[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