[Federal Register Volume 64, Number 229 (Tuesday, November 30, 1999)]
[Notices]
[Pages 66921-66923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Antitumor and Antimicrobial Lead--
Discovery and Development From Natural Products

    Opportunities for Cooperative Research and Development Agreements 
(CRADAs) are available for collaborations with the NCI intramural 
Laboratory of Drug Discovery Research and Development (LDDRD) to 
discover and identify novel antitumor and antimicrobial leads from 
natural products. Collaborative projects will focus upon cancer and/or 
areas of infectious diseases of high public health significance and 
high national and international priority.

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

ACTION: Notice of opportunities for Cooperative Research and 
Development Agreements (CRADAs).

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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 one or more Cooperative Research and 
Development Agreements (CRADAs) with pharmaceutical or biotechnology 
companies to discover and develop new potential antitumor and/or 
antimicrobial drug leads from natural products. 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, methods of treatment or prevention 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.

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,

[[Page 66922]]

MD 21701 (phone: 301-846-5465, fax: 301-846-6820).
    Scientific inquires should be submitted to Dr. Michael R. Boyd, 
Chief, Laboratory of Drug Discovery Research & Development, National 
Cancer Institute--Frederick Cancer Research & Development Center, Bldg. 
1052, Rm 121, Frederick MD, 21702-1201 (phone: 301-846-5391; Fax: 301-
846-6919; 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 January 31, 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:

    The LDDRD is an NCI intramural research laboratory dedicated to the 
discovery of new potential lead molecules for antitumor and/or 
antimicrobial drug development. Some general background and contact 
information for the LDDRD are available on the Internet at http://
dtp.nci.nih.gov/docs/branches/lddrd/lddrd__ home.html.
    The primary starting materials for LDDRD's discovery research 
principally comprise the remarkable library of natural product extracts 
residing in the NCI Natural Products Repository (NPR).
    The NPR contains the largest and most diverse natural products 
extracts collection in the world, derived during the past 15 years from 
an NCI contracts-based collections consortium led by renowned 
botanical, marine science and microbial research professionals and 
organizations globally. Most of these collections have been performed 
subject to legally-binding agreements between the NCI and relevant 
Source Country organizations or government agencies which commit the 
NCI to terms of collaboration and compensation in the event of 
discovery of a compound which meets the criteria for drug development. 
Even in instances where no agreement has been signed, the NCI still 
considers itself bound to the same policies of collaboration and 
compensation. Therefore, CRADA partners will be subject to similar 
requirements to those governing the NCI. (Further information may be 
obtained from the NCI--Developmental Therapeutics Program website, 
http://dtp.nci.nih.gov).
    The LDDRD also engages in selected lead-discovery collaborations 
based upon natural product extracts originating directly from specific 
collaborating researchers or organizations rather than from the NCI-
NPR. In such cases, collaborative projects are undertaken based both 
upon unique and mutual scientific and drug discovery and development 
interests, expertise and resources of the collaborating parties.
    LDDRD's principal lead-discovery strategy employs bioassay-guided 
fractionation, isolation, purification and structural elucidation of 
bioactive molecules. The sought-for bioactivity is defined by the 
specific type(s) of assay and/or target(s) employed in the primary 
screen(s) used for bioassay support of the process.
    The LDDRD comprises an interdisciplinary research team, and 
appropriate resources, expertise and experience, to carry out all 
essential aspects of natural products lead-discovery, including high-
throughput screening, cell-based bioassays, chemical isolation, 
purification and structural determinations.

Technology Sought

    LDDRD now seeks potential collaborators with expertise or resources 
in several areas including but not limited to: novel screening 
technologies, bioassays, reagents or targets; synthetic chemistry 
capabilities pertinent to the specific collaboration; novel or 
distinctive extract and/or compound collections; preclinical and/or 
clinical drug research and development expertise and experience; proven 
track record in moving preclinical lead-discoveries through lead-
optimization, drug candidate selection, preclinical and clinical 
development, regulatory approvals, and commercialization.

Collaborators Sought:

    Accordingly, DHHS now seeks collaborative arrangements for the 
joint LDDRD and collaborator discovery research and development of 
novel, natural product lead-derived, clinically useful, antitumor and/
or antimicrobial drugs of high public health priority. For 
collaborations 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.
    As a minimum, the successful Collaborator should either possess 
broad experience in most if not all of the following areas; or possess 
highly specialized, unique expertise in one or more of the following 
areas, as particularly pertinent to natural products lead-discovery and 
development: (a) Preclinical and clinical drug development; (b) ability 
to carry out or direct chemical synthetic studies supporting lead-
optimization, drug candidate selection and development; (c) application 
of automation and robotics technologies to antitumor and/or 
antimicrobial high-throughput screening (HTS) assays; (d) experience 
with other pertinent enzyme-based, biochemical, cellular in vitro and/
or in vivo assays; (e) application of database and bioinformatics 
technologies for the manipulation, storage and analysis of high-
throughput assay data, including the development of software as 
required; (f) the use of high-throughput assay methods to support 
antitumor and/or antimicrobial lead-discovery from natural products; 
(g) elucidation and validation of novel antitumor and/or antimicrobial 
molecular targets; and, (h) specific experience in development and 
applications of lead-discovery HTS assays addressing novel antitumor 
and/or antimicrobial molecular targets.

NCI and Collaborator Responsibilities

    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 isolated lead-molecules for 
evaluation.
    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.
    2. Providing essential research materials, such as extracts, 
enzymes or other reagents, compounds, hardware or software.
    3. Planning research studies and interpreting research results,
    4. Providing technical expertise and/or financial support (e.g. 
facilities, personnel and expertise) for CRADA-related research as 
outlined in the CRADA Research Plan.
    5. 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 research and development 
of this technology involving lead discovery/optimization and biological 
evaluation.

[[Page 66923]]

This ability can be demonstrated through experience, expertise, and the 
ability to contribute intellectually in this or related areas of drug 
developmental research and development.
    2. The demonstration of adequate resources to perform the research, 
development and commercialization of this lead discovery/optimization 
and biological evaluation 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, development and commercialization of this technology 
as defined above.
    4. The demonstration of expertise in the commercial development, 
production, marketing and sales of antitumor and/or antimicrobial 
natural products.
    5. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    6. 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.
    7. 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: November 19, 1999.
Kathleen Sybert,
Chief, Technology Development & Commercialization Branch, National 
Cancer Institute, National Institutes of Health.
[FR Doc. 99-30996 Filed 11-29-99; 8:45 am]
BILLING CODE 4140-01-P