May
2008 DAIT Council-Approved Concepts
NB: Concepts represent early planning stages for PAs, RFAs, or solicitations for Council 's input. Council approval does not guarantee that a concept will become an initiative.
If NIAID publishes an initiative from one of these concepts, we link to it below. For a full list of initiatives, go to NIAID Funding Opportunities.
Table of Contents
Development of Oral Form of Diethylenetriaminepentaacetate (DTPA) for Use in Radionuclide Decorporation - Radiological Emergency
For the published initiative, see the October 16, 2009, solicitation.
Broad Agency Announcement
Contact: Donald Collie
Phone: 301-496-0992
Email: dcollie@niaid.nih.gov
Objective: To provide additional funds to continue and expand non-clinical efforts for product development of an oral form of DTPA to decorporate radionuclides for inclusion in the Strategic National Stockpile for use during a radiological emergency.
Description: This program will support N01 contracts to support specific IND-enabling product development activities leading to an IND submission package to be submitted to FDA. The IND-enabling activities will include decorporation efficacy studies to optimize formulation, dose, and dose schedule; drug product stability studies; drug product GMP manufacturing scale-up; GLP toxicology and pharmacology safety studies; pharmacokinetic and metabolism studies; development of GLP analytical methods for efficacy studies and radiation committed dose assessments; and completion of IND package for FDA submission. The product development efforts will advance the oral DTPA radionuclide decorporation agents towards phase I clinical safety studies, GLP animal pivotal efficacy studies, and licensure.
Development of an Oral Radionuclide Decorporation Agents for Use in Radionuclide Decorporation in Radiological Emergencies
For the published initiative, see the October 28, 2009, solicitation.
Broad Agency Announcement
Contact: Andrea Giuliano
Phone: 301-451-3685
Email: giulianoan@niaid.nih.gov
Objective: To provide additional funds to continue and expand non-clinical efforts for product development of oral decorporation agents effective for a broad range of radionuclides for inclusion in the Strategic National Stockpile for use during a radiological emergency.
Description: This program will support N01 contracts to support specific IND-enabling product development activities leading to an IND submission package to be submitted to FDA. The IND-enabling activities will include decorporation efficacy studies to optimize formulation, dose, and dose schedule; drug product stability studies; drug product GMP manufacturing scale-up; GLP toxicology and pharmacology safety studies; pharmacokinetic and metabolism studies; development of GLP analytical methods for efficacy studies and radiation committed dose assessments; and completion of IND package for FDA submission. The product development efforts will advance the new radionuclide decorporation agents towards phase I clinical safety studies, GLP animal pivotal efficacy studies, and licensure.
Characterization and Validation of Biomarkers for Acute and Late Radiation Injuries
Request for Applications
Contact: Narayani Ramakrishnan
Phone: 301-451-3101
Email: nramakrishnan@niaid.nih.gov
Objective: To develop rapid, reliable, inexpensive, and easy-to-use devices with long shelf lives to be used to measure civilian radiation doses post-exposure, for both emergency triage and to inform medical treatment decisions.
Description: This program will support cooperative agreement grants on basic, applied, or translational research to identify novel methods for post-exposure radiation dose measurement in all segments of the civilian population. Biologically-based systems will be developed for this purpose, and may be founded on patterns of biomarker expression or other physiological changes that correlate well with the particular dose of radiation received. Dose determination may be performed for defined threshold levels for use in emergency triage, or may be finely tuned to provide more accurate dose measurements to assist in specific medical treatment decisions. Dynamic considerations will be incorporated into these studies, as well as assessment of variance with age, gender, ethnicity, and underlying health conditions.
Investigations on Primary Immunodeficiency Diseases
For the published initiative, see the July 18, 2008, Guide announcement.
Program Announcement
Contact: Josiah Wedgwood
Phone: 301-496-7104
Email: JWedgwood@niaid.nih.gov
Objective: To encourage Research Project Grant (R01) applications that propose investigations in primary immunodeficiency diseases focusing on ex vivo studies with human specimens and on studies with current or new animal models including novel clinical strategies for detecting, identifying the molecular basis of, or developing innovative therapies for primary immunodeficiency diseases.
It is expected that NICHD, NHLBI, and NIDDK will join NIAID in this announcement.
Description: This is a new program announcement which seeks R01 applications in primary immunodeficiency disease research.
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