division of research, innovation and ventures (drive)

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


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


Addressing End to End Solutions

Identify/

Characterize

Situational

Awareness/RecognizeDesign Production Administration

Validation Distribution


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


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


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


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.


– 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.


• 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


Early Notification to Act Control & Treat

(ENACT)

Justin Yang, Acting ENACT PM

October 16, 2019


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


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


Integration into Daily Life


Over the Counter Tests, Made for Everyone

20 25 30 35 40 45 50-0.2-0.10

0.10.2


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)


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


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


#TeamENACT!

Justin Yang

Acting ENACT Program Manager

[email protected]

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


DRIVe Solving Sepsis Program

Kimberly Sciarretta, PhD

October 16, 2019


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


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


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


• 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


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


BARDA is Working Across Government towards

Solving Sepsis


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


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


Kim Sciarretta, PhD

Solving Sepsis Program Manager

[email protected]

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


DRIVe’s Other Disruptive Innovations

Program

Donna Boston

October 16, 2019


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


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


#DRIVeODI – The Team

Program Manager:

Donna Boston

[email protected]

Technical Advisors:

Prakash Rao, PhD

Dev Mittar, PhD


The Accelerator Network

Donna Boston

October 16, 2019


• 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.”


• 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


2019 DRIVe Accelerator Network


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


• 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


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.)


DRIVe Accelerator Network – The Team

#DRIVeInnovation, #Health Security

Program Manager:

Donna Boston

[email protected]

Technical Advisors:

Abid Siddiqui

Rowan Cade


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)


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!

http://www.phe.gov/BARDA

http://www.fbo.gov/

http://www.drive.hhs.gov/

http://www.medicalcountermeasures.gov/

http://www.usajobs.gov/

division of research, innovation and ventures (drive)

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