Post on 07-Nov-2021
October 15-16, 2019 | Washington, D.C.UNCLASSIFIED
Division of Research, Innovation and
Ventures (DRIVe)
Gary Disbrow – Interim DRIVe Director
October 15-16, 2019
2Saving Lives. Protecting Americans.UNCLASSIFIED
Accelerate Innovation
21st CENTURY CURES ACT
INNOVATION LaunchBARDA
CONTRACTING
MCIPMedical Countermeasure
Innovation Partnership
3Saving Lives. Protecting Americans.UNCLASSIFIED
BARDA Program Divisions
Medical Countermeasures (MCM)
Program
Influenza & Emerging
Infectious Diseases
Chemical, biological,
radiological and nuclear
(CBRN) Program
Detection, Diagnostics, &
Device Infrastructure
Division of Research, Innovation,
and Ventures (DRIVe)
Pharmaceutical
Countermeasure
Infrastructure
4Saving Lives. Protecting Americans.UNCLASSIFIED
Addressing End to End Solutions
Identify/
Characterize
Situational
Awareness/RecognizeDesign Production Administration
Validation Distribution
5Saving Lives. Protecting Americans.UNCLASSIFIED
Division of Research Innovation and Ventures
(DRIVe)
DRIVe connects the dots between innovators,
industry, academia, non-profits, and government
LEVERAGEBARDA’s experience and
success in MCM
development
CATALYZEIndustry and government
in response to urgent
threats
EMPOWERNon-traditional partners
to connect with DRIVe
members
INNOVATEStrategies to get
disruptive ideas to the
market faster
6Saving Lives. Protecting Americans.UNCLASSIFIED
DRIVe IS A BOLD NEW APPROACH TO ENHANCE THE
POWER OF COLLABORATION AND INNOVATION.
Our goal is to transform health security innovation to
protect Americans from 21st-century health security threats.
DRIVe-X
Accelerator
Network BARDA Ventures
7Saving Lives. Protecting Americans.UNCLASSIFIED
DRIVe-X
Hyper-focused innovation development program, using non-dilutive funding to address national health security threats
DRIVE-X
EZ-BAA Application process
Request online
account
Fill out online form with
simplified technical
abstract & cost section
Awards in as few as 30
days
8Saving Lives. Protecting Americans.UNCLASSIFIED
Impact Areas
DRIVe is looking for new approaches, innovative clinical management strategies, detection
technologies, diagnostic platforms, and application of biological indicators (chemical, physical,
molecular, immunological, serological) among other novel technologies.
ENACT SEPSIS
Reducing the incidence, morbidity,
mortality, and cost of sepsis.
ODI
Extremely bold, radical, and
disruptive innovative to transform
health security
Early, actionable information to
alert individuals of presymptomatic
detection of illness.
9Saving Lives. Protecting Americans.UNCLASSIFIED
– A Year of Innovation
Decentralized
innovation across
the country with the
establishment of an
network of 13
regional
accelerators.
Created and
developed a division,
now with 29 staff
members with the
goal of disruptive
innovation.
Developed a
streamlined EZ-BAA
application process,
with nearly
245 abstract
submissions with
awards made in as
little as 30 days.
24 awards made in
key areas for Solving
Sepsis, ENACT, &
ODI funded through
$17,935,678.67
DRIVe investments
and $12,676,575.46
in cost-share.
