driving innovation - medical countermeasures › barda › documents... · 2019-01-30 · vacc (q-p...

October 29-30, 2018 | Grand Hyatt • Washington, D.C.

DRIVING INNOVATION2018 Director’s Report

Rick Bright, Ph.D.

2Saving Lives. Protecting Americans.

Wall Street Journalhttps://www.wsj.com/articles/suspicious-package-found-at-clintons-new-york-home-

1540388652?mod=cx_picks&cx_navSource=cx_picks&cx_tag=contextual&cx_artPos=6#cxrecs_s

ABC Newshttps://abcnews.go.com/US/explosive-device-maxine-waters-la-similar-obama-

clinton/story?id=58737042

3Saving Lives. Protecting Americans.

ASPR Mission

Save Lives and Protect

Americans from 21st Century

Health Security Threats

4Saving Lives. Protecting Americans.

ASPR Priorities for Building Readiness for 21st Century Threats

Strong Leadership

Regional Disaster Health

Response System

MedicalCountermeasures

Enterprise

PublicHealth

SecurityCapacity

BOTULISM

GLAN

DERS

5Saving Lives. Protecting Americans.

National Biodefense Strategy

NATIONAL BIODEFENSESTRATEGY

2018

https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-

Strategy.pdf

6Saving Lives. Protecting Americans.

Five Main Goals of the National Biodefense Strategy

Goal 1Enable risk

awareness to inform decision-

making across the biodefense enterprise

Goal 2Ensure biodefense

enterprise capabilities to

prevent bioincidents

Goal 3Ensure biodefense

enterprise preparedness to

reduce the impacts of

bioincidents

Goal 4Rapidly respond to limit the impacts of

bioincidents

Goal 5Facilitate recovery

to restore the community, the

economy, and the environment after

a bioincident

7Saving Lives. Protecting Americans.

21st Century: An Increasingly Complex gerous World& Dan

BOTULISM

GLA

NDE

RS

8Saving Lives. Protecting Americans.

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

9Saving Lives. Protecting Americans.

New BARDA Partners in FY 2018

10Saving Lives. Protecting Americans.

Our Government Partners

Our Industry Partners

11Saving Lives. Protecting Americans.

12Saving Lives. Protecting Americans.

BARDA’s 2018 Priorities

13Saving Lives. Protecting Americans.

BARDA TechWatch: Accelerating Success

NextSteps

U.S. Government

Industry

Academia

MCMsTechnology

AssaysPlatforms

Models

BARDAKnowledgebase

TechWatchStrategy - ExchangeExpertise - Planning

BARDA Portfolio

Continue Developing in Private Sector

Connect to Other Agencies

14Saving Lives. Protecting Americans.

End of FY17 FDA Approvals, Clearances & Licensures

H5NVacc(Q-P

ic Vaccine w/ AN®)

Influenza Diagnostic

14 2015 20161 Adjuvanted Pandemic ine for Pediatrics an®)

C. Diff Diagnostic

2017 2018 2019

H5N1 PandemAdjuvant (Q-P

Influenza Virus A/B Rapid Diagnostic (LIAT®)

H1N1 DiagnosticH5N1 Vaccine

2007 2009 2011 2012 2013 20

H1N1 Vaccine (Fluzone®)

15Saving Lives. Protecting Americans.

APR2018

JUN 2018

JULY 2018

JULY 2018

AUG2018

AUG2018

SEPT2018

SEPT2018

OCT2017

THERAPEUTICS

New Approvals in FY18

LightMixZika

Molecular DiagnosticZika blood screening

assay

34

LeukineColony

stimulating factor for Rad/Nuc

35

ZEMDRI (Plazomicin)

Broad Spectrum

Antibacterial

36

ProcliexZika Virus

AssayZika blood screening

assay

37

Arestvyr®ST-246

TecovirimatSmallpoxantiviral

38

FlucelvaxProcess 3.0

Influenza Vaccine Mfg

Process

39

XeravaBroad

Spectrum Antibacterial

40

SeizalamSeizures from any cause,

including chemical exposure

41

RECELLDefinitive

treatment of burns

42

PARTNER

16Saving Lives. Protecting Americans.

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

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

Influenza Virus A/B Rapid Diagnostic (LIAT®)

H1N1 DiagnosticH5N1 Vaccine

H1N1 Vaccine (Fluzone®)

Influenza Diagnostic

Zika Diagnostic

C. Diff Diagnostic

2007 2009 2011 2012 2013 2014 2015 2016 2017 2018 2019

FDA Approvals, Licensures, and Clearances

17Saving Lives. Protecting Americans.

NEW Antibiotics

18Saving Lives. Protecting Americans.

BARDA’s First MCM Approved for

Chemical Threats

19Saving Lives. Protecting Americans.

NEW Definitive Care Burn Device

20Saving Lives. Protecting Americans.

Combined BARDA BAA

21Saving Lives. Protecting Americans.

First BARDA Combined OTA

22Saving Lives. Protecting Americans.

First EZ BAA

23Saving Lives. Protecting Americans.

First On-line Pre-proposal Conference

Drive EZ-BAA Pre-Proposal Conference

24Saving Lives. Protecting Americans.

Expanded use of Other Transaction Agreements

25Saving Lives. Protecting Americans.

Accelerate Innovation

21st CENTURY CURES ACTINNOVATION VENTURES

BARDA CONTRACTING

MCIPMedical Countermeasure

Innovation Partnership

27Saving Lives. Protecting Americans.

DriveTransforming the way Government does Business

• Decentralizing idea generation and capture Accelerator Network

• Streamlining acquisition process EZ BAA DRIVe Digital Resources Multiple Award Options

• Multiple program entry points MCIP (coming soon) Accelerator Network EZ BAA

28Saving Lives. Protecting Americans.

29Saving Lives. Protecting Americans.

1918 2009 Future

1918

pons

ese

R & ss

dne

repa

reP

Time

Influenza and Emerging Infectious Diseases

30Saving Lives. Protecting Americans.

CBRN Medical Countermeasures

Hospital Formulary

Cloud Reporting

Diagnosis Appropriate Treatment

PREVENTION MITIGATION

PUBLIC AWARENESS PREDICTION DIAGNOSIS PROGNOSIS TREATMENT RECOVERY

31Saving Lives. Protecting Americans.

32Saving Lives. Protecting Americans.

Addressing End to End Solutions

Situational Awareness/Recognize

Identify/Characterize

Design of MCMs

MCM Production

Validation of MCM

MCM Distribution

Administration of MCMs

33Saving Lives. Protecting Americans.

2019 Priorities

SUSTAIN THE ENTERPRISE

BUILD ON DOMESTIC RESPONSE

CAPABILITIES

CLOSE THE PREPAREDNESS

GAPS

DRIVE INNOVATION

COORDINATE/ ALIGN WITH

DoD AND SNS

Save Lives and Protect

Americans from 21st Century

Health Security Threats