Small Business Innovation Research Small Business Innovation Research (SBIR) Grant Writing(SBIR) Grant Writing

My Qualifications:My Qualifications:– PhD in molecular genetics with 18 years R&D experience PhD in molecular genetics with 18 years R&D experience – Specialized in pre-clinical in-vivo pharmacology Specialized in pre-clinical in-vivo pharmacology – Founder and senior manager of 3 life science companiesFounder and senior manager of 3 life science companies– 9 SBIR/STTR Phase 1 and 2 grant awards from $100K-$1.0M/yr9 SBIR/STTR Phase 1 and 2 grant awards from $100K-$1.0M/yr– Invited speaker and authority on SBIR/STTR funding mechanismsInvited speaker and authority on SBIR/STTR funding mechanisms– Independent Biomedical Consultant and SBIR CoachIndependent Biomedical Consultant and SBIR Coach

SBIR ProgramSBIR Program Established in 1982 Established in 1982

– provide increased opportunities for small businesses provide increased opportunities for small businesses – meet federal research and development needs, meet federal research and development needs, – increase employment, increase employment, – foster and encourage participation in technological innovation by socially and foster and encourage participation in technological innovation by socially and

economically disadvantaged persons, economically disadvantaged persons, – increase private-sector commercialization of innovations derived from federal R&Dincrease private-sector commercialization of innovations derived from federal R&D

2.5% of Federal Agencies budgets2.5% of Federal Agencies budgets– In FY2008, = $2 Billion in awardsIn FY2008, = $2 Billion in awards– $550 Million from NIH (DHHS)$550 Million from NIH (DHHS)

AdvantagesAdvantages– Supports high risk, high reward research Supports high risk, high reward research – Solicits research in a variety of subject areas Solicits research in a variety of subject areas – Most patent and proprietary rights remain with the small business Most patent and proprietary rights remain with the small business – Funds do not have to be repaid---SBIR is not a loan program Funds do not have to be repaid---SBIR is not a loan program – Does not require owner to sacrifice equity in the company Does not require owner to sacrifice equity in the company

SBIR GrantsSBIR GrantsEligible Small Business Concern (at the time of the award)Eligible Small Business Concern (at the time of the award)• Independently owned and operated by >51% US citizensIndependently owned and operated by >51% US citizens• <500 employees<500 employees• Research space is controlled by awardee, not sharedResearch space is controlled by awardee, not shared• PI is 51% employee at the time of the awardPI is 51% employee at the time of the award

3 Phase Process3 Phase Process• Phase 1:Phase 1: Feasibility (Proof of Concept) Feasibility (Proof of Concept)

Average Award =<$170K <12months with <33% subcontractsAverage Award =<$170K <12months with <33% subcontractsCertain ICs: $500K -$1M over 2 years (ex: NIAID)Certain ICs: $500K -$1M over 2 years (ex: NIAID)15-20% probability of success first submission15-20% probability of success first submission

• Phase 2: Phase 2: Product or Prototype DevelopmentProduct or Prototype DevelopmentAverage Award =<$500K/yr <24months with <50% subcontractsAverage Award =<$500K/yr <24months with <50% subcontracts36% probability of success 36% probability of success

• Phase 3: Phase 3: Partnering with Gov’t and non-Gov’t toward CommercializationPartnering with Gov’t and non-Gov’t toward Commercialization

Small Business EligibilitySmall Business Eligibility1. 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

e-Submissione-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 Commons.

Timeline to FundingTimeline to Funding

• SBIR/STTR GrantsSBIR/STTR Grants– Deadlines: April 5, August 5, and December 5Deadlines: April 5, August 5, and December 5

• Timeline example:Timeline example:– Submission on April 5, 2012Submission on April 5, 2012– Scientific Merit ReviewScientific Merit Review: June - July 2012: June - July 2012– Advisory Council ReviewAdvisory Council Review: Sept. – Oct. 2012: Sept. – Oct. 2012– EarliestEarliest Start Date Start Date: Dec. 2012: Dec. 2012**

( 9-10 months later)( 9-10 months later)* * Possible to Possible to request reimbursement for 3 months prior expenses upon award

notification (although your investment is at risk) = 6 month window

Organizing for SBIROrganizing for SBIR

• Focus on your product not your platform Focus on your product not your platform technologytechnology

• Define achievable milestonesDefine achievable milestones• 2010 (Revised) Applications 2010 (Revised) Applications – much shortermuch shorter– 1 page Specific Aims 1 page Specific Aims – 6 pages Research Strategy6 pages Research Strategy

