FreeMindGroup

@FreeMindGrp

FreeMind Group

Introduction to SBIR and STTRFunding Opportunities

Shira Aharoni Machluf

Director, Business Development

July 5, 2017

FreeMind Group, LLCJuly 5, 2017 2

FreeMind Group

FreeMind Group, LLC

Est. 1999

60 Fulltime Employees

Diverse Client Base:

• Academics, University Medical Centers, and Independent Research Institutes

• Industry – Small Startups to Large Pharmaceutical Companies

~500 Applications Annually

FreeMind Group, LLCJuly 5, 2017 3

A Tool to Maximize Your Funding Potential

FreeMind Group, LLC

• Identify the most relevant funding opportunities

• Strategize to maximize the application’s chance of success

• Manage complex project production processes

• Lead joint application writing

• Support final contract negotiations

Non-Dilutive Funding – A Strategic Financial Tool

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Adapted from the NIH Data Book, www.report.nih.gov

NIH 2017 Budget - $34B

$28,000,000

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Categorical Spending

Adapted from the NIH Data Book, www.report.nih.gov

Cancer - ~$6BNeurosciences - ~$6BInfectious Diseases - ~$4B

FreeMind Group, LLC

Small Business Innovation Research (SBIR)

Small Business Technology Transfer (STTR)

Features of the SBIR and STTR programs (Differences and similarities)

Eligibility criteria for SBIR and STTR applicants

Review various SBIR and STTR funding opportunities

Additional interesting information on the SBIR and STTR mechanisms

July 5, 2017 6

SBIR / STTR

FreeMind Group, LLC

Congressionally-mandated set-aside programs (for 2017 SBIR 3.2% and STTR 0.45% of the budget).

• For domestic small business concerns (SBCs)

(see: www.sba.gov/size)

• Engage in R&D

• Potential for commercialization

The DoD, CDC, FDA, and NSF also have SBIR & STTR programs.

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SBIR & STTR Programs

SBIR / STTR Programs

FreeMind Group, LLC

Mission

“To support scientific excellence & technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy.”

Goals

• Stimulate technological innovation

• Meet Federal R&D needs

• Commercialization of innovations

• Small business growth & development

• Socially and economically disadvantaged SBCs and women-owned business

July 5, 2017 8

SBIR & STTR Mission and Goals

FreeMind Group, LLC

SBIR

• Fuel growth in private sector

• Commercialization of innovations

STTR

• Stimulate a partnership of ideas and technologies between innovative SBCs and non-profit research institutions

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SBIR vs. STTR

Purpose

FreeMind Group, LLC

Only US small businesses are eligible and must meet

all of the following:

• For profit

• Located in the United States

• No more than 500 employees

• At least 51 percent US owned

• VC / Private Equity ownership ok, as long as no one owns more than 50%

July 5, 2017 10

SBIR & STTR Requirements

Requirements

FreeMind Group, LLC

SBIR

• PI must be primarily employed with the SBC

• Permits (encourages) research partnerships

STTR

• Primary employment of the PI is not stipulated

• Requires formal collaboration with a non-profit research institution

July 5, 2017 11

SBIR vs. STTR

Requirements

Must meet eligibility criteria at the time of award!

FreeMind Group, LLC

Phase I

• Establish the technical merit, feasibility and commercial potential of the proposed R&D efforts

• Proof-of-Concept

Awards for:

SBIRs normally do not exceed $225K total costs for 6 months

STTRs normally do not exceed $225K total costs for 1 year

July 5, 2017 12

NIH Phased Program

SBIR / STTRPhase I

FreeMind Group, LLC

Phase II

• To continue R&D efforts initiated in Phase I

• Commercialization plan required

Awards for:

SBIRs normally do not exceed $1.5M total costs over 2 years

STTRs normally do not exceed $1.5M total costs over 2 years

July 5, 2017 13

NIH Phased Program

SBIR / STTRPhase II

FreeMind Group, LLC

Phase IIB or Phase IIB Bridge Award

• To address the funding gap, known as the "Valley of Death," between the end of the Phase II award and the subsequent round of financing needed for commercialization

July 5, 2017 14

NIH Phased Program

SBIR / STTRPhase IIB

FreeMind Group, LLC

Direct to Phase II SBIR

• Receive Phase II award even if they have not previously received a Phase I award

• Must have performed work equivalent to a Phase I

• Not available for STTRs

July 5, 2017 15

NIH Phased Program

SBIRDirect to Phase II

FreeMind Group, LLC

Fast-Track Award

• Both Phase I and Phase II grant applications are submitted and reviewed together as one application

• The NIH Fast-Track mechanism can reduce or eliminate the funding gap between phases

July 5, 2017 16

NIH Phased Program

SBIR / STTRFast Track

FreeMind Group, LLC

NEW TIMELINE GOAL: Funding of > 50% of applications within 6 months!

