BARDA: Investing in the Future

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BARDA Investing in the Future of Medical and
Biological Engineering AIMBE Federal
Symposium Washington, DC September 15, 2008
Dr. Robin Robinson Director HHS/ASPR/BARDA

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HHS Public Health EmergencyMedical
Countermeasures Enterprise
National Biodefense Science Board
BARDA and CDC
CDC
BARDA
CDC and OPEO
NIH
FDA
Research and Development
Advanced Development
Surveillance/Storage/Maintenance
Utilization
Deployment
Acquisition
PHEMCE COORDINATED PLANNING EXECUTION
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Whats BARDA

• BARDA (CBRN PI ED)MCM
• Coordination PHEMCE Enterprise
• Advanced development
• Stockpile procurement establishment
• Manufacturing infrastructure building
• Innovation

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Federal Planning and Funding Initiatives
BARDA
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CBRN MCM Product Portfolio
rPA Vaccine
Oral DTPA
Vaccines Stability Immune Enhancement
Animal Models
Anthrax
Rad/Nuc
Hu-Polyclonal
Cutaneous, Lung Injuries
Monoclonal Ab Rx
ARS Biodosimetry
2.1 B
Antiviral (ST-246)
Inhalational Gentamicin
Small- pox
Antivirals
Broad Spectrum
Antimicrobials
Platforms
Chem
Midazolam
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Pandemic Influenza Product Portfolio
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Retrofitting Existing Vaccine Manufacturing
Facilities

• Program goal is to renovate U.S. existing
  manufacturing facilities of licensed biologicals
  for manufacturing of pandemic influenza vaccine
  and provide warm base manufacturing capacity that
  will increase pandemic influenza vaccine
  manufacturing capacity by 11
• Two contracts awarded June 2007 for 133 M with a
  minimum mfg. capacity requirement of 100 M
  vaccine doses within 6 mos. Of pandemic onset
• Contract to sanofi pasteur for renovation of
  existing U.S. egg-based inactivated influenza
  vaccine (Fluzone) bulk manufacturing facility
• Contract to MedImmune for renovation of existing
  U.S. egg-based live, attenuated influenza vaccine
  (FluMist) bulk, fill-finish, and distribution
  manufacturing facilities

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Construction of New Cell-based Vaccine
Manufacturing Facilities

• Program goal is to establish new U.S. cell-based
  vaccine manufacturing facilities for seasonal,
  pre-pandemic, and pandemic influenza and emerging
  diseases and provide warm base manufacturing
  capacity that will increase U.Sgt pandemic
  influenza vaccine manufacturing capacity by
  50-60
• Contracts awards expected by Dec.. 2008 with
  minimum mfg. capacity requirement of 150 M
  pandemic vaccine doses within 6 mos. of pandemic
  onset
• Cost Sharing maximum 40 USG minimum 60
  Contractor
• Pandemic vaccine price will be based annually on
  actual cost for manufacturing of commercial scale
  manufacturing of pre-pandemic influenza vaccine
  plus a fixed management fee (10) for 20 years
• USG will purchase the first 150 M doses direct
  sale of remaining pandemic vaccine

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Diagnostics Advanced Development

• Two Projects (6 contracts - 65 M with CDC)

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Point of Care Influenza Diagnostics

• GOAL
• Facilitate development of 30 minute point-of-care
  diagnostics towards U.S.-approval for detection
  of pandemic flu viruses
• Detect and differentiate influenza A H5N1 from
  seasonal influenza
• Dec. 06 Contracts awarded
• Cepheid GeneXPert Flu Assay (Terminated Aug.
  07)
• Iquum LAIT -- Lab-in-a-Tube (Terminated May
  07)
• MesoScale Multi-Array Detection
• Nanogen Point of care immunoassay system

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Other Engineering Endeavors

• Biodefense industrial base
• Other influenza products Antivirals,
  Antibodies, Ventilators
• Biosafety, Biosecurity, Bioassurance
• USG-sponsored bioproduction/development facilties
  - analysis

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• This event will bring together public and private
  stakeholders for a dynamic dialogue on
• BARDA Strategic Plan unveiling
• Countermeasure Preparedness and PHEMCE
  Initiatives
• Cutting Edge Medical Countermeasure Research and
  Development
• Distribution and Utilization of Medical
  Countermeasures at the Point of Care
• NEW! BARDA Industry Afternoons and Evening
  Poster Sessions

Registration and Call for Abstracts Now
Available http//www.hhs.gov/aspr/barda/
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Contact Us

• BARDA
• URL www.hhs.gov/aspr/barda/
• E-Mail BARDA_at_hhs.gov
• Upcoming Events
• Acquisitions
• BioShield
• Influenza Programs

• Federally-sponsored conferences
• Funding opportunities
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