Submission Application web page used for registration. Once registered, suppliers should log in and access the DTP on-line submission form by clicking on "Add New Compound for NCI 60 Screening". The structures of compounds requested for screening are submitted through the on-line submission form. Only the chemical structure and molecular formula are required, additional information is optional. Structures are then selected or declined for testing after review by DTP staff based on defined guidelines. If compounds are of particular interest based on a biological and/or structural rationale or the activity of similar analogs, it is recommended that a brief explanation be entered in the appropriate field with the initial structure submission to strengthen the case for selection. After the DTP selection process is complete, the supplier will receive e-mail notification of a decision and if selected, instructions for mailing the physical sample(s) to the NCI Repository. Suppliers should not send in any samples until instructed. The sample size requirement is 10-15 mg, but for relatively inaccessible natural products, 5 mg is acceptable.
Requests for the testing of small molecules, natural products and small peptides are no longer accepted by letter or electronic mail and must be executed through the on-line submission process as described above. For the testing of biologics, such as, antibodies, gene therapeutics, large peptides, proteins, oligos and vaccines, where the on-line submission form does not support entry of the structure, the request, including the structure (required) and other relevant information should be submitted directly to the Drug Synthesis & Chemistry Branch by e-mail, fax or ordinary postal letter.
Screening and Data Retrieval
After compounds are received at the NCI Repository, they are assigned an identifying NSC number, inventoried and placed into the screening queue. All subsequent communications regarding a compound should include its NSC number. When complete, screening results together with information on any DTP recommendations for further evaluation of compounds can be retrieved by logging into the secure DTP Compound Submission Application and clicking on "View Tests" at the bottom of the page. The Biological Evaluation Committee (BEC), comprised of DTP staff, reviews data for compounds, and may select compounds for additional studies. The BEC review is based upon a number of criteria including compound "drugability," novelty of structure and mechanism of action, potency and cell panel selectivity. The supplier will be contacted for additional compound supply and/or information if the BEC recommends further testing.
Submission Process Flow Chart
A summary of the overall registration, submission and data retrieval process can be viewed as a printable Flow Chart .
Drug Synthesis & Chemistry Branch
National Cancer Institute
Executive Plaza North, Suite 8029
6130 Executive Boulevard MSC 7448
Bethesda, MD 20892-7448