SBIR Grant Application Overview

1. Small Business Innovation Research
(SBIR) Grant Writing
My Qualifications:
– PhD in molecular genetics with 18 years R&D experience
– Specialized in pre-clinical in-vivo pharmacology
– Founder and senior manager of 3 life science companies
– 9 SBIR/STTR Phase 1 and 2 grant awards from $100K-$1.0M/yr
– Invited speaker and authority on SBIR/STTR funding mechanisms
– Independent Biomedical Consultant and SBIR Coach

2. SBIR Program
 Established in 1982
– provide increased opportunities for small businesses
– meet federal research and development needs,
– increase employment,
– foster and encourage participation in technological innovation by socially and
economically disadvantaged persons,
– increase private-sector commercialization of innovations derived from federal
R&D
 2.5% of Federal Agencies budgets
– In FY2008, = $2 Billion in awards
– $550 Million from NIH (DHHS)
 Advantages
– Supports high risk, high reward research
– Solicits research in a variety of subject areas
– Most patent and proprietary rights remain with the small business
– Funds do not have to be repaid---SBIR is not a loan program
– Does not require owner to sacrifice equity in the company

3. SBIR Grants
Eligible Small Business Concern (at the time of the award)
• Independently owned and operated by >51% US citizens
• <500 employees
• Research space is controlled by awardee, not shared
• PI is 51% employee at the time of the award
3 Phase Process
• Phase 1: Feasibility (Proof of Concept)
Average Award =<$170K <12months with <33% subcontracts
Certain ICs: $500K -$1M over 2 years (ex: NIAID)
15-20% probability of success first submission
• Phase 2: Product or Prototype Development
Average Award =<$500K/yr <24months with <50% subcontracts
36% probability of success
• Phase 3: Partnering with Gov’t and non-Gov’t toward Commercialization

4. Small Business Eligibility
1. A for-profit United States SBC >51% owned and controlled by US citizens of, or
permanent resident aliens, or in the case of a publicly-owned business, >51% of its
voting stock is owned by US citizens or lawfully admitted permanent resident aliens.
or
A for‑profit business concern that is >51% owned and controlled by another (one) for-
profit business concern that is >51% owned and controlled by US citizens or permanent
resident aliens
2. Not dominant in the field in which it is proposing, has its principal place of business
located in the US, has, including its affiliates, <500 employees, is not involved in a
merger/acquisition that is near complete, and meets regulatory requirements in Title
13, (CFR), Part 121.
3. The research space occupied is available to and under the control of the awardee
organization for the conduct of its portion of the proposed project.
4. All research will be performed in its entirety in US, unless otherwise approved.
5. PD’s/PI's primary employment is with organization (>50.5% ) at the time of award and
for the duration of the project, unless otherwise approved. For Multiple PD/PI projects,
the Contact PD/PI meets the primary employment requirement.
6. Organization has in place written policies and procedures for financial and business
management systems that comply with 45 CFR 74

5. e-Submission
• Register organization at Grants.gov and assign roles. (ebiz POC; AOR)
• Grants.gov is a central storehouse for information on over 1,000 grant programs and provides access to
approximately $500 billion in annual awards.
• Register at eRA Commons and CCR and assign roles (SO = AOR; PI)
• Electronic Research Administration (ERA) Commons is a virtual meeting place where NIH extramural grantee
organizations, grantees, and the public can receive and transmit information about the administration of
biomedical and behavioral research.
• Find Funding Opportunity Announcement (FOA) and SF424 (R&R) forms
• Download Application Package (PHS 2010-02 Omnibus Solicitation,
Parent SBIR [R43/R44]) from Grants.gov.
• Complete application components, convert to PDFs and upload PDFs into
application component.
• Review application internally.
• Authorized Organizational Representative (AOR) submits application to
Grants.gov
• PI and SO receive the Grants.gov tracking number.
• After agency validation, receive the agency tracking number (accession
number).
• PI and Signing Official (SO) complete verification process in eRA

