A -- NIH INITIATIVE FOR CLINICAL IMAGING DRUGS & ENHANCERS (DCIDE)

Notice Date

February 6, 2001

Contracting Office

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

ZIP Code

21702-1201

Solicitation Number

S01-038

Response Due

April 1, 2001

Point of Contact

Jane A. Wells, Sr. Contract Specialist, 301-846-5423, Contracting Officer -- Dennis J. Dougherty, 301-846-1087

E-Mail Address

Jane A. Wells, Sr. Contract Specialist (jwells@mail.ncifcrf.gov)

Description

Introduction: R&D -- Potential Sources Sought. The National Institutes of Health (NIH) is initiating a new program for the development of Clinical Imaging Drugs & Enhancers (DCIDE). With the advent of new molecular therapies in the treatment of cancer, there is a clinical need for more sophisticated imaging methodology that will allow in vivo evaluation of the multiple parameters that impact on the appropriateness and effectiveness of such therapies. These parameters range from determinations of delivery of therapy to alterations in phenotype at the molecular level. For imaging to be useful in providing information at this level of molecular detail, unique contrast enhancers or molecular probes will be required. The purpose of the DCIDE program is to facilitate the development of such promising compounds by providing resources to supply missing steps in their preclinical development, leading to successful IND filing. Although many steps in the development and approval of imaging compounds are similar to those of therapeutic drugs, imaging agent development has several unique needs. It is the purpose of this Sources Sought notice to identify contractors who can perform these unique, specific analyses, which are necessary to supplement the routine components of the pre-clinical development of an investigational new imaging compound. Contractors should have expertise in a broad range of imaging modalities and be able to provide high quality data that meets FDA requirements. We are seeking contractors who can provide a broad range of services in three specific areas: Imaging Agent Certification (i.e., biological or physiological validation), Imaging Optimization, and Radiolabeling. Contractors may respond to one or all areas; however, the ability to perform a range of modality certifications will be preferred. We intend to impanel a group of contractors that, in total, will be able to cover the scope of work in all three areas across multiple modalities (PET, Nuclear Medicine, MR, CT, Optical, etc.). Imaging Certification -- For any new imaging agent, particularly a molecular target-directed probe, determining the clinical and/or research potential, and therefore the feasibility for full development, will require sophisticated certification. This entails demonstrating and documenting the agent's distribution, its interaction with receptors or targets, and its ability to quantitate subcellular molecular processes. These analyses may involve multiple individual steps, including but not limited to: (1) Pharmacokinetics, pharmacodynamics, and biodistribution; (2) Evaluation of probe specificity for specific targets or processes; (3) Evaluation of the dynamics of probe-target interaction, including probe stability; (4) Determination of quantitative validity of information produced by probe when compared to an acceptable standard such as in vitro or in vivo models. Imaging Optimization -- Based on the pharmacodynamic, biodistribution, and other pertinent data, contractors will be asked to determine the optimum parameters for imaging, including the most appropriate modalities and the methodology for each modality. Such optimization will be aligned to fulfilling a research or clinical need. Contractors should have the ability to perform such evaluations in multiple imaging modalities to reduce duplication of effort when there is interest in feasibility in more than one methodology. The types of analyses that will be required include but are not limited to: (1) Determination of optimum dose for imaging (2) Determination of timing and dynamics of imaging (3) Reproducibility of non-invasive measures performed with the probe/agent (4) Signal optimization (i.e., photopeaks, windows, pulse sequences, etc.). Radiolabeling -- The contract activities in radiolabeling may fall into a number of categories, including but not limited to: (1) Development of a labeling process for a ligand (2) Optimization of an established labeling process (3) Automation of a labeling process, such as with PET radiopharmaceuticals (including the possibility of optimization and automation simultaneously) (4) Development of "kits" for preparation of radiopharmaceutical compounds. Contractors are needed for both PET and single-photon radionuclide labeling. Contractors should be capable of performing the necessary analyses to determine biodistribution and dosimetry in relation to dosing requirements. This will be particularly imperative in the case of PET radiopharmaceuticals, where dosimetry calculations and synthetic production must be performed at the same site. Organizations interested in participating are requested to contact Jane A. Wells, Sr. Contract Specialist, #301-846-5423, or e-mail @ jwells@mail.ncifcrf.gov

Record

Loren Data Corp. 20010208/ASOL012.HTM (W-037 SN50C8S0)