Writing a fundableWriting a fundable SBIR grantSBIR grant

Paul Olson, PhDPresident of Kypha, Inc. andPresident of Kypha, Inc. and Adjunct Professor, University of Louisville

About Kypha

Founded in 2009 after licensing and acquisition deal of former compan Potentiaof former company, Potentia.

Developing diagnostics for monitoring inflammation. Lead diagnostic device was initially developed using

SBIR funds. Lead imaging agent also initially developed using

SBIR/STTR funds. Over $3MM in SBIR/STTR funds.

The Basics

Applicant must be a small, for-profit business. Need to have a innovative idea for a product or

service - No “me, too” products or minor advances allowed.

Project must map out course for getting to j p g gmarket!

Be sure you have the team collaborators and Be sure you have the team, collaborators, and facilities to get the job done.

A tangible product has generally been the most A tangible product has generally been the most successful approach for me.

Illustrate Why Your Idea IsIllustrate Why Your Idea Is Innovative

Your idea should l l dsolve a clear and

significant problem. Find a way to convey

your idea plainly. An innovative idea

can be a new way of yusing existing tools.

K h ’ C A t™ I fl ti M it iKypha’s CompAct™ Inflammation-Monitoring Diagnostics Were Initially SBIR Funded

Monitors inflammatory bi k fbiomarkers from a drop of blood.

Easy to use. Represented a faster p

and more accurate way to monitor these ybiomarkers.

Getting Started: Know What Your FinalGetting Started: Know What Your Final Product Is and How to Get There. Think backwards!

St t ith th fi l d t d k b k f th Start with the final product and work back from there. Determine what is this first major obstacle or unknown

could cause the project to fail? If you can’t past thiscould cause the project to fail? If you can t past this hurdle the project will fail.

Make this the topic of your Phase I project! Make this the topic of your Phase I project! Sketch out in one or two paragraphs how the project will

proceed after the Phase I is complete This tells theproceed after the Phase I is complete. This tells the reviewer what your Phase II will be.

Kypha example: the CompAct™ TestKypha example: the CompAct™ TestBedside monitoring of immune disorders

Phase I (Proof Of Concept)

Phase II(Development)

Phase III(Market)p

Does it Work ?

Market!Yes!Write

Have Idea, Develop Prototype to  Phase II helps advance 

Phase II

Apply,Get Award!

measure inflammationbiomarker in blood & plasma

pprototype to market andobtain FDA 510(k) Clearance!

Find the right home for your grant

Decide on the appropriate Institute. If you request the wrong institute, your application might not be understood or seem

i h d i h i i ’ i imismatched with institute’s mission.

Is there an appropriate Request For Applications or ProgramIs there an appropriate Request For Applications or Program Announcement? Grants.gov is a good resource.

Discuss with Program Officer before applying Are we being Discuss with Program Officer before applying. Are we being responsive? Promote their understanding of your project and interest in it.

Understand how your grant will beUnderstand how your grant will be reviewed Read the instructions for grant review:

Definitions of Criteria and Considerations forDefinitions of Criteria and Considerations for SBIR-STTR Critiques at http://grants nih gov/grants/peer/critiques/sbir-http://grants.nih.gov/grants/peer/critiques/sbirsttr.htm

Understanding the evaluation criteria helps you Understanding the evaluation criteria helps you write a better grant.

It also makes the reviewer’s job easier -- which It also makes the reviewer s job easier which can be to your benefit.

Writing the proposal The Specific Aims page is the most important section.

It shapes 90% of the reviewer’s opinion of your p % p yapplication.

W it l d i t b t t M i Write a clear and succinct abstract. Many reviewers read the abstract before the Specific Aims. Capture the reviewer’s interest early.y

Use pictures and flow charts. They are easier to read and nderstand (especiall for a tired re ie er )and understand (especially for a tired reviewer.)

Writing the proposal Spell out directly how your proposal is significant

and innovative so the reviewers don’t have toand innovative, so the reviewers don t have to figure it out themselves.

Have a clear approach in the Research Strategy section. Use figures. Lot’s of figures.

In Phase I, write a paragraph describing your commercialization strategy If you’ve been thinkingcommercialization strategy. If you ve been thinking backwards, this will be straight forward!

Specific Aims Most important part of application. This is the first part of your

application that will be read thoroughly. This page should describe: This page should describe:

the problem you are trying to solve the importance of the problem your solution and why it’s innovative your solution and why it s innovative how you will get there (the Aims) metrics for project success

All i t i th i t ti f i d t h ld b All points in the instructions for reviewers document should be answered here.

Keep It Simple Scientist. Remember, the reviewer may be i d f di h h htired after reading through so many other grants.

Significance and Innovation The most overlooked sections of the application. The significance of the problem and the The significance of the problem and the

innovativeness of your solution are key to your scorescore.

These sections give you the chance to explain it to the reviewer so s/he can in turn explain it to thethe reviewer so s/he can in turn explain it to the other reviewers.K th ti i t If ’t Keep these sections succinct. If you can’t, you may need to refine your project as a whole.

The Approach The most critical section. You’ve worked hard to

kindle their interest Don’t blow it now!kindle their interest. Don t blow it now! Begin with timeline showing key milestones and

who will perform the work. This is critical to fshowing how you will get from Point A to Point B.

Diagram your experimental scheme.If ibl di h Ai If possible, diagram each Aim.

State the metrics of success for each Aim.At the end remind them hat the project ill be At the end, remind them what the project will be and what success will allow.

Use a GANTT chart to clearly define tasksUse a GANTT chart to clearly define tasks, timelines, and who performs them

What I have learned

Reviewers lose about 50 points of IQ when reading grants!

(I have experienced this phenomenon.)( p p ) If it is possible to misunderstand or fail to

read something in your application they willread something in your application, they will. You need to explain everything at a seventh

grade level.

Reviewers enjoy spending hoursReviewers enjoy spending hours poring through grant applicationsp g g g pp

The reviewer has to read severalread several applications.

Make yours easy to d D ’t t thread. Don’t put the

reviewer to sleep. Tell them why the Tell them why the

problem you are tackling is important and why your idea isand why your idea is the best solution.

More on the reviewer

Keep it Simple. If a reviewer can misunderstand

something they willsomething, they will. Don’t try to show how smart and complex

l i Th i k /h iyour plan is. The reviewer know s/he is smarter than you. This a Law of Nature.

Keep it Simple.

Preparing the document

Prepare the application package early. Chaeck for errors. Have at least one other person proofread Have at least one other person proofread

your grant for clarity and content. Submit a test run application several days

before deadline to catch errors not caughtbefore deadline to catch errors not caught by the application or grants.gov.

Is preliminary data required? Preliminary data is not required for phase I

applicationsapplications. However, good preliminary data can go a long way

to convincing the reviewer of: Feasibility AND Your commitment to the project

I h h d li ti d d b th ith I have had applications awarded both with or without preliminary data.

I have also had replication reject with or without I have also had replication reject with or without preliminary data.

Final notes

You need to register with CCR, grants.gov and eRA Commons before filing. CCR approval can take several weeks. The ppother two are far quicker.

Do not wait until 4:55 p m on submission Do not wait until 4:55 p.m. on submission day to submit the application package. Many people (including Kypha personnel) feel this is the perfect time to do so.p

Thank you!