Loren Data's SAM Daily™

FBO DAILY ISSUE OF FEBRUARY 27, 2003 FBO #0452
SPECIAL NOTICE

A -- Identification and functional characterization of genes involved in the pathophysiology of insulin resistance and Type 2 diabetes and further identification of therapeutic targets.

Notice Date

2/25/2003
 

Notice Type

Special Notice
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd., MSC 5455, Bethesda, MD, 20892-5455
 

ZIP Code

20892-5455
 

Solicitation Number

Reference-Number-NIDDK-02-0341
 

Archive Date

4/16/2003
 

Point of Contact

Linda Schilling, Technology Development Specialist, Phone 301-451-3638, Fax 301-402-7461, - Rochelle Blaustein J.D., Director, Technology Transfer and Development, Phone 301-451-3636, Fax 301-401-7461,
 

E-Mail Address

lindas@intra.niddk.nih.gov, rochelleb@intra.niddk.nih.gov
 

Description

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) seeks collaborators for Cooperative Research and Development Agreements (CRADAs) that will result in the identification and functional characterization of genes involved in the pathophysiology of insulin resistance and Type 2 diabetes, and allow for identification of therapeutic targets for the development of new drugs to prevent and treat this disease. The NIDDK is seeking partners to functionally characterize the pathological effects of genes dysregulated in insulin-resistant patients for the commercial development of therapies that will alter expression and/or function of the identified targets. POTENTIAL AREAS OF APPLICATION: Commercial development of therapies for: 1. Early treatment and prevention of insulin resistance, a precursor to Type 2 diabetes, reversal of metabolic and transcriptional defects in insulin resistance and/or Type 2 diabetes, reversal or prevention of complications that may be secondary to or accompany insulin resistance (i.e. the metabolic syndrome, including obesity, atherosclerosis and hypertension) 2. Detection of clinical markers and development of diagnostic tools and for prediction, detection and stratification of yet unknown subclasses (or stages) of insulin-resistance and Type 2 diabetes important for the design and development of individualized therapies (pharmacogenetics). 3.Development of therapies which have direct, known, predicted effects the disease-causing gene variants and their products which would increase its specificity of action and improve the drug?s toxicological profile. MAIN ADVANTAGES OF TECHNOLOGY/INVENTION: There are no therapies available for the cure of Type 2 diabetes, and its complications. Current therapies for glycemic control such as thiazolidinediones are not useful in all patients and their mechanisms of action are only partially understood. They are known to cause sometimes life-threatening side effects, and long-term use may lead to therapeutic failure and ultimately the need for insulin replacement. CURRENT STATE OF DEVELOPMENT: 1.NIDDK currently has a database for skeletal muscle and adipose cells obtained from pre-clinical (or normoglycemic) insulin resistant patients and insulin-sensitive controls. 2.NIDDK has a list of genes in which expression is significantly altered in these patients, and has validated a number of these findings by real-time PCR. 3.NIDDK has developed a novel algorithm, which more sensitively detects changes in gene expression when analyzing data obtained from a leading commercial microarray platform with high gene coverage, Affymetrix GeneChips. 4. NIDDK has tools for systematic study of effects of overexpression of genes on GLUT4 translocation, which can be scaled up for high-throughput analysis (gene screening). These include cell lines/animals stably expressing GLUT4-GFP. FURTHER R&D REQUIRED: 1.Further characterization of genetic abnormalities in a larger population of pre-clinical (and clinical) diabetic patients 2.Development of high-throughput screens for pathological function of genes differentially expressed in insulin-regulated tissue of insulin-resistant patients 3. Evaluation and testing of drugs for newly identified therapeutic targets SUPPLEMENTARY INFORMATION: A CRADA is an agreement designed to enable certain collaborations between Government laboratories and non-Government laboratories. It is not a grant, and is not a contract for the procurement of goods/services. The NIDDK is prohibited from transferring funds to a CRADA collaborator. Under a CRADA NIDDK can contribute facilities, staff, materials, and expertise to the effort. The collaborator typically contributes facilities, staff, materials, expertise and funding to the collaboration. The CRADA collaborator receives an exclusive option to negotiate an exclusive or non-exclusive license to Government intellectual property rights arising under the CRADA in a pre-determined field of use and contributions that qualify one or more of its employees as a co-inventor(s) of new technology developed under the CRADA. CRADA CONTRIBUTORS EXPERTISE: 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 technical and/or financial support to facilitate scientific goals and for further design of applications of the technology outlined in the agreement. CAPABILITY STATEMENTS: A Selection Committee will utilize the information provided in the Collaborator Capability Statements received in response to this announcement to help in its deliberations. It is the intention of the NIDDK that all qualified Collaborators have the opportunity to provide information to the Selection Committee through their capability statements. The Capability Statement should not exceed 10 pages. The capability statement should address the collaborators ability to use high-throughput post-transcriptional gene slicing methods such as RNA interference, to establish the function of target genes of interest in a cellular process. The potential Collaborator(s) capability statement should provide proof of expertise in 1. Performing high-throughput functional assays for further characterization of potential disease-causing genes 2. Experience in conducting preclinical studies and early phase clinical trials with small molecules 3. The design and implementation of clinical trials. 4. The capability to scale up production of therapeutics. Researchers will screen hundreds of genes in real time, enabling rapid identification of the genes and related proteins involved in key biological pathways. The statement must address willingness to promptly publish research results and ability to be bound by PHS intellectual property policies (see CRADA: http://ott.od.nih.gov/newpages/crada.pdf). DATES: Only written CRADA capability statements received by the NIDDK on or before April 1, 2003 will be considered. Applicants meeting the criteria as set forth in this announcement will be invited at the Applicants own expense to discuss with the Study Steering Committee their plans, capabilities, and research findings pertinent to the study at a meeting of the Study's Steering Committee on or about April 30, 2003. SUBMIT CAPABILITY STATEMENTS to Linda Schilling Technology Transfer and Development, National Institute of Diabetes and Digestive and Kidney Diseases, 9000 Rockville Pike, MSC 5632, Bethesda, MD 20892-5632, phone: (301) 451-3636, fax: (301) 402-7461, e-mail: lindas@intra.niddk.nih.gov
 

Place of Performance

Address: NIH/NIDDK, Bld 10, Rm 9N222, 10 Center Drive, Bethesda, MD,

Zip Code: 20892

Country: USA
 

Record

SN00264859-W 20030227/030225213223 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |