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NOT-DK-07-013: Request for Information. Agents to be tested for Preclinical Efficacy in Prevention or Reversal of Diabetic Complications in Rodent Models. Request for Information. Agents to be tested for Preclinical Efficacy in Prevention or Reversal of Diabetic Complications in Rodent Models.

Notice Number: NOT-DK-07-013

Key Dates
Release Date: July 12, 2007

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)

The NIDDK has recently awarded a contract establishing a rodent model testing program to assist in development of therapeutic interventions for the prevention or reversal of complications of type 1 diabetes.  The contract provides independent investigators with access to the resources and expertise required to evaluate agents for preclinical therapeutic efficacy in rodent models.  NIDDK invites scientists to submit information describing promising new therapeutics or intervention strategies that may require further testing in rodent models prior to moving forward for evaluation in patients with diabetic complications.
Investigators recommending agents for testing (“sponsors”) should provide the following information:

  1. A rationale supporting the intervention concept as well as preliminary data supporting efficacy of the specific agent to be tested. Proof of concept studies in animal models of diabetes or in other relevant disease models should be provided. Utility of the agent for use in humans should be indicated.
  2. Proper dose, route, and timing of the intervention.
  3. Methods for documenting expected biochemical and/or physiological effects.
  4. Assays to monitor compound stability and concentration in vivo.  
  5. Information, if available, for mechanistic testing that could lead to development of biomarkers useful for monitoring efficacy in clinical trials.
  6. If selected to participate in the program, the sponsor will be involved in selecting and developing the most appropriate testing regimens.  Sponsors will be involved in data analysis and in coauthoring publications.  All data obtained under this program will be released to the public following completion of the study in a timeframe that is determined by mutual agreement between the sponsor and the NIDDK. 

It is important to emphasize that this program is not a funding opportunity, and provides support solely for testing promising agents in the contractor’s facility.
Applications will be accepted at any time, but recommended target submission dates for expeditious review are October 30th, 2007 and February 29, 2008. 

Requests will be reviewed for scientific merit by an NIDDK appointed special review panel.  Acceptance into the program will be based on scientific merit, programmatic relevance, perceived translational potential and availability of resources. Format for applications and additional information can be found by navigating from the T1D-RAID web page, (http://www.niddk.nih.gov/fund/diabetesspecialfunds/T1D-RAID/ ).


Inquiries regarding this notice may be directed to:

Kristin M. Abraham, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd. Rm. 795
Bethesda, MD 20892-5460
Telephone: (301) 451-8048
FAX: (301) 480-268480-0475
E-mail: abrahamk@extra.niddk.nih.gov

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