20190625_DRIVe Accelerator Network Pre-App Tcom_FINAL.pdf

Unclassified/For Public Use

The DRIVe Accelerator Network

HHS/ASPR/BARDA

Pre-Application Teleconference Funding Opportunity #EP-IDS-19-003

June 25, 2019 https://www.grants.gov/web/grants/view-opportunity.html?oppId=316344

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Agenda

• Background of ASPR, BARDA, and the DRIVe Program

• Purpose of the DRIVe Accelerator Network

• Application process and deadlines

• Execution and expectations

• Q&A – open discussion

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Background of ASPR, BARDA, and DRIVe

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ASPR Mission

Save Lives and Protect

Americans from 21st Century

Health Security Threats

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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-year funding

Cutting edge expertise

Facilitate partnerships

Promote innovation

Our Industry Partners

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Our Government Partners

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BARDA MCM Program Divisions

Biomedical Advanced Research & Development Authority (BARDA)

Influenza & Emerging Infectious Diseases

CBRN Program Detection, Diagnostics, & Device Infrastructure

DRIVe

Pharmaceutical Countermeasure

Infrastructure

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21st Century: An Increasingly Complex & Dangerous World

BOTULISM

G

LA

N

DE

RS

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Addressing End to End Solutions

Identify/ Characterize

Situational Awareness/Recognize

Design of MCMs

MCM

Production

Administration of MCMs

Validation of MCM

MCM

Distribution

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Accelerate Innovation

21st CENTURY CURES ACT

INNOVATION LAUNCH

BARDA

CONTRACTING

MCIP

Medical Countermeasure

Innovation Partnership

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Division of Research Innovation and Ventures (DRIVe)

DRIVe connects the dots between industry, academia, non-profits, and government

LEVERAGE

BARDA’s experience and success in MCM development

CATALYZE

Industry and government in response to urgent threats

EMPOWER

Non-traditional partners with disruptive ideas in health security

INNOVATE

Strategies to get disruptive ideas to the market faster

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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.

ACCELERATOR

NETWORK

LAUNCHDRIVE-X

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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

Early, actionable information to alert end users of potential pathogen exposures prior to the user being aware that they are ill.

SEPSIS

Reducing the incidence, morbidity, mortality and cost of sepsis by investing in key strategic areas

OTHERS

Extremely bold, radical, and disruptive innovative solutions that will have the ability to transform health security.

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Purpose and Description of the DRIVe Accelerator Network

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The DRIVe Accelerator Network

PHILADELPHIA, PA

NEW ORLEANS, LA

LONG ISLAND, NY

RALEIGH, NC

SEATTLE, WA

BOSTON, MA

LOS ANGELES, CA

HOUSTON, TX

The DRIVe Accelerator Network is working with regional accelerators to identify promising innovation and provide wraparound technical and business development support servicesACCELERATOR

NETWORK

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Purpose of Accelerator Network

• BARDA plans to partner with Accelerators to:

Build the pipeline and identify promising products and technologies of interest to address BARDA’s National Health Security Initiative Amplify BARDA’s initiatives through existing outreach mechanisms Provide wrap-around support to DRIVe partners:

Technical and business advice/acumen/support Project-specific or common needs across projects

Cultivate the community of experts: network and team-build Researchers, industry leaders, academia, “deep thinkers”

Leverage existing physical and/or virtual environments that are programmed to increase collaboration and spur innovation

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Accelerator Network Structure

Accelerator in Region #1

Accelerator in Region #2

Accelerator in Region #3

BARDA DRIVe (Oversight/Guidance)

R&D incubator spaces

Industry forums, networking events

Life science, biotech expertise

Financial, business, and operational mentorship

Prospecting/Outreach:

who are the innovators in your region?

etc…

Cooperative Agreements

Services Provided:

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Accelerator Network Expansion

Regions of Interest Ineligible Regions Atlanta, GA Houston, TX

Baltimore, MD Long Island, NY Chicago, IL Los Angeles, CA Denver, CO Lowell, MA Dallas, TX New Orleans, LA

Indianapolis, IN Philadelphia, PA Kansas City, MO Raleigh, NC Minneapolis, MN Seattle, WA

San Francisco Bay Area, CA Spokane, WA

Washington, DC

* Applicants not based in one the identified regions of interest and NOT located within an ineligible region may still apply under “Other Regional Hubs.”

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Cost Share Requirement

• BARDA DRIVe envisions that every $1 of funding from BARDA DRIVe to each accelerator in the DRIVe Accelerator Network will be matched with $1 to $2 of non-dilutive funding contributed by the accelerator (may include in-kind support services).

• All match funds must follow the same cost principles and regulations that are used for Federal funds – to count as match you must be able to use Federal funds to purchase the item.

