SBIR/STTR Phase 1 Proposal Guidance

SBIR/STTR program goals Stimulate technological innovation in private sector; Strengthen the role of small business in meeting Federal R&D needs; Increase the commercial application of Federally-supported research results; Foster and participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program; Improve the return on investment from Federally-funded research for economic and social benefits to the Nation.

Pre-submission Timeline: -8 -6 -7 -5 -4 -3 -2 -1 +1 Assess yourself, field, resources Brainstorm ideas, contact program staff Determine human and animal requirements (if applicable) Outline application structure Write application Get feedback Edit Proofread Receipt date Track application online Months

Electronic Submission-Government Registrations Prepare for electronic application Registrations - allow 2 months for this process: DUNS number SAM Registration (System for Award Management) SBA Grants.gov eRA commons registration – NIH Others for other agencies

Now that you have identified a Solicitation…

Communicate with Agency Each solicitation provides a point of contact - Contact to discuss the fit Brief conversation to nail down whether your proposed idea is a match with the institutes interests.

Proposal Review

Who are the reviewers? INTERNAL at Contract Agencies vs. EXTERNAL at Grant Agencies Academic scientist – expert in your field Scientist from Small Business/Corporate setting Business Development specialist from Small Business/Corporate setting From podcast: What would Rob do? – alt.NPR

REVIEW CRITERIA SIGNFICANCE INNOVATION APPROACH INVESTIGATOR ENVIRONMENT

Review Criteria Significance The importance of the public health problem What is the pain? Who cares? How important is the problem? Is there a market?

Review Criteria Innovation Will it significantly impact a need in the market? Does it bit the mission of the agency? Is the proposed product novel? Better, faster, lower cost How are you protecting your IP

Review Criteria Approach How well defined is the research? Is there preliminary data?

Review Criteria Investigators Include bios for Investigators, key personnel and significant contributors Demonstrate research management experience

Review Criteria Environment Strength of collaborators Facilities

A Criticism is a gift Reviewers area not adequately compensated for their time. Respect the time they are taking to read your grant by being clear and concise Read review comments carefully Use this as an opportunity to improve your application Take each critique to heart

Proposal Components Title Include Significance and Innovation (i.e. One product and one problem) Abstract Specific Aims (1 page - NIH) Research Plan (6 pages - NIH) Significance Innovation Preliminary Studies Research Design Facilities Bios

Abstract No proprietary information Contents of abstract: the problem, issues with current solutions, how product will address unmet needs, summary of approach, collaborators and unique resources, Phase I Specific Aims, how anticipated results will justify Phase II additional time and funding necessary to bring your product to market after the completion of Phase I.

Specific Aims Keep your Phase I well focused Limit Aims to those absolutely necessary to support your application for Phase II Easily assessed by review committee Timeline

Specific Aims / Technical Objectives Paragraph #1: describe problem why it is significant current status of solutions unmet public health needs. Paragraph #2: Describe product Hypothesize why your product is an innovative solution   Present Specific Aims in bullet format: Two to four measurable Aims for Phase I research and for each, the criteria by which success will be judged. Make your Specific Aims "end points“ and milestone driven

Research Plan Significance Describe the significance of public health problem Focus on a single problem Number and composition of the population affected References to supporting statistical data Background on the current solutions to the problem Fairly critique previous work (they could be your reviewers)

Research Plan Innovation Why is product innovative. Does it work better, faster, cheaper What are the implications Public health - NIH Agriculture – USDA National Security / warfighter – DOD Product's potential financial projections IP protection plan Why Phase I milestones will justify a Phase II award Milestones projected for Phase II Progress necessary to lead to commercialization

Research Plan Preliminary Data Preliminary data is important Should support the feasibility of your project Emphasize work YOU have accomplished   Interpret results critically Convince reviewers that your approach could work.  

Research Plan Approach Organize by Specific Aims Include a timeline Describe results you expect Present contingency plans Define the criteria for evaluating the success Include statistical analysis Collaborator participation in your proposed research

Budget and Fee Follow the budget instructions Do not exceed the salary cap A fee up to 7% can be used for expenses that may not be charged to your grant. Patent costs Market research Expenses outside the U.S.

Letters of Support Show that you have relationships with people/organizations that can do part of the work that you cannot. These can be collaborators or consultants Include letters of interest from potential customers

Cover Letter for NIH NIH - The cover letter helps you to direct your application to the best institute and study section You may suggest more than one institute – give a one sentence reason for the additional assignment request It lets you suggest the field of expertise needed for a fair review – a frequent problem with reviews are that a reviewer may not appreciate the science behind your idea.

Multiple Submissions? Is your technology a platform Seek solicitations for each application area

IP Protection DO NOT submit a grant application until intellectual property protection plan is devised Patent protection is an absolute requirement for a business. Provisional Patent Application – Allows one year to file full application

Review Comments / Revisions Use the review comments to your advantage NIH – Allows for 1 resubmission Other agencies – Must wait for new solicitations to be published

Summary Start Early Complete registrations Put team together Gather information Write proposal Request reviews Submit – at least 1 day before deadline