introduction to sbir and sttr funding opportunities€¦ · february 24, 2016 freemind group, llc...

Introduction to SBIR and STTR Funding Opportunities

FreeMind Group WebinarMeytal WaissFebruary 24, 2016

FreeMind Group, LLC www.FreeMindConsultants.com

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FreeMindGroup

@FreeMindGrp

February 24, 2016

February 24, 2016FreeMind Group, LLC

www.FreeMindConsultants.com2/34

FreeMind Group

FreeMindGroup, LLC Est. 1999

55 Fulltime Employees

Diverse Client Base:

• Academics, University Medical Centers, and Independent Research Institutes

• Industry – Small Startups to Large Pharmaceutical Companies.

~400 Applications Annually



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

A Tool to Max. Your Funding Potential

FreeMindGroup, LLC

Non-Dilutive Funding – A Strategic Financial Tool

In this webinar



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 many SBIR and STTR funding opportunities

Other interesting information

on the SBIR and STTR mechanisms



Dollars Awarded

Some Interesting Statistics

$50B allocated annuallyto fund the life sciences

The majority of that comes from the NIH



NIH 2016 Budget - $32.31B

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

Research Projects $17,820,973

55%

Research Centers $2,644,811

8%

Other Research $2,010,924

6%

Training $830,430

3%

Research & Develop. Contracts $2,995,825

10%

Intramural Research $3,581,878

11%

Res. Management & Support 1,692,585

5%

All others $733,9232%

~$27,000,000,000

Categorical Spending



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

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

~$27,000,000,000

SBIR & STTR Programs


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Congressionally-mandated set-aside programs (SBIR 3.1% 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

SBIR / STTR Programs

February 24, 2016

http://www.sba.gov/size

SBIR & STTR Mission & Goals


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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

February 24, 2016


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SBIRFuel growth in private sector And commercialization of innovations

STTRStimulate a partnership of ideas & technologies between innovative SBCs and non-profitresearch institutions

February 24, 2016

Purpose

SBIR vs. STTR



SBIR / STTR Eligibility

Only US small businesses are eligibleand must meet all of the following:

For profit organizations

Located in the United States

No more than 500 employees

At least 51 percent US owned

VC backing: Either multiple or none

Must meet eligibility criteria at the time of award!

Requirements


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SBIR vs. STTR

SBIRPI must be primarily employed with the SBC

Permits (encourages) research partnerships

STTRPrimary employment of the PI is not stipulated

Requires formal collaborationwith a non-profit research institution

February 24, 2016

Requirements

Must meet eligibility criteria at the time of award!


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NIH Phased Program

February 24, 2016

Phase IIPhase I


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NIH Phased Program

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

Awards for: SBIRs normally do not exceed $225K total costs over 6 monthsSTTRs normally do not exceed $225K total costs over 1 year

SBIR / STTR Phase I

February 24, 2016

Phase IIPhase I


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NIH Phased Program

Phase IITo continue the R&D efforts initiated in Phase IAwards 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

SBIR / STTR Phase II

February 24, 2016

Phase IIPhase I


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NIH Phased Program

February 24, 2016

Phase II

Phase IIBCompeting renewal to bridge Phase IIand commercialization

Phase IIB

Phase I

SBIR / STTR Phase IIB


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NIH Phased Program

February 24, 2016

Phase IIPhase I Fast-Track

Fast-Track Award

Both Phase I and Phase II grant applications are submitted and reviewed togetheras one application

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

SBIR / STTR Fast-Track

Phased Program


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Direct to Phase IIReceive Phase II award even if they have not previously received a Phase I award

Must have performed the Phase I stage-type of research

Only SBIRs

SBIR Direct to Phase II

February 24, 2016

Phase IIPhase I

Important SBIR & STTR Dates


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Due DatesPhase I and Phase II

Estimated AwardDate

April 5 September (2016)

September 5 April (2017)

January 5 July (2017)

Dates

* Some have non-standard due dates

February 24, 2016

Some Interesting Statistics


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Awarded domestic, for-profit organizations



Funding Opportunities

Funding Routes1. Solicited –

Address a specific area of interest

2. Unsolicited –Investigator Initiated

12549 awards7610 unsolicited


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SBIR / STTR Funding Opportunities

