[Federal Register Volume 62, Number 175 (Wednesday, September 10, 1997)]
[Notices]
[Pages 47672-47673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23901]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute: Opportunities for Cooperative Research 
and Development Agreements (CRADAs) for the Development of New Targeted 
Drugs, Made Partly of Entities Provided by the National Cancer 
Institute (NCI), as Treatments for Patients With Cancer

    The NCI is looking for multiple CRADA Collaborators to develop 
independently different aspects of their targeted drug technology with 
the goal of moving candidates into clinical trials.

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice of opportunities for cooperative research and 
development.

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710; Executive Order 12591 of April 10, 1987 as amended by 
the National Technology Transfer and Advancement Act of 1995), the 
National Cancer Institute (NCI) of the National Institutes of Health 
(NIH) of the Public Health Service (PHS) of the Department of Health 
and Human Services (DHHS) seeks Cooperative Research and Development 
Agreements (CRADAs) with pharmaceutical or biotechnology companies or 
academic institutions to create, optimize and test new targeted drugs 
as therapeutics for cancer.
    Any CRADA for the biomedical use of this technology will be 
considered. The CRADAs would have an expected duration of one (1) to 
five (5) years. The goals of the CRADAs include the rapid publication 
of research results and timely commercialization of products, 
diagnostics and treatments that result from the research. The CRADA 
Collaborators will have an option to negotiate the terms of an 
exclusive or nonexclusive commercialization license to subject 
inventions arising under the CRADAs.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Thomas M. Stackhouse, Office of Technology 
Development, National Cancer Institute-Frederick Cancer Research and 
Development Center, P.O. Box B, Frederick, MD 21702-1201, Telephone: 
(301) 846-5465, Facsimile: (301) 846-6820.

EFFECTIVE DATE: Organizations must submit a confidential proposal 
summary preferably one page or less, to NCI within 90 days from date of 
this publication. Guidelines for preparing full CRADA proposals will be

[[Page 47673]]

communicated shortly thereafter to all respondents with whom initial 
confidential discussions will have established sufficient mutual 
interest.

SUPPLEMENTARY INFORMATION:

Technology Available

    DHHS scientists are developing a variety of novel targeted drugs 
defined as a conjugated molecule consisting of a specific binding 
moiety, such as a monoclonal antibody, a receptor ligand or a similar 
construct, and a natural product or synthetic cytotoxic moiety which 
may include, but not be limited to the broad category of toxins and 
drugs. The specific binding and cytotoxic moieties would be joined by 
appropriate linker molecules. The NCI can provide a variety of natural 
product cytotoxic drugs either in the unaltered state or chemically-
modified (to facilitate conjugation) as starting substances for the 
creation of new targeted drug agents. In addition, a limited number of 
monoclonal antibodies which can be used in this drug development effort 
are available from the NCI. The NCI can also provide the chemical 
expertise to modify agents, as well as the resources to test newly 
constructed agents in an in vitro cell line screen. Publications 
outlining these developments are available on request, and descriptions 
of other (unpublished) advances can be obtained from Dr. Stackhouse via 
a Confidential Disclosure Agreement.
    DHHS now seeks collaborative arrangements for the creation, 
optimization, evaluation and possible clinical exploitation of these 
agents. A Cooperative Research and Development Agreement (CRADA) will 
be established to provide for distribution of intellectual property 
rights developed under the Agreement. The successful CRADA collaborator 
will provide expertise and experience in the preparation of targeted 
drugs, and will prepare one or more targeted drug candidates using 
starting substances provided jointly by the NCI and the CRADA 
collaborator. For targeted drug candidates selected for clinical 
trials, the Collaborator will also provide the necessary resources and 
expertise to perform tests to determine the drug candidate's 
physicochemical makeup, biological activity, stability and other 
characteristics necessary for filing an Investigational New Drug (IND) 
application with the FDA. The NCI will provide starting substances as 
well as consultation and expertise on drug preparation and development. 
Also, the NCI may elect to provide resources for preclinical and/or 
clinical evaluation, subject to future review and approval. CRADA aims 
will include rapid publication of research results as well as timely 
clinical evaluation and exploitation of any commercial opportunities.
    The role of the National Cancer Institute in this CRADA will 
include, but not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Providing the Collaborator with samples of the subject compounds 
to create, optimize, test and develop targeted drugs for clinical 
studies .
    3. Planning research studies and interpreting research results.
    4. Additional support for preclinical and/or clinical development 
of the targeted drug candidate(s) derived from this CRADA. Commitment 
of substantial resources would require specific review and approval by 
the Decision Network Committee of the NCI's Division of Cancer 
Treatment, Diagnosis, and Centers (DCTDC). These resources may include:
    (A) In vitro testing in the DCTDC cell line screen.
    (B) Assistance with design and conduct of preclinical in vivo 
efficacy experiments.
    (C) Toxicology experiments.
    (D) Provision of additional starting materials for use by the 
Collaborator in preparing final targeted drug product.
    (E) IND filing and sponsorship of clinical trials.
    5. Publishing research results.
    The role of the CRADA Collaborator may include, but not be limited 
to:
    1. Providing significant intellectual, scientific, and technical 
expertise or experience to the research project.
    2. Planning research studies and interpreting research results.
    3. Providing samples of the subject compounds to create, optimize, 
test and develop targeted drugs for clinical studies.
    4. Providing technical and/or financial support to facilitate 
scientific goals and for further design of applications of the 
technology outlined in the agreement.
    5. Production, by current Good Manufacturing Practices (cGMP), 
purification, vialing, product release, and post-release testing of 
targeted drug candidates for clinical trials.
    6. Publishing research results.
    Selection criteria for choosing the CRADA Collaborator may include, 
but not be limited to:
    1. The ability to collaborate with NCI on further research and 
development of this technology. This ability can be demonstrated 
through experience and expertise in this or related areas of technology 
indicating the ability to contribute intellectually to ongoing research 
and development.
    2. The demonstration of adequate resources to perform the research 
and development of this technology (e.g. facilities, personnel and 
expertise) and accomplish objectives according to an appropriate 
timetable to be outlined in the CRADA Collaborator's proposal.
    3. The willingness to commit best effort and demonstrated resources 
to the research and development of this technology, as outlined in the 
CRADA Collaborator's proposal.
    4. The demonstration of expertise in the commercial development and 
production of products related to this area of technology.
    5. The level of financial support the CRADA Collaborator will 
provide for CRADA-related Government activities.
    6. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    7. The agreement to be bound by the appropriate DHHS regulations 
relating to human subjects, and all PHS policies relating to the use 
and care of laboratory animals.
    8. The willingness to accept the legal provisions and language of 
the CRADA with only minor modifications, if any. These provisions 
govern the distribution of patent rights to CRADA inventions. 
Generally, the rights of ownership are retained by the organization 
that is the employer of the inventor, with (1) the grant of a license 
for research and other Government purposes to the Government when the 
CRADA Collaborator's employee is the sole inventor, or (2) the grant of 
an option to elect an exclusive or nonexclusive license to the CRADA 
Collaborator when the Government employee is the sole inventor.

    Dated: August 25, 1997.
Kathleen Sybert,
Acting Director, Office of Technology Development, National Cancer 
Institute, National Institutes of Health.
[FR Doc. 97-23901 Filed 9-9-97; 8:45 am]
BILLING CODE 4140-01-P