Natural Products Branch Active Repository Program

The Active Repository Program has been established to enable qualified investigators in the U. S. extramural community to investigate materials that, since January 1996, have been judged by the Natural Products Branch to be active in the 60 cell line anti-tumor screen.

Qualifications for access to the Active Repository

• U. S. based investigators who have been peer-reviewed by suitable bodies (e.g., U. S. Government funding agencies, the American Cancer Society and other comparable U. S. funding organizations). Such investigators will have to submit details of their current grant number(s).
• U. S. chartered organizations that have not been peer-reviewed. Such organizations will have to submit short proposals for review as discussed under "Requests for Access" in the section on the Open Repository Program.
• Organizations based in Countries of Origin that have participated in NCI collection programs. Such organizations will only have access to extracts of organisms collected in their own countries.

All investigators and organizations requesting access to the Active Repository Program will be required to provide the following information:

1. A brief description of their assays and their relevance to cancer.
2. The number of chemists available for bioassay-guided isolation studies.
3. The types of extracts desired for testing (one or more of marine or terrestrial plants or marine invertebrates).

Distribution of Materials from the Active Repository

• Upon signing of the special terms of the Material Transfer Agreement (to which this policy statement is attached), NPB will provide investigators with electronic media containing details of all materials available (full taxonomy and anti-cancer screening data sets composed of single- and multi-dose tests, together with mean graphs).
• Investigators may choose up to 20 samples for further study.
• 10 mg of each selected sample will be provided for investigators to determine if their assays will detect the activities.

Plated Samples: Investigators receiving plated samples through the Open Repository Program may identify extracts restricted to the Active Repository Program. Such extracts may be made available to the investigators providing they qualify for access to the Active Repository, and subject to the 20 sample restriction mentioned above.

Upon identification of active extracts, investigators will communicate with NPB directly by e-mail of fax, and will be informed whether or not the active materials are available.

Investigators will have active samples reserved for further investigation on a first-come first-serve basis. Where more than one investigator observes activity for a particular extract, it will be reserved for the first investigator to report activity, and a waiting list of other interested investigators will be established.

• A three month exclusivity period will be granted from the date of receipt of the samples during which time the investigators will inform NPB whether their assays are effective.
• Materials for further investigation may be obtained as follows:
  • Grantees, non-profit organizations and small businesses (SBIR criteria): NPB will provide further materials in negotiated amounts.
  • For-profit organizations not qualifying as small businesses under SBIR regulations will be responsible for the acquisition of further material, working in collaboration with the original collector (if possible), and the Country of Origin as stipulated in Article 9 of the MTA.
• A further exclusivity period of one year from the time of receipt of the second amount of material will be given to perform bioassay-guided isolation of the active agents. If necessary, under special circumstances, this period may be extended after review of progress by NPB and the investigator.
• The 20 samples are on a rotating basis. When samples are reclassified as dropped, or the active agents identified, the remaining samples will be returned to NPB within five working days of reclassification.
• For each sample reclassified, one new sample may be requested. No more than 20 samples from the Active Repository Program may be held at one time.
• NCI will be kept informed of the progress of the investigations, and will help in the development of any agents meeting the approval criteria of DCTD decision making committees.
• Since it is the responsibility of the NCI to see that the conditions of the MTA are maintained during this and subsequent stages of development, NPB will maintain interaction with the investigators and the relevant Countries of Origin.
• If requested, the Countries of Origin will be given the name of the recipient organization, and will be informed that the organization will contact them if further material is required. Acquisition of further material will normally be the responsibility of the recipient organization working through the original collector (if possible) and the relevant Source Country permitting agency.

The test results, isolated chemical structures, published manuscripts and requests for additional samples of active extracts are submitted to:

Request contact:

Carol Haggerty
Natural Products Branch
Developmental Therapeutics Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Riverside Five, Suite 400, Room 4101
P. O. Box B
Frederick, MD, 21702
+1.301.624.1269 (Voice)
+1.301.631.3026 (Facsimile)
Email: NCINatProdRep@mail.nih.gov

Requests must be copied to:

Barry R. O’Keefe, Ph.D.
Chief, Natural Products Branch,
Developmental Therapeutics Program
Division of Cancer Treatment and Diagnosis
NCI
Bldg. 562, Rm. 201 Frederick, MD 21702
Tel: (301)-846-5332
Fax: (301)-846-6872
okeefeba@mail.nih.gov

Further technical information may be obtained from:

Barry R. O’Keefe, Ph.D.
Chief, Natural Products Branch,
Developmental Therapeutics Program
Division of Cancer Treatment and Diagnosis
NCI
Bldg. 562, Rm. 201 Frederick, MD 21702
Tel: (301)-846-5332
Fax: (301)-846-6872
okeefeba@mail.nih.gov