NCI Frederick Cancer Research and Development Center (NCI-FCRDC), P.O. Box B, Frederick, Maryland 21702-1201

A -- MOLECULAR TARGET LABORATORIES SOL S00-139 POC Heather Wells, CPCM -- 301-846-1520 WEB: MTL, http://www.ncifcrf.gov/mtl. E-MAIL: Sr. Contracts Specialist, hwells@mail.ncifcrf.gov. PRE-SOLICITATION NOTICE Over the past decade our understanding of the molecular basis of cancer has increased dramatically. Exploiting technological advances, the NCI has established interdisciplinary programs, such as the Cancer Genome Anatomy Project, to put in place technology, physical resources, and information to allow deciphering of the molecular anatomy of a cancer cell. The cancer research community now has access to large collections of genes, which represent the majority of all human genes, and is utilizing these resources most effectively to classify cancers at the molecular level. These advances have occurred in parallel with evolutionary changes in the ability to synthesize highly diverse collections of compounds, manipulate genetic sequences, and perform biological screens in a more precise and high-throughput manner. New approaches and advances in imaging technology and bioinformatics have enabled a fundamental re-conceptualization of the process of discovery. The expected result is a more precise understanding of the roles that genes and networks of genes (and their products) play in various aspects of cancer development, thereby enabling new approaches to cancer intervention. In order to empower the research community to fully exploit this remarkable new opportunity, the NCI intends to establish Molecular Target Laboratories (MTLs) to mount an intensive program of ligand discovery for cancer-related targets. The immediate benefits of ligand identification will be a resource of chemical probes for biological studies of cancer, including physiological and biochemical monitoring. In addition, it is expected that the resources generated by this program will build a platform for drug discovery, and for imaging resource construction. More specifically, the ultimate products of the MTLs are envisioned to be: * Chemical libraries -- will constitute the principal sources of chemical diversity to be interrogated by the biological assays developed in the MTLs. The collection of librarieswill constitute an invaluable public resource and will therefore be made available by the MTLs to qualified research groups in a manner to be established by the MTLs, SAIC and the NCI. * Chemical probes for biological studies -- Ligands with important biochemical or phenotypic effects will be placed into a repository and made available to qualified research groups. * Cancer-relevant target assays -- will be suitable for high-throughput screening of chemical libraries. These assays will not be claimed as intellectual property and will be made publicly available as described below. * Information -- the identification of biologically active small molecules and the relationship of particular chemical structures to biochemical activity and cellular phenotype. This information will be made publicly available expeditiously and systematically. To accomplish this goal, the MTLs will work with SAIC and the NCI to construct a publicly available database relating chemical structure to biological function. This database will be populated with data from research projects in the MTLs as soon as possible after discovery, verification, and intellectual property review. This database will also incorporate data from other qualified research groups in the cancer research community wishing to participate. NCI envisages that it will, in time, serve a role for ligand discovery efforts analogous to that of DNA sequence databases for gene discovery. In order to achieve the scientific objectives of NCI each MTL shall have expertise and capability in chemistry, biology, and the integration of biological and chemical resources: 1) Chemistry * design, synthesize, store and format chemical libraries * perform chemical synthesis including structural modification, as well as the ability to scale-up synthesis * design and implement biological, synthetic, or biochemical screens 2) Biology * provide expertise in cancer biology * develop assays suitable for screening * perform biological studies for probe validation and target identification 3) Integration * design and operate high-throughput screens on selected targets * evaluate the imaging potential of selected probes * provide informatics know how and resources for effective project management, to make MTL resources accessible to the research community, and to participate in the development of a public database relating chemical structure to biological function * produce and distribute resources to the community * provide an independent business management system to support MTL activities To meet the special needs of this scientific program, the NCI will provide funding through a contract to Science Applications International Corporation (SAIC), the operator of a Federally Funded Research and Development Center (FFRDC), for the establishment of the MTLs. This is intended to be a multi-year program with an initial one-year contract and multiple option years. It is anticipated that up to two awards will be made. The NCI wants to ensure that new technologies that may be developed by MTLs under this contract are made available, as much as possible, to the research community for further research and development. It is anticipated that this will more rapidly and effectively lead to products of benefit to the public. The National Institutes of Health (NIH) recognizes the rights of contractors/subcontractors normally to elect and retain title to subject inventions developed with Federal funding under the provisions of the Bayh-Dole Act. However, to address the Government's present interest in the availability of the new technology developed under this Contract, the NIH is invoking the provision of the Bayh-Dole Act at 35 U.S.C. 202 (a)(ii) that enables the Government to restrict or eliminate the right to retain title "in exceptional circumstances when it is determined by the agency that restriction or elimination of the [contractor/subcontractor's] right to retain title to any subject invention will better promote the policy and objectives of [the Bayh Dole Act]". Therefore, respondents are advised that a Determination of Exceptional Circumstances (DEC) along with the associated deviated FAR clauses will be used for this Initiative. The respondents should note that the DEC will enable the NCI to either elect title to inventions developed by the MTL under this Initiative, or to grant greater rights to such inventions to the MTL. The finalized version of the deviated FAR clauses will be available before final award of any potential contracts. There will be a pre-solicitation conference held on Wednesday, April 19th to further discuss the goals of this initiative, IP issues and DEC guidelines and considerations. Further details and a registration form are available at http://www.ncifcrf.gov/mtl. A draft solicitation will be available by contacting Ms. Heather Wells at phone: 301-846-1520 or via. fax: 301-846-5414. Potential offerors are invited to submit questions to Ms. Wells, prior to the pre-solicitation conference. Questions received will be addressed in the final solicitation. Posted 03/29/00 (W-SN439069). (0089)

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