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Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (STTR) (R41/R42)

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Agency: Department of Health and Human Services
Program/Year: STTR / 2014
Solicitation Number: RFA-HD-14-032
Release Date: November 7, 2013
Open Date: January 27, 2014
Close Date: February 27, 2014
001: Funding Opportunity Description
Description:
Purpose

The purpose of this funding opportunity announcement (FOA) is to encourage grant applications that will identify molecular targets for pregnancy associated/induced disorders and will lead to the development of new safer and more effective medications for use in pregnancy.     

Background

Pregnancy is a period of significant physiological changes that affect the function of many biological systems. Changes that occur during pregnancy may cause the exacerbation/worsening of pre-existing conditions or the development of new ones. Gestational diabetes mellitus, hypertension, preeclampsia and premature labor complicate a significant percentage of pregnancies and remain some of the major causes of maternal and neonatal morbidity and mortality. Gestational diabetes, for example, complicates 5-12% and preeclampsia 3-5% of pregnancies.  Despite their high prevalence, drug development for obstetric indications is practically non-existent. There is almost a complete lack of drug development for obstetric indications, with only one new class of drug licensed for obstetric patients in the past 20 years, and no new class of drugs in clinical trials for primary obstetric applications. Reasons for the paucity of new drugs for obstetrics include risk aversion, the cost of reproductive toxicology studies, and perceived small or time-limited market.

Identification of specific molecular targets associated with these disorders can lead to the development of new, effective therapeutics, with a better safety profile, a critical issue in this vulnerable population.

Objectives/Scope

The proposed FOA will support research that aims to identify specific targets that will lead to the development of new, targeted therapeutics for the prevention and/or treatment of pregnancy-related/induced diseases that are safe and effective for the mother and developing fetus. Translational research methods should be employed. An applicant is expected to assemble and develop the infrastructure, capabilities, research programs, and teams required to conduct translational research to accomplish these objectives.

Research areas appropriate for this announcement include but are not limited to, the following:

  • Animal and human trials of already available therapeutics that target already identified critical molecular pathways  in the maternal and fetal compartments;
  • Animal and human trials of existing experimental drugs that target already identified critical molecular pathways in the maternal and fetal compartments;
  • Identification of new targets from already identified critical molecular pathways using high throughput screening;
  • Development of novel therapeutics based on newly identified targets; and
  • Safety and pharmacokinetic studies of the above medications.