[Federal Register Volume 60, Number 79 (Tuesday, April 25, 1995)]
[Notices]
[Pages 20279-20280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10108]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Cancer Institute: Opportunity for a Cooperative Research 
and Development Agreement (``CRADA'') for the Scientific and Commercial 
Development of Certain Signal Transduction Inhibitors as Anticancer 
Agents

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

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SUMMARY: The Department of Health and Human Services (DHHS) seeks a 
pharmaceutical company which can effectively pursue the preclinical 
development and possible eventual clinical development of a family of 
agents which inhibit the signal transduction pathways required for the 
growth and metastasis of cancer cells. The National Cancer Institute 
has preclinical data suggesting that these agents may have potential 
for the treatment and/or prevention of cancer. The selected sponsor 
will be awarded a CRADA for the co-development of these agents in a 
specified field of use to be determined upon mutual agreement of the 
parties.

ADDRESSES: Questions about this opportunity may be addressed to Mark W. 
Noel, Office of Technology Development, NCI, Building 31/Room 4A51, 
9000 Rockville Pike, Bethesda, Maryland 20892, (301) 496-0477, 
facsimile (301) 402-2117, from whom further information including a 
summary copy of the preclinical data may be obtained.

DATES: In view of the important priority of developing new drugs for 
the treatment or prevention of cancer, interested parties should notify 
this office in writing no later than June 26, 1995. Respondents will 
then be provided an additional 60 days for the filing of formal 
proposals.

SUPPLEMENTARY INFORMATION: ``Cooperative Research and Development 
Agreement'' or ``CRADA'' means the anticipated joint agreement to be 
entered into by NCI pursuant to the Federal Technology Transfer Act of 
1986 and Executive Order 12591 of October 10, 1987 to collaborate on 
the specific research project described below.
    The Government is seeking a pharmaceutical company which, in 
accordance with the requirements of the regulations governing the 
transfer of Government-developed agents (37 CFR 404.8), can develop the 
subject agents to a marketable status to meet the needs of the public 
and with the best terms for the Government. These agents are a novel, 
chemically-defined family of agents being investigated in the 
Laboratory of Pathology of the Division of Cancer Biology, Diagnosis 
and Centers, National Cancer Institute. These agents have been 
demonstrated to inhibit the signal transduction pathways required for 
the growth and metastasis of cancer cells and have shown promising 
antitumor activity in preclinical investigations. The majority of the 
agents which are the subject of the CRADA opportunity are the subject 
of patent U.S. Patent 5,359,078 which is assigned to the Dept. of 
Health and Human Services. A method for the detection and quantitation 
of the levels of these agents in blood is claimed in U.S. Patent 
5,405,782 which is also assigned to the Dept. of Health and Human 
Services. The Cooperative Research and Development Agreement 
(``CRADA'') will allow a pharmaceutical company to provide resources, 
in collaboration with the NCI, for the continuing preclinical 
development and possibly the clinical development for this group of 
agents.
    The government will provide all relevant available expertise and 
information to date and will, jointly pursue further preclinical 
development of these agents with the chosen Collaborator. Relevant 
background patent rights are available for licensing to the 
Collaborator.
    The successful pharmaceutical company will provide the necessary 
quantities of the agents plus the necessary technical expertise, 
financial and organizational support to complete further development of 
these agents to establish their efficacy and possible commercial 
status.
    The expected duration of the CRADA will be three (3) to five (5) 
years.
    The role of the National Cancer Institute, includes the following:
    1. The government will continue preclinical development of the 
agents as [[Page 20280]] signal transduction inhibitors in vitro and in 
vivo. Data from these studies will be provided to the Collaborator and 
evaluated jointly.
    2. The government will provide data for the production of the 
subject agents. The successful pharmaceutical company will be allowed 
exclusive access to this resource.
    3. As appropriate, agents showing promise in preclinical studies 
may proceed to collaborative clinical development under NCI's clinical 
trials network, as mutually agreed upon by both parties and subject to 
appropriate amendment of this CRADA or alternatively by negotiation and 
execution of a Clinical Trials CRADA. The Clinical Trial CRADA is a 
modification of the standard NIH Model Agreement wherein additional 
language has been drafted to enable the Collaborator to access and 
utilize clinical trial data.
    4. Relevant Government patent rights are available for licensing 
through the Office of Technology Transfer, National Institutes of 
Health. For further information contact Jack Spiegel, Office of 
Technology Transfer, National Institutes of Health, Box OTT, Bethesda, 
MD 20892; (301) 496-7735; Facsimile (301) 402-0220.
    The role of the successful pharmaceutical company under the CRADA 
will include the following:
    1. Provide plans to independently secure future continuing supplies 
of the selected agents for their continued preclinical development. The 
collaborator will also supply sufficient quantities of GMP produced and 
formulated material for the selected agents which, upon mutual consent 
of the parties, proceed to collaborative clinical development.
    2. Provide scientific development strategy and financial and other 
support for the collaborative preclinical development of the selected 
agents.
    Criteria for choosing the pharmaceutical company include its 
demonstrated experience and commitment to the following:
    1. Experience in preclinical and clinical drug development.
    2. Experience and ability to produce, package, market and 
distribute pharmaceutical products.
    3. Experience in the monitoring, evaluation and interpretation of 
the data from preclinical studies and investigational agent clinical 
studies under an Investigational New Drug Application (IND).
    4. A willingness to cooperate with the NCI in the collection, 
evaluation, publication and maintaining of data from preclinical 
investigations and clinical trials, as appropriate, of investigational 
agent(s).
    5. The ability to provide adequate quantities of the subject agents 
for their continued preclinical investigation and ability, as 
appropriate to provide adequate quantities of GMP produced and 
formulated material as needed for clinical development of one or more 
of these agents, as mutually agreed by the parties.
    6. Provide defined financial and personnel support for the 
preclinical studies and clinical trials (as appropriate) to be mutually 
agreed upon.
    7. An agreement to be bound by the DHHS rules involving human and 
animal subjects.
    8. The aggressiveness of the development plan, including the 
appropriateness of milestones and deadlines for preclinical and 
clinical development.
    9. Provisions for equitable distribution of patent rights to any 
inventions. Generally the rights of ownership are retained by the 
organization which is the employer of the inventor, with (1) an 
irrevocable, nonexclusive, royalty-free license to the Government (when 
a company employee(s) is (are) the sole inventor(s)) or (2) an option 
to negotiate an exclusive or nonexclusive license to the company on 
terms that are appropriate (when the Government employee(s) is (are) 
the sole inventor(s) or where a joint invention arises).

    Dated: April 13, 1995.
Thomas D. Mays,
Director, Office of Technology Development, OD, NCI.
[FR Doc. 95-10108 Filed 4-24-95; 8:45 am]
BILLING CODE 4140-01-P