From CARB-X To DRIVe · 2019. 1. 28. · on a single slide that’s readable! ... GYROX CZ-02 Debio1453 Helical AMP Non-BL PBPI TOPESKAPE FG-LpxC Pyrrolocytosines SMT-571 Series VNRX-PBP

From CARB-X To DRIVeHow BARDA is Building Novel Public-Private Partnerships with Non-

Dilutive Funding to Foster Disruptive Innovation to Enhance National

Health Security

Tyler Merkeley

DRIVe Director (Interim)

Non-Dilutive Funding Summit

January 9, 2019

DRIVe.hhs.gov

drive.hhs.gov

2Saving Lives. Protecting Americans.

SAVE LIVES,

PROTECT

AMERICANS


ASPR Mission


The BARDA Model

BARDA develops and makes

available medical

countermeasures (MCMs) by

forming unique public-private

partnerships with industry

partners


BARDA Seeks Innovation in Science

and in the Way We Do Business

OTA Portfolio

PartnershipCollaborations

Xccelerator

“X –Model”

Non-Clinical Studies Network

Broad Agency

Announce-ment

Medical Countermeas-

uresInnovation Partnership

(MCIP)


Est. 2018

Est. 2016


The Power of Non-Dilutive Investments

Often overlooked non-financial benefits

✓ A committed partner looking at a non-financial value proposition (e.g., preparedness)

✓ Scientific and Business due diligence

✓ Free consulting support

✓ Technical oversight

✓ Interim milestone funding decisions

✓ Access to internal knowledge and industries lessons learned

Access to funding to support R&D without financial strings attached:

✓ No equity positions

✓ No loans or convertible loans

✓ No requirement for revenue sharing

✓ Maintain your IP


CARB-X – The World’s Largest Global PPP to Accelerate

Antibacterial Innovation

Projects are selected through a competitive process by panels of experts.

Funded projects are supported by a network of world-class accelerators.


EOI

#2

+350

EOI #1

Expression of Interest

• Written Application

Short Form


Long Form


• Oral Presentation

Funding Decision

• Joint Oversight Committee

Powered By

CARB-X

• Non-Dilutive Funding

• Technical & Business Support

Graduate from CARB-

X

• Obtain follow-on external public and/or private investment

CARB-X State of Play: January 2017


What is in the CARB-X Portfolio?

Rapid Fire Overview

Visit www.CARB-X.org for the most up-to-date portfolio

http://www.carb-x.org/


* includes Spero Therapeutics, which graduated in 2Q2018

So many products - they no longer fit

on a single slide that’s readable!


Ten New Classes of Antibiotics

GYROX CZ-02 Debio1453 Helical AMP Non-BL PBPI

FG-LpxCTOPESKAPE Pyrrolocytosines SMT-571 Series VNRX-PBP


Eleven Candidates with New Molecular Targets

CZ-02 Debio1453 FG-LpxCLysinsCD201PEI

Pyrrolocytosines SMT-571 VIS-705INBRX-111 T3SS


Nineteen Small Molecules


Ten Nontraditionals and One Vaccine

PEI

T3SS

CD201 Lysins INBRX-111Amicidin-β IBT-V02

VIS-705SCB-102 SER-155 VE303

Immunotherapeutics, ADCs, microbiome, lysins


Five Diagnostics

Rapid/BSIOptical Bacterial

ImagingSPECIFAST T2MR

POC DX FOR

NG/CT


Five Therapeutic Candidates Achieved Clinical

Development

Oral Bl-BLI

combination

Oral and IV

penem

*Antibiotic

potentiator

Next generation

tetracycline

Microbiome

therapeutic

*Graduated from Powered by CARB-X portfolio in 2Q2018


Private Investment Followed CARB-X Funding

Every $1 that CARB-X invested in

Powered by CARB-X projects was

followed by $8.7 in private funding

$15.0M $20.0M

$40.0M $106.9M $15.0M

$93.1M

$65.0M $42.0M $46.7M$52.6M

$20.0M $123.2M $158.6M

$9.0M


CARB-X’s ability to:

✓ Populate a diverse R&D portfolio of antibacterial candidates

✓ Develop a network of R&D capabilities and technical support

✓ Perform the function of an Accelerator

✓ Progress antibacterial candidates in preclinical development

✓ Support business needs of innovators

How will we measure the success of

CARB-X?

Leadership naturally asks?

“WHAT’S next”….

“Why can’t we leverage

the accelerator model for

all BARDA?”


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.



Our Guiding Principles

EMPOWER

DECENTRALIZE

URGENCY

COLLABORATIVE

SCALEABLE

DISRUPTIVE


Response Framework

Identification/Characterize

What is it, is it drug resistant, are certain

subpopulations more susceptible, will it

become an epidemic?

Situational Awareness/Recognize

How do we know something is

happening, an agent has entered

the community?

Design

How do we stop the spread of

the disease? Drugs, vaccines,

PPE, social distancing?

Produce

On demand

manufacturing of X.

Administration

Everyone who needs X

is provided.

Validate

Methods under design are evaluated,

clinical trials, non-clinical trials,

epidemiology, surveillance.