Next Application

Deadline:April 5th

NIH, CDC, FDA, ACF

February 24, 2016

Parent Announcements

Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR PA-15-269)

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 Grant Applications (Parent STTR PA-15-270)

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

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


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SBIR / STTR Funding Opportunities

NIH

Next Application

Deadline:April 5th

February 24, 2016

NIHParent Announcements

Direct Phase II SBIR Grants to Support Biomedical Technology Development(Parent SBIR PA-14-088)

Funding is up to $1.5 million over up to 2 years


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NSF SBIR/STTR Programs

Industrial Innovation and Partnerships(Parent SBIR Phase I NSF 14-603)

Funding: Phase I up to $150K for 6 monthsPhase 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 SMCs 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: http://www.nsf.gov/eng/iip/sbir/topics/Combined.pdf

Application Window:

JuneDecember

NSF

February 24, 2016

http://www.nsf.gov/eng/iip/sbir/topics/Combined.pdf

NSF SBIR Program Summary


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STTRSBIR

June 2016

December 2016

June 2016

December 2016

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

February 24, 2016

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

Grants vs. Contracts


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Funding Solicitations for

SBIR Grants

Funding Solicitation for

SBIR Contracts Scope of the proposal Investigator-defined

within the mission of NIH

Defined by the NIH (focused)

Questions during solicitation

period?

May speak with any Program

Officer

MUST contact the contracting officer

Receipt Dates 3 times/year for Omnibus Only ONCE per year

Basis for Award Based on score during peer review If proposal scores well during peer

review, must then negotiate to

finalize deliverables with NIH

Reporting One final report (Phase I);

Annual reports (Phase II)

Monthly or quarterly progress

reports

Set-aside of funds

for particular areas? NO YES

Solicitation of the NIH & CDCfor SBIR Contract Proposals

http://grants.nih.gov/grants/funding/SBIRContract/PHS2015-1.pdf

Application Deadline:April 5th

February 24, 2016



Solicited

Solicited SBIR/STTR Opportunities

88 open solicitations

in the SBIR/STTR Programs across the NIH!

Examples:

Small Business Alzheimer's Disease Research (R43/R44)

Building Complex 3-Dimensional in Vitro Human Musculoskeletal and Skin Tissue Models (R43)

Imaging Diagnostics of Dental Diseases and Conditions (Caries, Periodontal Disease, Cracked

Teeth, and Pulp Vitality) (R43/R44)

Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use

Disorder and Alcohol-related Disorders (U44)

Novel Tools for Investigating Brain-derived GPCRs in Mental Health Research (R43/R44)

New Technologies for Viral Hepatitis STTR (R41/R42)


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Challenges

Major Challenges in Preparing SBIR/STTR Applications

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

February 24, 2016



Risk Management

NIH Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength


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What Next?

Strategic Choices Beyond SBIR/STTR

SBIR/STTR is a great mechanismand is considered by many as a gateway to larger awards

Submit as many as you can to increase your likelihood for success(no less than 3 and upwards of 6 )

Tap additional pockets of non-dilutive money(RO1, R21, U01, BAA etc.)

February 24, 2016



Key Issues

Maximizing your Chances

Know the interests of the Agency

Present a complete, focused project

Ask for what is necessary

Leverage on research collaborations

Systematic Approach



Key Issues

Maximizing your Chances

Different “pockets of money”

Different size of award/success rates

Conduct a thorough strategic assessment

Multi-Submission Granting Strategy

Target the Right Mechanism

FMG Professional Process



Core Service 1- Strategic Assessment

Long term Strategic approach Outline projects Tasks to be completed Link with existing pockets of money Solicited vs. Unsolicited Map of relevant funding opportunities

Core Service 2- Project Production Process

Project Management - coordinating Comprehensive templates Ongoing feedback and edits Budgets Converge information Final outcome – single coherent presentation



Contact Us!

Thank you!

Meytal WaissDirector, Business Development

[email protected]

(617) 648-0340 ext. 215

www.freemindconsultants.com

FreeMindGroup FreeMindGrp

mailto:[email protected]

introduction to sbir and sttr funding opportunities€¦ · february 24, 2016 freemind group, llc...

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