National Cancer Institute; Targeted Screening for Inhibitors of Human Herpesvirus 8 DNA Polymerase Activity

Opportunities for Cooperative Research and Development Agreements (CRADAs) are available for collaborations with the Screening Technologies Branch (STB), Developmental Therapeutics Program (DTP), National Cancer Institute (NCI) to discover and develop inhibitors of human herpesvirus 8 (HHV8) DNA polymerase. Collaborative projects will focus upon the inhibition of HHV8 as it relates to the disease processes of cancers which occur in patients with AIDS. This has been identified as an area of 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).

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 chemical companies to discover and develop new potential antiviral (HHV8) drug leads. 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, MD 21701 (phone: 301-846-5465, fax: 301-846-6820).

Scientific inquires should be submitted to Dr. Robert Shoemaker, Chief, Screening Technologies Branch, National Cancer Institute-Frederick Cancer Research & Development Center, Bldg. 431A, P.O. Box B, Frederick MD, 21702-1201 [phone: (301)-846-5432; Fax: (301)-846-6844; e-mail shoemaker@dtpax2.ncifcrf.gov .

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 within 30 days from date of this publication. 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 Screening Technologies Branch (STB) of the Developmental Therapeutics Program is an NCI extramural research activity dedicated to the discovery of new potential lead molecules for antitumor, antiviral, or antimicrobial drug development. General background and contact information for the DTP are available on the Internet at http://www.dtp.nci.nih.gov. The STB comprises an interdisciplinary research team, and appropriate resources, expertise and experience, to carry out all essential aspects of lead-discovery, including high-throughput screening (HTS), cell-based bioassays, chemical isolation, purification and structural determinations.

STB's principal lead-discovery strategy employs high-throughput screening (HTS) to identify 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. In the current solicitation, CRADA partners are sought for discovery efforts targeted to the DNA polymerase and processivity factor of human herpesvirus 8. This target was cloned and characterized in the laboratory of Dr. Robert Ricciardi and is proprietary to the University of Pennsylvania. STB is implementing HTS against this target in collaboration with Dr. Ricciardi. Therefore, it is anticipated that the University of Pennsylvania will either be a third party to this CRADA collaboration or the potential CRADA collaborator would obtain rights to the target under a separate agreement with the University of Pennsylvania.

Technology Sought

STB now seeks potential collaborators with novel or distinctive pure compound collections suitable for high-throughput screening and medicinal and synthetic chemical expertise and resources for follow-up and optimization of antiviral drug leads. Primary consideration will be given to collaborators with large well-characterized chemical libraries available as individual compounds in multiwell plates. Availability of bulk compound for “hit” confirmation and characterization and ability to rapidly perform synthetic work to optimize lead compounds will also be major factors in consideration of potential CRADA partners.

Collaborators Sought

Accordingly, DHHS now seeks collaborative arrangements for the joint STB and collaborator discovery research and development of novel, clinically useful, antiviral (HHV8) 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 drug lead-discovery and development: (a) creation of chemical libraries for use in high-throughput drug screening; (b) ability to carry out or direct chemical synthetic studies supporting lead-optimization, drug candidate selection and development.

NCI will provide no funding to the Collaborator in as much as financial contributions by the U.S. Government to non-Federal parties under a CRADA are not authorized under the Federal Technology Transfer Act [15 U.S.C. 3710(a)(d)(1)].

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 screening and test data 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 chemical libraries for use in high-throughput screening and synthetic compounds necessary for follow-up and optimization of leads identified by screening.

3. Planning research studies and interpreting research results.

4. 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. This ability can be demonstrated through experience, expertise, and the ability to contribute intellectually in this or related areas of drug discovery 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 willingness to cooperate with the National Cancer Institute in the timely publication of research results.

5. 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.

6. 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.