Federal Register announcement, spring 1996

National Institutes of Health

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

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.

ADDRESS: 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.

DATE: 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
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
utilitize 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

8. The aggressiveness of the development plan, including the
appropriateness of milestones and deadlines for preclinical and clinical

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).

Source: 60 FR 20279
(Published in Federal Register 4/25/95)