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

A -- MOLECULAR TARGET LABORATORIES (MTLS) SOL MTL POC Heather Wells: 301-846-1520 WEB: Molecular Target Laboratories, http://www.ncifcrf.gov/mtl. E-MAIL: Sr. Contracts Specialist, hwells@mail.ncifcrf.gov. PRE-SOLICITATION NOTICE In the past few years, striking scientific and technological advances have had a profound effect on cancer treatment. Increasing detail in the molecular description of cells, the ability of chemists to synthesize highly diverse collections of compounds, the manipulation of genetic sequences, and the most exciting promise of imaging are among the recent advances. Together, these advances have enabled a fundamental re-conceptualization of the process of discovery of a new generation of effective interventions for cancer. The basic step is the identification of specific ligands for key components of critical biological pathways. The discovery, assembling, and exploitation of a rich collection of ligands for components of essential cellular processes will expedite the discovery and development of drugs for cancer prevention and treatment. To meet this requirement, Science Applications International Corporation (SAIC), as the operator of a Federally Funded Research and Development Center (FFRDC) for the National Cancer Institute (NCI), wishes to contract for a selection of Molecular Target Laboratories (MTLs) rich in scientific expertise for the purpose of identifying ligands that may be used:  As chemical probes for biological processes  As probes that can be imaged for physiological and biochemical monitoring  As potential candidates for clinical trials This is intended to be a multi-year program with an initial one-year contract with multiple option years. It is also expected that multiple awards will be made. It is anticipated that the MTLs will derive drug candidates, imaging probes, and perturbational probes for biology. In time, the MTLs may also acquire or redirect their capacity to enable translation of drug candidates and imaging probes from the laboratory to the clinic, and may eventually contain fully developed programs in ligand discovery, drug and probe development, and possibly clinical testing. Each MTL shall have:  Capability to allow design and implementation of biological, synthetic, or biochemical screens  Chemistry for library synthesis  Practice of high-throughput screening  Resynthesis  Radiochemical and imaging expertise  Biological testing (at least at the in vitro level)  Demonstrated capacity to include molecules for cancer treatment and imaging or diagnostics as successful outcomes of their research programs  An independent business management system to support MTL activities The ultimate products of the MTLs will be repositories of chemicals, assays, and information:  Cancer-relevant target assays, 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.  Chemical libraries: these will constitute the principal sources of chemical diversity to be interrogated by the biological assaysdeveloped in the MTLs. This collection of libraries will 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 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  Information: the identification of biologically active small molecules and the relation of particular chemical structures to biochemical activity and cellular phenotype. This information will be maximally useful to the research community to the extent that it is made publicly available expeditiously and systematically. To accomplish this goal, the MTLs will work with SAIC and 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 IP review. This database will also incorporate data from other qualified research groups in the cancer research community wishing to contribute to it. NCI envisages that it will, in time, serve a role for ligand discovery efforts analogous to that of DNA sequence databases for gene discovery. 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 Tuesday, March 14th 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 is 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 02/18/00 (W-SN427040). (0049)

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