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January 2014 DAIT Council-Approved Concepts

Concepts represent early planning stages for program announcements, request 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

Centers for Medical Countermeasures Against Radiation

Request for Applications

Contact: Francesca Macchiarini

Objective: To maintain a network of national research centers to develop effective and comprehensive medical countermeasures applicable to all subsets of the civilian population in the event of radiological or nuclear emergencies. Multidisciplinary basic and translational research will 1) produce new techniques and devices to measure radiation exposure in the human body and follow biomarkers of tissue damage and recovery and 2) develop novel therapies to minimize tissue damage, hasten tissue recovery, restore normal physiological function, and improve survival.

Description: The Centers for Medical Countermeasures Against Radiation (CMCR) will operate in a flexible, cooperative, and multidisciplinary manner to provide comprehensive research support to develop medical products for the civilian population. These products will assess, diagnose, mitigate, and/or treat the short- and long-term consequences of radiation exposure after a radiological/nuclear incident. The overall program is designed for optimal research flexibility, synergy, and efficiency with the goal of rapidly developing effective countermeasures for clinical use. When appropriate and in accordance with NIH policies (NIH Data Sharing Policy and Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice), awardees will be expected to collaborate and share novel reagents, assays, and animal models, as well as share positive and negative results to help guide the research and development activities of other CMCR network members.

This program will support both basic and translational research in the following research areas:

  • Practical biodosimetry devices and techniques, biomarker assays, and other automated diagnostic systems to rapidly assess levels of radiation exposure and assess tissue damage early after an event and during the treatment and recovery phase.
  • Research and development of medical countermeasures for mitigating and/or treating acute and/or delayed radiation injuries to the hematopoietic, gastrointestinal, cutaneous, pulmonary, renal, cardiovascular, and/or central nervous system of the body with the ultimate goal of increasing survival when administered 24 hours or later post-irradiation.
  • Therapeutic regimens with emphasis on broad-effective efficacy, ease of administration to all at-risk populations, and safety.
  • Medical countermeasures to treat radiation combined injuries (radiation exposure concomitant with burn, wound, infection, or other physiological trauma).
  • Mechanism of action of potential countermeasures in irradiated animal models predictive of human responses.
  • Characterization of injury and countermeasures for treating radiation injuries in highly susceptible subpopulations, including pregnant, pediatric, geriatric, and immune-compromised persons.
  • Validation screening studies in conjunction with NIAID’s Radiation and Nuclear Medical Countermeasure Product Development Support Services Program leading to the submission of an investigational new drug (IND) application to FDA to facilitate eventual licensure and potential inclusion in the Strategic National Stockpile, including:
    • Efficacy studies to optimize formulation, dose, and dose scheduling
    • Good Laboratory Practice (GLP)-pilot efficacy studies to inform the design of GLP-pivotal efficacy study protocols
    • Drug product stability studies
    • Drug product current Good Manufacturing Practice (cGMP)
  • Manufacturing scale-up; GLP toxicology and pharmacology safety studies; pharmacokinetic (PK), pharmacodynamic (PD), and metabolism studies; development of GLP analytical methods for efficacy studies, PK, and product characterization; and completion of IND packages for FDA submission.

Development of Medical Countermeasures to Mitigate or Treat Radiation-Induced Lung Injury After a Nuclear Radiation Incident

Broad Agency Announcement

Contact: Emily Dubbaneh

Objective: The purpose of this solicitation is to invite investigator-initiated proposals for continued development of new or existing approaches to treat and/or mitigate radiation-induced lung injury due to a nuclear or radiation incident. Radiation exposure type, dose level, and dose rates proposed for study would be those that would be relevant following a terrorist incident or accidental exposure.

Description: The focus of the solicitation will be applied and translational research to accelerate the development of safe and effective medical products to mitigate and/or treat pulmonary injury arising from exposure to ionizing radiation from a radiological or nuclear incident, thereby leading to a reduction in lung-associated morbidities that can impact survival (e.g., pneumonitis and/or fibrosis). Countermeasures of interest may include novel or known drugs to mitigate and/or treat radiation-induced lung tissue damage when administered 24 hours or later after exposure. It is anticipated that research and development studies awarded from this BAA will advance medical countermeasures toward submission of an investigational new drug (IND) application and eventual FDA approval for reducing major morbidities and/or increased survival after radiation exposure under the FDA Animal Rule (21 CFR 314.600-314.650, 601.90-601.95). Infrastructure improvements would be limited to small equipment purchases necessary to upgrade existing laboratories.

Radiation and Nuclear Medical Countermeasure Product Development Support Services

Request for Proposals

Contact: Deborah Blyveis

Objective: To provide additional funds to continue and expand nonclinical and clinical efforts for product development of radiation and nuclear medical countermeasure candidate drugs and biodosimetry devices for inclusion in the Strategic National Stockpile for use during a radiation emergency.

Description: The initiative will provide funds to continue and expand the development of radiation countermeasures for the Radiation and Nuclear Countermeasures Program. The program will provide a comprehensive and broad range of nonclinical and clinical support services that will be available to organizations (companies, government, academic, and Centers for Medical Countermeasures Against Radiation) that have promising medical countermeasure candidates. The program will support product development efforts for licensure of both candidate drugs and biodosimetry devices. The types of product development support services include screening and efficacy evaluation of candidate drugs, Good Laboratory Practice (GLP) toxicology and safety pharmacology in animal models, current Good Manufacturing Practice (cGMP) manufacturing support, GLP pivotal animal efficacy studies, phase I clinical safety and pharmacokinetic studies, and regulatory submission support for candidate drugs and biodosimetry devices.

Last Updated February 13, 2014

Last Reviewed February 13, 2014