[Federal Register Volume 65, Number 56 (Wednesday, March 22, 2000)]
[Notices]
[Pages 15347-15348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Steroid Derivatives with Paclitaxel-
Like Activity

    An opportunity is available for a Cooperative Research and 
Development Agreement (CRADA) for the purpose of collaborating with the 
Screening Technology Branch, National Cancer Institute (STB, NCI) on 
further research and development of U.S. government-owned technology 
encompassed within U.S. Provisional Patent Application Serial No. 60/
161,533, entitled ``B-Homoestra-1,3,5(10)-trienes as Modulators of 
Tubulin Polymerization.''

AGENCY: National Cancer Institute, National Institutes of Health, PHS, 
DHHS.

ACTION: Notice of opportunity for cooperative research and development 
(CRADA).

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710; and 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 a Cooperative Research and Development 
Agreement (CRADA) with a pharmaceutical or biotechnology company to 
develop new drugs and therapeutic methods based on screening pre-
existing steroid libraries from the collaborator for paclitaxel-like 
activities and/or screening steroid derivatives from a directed 
synthetic effort by the collaborator to produce more active paclitaxel-
like compounds. The CRADA would have an expected duration of one (1) to 
five (5) years. The goals of the CRADA include the rapid publication of 
research results and timely commercialization of products or methods of 
treatment that may result from the research. The CRADA Collaborator 
will have an option to negotiate the terms of an exclusive or non-
exclusive commercialization license to subject inventions arising under 
the CRADA and which are subject of the CRADA Research Plan, and can 
apply for background licenses to the existing patent described above, 
subject to any pre-existing licenses already issued for other fields of 
use. Dr. Mark Cushman of Purdue University is a co-inventor on the U.S. 
Provisional Patent Application Serial No. 60/161,533, entitled ``B-
Homoestra-1,3,5(10)-trienes as Modulators of Tubulin Polymerization.'' 
Therefore, it is anticipated that negotiations with Purdue University 
regarding their interest in the original patent application would be 
required if the potential CRADA collaborator required exclusive rights 
to the technology encompassed by this patent.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Bjarne Gabrielsen, Technology Development & 
Commercialization Branch, National Cancer Institute-Frederick Cancer 
Research & Development Center, Fairview Center, Room 502, Frederick, MD 
21701 (phone: 301-846-5465, fax: 301-846-6820).
    Scientific inquiries should be directed to Dr. Ernest Hamel, Senior 
Investigator, Screening Technology Branch, National Cancer Institute-
Frederick Cancer Research & Development Center, Bldg. 469, Rm. 237, 
Frederick, MD 21702-1201 [phone: (301)-846-1678; fax: (301)-846-6014]; 
e-mail: [email protected]

EFFECTIVE DATE: Inquiries regarding CRADA proposals and scientific 
matters may be forwarded at any time. Confidential preliminary CRADA 
proposals, preferably two pages or less, must be submitted to the NCI 
on or before June 20, 2000. Guidelines for preparing final CRADA 
proposals will be communicated shortly thereafter to all respondents 
with whom initial confidential discussions will have established 
sufficient mutual interest.

SUPPLEMENTARY INFORMATION:

Technology Available

    DHHS scientists within the STB, NCI, in a collaboration with the 
laboratory of Dr. Mark Cushman, Purdue University, relating to steroid 
molecules that interact with tubulin, have discovered a subgroup of 
steroid derivatives that have paclitaxel-like effects on tubulin. 
Instead of inhibiting tubulin assembly, the new class induces formation 
of hyperstable microtubules and hypernucleates tubulin assembly. 
However, the most active molecules so far discovered are considerably 
less active than paclitaxel and have limited cytotoxicity. Details are 
in U.S. Provisional Patent Application Serial No. 60/161,533 available 
under an appropriate Confidential Disclosure Agreement.

Technology Sought

    Accordingly, DHHS now seeks collaborative arrangements for the 
screening, joint elucidation, evaluation and development of novel 
compounds and methods to produce more active paclitaxel-like compounds. 
For collaboration with the commercial sector, a Cooperative Research 
and Development Agreement (CRADA) will be established to provide for 
equitable distribution of intellectual property rights developed under 
the CRADA. CRADA aims will include rapid publication of research 
results as well as full and timely exploitation of any commercial 
opportunities.

NCI and Collaborator Responsibilities

    The role of the laboratory of Dr. Hamel, STB, NCI in this CRADA 
will include, but not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Undertake evaluation of compounds in their interactions with 
purified tubulin and examination of effects of promising compounds on 
cell growth and morphology. It is anticipated that such screening 
efforts would also reveal compounds that inhibit tubulin assembly and 
that have significant inhibitory effects on angiogenesis.
    3. Planning research studies and interpreting research results.
    4. 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 such as lead 
optimization, organic synthetic efforts directed toward new analogs, 
derivatives.
    2. Planning research studies and interpreting research results.
    3. Providing technical expertise and/or financial support for 
CRADA-related research as outlined in the CRADA Research Plan.
    4. Publishing research results.

[[Page 15348]]

    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 on-going 
research and development.
    2. Expertise and experience in the following areas: preclinical 
research and drug development of steroidal, paclitaxel-like compounds; 
ability to perform appropriate chemical synthetic efforts to support 
structure/activity (SAR) studies, lead-optimization, drug candidate 
selection and development.
    3. The demonstration of adequate resources to perform the research, 
development and commercialization 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.
    4. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology.
    5. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    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 equitable 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 non-exclusive license to the CRADA 
Collaborator when the Government employee is the sole inventor.

    Dated: March 7, 2000.
Kathleen Sybert,
Chief, Technology Development & Commercialization Branch, National 
Cancer Institute, National Institutes of Health.
[FR Doc. 00-7051 Filed 3-21-00; 8:45 am]
BILLING CODE 4140-01-P