Chemical, Radio Logical, Nuclear Countermeasures

8/7/2019 Chemical, Radio Logical, Nuclear Countermeasures

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Chemical/Radiological/Nuclear Countermeasures

Topic: Chemical/Radiological/Nuclear CountermeasuresLead IC: NIAIDLead IC POC: Dr. Jill Harper, NIAIDContributing ICs:

Brief Description

Radiological/Nuclear Countermeasures

y In 2004, on behalf of NIH, NIAID was directed by DHHS to develop a robust researchprogram to accelerate development of radiation/nuclear medical countermeasures

(MCMs) for the Strategic National Stockpile. Funding for this program is through adirect appropriation to the NIH OD.

y NIH-sponsored activities focus on MCMs and biodosimetry devices to be used in masscasualty radiation/nuclear incidents involving improvised nuclear devices or radiologicdispersal devices.

y In 2005, NIH developed and implemented a strategic plan/research agenda focused on: Developing drugs to improve survival/mitigate injury from acute radiation

syndromes (ARS) Improving efficacy/ease of use of decorporation agents Developing high-throughput, rapid, and accurate biodosimetry of radiation

exposures

Revitalizing the science base by establishing a cadre of highly qualifiedinvestigators and modernizing critical infrastructure and research facilities.

Chemical Countermeasures

y In 2003, on behalf of NIH, NIAID was directed by DHHS to ascertain the availability ofmedical products that could be used in a chemical terrorist attack and to develop a

comprehensive research plan for the development of new medical countermeasures

(MCMs) that would be useful during and following such an event. Funding for thisprogram is through a direct appropriation to the NIH OD.

y The NIH Chemical Countermeasures program focuses on the prevention, diagnosis, andtreatment of the conditions caused by potential and existing chemical agents of terrorism

and chemicals that may be released from transportation and storage facilities.y In 2007, NIH developed and implemented the NIH Strategic Plan and Research Agenda.

The plan focused on research strategies, taking into account the ongoing efforts of otherfederal agencies and departments. The Chemical Countermeasures program conducts

basic, translational, and clinical research aimed at the discovery and/or identification ofbetter therapeutic and diagnostic MCMs against chemical threat agents.

Disease Burden: Prevalence/Incidence DataN/A

Disease Burden: Affected PopulationsN/A

Importance Beyond Burden of Disease


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y Over the past decade, the growing threat of terrorism has become a primary nationalsecurity priority. There is increased awareness that terrorists might employ

unconventional tactics and weapons, including weapons of mass destruction.

y Terrorist threat scenarios could result in segments of the population being exposed toionizing radiation or chemicals. The worst-case scenario would be the detonation of a

nuclear explosive device.y To respond to these threats, the Federal government is committed to increasing the

availability of medical countermeasures that could be used in the aftermath of an attack

involving the release of radioactive material or chemicals.

Current Research Efforts


y NIH currently funds seven Centers for Medical Countermeasures against Radiation.These are multidisciplinary, extramural research centers comprised of academic,

commercial, and government laboratories that conduct basic and translational research toidentify new countermeasures, develop new techniques and devices to provide accurate

dose assessment in a triage scenario, and provide new/expanded education resources toimprove expertise in radiobiology.

y NIAIDs Radiation/Nuclear Medical Countermeasures Product Development SupportServices Program provides a broad range of research and development support servicesincluding efficacy testing of candidate MCMs in animals; non-clinical studies; Phase I

clinical safety studies; and chemistry and manufacturing support services to support FDAIND, IDA, and BLA submissions.

y NIAID collaborates with the Radiation Effects Research Foundation (RERF) in Japan tostudy the effects of atomic bomb radiation and aging on the human immune system. U.S.and Japanese experts will systematically analyze biological samples from the unique

population of elderly Japanese atomic bomb survivors to better understand the health

consequences of exposure to ionizing radiation on the natural aging process.y The following provides the link to the NIH Strategic Plan and Research Agenda for

Medical Countermeasures against Radiation and NuclearThreats (2005):http://www.niaid.nih.gov/about/whoWeAre/Documents/radnucstrategicplan.pdf .