10Saving Lives. Protecting Americans.UNCLASSIFIED
• DRIVe existing 28 partnerships towards disruption
• Identify and invest in new partnerships to transform Health
Security
• Broaden reach of our Accelerator Network
• Launch BARDA Ventures
– What to Expect in 2020
October 15-16, 2019 | Washington, D.C.UNCLASSIFIED
Early Notification to Act Control & Treat
(ENACT)
Justin Yang, Acting ENACT PM
October 16, 2019
12Saving Lives. Protecting Americans.UNCLASSIFIED
Traditional Healthcare Paradigm: Lack of Availability to
Care and Cost of Delays
Cost to the individual• Illness--fever, chills, coughing
• Risk of disease progression,
secondary bacterial infections
• Long wait times
SYMPTOMS
• Difficult to
differentiate
DIAGNOSIS
• Appointment with
healthcare provider
• Wait at clinic or ED
TREATMENT
• Filling prescriptions
• Many treatments
work best when
given early
Costs to the community• Burden on healthcare system
• Loss of Productivity
• Risk of transmission and spread in the community
13Saving Lives. Protecting Americans.UNCLASSIFIED
HEALTHY EXPOSED SYMPTOMATIC ILL MANAGEMENT & RECOVERY
Pathogen and Insult agnostic technology solutions that
bridge the gap between detection of infection and
treatmentENACT
Investment Targets
Bridging the gap in the continuum of response
• Areas of Interest Include:
Novel Diagnostics, Biosensing Technologies,
Wearables, and On-Person Tools
Health Signature Discovery and Validation
Indirect Indicators and Artificial Intelligence
for Prediction
14Saving Lives. Protecting Americans.UNCLASSIFIED
Integration into Daily Life
15Saving Lives. Protecting Americans.UNCLASSIFIED
Over the Counter Tests, Made for Everyone
20 25 30 35 40 45 50-0.2-0.10
0.10.2
16Saving Lives. Protecting Americans.UNCLASSIFIED
Platform Based Technologies – Scalable, Used
During Times of Need
LYMPH
Biomarkers measured before and after ultrasound on subjects exposed to LPS, flu and pneumonia (multiple time points; non-exposed control subjects)
17Saving Lives. Protecting Americans.UNCLASSIFIED
Putting It All Together: ENACT Strategic Framework
ENACT PRODUCT TYPES(Incorporating next-gen wearables, dx, novel biosensing & web-based technologies)
Integrated into Daily
Life
Over-the-Counter
Tests
Fully Integrated +
On Demand
18Saving Lives. Protecting Americans.UNCLASSIFIED
What’s Next: Powered by Artificial Intelligence,
Developed through Machine Learning
−2
−1
0
1
2
0 25 50 75 100
Time
Sig
na
l
Notional example − telemetry
• At its core, its an
anomaly detection
problem…
• Detect deviations
from the baseline
signature Exposure
Symptoms
/PCR
Return to
Baseline
19Saving Lives. Protecting Americans.UNCLASSIFIED
#TeamENACT!
Justin Yang
Acting ENACT Program Manager
ENACT@hhs.gov
Pejman Naraghi-Arani,
PhD
Subject Matter Expert
Jane Bearinger, PhD
Subject Matter Expert
Kerrie DeMarco, PhD
Program Consultant
Carlos Arguello-Ortiz, PhD
Senior Quantitative Analyst
October 15-16, 2019 | Washington, D.C.UNCLASSIFIED
DRIVe Solving Sepsis Program
Kimberly Sciarretta, PhD
October 16, 2019
21Saving Lives. Protecting Americans.UNCLASSIFIED
Influenza
An
thra
x
Pla
gu
e
All Roads
Can Lead
to Sepsis ASPR’s Mission
Save lives and protect
Americans
Sepsis is a secondary confounder that arises
from primary infection or secondary infection
from a primary insult (burn, etc) and threatens
our ability to protect our Nation
22Saving Lives. Protecting Americans.UNCLASSIFIED
ORGAN
DYSFUNCTION
SHOCK
ONSET
T=0
Sepsis
Phenotype
Detectable
Physical Signs
HOSPITAL
ACQUIRED
(<20%)
INFECTION
COMMUNITY
ACQUIRED
(>80%)
PREVENTION
SURVIVAL
Resilience
MORTALITY
RE-
ADMISSION
Sepsis Patient ContinuumEach Red Node is an Opportunity to Intervene
Solving Sepsis is catalyzing approaches for interventions along the entire continuum
23Saving Lives. Protecting Americans.UNCLASSIFIED
Solving Sepsis Strategy
DRIVe Solving Sepsis aims to reduce the incidence, morbidity,
mortality and cost of sepsis by investing in key strategic areas
AWARENESS PREDICTION DIAGNOSIS PROGNOSIS TREATMENT RECOVERY
24Saving Lives. Protecting Americans.UNCLASSIFIED
• Training for healthcare providers
along continuum of care
• Educational material to target
special populations: disaster
medical teams, maternal sepsis
Catalyzing the Field: Progress to Date
AWARENESS DIAGNOSISPREDICTION
• Host-based biomarker panels that detect sepsis of any etiology, inform on sepsis
outcome, distinguish sepsis from infection alone or other inflammatory responses
without infection
• Machine Learning/ Artificial Intelligence to predict risk, identify sepsis early
• Varied healthcare settings: Emergency Department, ICU, general wards
• Data: EHR data, biomarker and other clinical data
• Products: software as a medical device, in vitro diagnostics – bench, near-patient
25Saving Lives. Protecting Americans.UNCLASSIFIED
Catalyzing the Field: Future Focus Areas
PROGNOSIS TREATMENT RECOVERY
• Technologies that address neonatal and pediatric populations (diagnostics, devices)
• Post-sepsis monitoring that detects deterioration to empower patient/provider
• Patient stratification/endotyping for improved health outcomes
• (Prediction/Diagnosis): sepsis in pre-hospital settings
26Saving Lives. Protecting Americans.UNCLASSIFIED
BARDA is Working Across Government towards
Solving Sepsis
27Saving Lives. Protecting Americans.UNCLASSIFIED
Thinking About Solving Sepsis on a National Level
Proposed
Priority Action
1
Unifying Definition (s)
of sepsis along the
patient continuum
Proposed
Priority Action
2
Harmonizing Data for
Access and
Interoperability
Proposed
Priority Action
3
Optimizing Heath
Outcomes and
Reducing Economic
Burden
Proposed
Priority Action
4
Improving Evaluation
and Catalyzing
Adoption of Critical
Technologies
28Saving Lives. Protecting Americans.UNCLASSIFIED
Key Government Partnerships and Expanding!
Partnering in development
of sepsis training modules
and educational tools for
health care professionals
and patients
Developing methods for
analysis in order to provide
a more comprehensive
picture of the current
burdens and challenges
Sepsis is a priority for
HHS Value Based
Transformation (VBT)
Initiative
29Saving Lives. Protecting Americans.UNCLASSIFIED
Kim Sciarretta, PhD
Solving Sepsis Program Manager
SolvingSepsis@hhs.gov
Tim Buchman, PhD MD
IPA Senior Advisor
Steven Simpson, MD
IPA Senior Advisor
Meghan Pennini, PhD
Senior Consultant
Marie Wax, MBA
Senior Consultant
Robyn Woodbury, PhD
Senior Consultant
October 15-16, 2019 | Washington, D.C.UNCLASSIFIED
DRIVe’s Other Disruptive Innovations
Program
Donna Boston
October 16, 2019
31Saving Lives. Protecting Americans.UNCLASSIFIED
Notional Topic Areas for DRIVe’s Other Disruptive
Innovations Program
VACCINE & DRUG
ADMINISTRATION:
Increase compliance
& improve outcomes
CLINICAL DIAGNOSTICS:
Empower individuals and
clinicians with early,
actionable information
DEVELOPMENT &
MANUFACTURING:
Enable rapid drug development
and distributed/decentralized
manufacturing
THERAPEUTICS:
Develop universal
therapeutics with
broad-spectrum
efficacy
• Seeking bold and radical approaches that provide breakthrough solutions
to transform Health Security
• Targeting innovative and commercially-inclined products and technologiesODIN
32Saving Lives. Protecting Americans.UNCLASSIFIED
Projects Powered by DRIVe’s Other Disruptive
Innovations Program
VACCINE & DRUG ADMINISTRATION CLINICAL DIAGNOSTICS
Agnostic Diagnostic of
Respiratory Infections
ImplaVax
DEVELOPMENT & MANUFACTURING
3D Vaccine Printer
33Saving Lives. Protecting Americans.UNCLASSIFIED
#DRIVeODI – The Team
Program Manager:
Donna Boston
Donna.Boston@hhs.gov
Technical Advisors:
Prakash Rao, PhD
Dev Mittar, PhD
October 15-16, 2019 | Washington, D.C.UNCLASSIFIED
The Accelerator Network
Donna Boston
October 16, 2019
35Saving Lives. Protecting Americans.UNCLASSIFIED
• Start-up Company Accelerator: An
organization that provides support
through expertise, mentorship, physical
space, cohort based leaning, and
networking to develop a company or
product more quickly.
What is an Accelerator?
• Definition: noun. “a person or thing that causes
something to happen or develop more quickly.”
36Saving Lives. Protecting Americans.UNCLASSIFIED
• Established June 2018:
Eight biotech/life science accelerators awarded Cooperative Agreements with 1:1 cost sharing
Located in regions with dense biotech activity
Five years in duration, funded annually
• Expanded September 2019:
Added five Accelerators to the network
Increases DRIVe’s exposure to additional product development capabilities
Increased geographic diversity
The DRIVe Accelerator Network - Background
37Saving Lives. Protecting Americans.UNCLASSIFIED
2019 DRIVe Accelerator Network
38Saving Lives. Protecting Americans.UNCLASSIFIED
Four primary objectives of the DRIVe accelerators:
1. Tech Scouting: Deal sourcing of potential unknown solutions
to BARDA’s Areas of Interest
2. The Network Effect: Amplification of BARDA messaging and
needs to untapped talent and solution pools
3. Wrap Around Services: Providing technical and business
advisory services to DRIVe funded companies
1. Physical and/or virtual curriculum
2. Industry leading mentors, investor readiness, product
development tools
3. Build a robust health security focused ecosystem
4. Healthcare Trends: Assist identifying technology trends before
they hit the market
The Accelerator Network extends BARDA’s reach
39Saving Lives. Protecting Americans.UNCLASSIFIED
• Wet and dry lab space
• 3D printing and design facilities
• Clinical research and trial support
• Experts in Residence/mentors
• Fabrication space
• Research reactor
• Medical Device and Innovation Labs access (e.g. J-Labs)
• Administrative services (shared office space, accounting, legal, events)
Example of Accelerator Network Capabilities
40Saving Lives. Protecting Americans.UNCLASSIFIED
How does DRIVe work with the Accelerators?
• Areas of Interest
Source technologies for: Solving Sepsis, ENACT, ODI
• Landscape Reviews
E.g. “Give BARDA a review of [XYZ] technologies”
• Media outreach amplification
E.g “Please let your networks know we are announcing [XYZ] as an area of interest”
• Host events together (e.g. pitch competitions, networking events, etc.)
41Saving Lives. Protecting Americans.UNCLASSIFIED
DRIVe Accelerator Network – The Team
#DRIVeInnovation, #Health Security
Program Manager:
Donna Boston
Donna.Boston@hhs.gov
Technical Advisors:
Abid Siddiqui
Rowan Cade
42Saving Lives. Protecting Americans.UNCLASSIFIED
The Heart of BARDA DRIVe
Lillian Mu
Senior Venture
Consultant
Carlisle Runge
Quantitative Analyst
(Contractor)
Rachel Evans
Program Analyst
Joseph Chapman
Program Manager
Craig Hughes
Chief of Innovation &
Strategic Initiatives
Lydia Michalitsianos
Website Developer
(Contractor)
Rekia Speight
Management Analyst
(Contractor)
43Saving Lives. Protecting Americans.UNCLASSIFIED
Join Our Mission
www.phe.gov/BARDAGet to know BARDA!
www.fbo.gov/(“FedBizOpps”)
Find our solicitations
www.drive.hhs.govMeet our accelerators
and learn about DRIVe
medicalcountermeasures.gov Request a TechWatch meeting!
www.usajobs.gov
Join the team!