The Pandemic Influenza Countermeasures Portfolio · 2012-04-11 · Help to develop and sustain influenza vaccine ity and pandemic readiness: promote investment; establish partnerships.

The Pandemic Influenza Countermeasures PortfolioCountermeasures Portfolio

Biomedical Advanced Research and Development Authority (BARDA)

Michael Perdue, Ph.D.Michael Perdue, Ph.D.Director, Influenza Division

HHS/ASPR/BARDA

Today:

•Influenza: Virus((es) and disease) (s)

•Consequences of Pandemic InflI fluenza

•USUS response(s)response(s) andand evolutionevolution ofof thethe Pandemic Influenza Portfolio

•BARDA’s Influenza Division

( )

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InfluenzaVirus(es)

Mild URT infectionsMild URT infections

Severe URT Severe URT infectionsinfectionsVViiral pneumoniaral pneumonia

Bacterial pneumoniaBacterial pneumoniaSevereSevere AAcutecuteSevereSevere AcuteAcute RespiratoryRespiratory ddiseaseiseaseRespiratoryRespiratory diseasedisease..

Systemic infectionsSystemic infections

EpidemicsEpidemics ppandemicsandemicsEpidemicsEpidemics, , pandemicspandemics, , sporadic infectionssporadic infections

High risk groupsHigh risk groups

Disease(s)Disease(s)

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1918-19 Influenza

3

Measures of Disease BurdenEstimates of morbidity and mortality 2009 pH1N1 Influenza

A il 2009 A il 2010April 2009 - April 2010

Dead12 469 on

Hospitali ed

12,469

0 po

pula

tio

C

Hospitalized274,304

er 1

00,0

00

Cases60,837,748

4 4 9 4 5

Rat

e pe

0-4

5-24

25-4

9

50-6

4

≥65

Slide courtesy of Lyn Slide courtesy of Lyn FinelliFinelli-- CDCCDC

H1N1 hospitalization rates

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OUR MISSION: Using the influenza virus aggainst itself

AAdvancing science dvancing science and and technology into technology into

countermeasurescountermeasures

6

Slide courtesy of Slide courtesy of D N C CDCD N C CDCDr. N. Cox CDCDr. N. Cox CDC

New Technologies New Technologies advantage? advantage?

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HHS Responses to Influenza Pandemics

Effective Vaccines and Programs-More, Better, Faster

Effective Antivirals and Delivery- Avoiding resistanceEffective Antivirals and Delivery- Avoiding resistance

Sensitive Specific Diagnostics Usage and interpretationSensitive, Specific Diagnostics- Usage and interpretation

Mitigation of Severe Respiratory Impact- Stockpiles, surge, simplicity

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Infrastructure Development-cell based pproduction

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ID International Program Objectives

1. Protect America by reducing risks of influenza epidemics outside our borders-one worldepidemics outside our onehealth.

borders one world one

2.manuffacturiing capabilibilitiies andd capaci dHelp to develop and sustain influenza vaccine

ity and pandemic readiness: promote investment; establish partnerships

3.p pHelp achieve sustainable influenza vaccine

BARDA’s niq e rproduction capacity

eso rcesworldwide by leveraging

BARDA’s unique resources.

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International Capacity BuildingTotal Financial Commitment through 2009: $52 million

• FY 2005 $1 million ASPR funding to Vabiotech-Vietnam•• FYFY 20062006 $10$10 milliillion off emergency suppllementtall

funding to WHO; granted to India, Indonesia, Vietnam, Thailand, Mexico & Brazil

• FY 2007 Funding requested in annual budget; notFY 2007 Funding appropriated

requested in annual budget; not

• FY 2008 $14.4 million of annual funding to WHO; granted to six original grantees plus Egypt, Serbia and Romania.

• FY 2009 $3.6 million to WHO; granted to Russia’s Institute for Experimental Medicine; plus $7.9 million to PATH; and $3.5 for rapid diagnostics to support clinical trials$3 5 for rapid diagnostics to support clinical trials

• FY 2010 $11M to WHO, Universities: Lausanne, NC State, Utah State. Non-profit: IDRI (Seattle)

• FY 2011 $11: WHO, adjuvants, training multiproductFY 2011 $11: WHO adjuvants training, multiproduct manufacturing feasibility

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Serum Institute of India, Pune

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BARDA Influenza Division(Transitional)(Transitional)

Director: Michael Perdue (until July 19)epuD t Di t R b t H bD ty Director: Robert Huebner

Current Staff: 32 (27 FTE 5 Contractors)Current Staff: 32 (27 FTE, 5 Contractors)

5 Divisional Teams: Antivirals; Vaccines-advanced development; Vaccines Stockpiles; Diagnostics/Devices; “International”Vaccines-Stockpiles; Diagnostics/Devices; “International”

BARDA Pandemic Influenza PBARDA P d i I fl Program: > 50 t ff i l di> 50 staff including manufacturing, clinical, regulatory, innovation

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Interfacing with Interfacing with BARDABARDA

•• wwwwww.phe.gov.phe.govProgramProgram descriptiondescription informationinformation── ProgramProgram descriptiondescription, , informationinformation, , newsnews announcementsannouncementsnewsnews, , announcementsannouncements

•• wwwwww.medicalcountermeasures.gov.medicalcountermeasures.gov── PPoortrtaao ao al tl toooo BARD BARDAA── RegisterRegister, request , request a meetinga meeting── TTeech Wch Waatchtch

•• wwwwww.fedbizopps.gov.fedbizopps.gov── OfOfficial ficial announcements and detailed announcements and detailed information about all information about all

governmentgovernment contractcontract solicitationssolicitationsgovernmentgovernment contractcontract solicitationssolicitations

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