[Federal Register Volume 66, Number 141 (Monday, July 23, 2001)]
[Notices]
[Pages 38294-38295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18281]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute (NCI); Development of Therapeutic 
Antibodies and Vaccines From Tumor Associated Antigens in Human 
Lymphoma

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

ACTION: Notice of an opportunity for Cooperative Research and 
Development Agreement (CRADA).

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    An opportunity for a Cooperative Research and Development Agreement 
(CRADA) is available for collaboration with the NCI intramural Center 
for Cancer Research (CCR) to develop therapeutic antibodies and 
vaccines from novel tumor associated antigens in human lymphoma. This 
collaboration specifically excludes idiotype as the lymphoma antigen. 
Collaborative projects will focus upon cancer and/or areas of high 
public health significance and high national and international 
priority.

SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710 as amended; and Executive Order 12591 of April 10, 1987, 
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 Cooperative Research and 
Development Agreement (CRADA) with a pharmaceutical or biotechnology 
company to develop therapeutic antibodies and vaccines from tumor 
associated antigens in human lymphoma. 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, and/or 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 the 
subject of the CRADA Research Plan.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Jeffrey W. Thomas, Ph.D., Technology Transfer Branch, 
National Cancer Institute, Fairview Center, Room 502, Frederick, MD 
21701 (phone: 301-846-5465; fax: 301-846-6820; email: 
[email protected]). Scientific inquires should be submitted to 
Larry W. Kwak, M.D., Ph.D., CCR, National Cancer Institute, Bldg. 567, 
Room 205, Frederick MD, 21702-1201 (phone: 301-846-1607; Fax: 301-846-
6107; 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 August 22, 2001. 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. CRADA proposals may be accepted after the 
initial 30 day period if a CRADA Collaborator is not identified from 
the initial pool of respondents.

SUPPLEMENTARY INFORMATION:

Technology Available

    The intramural CCR NCI is seeking a collaborative partner to 
develop therapeutic antibodies and vaccines from novel tumor associated 
antigens (TAAs) in human lymphoma. Identification of novel TAA proteins 
differentially expressed in human lymphoma samples may be useful 
targets for the development of such therapeutic antibodies and 
vaccines. This collaboration specifically excludes idiotype as the 
lymphoma antigen. The CCR has experience with collection and 
characterization of primary human lymphomas, understanding of basic 
lymphoma immunobiology, and unique reagents generated from patients who 
have undergone immunotherapy. As part of the proposed collaboration, 
the CCR will utilize its expertise to collect and characterize human 
lymphoma samples prior to protein and genetic analysis. Also, clinical 
data from well-characterized vaccinated patients will be available for 
clinical correlation. CCR is seeking a collaborative partner with 
experience in proteomics to identify TAAs differentially expressed in 
lymphoma samples that may have potential as therapeutic or diagnostic 
targets. For example, the partner may have expertise in liquid 
chromatography and mass spectrometry to identify proteins 
differentially expressed in lymphomas, compared to normal B 
lymphocytes. Additionally, the use of gene expression techniques to 
confirm the proteomics results is envisioned. Genetic analysis of the 
identified TAAs will be essential in the development of effective 
immunotherapies; thus, the collaborative partner must have a strong 
background in genetic analysis to understand the effects of variations 
(e.g. polymorphisms) and to recognize genetic components that could be 
used to develop effect vaccines and therapeutic antibodies. Thus, the 
potential collaborator must be a leader in proteomics, bioinformatics 
and genomics and have a demonstrated interest, expertise, or ability in 
the development of cancer vaccines.

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.

[[Page 38295]]

    2. Providing the Collaborator with human lymphoma samples suitable 
for proteomic and genomic analysis.
    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 enzymes or other 
reagents, extracts, compounds, hardware, software and access to 
databases.
    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 the development of lymphoma vaccines. This 
ability can be demonstrated through experience, expertise, and the 
ability to contribute intellectually in this or related areas.
    2. 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.
    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 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, PHS policies relating to the use and care 
of laboratory animals, and the dissemination of research tools 
according to NIH policy.
    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: July 11, 2001.
Kathleen Sybert,
Chief, Technology Transfer Branch, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 01-18281 Filed 7-20-01; 8:45 am]
BILLING CODE 4140-01-P