Review CriteriaImpact by Section, PrioritizedImpact by Section, Prioritized– SignificanceSignificance

• How will success change current concepts/standards of careHow will success change current concepts/standards of care

– Investigators QualificationsInvestigators Qualifications• Track record, leadership experience, governance and org structureTrack record, leadership experience, governance and org structure

– InnovationInnovation• Challenge current thought/practices using novel or refined Challenge current thought/practices using novel or refined

concepts, methods, instruments, and inventionsconcepts, methods, instruments, and inventions

– ApproachApproach• Well-reasoned, appropriate, manages risk and achieves milestonesWell-reasoned, appropriate, manages risk and achieves milestones

– ResourcesResources• Adequate, presents advantages, contributes to successAdequate, presents advantages, contributes to success

* Each Section Scored 1.0-9.0 (1.0 = exceptional); Average Establishes Competiveness* Each Section Scored 1.0-9.0 (1.0 = exceptional); Average Establishes Competiveness

SBIR ApplicationRevised in 3 sections:Revised in 3 sections: Research PlanResearch Plan

• Specific Aims (1 page) should describe the impact of proposed research.should describe the impact of proposed research. • Research Strategy (6 pages) will include:will include:

– SignificanceSignificance– InnovationInnovation– Research Plan (and Preliminary Data)Research Plan (and Preliminary Data)

Biographical SketchBiographical Sketch• Describe why your experience and qualifications make you particularly well-Describe why your experience and qualifications make you particularly well-

suited for your role in the projectsuited for your role in the project• Publications limited to 15 relevant publicationsPublications limited to 15 relevant publications

Resources and FacilitiesResources and Facilities• How scientific environment will contribute to probability of successHow scientific environment will contribute to probability of success• Describe the institutional investment in the success of the investigatorDescribe the institutional investment in the success of the investigator

StrategyStrategyInitial Feasibility Review:Initial Feasibility Review:– Establish Project LeaderEstablish Project Leader– Agree on Best Grant Candidate(s)Agree on Best Grant Candidate(s)– Establish Roles and Responsibilities (ie. Project Establish Roles and Responsibilities (ie. Project

Consultant/writer, PI and key personnel)Consultant/writer, PI and key personnel)– Generate Abstract (Draft)Generate Abstract (Draft)– Sketch out General Plan (what’s missing)Sketch out General Plan (what’s missing)– Set Milestones and Delegate ResponsibilitiesSet Milestones and Delegate Responsibilities– Communicate Progress at Regular MeetingsCommunicate Progress at Regular Meetings– Register ~1mo in advance with eRA Commons, Register ~1mo in advance with eRA Commons,

Grants.gov and SAM (previously CCR)Grants.gov and SAM (previously CCR)

Proposed Timeline>30 days prior to submission:Wk 1: Define Scope of Work and Executed Contract

Registration with Grants.gov and eRA commonsReview 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 AimsIdentify ICs and download FOAs for topic; Search CRISP

Wk 3: Compose Research Plan (Experiment Design and Methods) Compose Budget and Budget JustificationCompose Significance Section and ReferencesCompose Biosketch, Resources and Vertebrate Animals Sections

Wk 4: Assemble Grant, Executive/Legal Review and ApprovalFinal Proof, and Submission (48hr pre-deadline)Address Any e-submission Errors/Warnings and Complete

Submission

AbstractOverview: 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)

Phase 1 SBIR Budget (12month budget)Phase 1 SBIR Budget (12month budget)Directs (>67% of Total): Directs (>67% of Total): $90-200K$90-200KSalary (typically <4 key personnel)Salary (typically <4 key personnel)includes Base+ fringe benefits(+26%) includes Base+ fringe benefits(+26%) $50-100K

PI may require 2 calendar months effort = 15%PI may require 2 calendar months effort = 15%

Technician may require 6 calendar months = 50% effortTechnician may require 6 calendar months = 50% effort

ConsultantsConsultants $0-10KMaterials and SuppliesMaterials and Supplies $30-50KSubcontract (<33% of Total)Subcontract (<33% of Total) $50-100KIndirect Cost Rate (<40% max)Indirect Cost Rate (<40% max) $60-120K$60-120KTotalTotal Phase 1 BudgetPhase 1 Budget $150-300K $150-300KEligible for Fixed Fee (add ~5% profit) Eligible for Fixed Fee (add ~5% profit) $7.5-15K$7.5-15K