[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