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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