introduction to sbir and sttr funding opportunities€¦ · freemind group, llc 2/29 freemind group...

Introduction to SBIR and STTR Funding Opportunities

FreeMind Group WebinarJonathan AdalistNovember 2, 2016

FreeMind Group, LLC www.FreeMindConsultants.com

1/29November 2, 2016

FreeMindGroup

@FreeMindGrp

FreeMind Group

https://www.youtube.com/user/FreeMindGroup


https://twitter.com/freemindgrp




https://www.linkedin.com/company/freemind-group



November 2, 2016FreeMind Group, LLC

www.FreeMindConsultants.com2/29

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.

400-450 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 various SBIR and STTR funding opportunities

• Additional interesting information on the SBIR and STTR mechanisms



NIH 2016 Budget - $32.31B

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

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


7/29

Congressionally-mandated set-aside programs (SBIR 3% 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

November 2, 2016

http://www.sba.gov/size

SBIR & STTR Mission & Goals


8/29

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

November 2, 2016


9/29

SBIRFuel growth in private sector And commercialization of innovations

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

November 2, 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

Requirements


11/29

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

November 2, 2016

Requirements

Must meet eligibility criteria at the time of award!


12/29

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 months

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

SBIR / STTR Phase I

November 2, 2016


13/29

NIH Phased Program

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

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

SBIR / STTR Phase II

November 2, 2016


14/29

NIH Phased Program

November 2, 2016

Phase IIB

Competing renewal to bridge Phase IIand commercialization

SBIR / STTR Phase IIB


15/29

NIH Phased Program

November 2, 2016

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

NIH Phased Program


16/29

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

SBIR Direct to Phase II

November 2, 2016

Important SBIR & STTR Dates


17/29

Due DatesPhase I and Phase II

Estimated AwardDate

January 5 July

April 5 September

September 5 April (2018)

Dates

* Some Mechanisms have non-standard due dates

November 2, 2016



Funding Opportunities

Funding Routes1. Solicited –

Address a specific area of interest

2. Unsolicited –Investigator Initiated

12549 awards7610 unsolicited


19/29

SBIR / STTR Funding Opportunities

Next Application

Deadline:Jan 5th

NIH, CDC, FDA, ACF

November 2, 2016

Parent Announcements

Omnibus 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 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


20/29

SBIR / STTR Funding Opportunities

NIH

Next Application

Deadline:Jan 5th

November 2, 2016

Parent 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


21/29

NSF SBIR/STTR Programs

Industrial Innovation and Partnerships(Parent SBIR Phase I NSF 16-559)

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

Deadlines:December

June

NSF

November 2, 2016

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

NSF SBIR Program Summary


22/29

STTRSBIR

December 2016

June 2017

December 2016

June 2017

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

November 2, 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



Solicited

Solicited SBIR/STTR Opportunities

Currently, 88 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 (R41/R42)

• Novel Genomic Technology Development (R43/R44)

• New Technologies for Viral Hepatitis SBIR (R43/R44)

• 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)

• Early Stage Development of Technologies in Biomedical Computing, Informatics, and Big Data Science (R41/R42)

• Lead Optimization and Pre-Clinical Development of Therapeutic Candidates for Diseases of Interest to NIDDK (STTR (R41/R42))


24/29

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

November 2, 2016



Risk Management

NIH Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength



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!

Jonathan AdalistSenior Director, Business [email protected]

+1 (617) 648-0340 ext 285

FreeMindGroup

@FreeMindGrp

Watch past presentations and webinars online on our YouTube Channel

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

www.freemindconsultants.com

FreeMind Group

mailto:[email protected]







http://www.freemindconsultants.com/




introduction to sbir and sttr funding opportunities€¦ · freemind group, llc 2/29 freemind group...

Documents