Sbir Presentation July 2012


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SBIR Grant Application Overview

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Sbir Presentation July 2012

  1. 1. Small Business Innovation Research (SBIR) Grant WritingMy 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. 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. 3. SBIR GrantsEligible 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 award3 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. 4. Small 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 aliens2. 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/PIs 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. 5. e-Submission• Register organization at and assign roles. (ebiz POC; AOR) • 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• Complete application components, convert to PDFs and upload PDFs into application component.• Review application internally.• Authorized Organizational Representative (AOR) submits application to• PI and SO receive the tracking number.• After agency validation, receive the agency tracking number (accession number).• PI and Signing Official (SO) complete verification process in eRA
  6. 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. 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. 8. Review CriteriaImpact 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. 9. SBIR ApplicationRevised 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. 10. StrategyInitial 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, and SAM (previously CCR)
  11. 11. Proposed Timeline>30 days prior to submission:Wk 1: Define Scope of Work and Executed Contract Registration with and eRA commons Review preliminary data, PI qualifications, and priorities Identify and agree upon best grant ideasWk 2: Researched Subject and Developed an Draft Abstract Abstract is compatible with Specific Aims Identify ICs and download FOAs for topic; Search CRISPWk 3: Compose Research Plan (Experiment Design and Methods) Compose Budget and Budget Justification Compose Significance Section and References Compose Biosketch, Resources and Vertebrate Animals SectionsWk 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. 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. 13. Phase 1 SBIR Budget (12month budget)Directs (>67% of Total): $90-200KSalary (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% effortConsultants $0-10KMaterials and Supplies $30-50KSubcontract (<33% of Total) $50-100KIndirect Cost Rate (<40% max) $60-120KTotal Phase 1 Budget $150-300KEligible for Fixed Fee (add ~5% profit) $7.5-15K