[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
