Emergency Medical Countermeasures Development and Acquisition

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• Emergency Medical Countermeasures Development and
  Acquisition
• BARDAs Role and Biodosimetry
• Ronald G. Manning, Ph.D.
• Chief, Chemical, Radiological and Nuclear
• Medical Countermeasures
• Project BioShield
• Biomedical Advanced Research and Development
  Authority (BARDA)

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HHS Assistant Secretary forPreparedness and
Response (ASPR)
Vision A nation prepared to prevent, respond to
and reduce the adverse health effects of public
health emergencies and disasters.
Mission Lead the Nation in preventing, preparing
for and responding to the adverse health effects
of public health emergencies and disasters.
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BARDA Roles and Responsibilities

• Coordinates an integrated, systematic approach to
  planning for, and executing research, development
  and acquisition of medical countermeasures for
  public health emergencies
• Supports the ASPR in leading the Public Health
  Emergency Medical Countermeasure Enterprise
  (PHEMCE)
• Drives medical countermeasure analysis and
  prioritization
• HHS PHEMCE Strategy for CBRN Threats
• HHS PHEMCE Implementation Plan for CBRN Threats
• Executes advanced development and acquisition of
  medical countermeasures for CBRN threats and
  pandemic influenza
• Advanced development under BARDA
• Acquisition under Project BioShield (CBRN
  material threats)
• Acquisition with direct appropriations for
  pandemic influenza

CBRN chemical, biological, radiological, and
nuclear
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HHS Public Health EmergencyMedical
Countermeasures Enterprise
National Biodefense Science Board
BARDA and CDC
CDC and DHS
BARDA
NIH
CDC
CDC and OPEO
FDA
Research and Development
Biosurveillance/ Detection
Advanced Development
Storage/Maintenance
Utilization
Deployment
Acquisition
PHEMCE COORDINATED PLANNING EXECUTION
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HHS Public Health Emergency Medical
Countermeasures Enterprise

• Purpose To coordinate across the full spectrum
  of public health emergency preparedness
  activities for all intentional and naturally
  occurring threats 
• Established by HHS in July 2006

• Interagency partners include
• Department of Defense
• Department of Homeland Security
• Veterans Administration

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Defining and Prioritizing Medical Countermeasure
Development and Acquisition ProgramsScoping the
Mission
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Maximizing Opportunities for Collaboration
Building a True Enterprise

• Bring together medical and public health assets
  more effectively
• Measurement is vital
• Build capacity to perform best practices
• Provide coordinated federal assistance to
  supplement state, tribal, and
  local resources in response to
  public health and medical
  care needs

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Establishment of Medical Countermeasure
Requirements

• HHS will establish concepts of operations
  (conops), including storage, maintenance,
  utilization policies and deployment plans for
  each medical countermeasure in the context of all
  available consequence mitigation strategies and
  capabilities.
• HHS will define specific medical countermeasure
  requirements, including product specifications
  consistent with US Government storage plans and
  operational capabilities for deployment and
  utilization by federal, state, and local
  authorities.

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Medical Countermeasure Preparedness for CBRN
Threats
BIOLOGICAL THREATS

• CHEMICAL THREATS

• Plague
• Antibiotics
• Smallpox
• Smallpox vaccines (MVA and ACAM2000)
• Vaccinia Immune Globulin (VIG)
• Tularemia
• Antibiotics

• Anthrax
• AVA Vaccine
• Oral ciprofloxacin
• Doxycycline
• Amoxicillin
• Other IV antibiotics
• Human polyclonal antibody
• Botulism
• Antitoxins from legacy DOD program and legacy
  CDC/Cangene program
• Other monovalent and bivalent antitoxins

• CHEMPACKs

RADIOLOGICAL / NUCLEAR THREATS

• KI tablets and Pediatric KI
• Prussian Blue
• Cytokines
• Antibiotics
• Anti-emetics
• Blast and burn supplies
• Ca Zn DTPA

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Radiological/Nuclear Threats

• Nuclear Detonation
• Radiologic dispersive devices (dirty bombs)
• Industrial and shipping accidents
• Power plant releases
• Food and medical irradiators
• Sealed sources

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Radiation Exposure Events

• IND Models for a 10 KT event estimate 1.8
  million affected
• 1 million may seek information on their
  personal risk (dosimetry),
• Hundreds of thousands estimated to receive gt 2
  Gy if event occurs in a large metropolitan area

adapted from Blood, 15 June 2008, Vol. 111, No.
12, pp. 5440-5445.
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Triage and Patient Monitoring after an IND Event

• TRIAGE
• People requiring immediate medical intervention
  (burns, fractures, blood loss)
• People receiving radiation doses gt 2 Gy (risk of
  hematological ARS)
• Concerned citizens
• Expectant (likely to die)
• Complications Many inhomogeneous irradiations
  (partial body exposures)
• Correct triage and treatment depends on rapid and
  accurate radiation dose estimates
• Currently a multi-parametric approach is used to
  estimate radiation dose
• Location relative to event
• Time from event to first emesis
• Peripheral blood lymphocyte counts depletion
  kinetics (hours to days)
• The utility of these measures in response to an
  IND event is not clear.

NO mass casualty biodosimetry capabilities at
this time
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Current Biodosimetry Capacity

• Biodosimetry capability will be integral to
  triage, treatment, and medical management of
  radiation-exposed individuals.
• Dose evaluation based on clinical signs and
  symptoms can lead to a high level of false
  positives and lead to unneeded treatment.
• The "gold standard" for biodosimetry is
  chromosomal aberrations (i.e. dicentrics).
• Dicentric quantification
• requires several days to perform
• is labor intense
• is only available in specialized centers (a
  Laboratory Response Network is in development).
• Immediate need Rapid dose assessment tools or
  bioassays.

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CBRN Dosimetry Objectives

• Pursue diagnostic capabilities for dose
  determination
• Physical dosimetry tools for exposure
• Rapid biodosimetry assays to estimate doses gt2 Gy
• Rapid biodosimetry assays to determine dose 1
  20 Gy
• Gold standard assays using novel biomarkers
• i.e. organ-specific radiation
  injury/susceptibilities
• Rapid determination of radionuclide exposure and
  body burden

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ANY QUESTIONS?????
Contact Information BARDA_at_hhs.gov www.hhs.gov/asp
r/barda www.medicalcountermeasures.gov