Distribute

Novel ways to get

product/information to those

who need it.


Our goal is to transform health security innovation to

protect Americans from 21st-century health security threats

DRIVE IS A BOLD NEW APPROACH TO THE POWER OF

COLLABORATION AND INNOVATION


ACCELERATORLAUNCH/

VENTURESDRIVE-X


The DRIVe Accelerator Network

Seattle, WA

Los Angeles, CA

Houston, TX

New Orleans, LA

Raleigh, NC

Philadelphia, PA

Long Island, NY

Lowell, MA


Impact Areas

DRIVe is looking for new approaches, innovative clinical management strategies, detection technologies,

diagnostic platforms, application of biological indicators (chemical, physical, molecular, immunological,

serological), and diagnostics. Opportunities could include non-dilutive funding and/or dilutive funding through

DRIVe Launch or DRIVe Ventures.


OTHERSENACT SEPSIS


• Infectious disease agents, such as influenza, are a significant threat to health security

▪ CDC estimates that influenza infections have led to up to 710,000 hospitalizations and up to

56,000 deaths annually since 2010

▪ A pandemic strain could

cause millions more deaths

▪ Novel diseases can spread

in communities undetected

• Late or no diagnosis prevents

best use of medications,

contributes to spread of

infectious diseases in

communities, and delays in

public health response in an

emergency


• Empower patients & healthcare providers

• Reduce impact

• Reliable data to inform outbreak response

• Bring innovation into the home and on the person

Early, Actionable Information is Needed


SOLVING

SEPSISIn the event of a bio

attack or pandemic, all

roads potentially lead

to sepsis.



Why is DRIVe taking on Sepsis?

MORTALITY

Americans die

each year

are discharged

to hospice

MANAGEMENT

patients who die

in hospital have

sepsis

ECONOMIC

BURDEN

responsible for

nearly

Billion$24

Annually(6.2% of hospital costs)

MORBIDITY

each year in

U.S.

CDC.gov


Program Vision

PUBLIC AWARENESS

• Virtual partnerships

• Patient and clinician

decision support toolkits

PREDICTION DIAGNOSIS PROGNOSIS TREATMENT

• Redirect host

response, restore

homeostasis

• Individualized

plans

RECOVERY

• Prevent hospital

readmission• Machine learning algorithms

• Host-based biomarker

identification

• POC/wearable device

• AI clinical

prediction/management

• Continuous Monitoring

Devices/integrated feedback

• Data enclave access


Bringing It All Together

Driving Life-Saving Innovation

Impact

Areas DRIVe Partnering Model

TRADITIONAL

PRODUCT

DEVELOPMENT

Hit - Lead OP

Feasibility & OP

Development

Preclinical

Development

Product

Development

Clinic

Clinical

Evaluation Market

TRADITIONAL VC FUNDING Friends & Family Angel Series A Series B Series C IPO

DRIVe-LaunchDRIVe VC FUNDING

DRIVe R&D Support

Augmenting other USG Partners (NIH/DOD)

DRIVe-X

Solve

Sepsis

ENACT

DTRABARDA ARD BARDA PBS MCSNIH FDA


Augmenting other USG Partners


San Francisco, CA

HEALTH TAGWear and forget health tracker that invisibly monitors

respiration, heart rate, sleep, and other markers.

Chicago, IL

PREDICTIVE ANALYTIC ASSAYValidation of sepsis biomarker assays with the

potential to incorporate into a point of care device.

Allen, TX

SWEATSENSER DxLeveraging sweat to tell you you're sick

before you feel sick.

Philadelphia, PA

SEPSIS BIOMARKER

DETECTION ASSAYElectrochemical proximity assay for rapid detection

of a promising sepsis biomarker

Israel

FLU WEARABLE MONITORING

DEVICEBodily changes that signal the user has been

exposed to an influenza virus or other pathogen

San Francisco, CA

DEFORMABILITY CYTOMETRY

DIAGNOSTIC5 minute, easy to use, point of care diagnostic for

measuring immune cell dysregulation associated

with sepsis


Stay in touch with us!

Saving Lives. Protecting Americans.

Program Managers

Julie Schafer, PhD, MPH, MS

ENACT Acting Program Manager

[email protected]

Kimberly Sciarretta, PhD

Solving Sepsis Acting Program Manager

[email protected]

Donna Boston, MS

Accelerator Network Program Manager

[email protected]

Links

Learn more about DRIVe

www.DRIVe.hhs.gov

Official announcements and info on all

government contract solicitations

https://www.fbo.gov/


mailto:[email protected]



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

https://www.fbo.gov/

https://twitter.com/barda

https://www.linkedin.com/showcase/barda/

https://www.facebook.com/phegov/?tn-str=k*F


WILL YOU BE?


DRIVe.hhs.gov

drive.hhs.gov

Documents

From CARB-X To DRIVe · 2019. 1. 28. · on a single slide that’s readable! ... GYROX CZ-02 Debio1453 Helical AMP Non-BL PBPI TOPESKAPE FG-LpxC Pyrrolocytosines SMT-571 Series VNRX-PBP