• Examples of in-kind support Labor/personnel Fringe benefits Equipment/supplies

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Application Process

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Application Process https://www.grants.gov/web/grants/view-opportunity.html?oppId=316344

• Applications DUE July 23, 2019 by 11:59 p.m. EDT

• Registration procedures (see pages 16-17 of FOA)

Register with (and submit applications thru) www.Grants.gov Register with Central Contractor Registration Obtain DUNS number Register in the System for Award Management

• Review Funding Opportunity Announcement for details on content to include in application

• Resulting awards will be Cooperative Agreements with HHS/ASPR/BARDA and AMCG https://www.grants.gov/web/grants/view-opportunity.html?oppId=316344 http://www.grants.gov/

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Review Criteria

Five areas of scoring:

See Section V (pages 22 – 24) of the Funding Opportunity Announcement

1. Technical Approach Foster, identify promising early stage R&D Foster a physical and virtual environment to increase collaboration and spur innovation Support business and entrepreneurial needs of innovators, provide wrap-around support capabilities Leverage best practices

2. Organizational Capability and Experience Does the applicant have experience:

Establishing/maintaining a network of R&D capability and tech support?

Performing functions of accelerator?

Successfully identifying and transitioning candidates for follow-on investment?

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Review Criteria, continued

Five areas of scoring (continued):

3. Key Personnel

Does Key Personnel have capability and experience of:

Evaluating early stage technologies?

At least one full-time employee (90%) on DRIVe initiative?

4. Ability to Leverage Incentives Prior experience with bringing multiple parties together, forming alliances, identifying external funding opportunities?

5. Geographic Location

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Execution and Expectations

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Key Performance Parameters (KPPs)

KPP Top-Level Metrics Threshold

(Minimally Acceptable Performance)

Objective (Optimal or Ideal Level of

Performance) Geographic

Location DRIVe Accelerator Network includes an active accelerator in one of each of the desired US regions

An active accelerator in one of the identified desired regions

One active accelerator in each of the identified regions with additional accelerators added to other regions across the country with strong biotech/medtech innovation

A Network of R&D capabilities and

Technical Support

The ability of the accelerator to select, foster, advance and transition product candidates requires sufficient network of internal and external R&D capabilities

The accelerator must maintain minimal paid or volunteer R&D advisor consultants to provide technical support to BARDA DRIVe product developers

A diversified network of R&D advisors and consultants to provide quality R&D research and development support services to BARDA DRIVe product developers

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KPP Top-Level Metrics Threshold

(Minimally Acceptable Performance)

Objective (Optimal or Ideal Level of

Performance) Perform the functions of an Accelerator

The accelerator must have the structure, policies and experience to function in the role of a traditional accelerator but with specific expertise in health security innovation.

An established entity operating under an accelerator model with a track record of successfully transitioning R&D products from “Proof of Concept,” prototype, product candidate selection and finally transitioning [graduating] the innovator for external product development.

An established accelerator with a proven track record of successfully transitioning R&D products from “Proof of Concept,” prototype, product candidates, through selection and finally transitioning [graduating] the innovator for external product development.

Supporting the Business Needs of

Innovators

The ability of the accelerator to provide wrap-around support capabilities and services (e.g.

technical, strategic, operational, legal, business, access to stakeholders.) to ensure innovators have access to the necessary resources to foster success.

Accelerator to provide strategic, regulatory, operational, legal and business development support services to innovators after selection through graduation.

The accelerator will provide introductions to follow-on support and/or R&D transition partner prior to graduation from accelerator.

Accelerator to provide strategic, regulatory, legal and business development and support services to innovators after selection through graduation.

The innovator will secure follow-on support and/or R&D transition partner prior to graduation from accelerator.

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Reporting Table If selected for award, accelerators will be expected to report monthly, including:

Reports Report Description Reporting Procedures and Due Dates

Conflict of Interest (COI) Report and

Plan

The accelerator will provide a COI plan within 30 days of award and provide annual report on their compliance with the plan.

• The accelerator will submit their COI plan by e-mail or other electronic format to be provided by BARDA coinciding with their first monthly report, and on 20th day of the month after the end of the first year

Monthly Activity Report and

Information Capture on Innovation

Opportunities and Portfolio Progress

On a monthly basis, the accelerators will:

1. Report activity/progress toward milestones

2. Report key DRIVe Accelerator Network metrics

3. Describe next three months plan

4. Capture innovation opportunities and product developer portfolio progress on accelerator’s objectives on a regular basis, but not less than monthly.

• The accelerator will submit to BARDA (.e.g. via BARDA DRIVe Digital Resources) capture information on a regular basis, in the form of a monthly report

Product Transition Strategy

The accelerator shall provide a 1-2 page summary document containing a Product Transition Strategy for each product developer they are overseeing on annual basis, if applicable. The Product Transition Strategy should provide a strategic plan for further development and transitioning the product for follow-on investment after BARDA DRIVe.

• The accelerator shall provide the Product Transition Strategies 30 days prior to the end of each year of the agreement.

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Q&A

BARDA DRIVe Accelerator Network Points of Contact:

Donna.Boston@hhs.gov – Technical

Virginia.Simmons@hhs.gov – Grants Manager mailto:Donna.Boston@hhs.gov mailto:Virginia.Simmons@hhs.gov