Chemical Countermeasures

y The NIAID Chemical Countermeasures program is guided by Department of HomelandSecurity Chemical Threat Risk Assessments (CTRAs) from 2009 and 2011 as well asNIAID/NIH Expert Panel reviews and workshops.

y The Chemical Countermeasures program is focused on medical countermeasures against: nerve agents (e.g. sarin and VX);

metabolic poisons (e.g. hydrogen cyanide and sodium cyanide); pulmonary agents (e.g. chlorine and phosgene); and vesicants (e.g. sulfur mustard).

y Phase II/III clinical studies are underway to determine if midazolam can replacediazepam as anti-convulsant to be used as a chemical countermeasure. The studies utilizea nationwide network for seizure treatment trials consisting of 17 hospital hub institutions

and three primary hospital centers.


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y NIAID/NIH workshops planned for 2011 will address increased concern about metabolicpoisons (e.g., cyanide) and non-traditional agents (NTAs). The NTA threat is of high

interest to the Department of Defense, the Department of Homeland Security, and theWhite House.

y The NIH Countermeasures Against Chemical Threats (CounterACT) program, managedby NINDS, funds six Research Centers of Excellence and more than 30 research grantsand targeted research contract facilities. The CounterACT program supports the NIHs

effort to develop FDA-approved therapies and diagnostic technologies that can be usedafter a terrorist attack or accident involving chemical agents. It is complemented by

Interagency Agreements between the NIH and DoD laboratories.

y An interagency agreement (IAA) between NIH and the Department of Defense allows forclose interagency research collaboration with the Department of Defense on medical

products (renewal of the IAA for FY 2011 is currently pending).y The following provides the link to the NIH Strategic Plan and Research Agenda for

Medical Countermeasures against Chemical Threats (2007):http://www.niaid.nih.gov/topics/BiodefenseRelated/ChemicalCountermeasures/Documents/nihstr

ategicplanchem.pdf.

Latest Advances (including hyperlinks to publications)


y Ninety-eight medical countermeasure candidates have been identified for furtherevaluation for mitigation of acute radiation syndrome (ARS).

y Rodent animal models have confirmed the potential efficacy of eight candidates for acuteradiation syndromes.

y A study in non-human primates supports the efficacy of filgrastim (G-CSF) for mitigationof hematopoietic ARS.

y A prototype biodosimetry device capable of analyzing 30,000 clinical samples per dayhas been developed.

y There are currently 25 patents pending for countermeasure candidates, and biodosimetrymethods and devices.

y Selected Publications: The RABIT is an ultra-high throughput biodosimetry workstation that utilizes

advanced image acquisition technology and automates well-established

biodosimetry assays for rapid radiological triage. The prototype has achieved athroughput of 6,000 samples per day and is designed to ultimately accommodate30,000 samples per day. Garty C, Chen Y, et al. The RABIT: a rapid automated

biodosimetry tool for radiological triage. Health Phys. 2010; 98(2):209-17.,http://www.ncbi.nlm.nih.gov/pubmed/20065685

The soluble growth factor pleiotrophin acts on both mouse and humanhematopoietic stem cells (HSCs) and can induce long-term HSC expansion ex

vivo and HSC regeneration in vivo. Pleiotrophin therefore has potential clinicalutility for expanding human HSCs ex vivo and for accelerating hematopoietic

recovery in vivo in patients after chemo- or radiotherapy. Himburg HA,Muramoto GG, et al. Pleiotrophin regulates the expansion and regeneration of

hematopoietic stem cells. Nat Med. 2010 16(4):475-82.,http://www.ncbi.nlm.nih.gov/pubmed?term=20305662


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