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UNCLASSIFIED BARDA’s Role in Incentivizing Medical Countermeasure Research and Development Julio Barrera-Oro, PhD Project Officer, Burn Medical Countermeasures Biomedical Advanced Research and Development Authority (BARDA) 2019 CBRN Defense Conference & Exhibition Wilmington, DE July 23, 2019

BARDA’s Role in Incentivizing Medical Countermeasure Research … · 2019-08-08 · UNCLASSIFIED BARDA’s Role in Incentivizing Medical Countermeasure Research and Development

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Page 1: BARDA’s Role in Incentivizing Medical Countermeasure Research … · 2019-08-08 · UNCLASSIFIED BARDA’s Role in Incentivizing Medical Countermeasure Research and Development

UNCLASSIFIED

BARDA’s Role in Incentivizing Medical Countermeasure Research and Development

Julio Barrera-Oro, PhDProject Officer, Burn Medical Countermeasures

Biomedical Advanced Research and Development Authority (BARDA)

2019 CBRN Defense Conference & ExhibitionWilmington, DE

July 23, 2019

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2Saving Lives. Protecting Americans.UNCLASSIFIED

U.S. Department of Health & Human

Services

Assistant Secretary for

Preparedness & Response

Biomedical Advanced Research

& Development Authority

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3Saving Lives. Protecting Americans.UNCLASSIFIED

ASPR Mission

Save Lives and Protect

Americans from 21st Century

Health Security Threats

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4Saving Lives. Protecting Americans.UNCLASSIFIED

ASPR Priorities for Building Readiness for 21st Century Threats

Strong Leadership

Regional Disaster Health

Response System

MedicalCountermeasures

Enterprise

PublicHealth

SecurityCapacity

BOTULISM

GLAN

DERS

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5Saving Lives. Protecting Americans.UNCLASSIFIED

The BARDA Model

BARDA develops and makes available medical

countermeasures (MCMs) by forming unique public-private

partnerships to drive innovation off the bench to the patient to

save lives.

Flexible,nimble

authorities

Multi-yearfunding

Cutting edgeexpertise

Facilitatepartnerships

Promoteinnovation

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6Saving Lives. Protecting Americans.UNCLASSIFIED

Our Government Partners

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Our Industry Partners

Page 8: BARDA’s Role in Incentivizing Medical Countermeasure Research … · 2019-08-08 · UNCLASSIFIED BARDA’s Role in Incentivizing Medical Countermeasure Research and Development

8Saving Lives. Protecting Americans.UNCLASSIFIED

H5N1 Adjuvanted Pandemic Vaccine for Pediatrics (Q-Pan®)

H5N1 Pandemic Vaccine w/ Adjuvant (Q-PAN®)

Influenza Virus A/B Rapid Diagnostic (LIAT®)

45 FDA Approvals, Licensures, and Clearances

H1N1 DiagnosticH5N1 Vaccine

H1N1 Vaccine (Fluzone®)

Influenza Diagnostic

Zika Diagnostic

C. Diff Diagnostic

2007 2009 2011 2012 2013 2014 2015 2016 2017 2018 2019

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9Saving Lives. Protecting Americans.UNCLASSIFIED

Products supported

Products added to the Strategic National Stockpile

Products taken to FDA approval/licensure/clearance

Project BioShieldA COMMITMENT

271510

RECELL

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10Saving Lives. Protecting Americans.UNCLASSIFIED

21st Century: An Increasingly Complex & Dangerous World

BOTULISM

GLA

NDE

RS

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11Saving Lives. Protecting Americans.UNCLASSIFIED

CBRN Priority Investment Areas

Develop innovative rapid response capabilities to address unknown threats

Repurpose products to treat injuries from radiological, nuclear and chemical threats

Invest in new antibacterial agents, vaccines and rapid point of care diagnostics

Deliver countermeasures against chemical and viral hemorrhagic fever threats

Stockpile at least one

countermeasure for all threats

that have a material threat determination

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12Saving Lives. Protecting Americans.UNCLASSIFIED

FUNDERS

ALLIANCE PARTNER

OTHER PARTNERS & ACCELERATORS

Biopharmaceutical accelerator: Model partnership to support innovation and early R&D

ADMINISTRATION

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13Saving Lives. Protecting Americans.UNCLASSIFIED

BARDA Division of Research, Innovation, and Ventures (DRIVe)

DRIVe Mission: Transforming Health Security Accelerate the research, development, and availability of transformative countermeasures to protect Americans from natural and intentional health security threats.

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14Saving Lives. Protecting Americans.UNCLASSIFIED

BARDA Has Had a Successful Decade

Formed strong partnerships with over 250 industry

partners

Supported 45 FDA licensure/

approvals across 40 different

medical countermeasures

Supported 27 different projects

under Project BioShield,15

products added to the Strategic

National Stockpile,10 FDA licensures

Significantly expanded

domestic vaccine production

capacity: 60 M doses to 600 M

antigen doses for influenza

Accelerated antibacterial

product development to address critical vulnerabilities

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15Saving Lives. Protecting Americans.UNCLASSIFIED

How to Contact BARDA

www.phe.gov/BARDAProgram description, information,

news, announcements

www.fbo.gov/(“FedBizOpps”)

Official announcements and info for all government contract solicitations

www.drive.hhs.govDRIVe questions

www.usajobs.govJoin the team!

medicalcountermeasures.gov

Portal to BARDA: Register to request a TechWatch meeting!

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16Saving Lives. Protecting Americans.UNCLASSIFIED

Our People Are Our Success