6. Timeline to Funding
• SBIR/STTR Grants
– Deadlines: April 5, August 5, and December 5
• Timeline example:
– Submission on April 5, 2012
– Scientific Merit Review: June - July 2012
– Advisory Council Review: Sept. – Oct. 2012
– Earliest Start Date: Dec. 2012*
( 9-10 months later)
* Possible to request reimbursement for 3 months prior expenses upon award
notification (although your investment is at risk) = 6 month window

7. Organizing for SBIR
• Focus on your product not your platform
technology
• Define achievable milestones
• 2010 (Revised) Applications
– much shorter
– 1 page Specific Aims
– 6 pages Research Strategy

8. Review Criteria
Impact by Section, Prioritized
– Significance
• How will success change current concepts/standards of care
– Investigators Qualifications
• Track record, leadership experience, governance and org structure
– Innovation
• Challenge current thought/practices using novel or refined
concepts, methods, instruments, and inventions
– Approach
• Well-reasoned, appropriate, manages risk and achieves milestones
– Resources
• Adequate, presents advantages, contributes to success
* Each Section Scored 1.0-9.0 (1.0 = exceptional); Average Establishes Competiveness

9. SBIR Application
Revised in 3 sections:
 Research Plan
• Specific Aims (1 page) should describe the impact of proposed research.
• Research Strategy (6 pages) will include:
– Significance
– Innovation
– Research Plan (and Preliminary Data)
 Biographical Sketch
• Describe why your experience and qualifications make you particularly well-
suited for your role in the project
• Publications limited to 15 relevant publications
 Resources and Facilities
• How scientific environment will contribute to probability of success
• Describe the institutional investment in the success of the investigator

10. Strategy
Initial Feasibility Review:
– Establish Project Leader
– Agree on Best Grant Candidate(s)
– Establish Roles and Responsibilities (ie. Project
Consultant/writer, PI and key personnel)
– Generate Abstract (Draft)
– Sketch out General Plan (what’s missing)
– Set Milestones and Delegate Responsibilities
– Communicate Progress at Regular Meetings
– Register ~1mo in advance with eRA Commons,
Grants.gov and SAM (previously CCR)

11. Proposed Timeline
>30 days prior to submission:
Wk 1: Define Scope of Work and Executed Contract
Registration with Grants.gov and eRA commons
Review preliminary data, PI qualifications, and priorities
Identify and agree upon best grant ideas
Wk 2: Researched Subject and Developed an Draft Abstract
Abstract is compatible with Specific Aims
Identify ICs and download FOAs for topic; Search CRISP
Wk 3: Compose Research Plan (Experiment Design and Methods)
Compose Budget and Budget Justification
Compose Significance Section and References
Compose Biosketch, Resources and Vertebrate Animals Sections
Wk 4: Assemble Grant, Executive/Legal Review and Approval
Final Proof, and Submission (48hr pre-deadline)
Address Any e-submission Errors/Warnings and Complete Submission

12. Overview: Abstract
Important to describe succinctly every major aspect of the proposed project
except the budget. It is used in the grant referral process to determine what
study section is appropriate to review the application and to what institute at NIH
it is most relevant. Members of the Study Section who are not primary reviewers
may rely heavily on the abstract to understand your proposal. It is published also.
Include (in order):
• a brief background of the project;
• specific aims, objectives, or hypotheses; (2-3 aims per grant)
• the significance of the proposed research;
• refer to the health relatedness of the project (i.e., relevance to the mission of the
agency);
• the unique features of the project;
• the methodology (action steps) to be used;
• expected results;
• evaluation methods; and
• description of how your results will impact on targeted research area.
(Length <30 lines)

13. Phase 1 SBIR Budget (12month budget)
Directs (>67% of Total): $90-200K
Salary (typically <4 key personnel)
includes Base+ fringe benefits(+26%) $50-100K
PI may require 2 calendar months effort = 15%
Technician may require 6 calendar months = 50% effort
Consultants $0-10K
Materials and Supplies $30-50K
Subcontract (<33% of Total) $50-100K
Indirect Cost Rate (<40% max) $60-120K
Total Phase 1 Budget $150-300K
Eligible for Fixed Fee (add ~5% profit) $7.5-15K