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June 2014 DAIT Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to the Opportunities and Announcements portal.

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Radiological and Nuclear Medical Countermeasure Product Development Program

Program Announcement

Contact: Carmen Rios

Objective: To provide funds to continue and expand nonclinical efforts for product development of radiological and nuclear medical countermeasures effective for mitigating or treating acute radiation syndromes, radionuclide decorporation agents to treat internal contamination, and radiation biodosimetry products for inclusion in the Strategic National Stockpile for potential use during a radiological emergency.

Description: This program will fund Small Business Innovation Research (R43/R44) grants (Phase I, Phase II, and Phase II renewals) to support specific investigational new drug (IND)-/investigational device exemption (IDE)-enabling product development activities leading to IND or IDE packages to be submitted to FDA. The IND-/IDE-enabling activities will include:

  • Efficacy studies to optimize formulation, dose, and dose schedule.
  • Drug product stability studies.
  • Drug product GMP manufacturing scale-up.
  • Good laboratory practice (GLP) toxicology and pharmacology safety studies.
  • Pharmacokinetic and metabolism studies.
  • Developing GLP analytical methods for efficacy studies and product characterization.
  • Completing IND or IDE package for FDA submission.

The product development efforts will advance the new medical countermeasures towards Phase I clinical safety studies, GLP animal pivotal efficacy studies, and licensure.

Immune Defense Mechanisms at the Mucosa Cooperative Studies Group

Request for Applications

Contact: Annette Rothermel

Objective: To support innovative basic research projects on immune defense mechanisms and immune regulation at respiratory, gastrointestinal, and urogenital tract mucosal surfaces. The long-term goal is to develop the knowledge base needed to promote development of vaccines and therapeutics for protection from mucosal pathogens and mucosa inflammation.

Description: This program will solicit innovative basic research projects with the potential to increase understanding of immunity at mucosal surfaces. The goal is to gain new insights that will facilitate future development of vaccines and immunotherapies to protect mucosal surfaces from infection and inflammation. The initiative will promote cross-disciplinary collaborations, development of new technologies and tools, and discovery of new cells and pathways operating at the mucosa. The program will continue to include U01 projects and an infrastructure and opportunities pool.

Asthma and Allergic Diseases Cooperative Research Centers

Request for Applications

Contact: Gang Dong

Objective: With the continuing increase in the prevalence of asthma and allergic diseases worldwide, this program aims to promote innovative, multidisciplinary, and translational research on asthma and allergic diseases. The overarching goal of the program is to improve the diagnosis and treatment of asthma and allergic diseases and provide a strong scientific foundation for developing effective prevention strategies.

Description: The initiative will support NIAID's unique and long-standing Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) program, which funds research centers across the U.S. to conduct interdisciplinary and translational research in asthma and allergic diseases. The Centers coordinate their efforts through a steering committee and collaborate with each other through an opportunity fund that supports small, independent pilot studies. This is a renewal initiative and no substantial change in the overall goal is anticipated. A change in duration of awards from five years to seven years will be proposed. Longer grant duration allows the program to accommodate clinical trials of immune modulation and longitudinal cohort studies that are required towards the goal of asthma and allergic diseases prevention.

Last Updated June 25, 2014

Last Reviewed June 25, 2014