* Some mechanisms have non-standard due dates

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Important NIH SBIR / STTR Dates

Dates Due DatesPhase I and Phase II

Estimated AwardDate

January 5 July

April 5 Sept or Dec

September 5 March (2018)

FreeMind Group, LLC

Funding Routes

1. Solicited –

Address a specific area of interest

2. Unsolicited –

Investigator Initiated

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Funding Opportunities

2016 NIH Total Awards

Unsolicited % Unsolicited

1,847 1,244 67%

$817.7m $521.9m 64%

FreeMind Group, LLC

Parent AnnouncementsOmnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications

(Parent SBIR PA-16-302)

Phase I: Up to $225,000 up to 6 months

Phase II: Up to $1.5 million up to 2 years

Omnibus Solicitation of the NIH for Small Business Technology Transfer Research Grant Applications

(Parent STTR PA-16-303)

Phase I: Up to $225,000 up to 1 year

Phase II: Up to $1.5 million up to 2 years

July 5, 2017 19

SBIR / STTR Funding Opportunities

NIH, CDC,FDA, ACF

Next Application Deadlines:

September 5

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NSF SBIR / STTR

NSF

Deadlines:December, June

Directorate for Engineering, Industrial Innovation and Partnerships

(Parent SBIR Phase I NSF 17-544)

Funding: Phase I up to $225K for 6-12 months

Phase II up to $750K over 2 years

Scope: Early-stage R&D, for small businesses, based on innovative,

transformational technology with potential for great commercial and/or societal

benefits. The program invites proposals from SBCs across a broad range of

science and engineering disciplines.

Selected Topics: Advanced Materials and Instrumentation (MI), Biological

Technologies (BT), Smart Health (SH), Biomedical Technologies (BM)

See: https://www.nsf.gov/pubs/2017/nsf17544/nsf17544.pdf

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NSF SBIR Program Summary

STTRSBIR

December 2017

June 2018

December 2017

June 2018

Deadline

Phase I: $225K, 12 months

Phase II: $750K, 2 years

Phase I: $150K, 6 months

Phase II: $750K, 2 years

Funding

Minimum 2 calendar months* on

the project

Minimum 1 calendar month* on

the project

PI

Feasibility and commercialization planPhase I

Prototype developmentPhase II

not availablenot availableFast track

*Calendar Month= Amount of time dedicated to working on this project 10% over 12 months = 1.2 calendar months; 10% over 6 months = 0.6 calendar months

FreeMind Group, LLC

Currently, 79 open SBIR/STTR solicitations from the NIH

Examples:

• NIDDK Exploratory Clinical Trials for Small Business (R44)

• NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)

• Development and Commercialization of Technologies to Create, Characterize or Improve Animal Models of Human Disease (R43/R44)

• Novel Genomic Technology Development (R43/R44)

• New Technologies for Viral Hepatitis STTR (R41/R42)

• Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44)

• NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44)

• Novel Tools for Investigating Brain-derived GPCRs in Mental Health Research (R41/R42)

• Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42)

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Solicited SBIR / STTR Opportunities

Solicited

FreeMind Group, LLC

• Overcoming limitations of the SBIR/STTR program – virtual companies

SBIR Phase I at least 67% in house

Phase II at least 50% in house

STTR 40% by Company and

30% by Academic collaborator

• Product development driven – Milestones!

• Atypical Sections: Commercialization plan, Consortium,

multi PI, etc.

• One consolidated, coherent, and responsive application

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Major Challenges in Preparing SBIR / STTR Applications

Challenges

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NIH Review Process

Risk Management

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

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Turn NDF into a Strategic Source of Funding

Strategic Approach

Maximize the Company’s

Funding Potential

VCs

NDFAngels

FreeMind Group, LLC

Systematic Approach

Conduct a thorough strategic assessment

Identify ALL relevant funding opportunity

Seek insight into the interests and goals of the funding agencies

Correlate the granting strategy with your long term R&D plan

Target the Right Mechanism

Different “pockets of money”

Different size of award/success rates

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Maximize Your Chances for Award

Strategic Approach

NDF

Plan and execute a long-term,

multi-submission granting

strategy

FreeMind Group, LLC

Lower the Risk

Know your weaknesses

Find the right partners (if necessary)

Know the interests of the agency/mechanism

Address the “non-important” admin parts

Establish yourself both as a top researcher as well as an experienced manager

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Maximizing Your Chances for Award

Risk Management

NDF

FreeMind Group, LLC

Maximize Funding Potential

July 5, 2017 28

FreeMind Group, LLC

What do we do?

1. Identify ALL relevant funding opportunities

2. Create a multi-submission granting strategy

3. Submit as many top quality applications as possible

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Thank you!

Contact Us!

Watch past presentations and webinars online on our YouTube Channel

Join our LinkedIn network and follow us on Twitter for updates and announcements relating to non-dilutive funding

www.freemindconsultants.com

FreeMindGroup

@FreeMindGrp

FreeMind Group

Shira Aharoni MachlufDirector, Business Development

Shira.a@freemindconsultants.com

+1 (617) 648-0340 ext 285