# Presentation: 064964

## NIH Plans for Development of Radiological and Nuclear Medical Countermeasures

- Ernest T. Takafuji, M.D., M.P.H.
- Assistant Director of Biodefense
- National Institute of Allergy & Infectious Diseases, NIH
- December 15, 2004

## Slide 2

## Radiological and Nuclear Threats

**■****	****Nuclear explosion**
**■****  ****Attacks on nuclear power plants, reactors,  storage/waste sites & laboratories with radioactive material**
**■****  ****Detonation of Radiation Dispersal Device (RDD)**
**■****  ****Placement of Ionizing Radiation Source in Public Places **
**■****  ****Contamination of Food or Water**

## NIH Research Planning Activities

- ■	Expert Workshops:
- 	-	**Non-human Primate Models of Acute Radiation Syndrome and ****	****Hematopoietic Recovery (Fall 2004)**
**	****-****	****Rapid Drug Screening Assays (Fall 2004)**
**	****-****	****Protection & Recovery from Radiation-Induced Mucosal Injury ****	****(Fall 2004)**
**	****-****	****Biomarkers and Bioassays of Radiation Injury (Fall 2004)**
**	****-****	****Animal Models of Radiation Injury, Protection, and Therapy****	**** ****	****(Spring 2004)**
**	****-****	****Hematopoietic Stem Cell Expansion & Immune Reconstitution ****	****(Spring 2004)**
**	****-****	****Models and Procedures for Evaluating Radioprotectors **
**	****	****(NCI, Winter 2003)**
**	****-****	****Radiobiology Workshop on Medical Countermeasures**
**	****	**** ****(Winter 2003)**
- ■  Collaborations: **OPHEP (HHS), NCI, AFRRI, and other agencies**

## NIH Blue Ribbon Panel

- 	**      “****NIH Strategic Plan &**
**   ****Research Agenda for Medical  **
**     ****Countermeasures against **
** ****Radiological/Nuclear Threats”**
** **
**	****            ****October 2004**

## Some Issues Addressed by Blue Ribbon Panel

- Biodosimetry
- 	- Rapid assessment tools for first responders
- 	- Quantification of internal and external radiation exposure
- Medical products
- 	-	**Radioprotectants **
**	****	****  ****(pre-exposure scenarios)**
**	****- ****	****Radiation mitigators**** **
**	****	****  ****(decorporation agents, chelators, eliminators) **
**	****- ****	****Restorative drugs**** **
**	****	****  ****(restoration of hematopoietic, gastrointestinal, and ****	****  other damaged cells/tissues)**
**	****-****	****Immunotherapies **
**	****	****  ****(immunomodulators, enhancement of  innate **
**	**** ****	****  ****immunity)**

## Some Issues Addressed by Blue Ribbon Panel

- ■	Basic and Translational Research
- 	**-** 	**Mechanisms of acute injury**
**	****-****	****Predisposing factors associated with injury**
**	****-****	****Factors in protection, mitigation, treatment **
**	****-****	****Factors promoting immune reconstitution**
**	****-****	****Teratogenic, mutagenic and other adverse effects**
**	****-****	****Long-term effects of radiation injury**
- Research Infrastructure
**	****-****	****Collaborations across disciplines**
**	****-****	****Focused research centers in radiobiology  **
**	****-****	****Animal model development**
**	****-****	****Product evaluation and development (GLP & GMP)**
**	****-****	****Standardized methods in research**
**	****-****	****Research personnel in radiobiology research**
**	****-****	****Information management and data banks**

## Other Issues Addressed

- ■	Psychological Impact
- 	**-**** **	**importance of early intervention & education**
- ■	Preparedness Training & Education
- 	**-** 	**community-based education & risk management**
**	****-**** ****	****training of health care providers & first **
**  ****	****  ****	****responders to different radiological threats**
- Radiobiology Researchers
**	****- ****	****new R&D programs for researchers**** **
**	****-****	****involvement of affiliated specialties in radiation-****	****related research****	**

## NIAID/NIH FY2005 Plans for Medical Countermeasures

- Focused Product Development
- Centers for Medical Countermeasures Against Radiation (CMCR)
- 	**(Centers will develop new medical products to protect against, mitigate the effects of  and/or treat the long- and short-term consequences of radiation exposure)**
**Selective Projects**

## Focus:  Product Development

## FY 2005 - Centers for Medical Countermeasures Against Radiation (CMCRs) – RFA-A1-04-045

-  Dates for Submission:
**     ****Letters of Intent due: January 24, 2005   ****	****                          **
**     ****Applications due:       February 22, 2005**
-  CMCR Public Briefing**:****  ****Dec. 15, 2004**
** **Website for more info**:**
**     ****www.niaid.nih.gov/biodefense**

## Partnership Effort

- OPHEP
-  DHHS

- NIAID

- OTHER NIH
- INSTITUTIONS,
- E.G., NCI

- ACADEMIA

- INDUSTRY

- OTHER
- GOVERNMENT
- RESEARCH LABS

-   **MEDICAL**
** ****COUNTER-     MEASURES**

- FDA