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Funding for Life Sciences: SBIR and STTR Grant Basics

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www.securedocs.com- Complete set of slides from a November 21st, 2013 webinar covering the SBIR and STTR Grant application process for Life Science companies. This webinar was presented by Jerry …

www.securedocs.com- Complete set of slides from a November 21st, 2013 webinar covering the SBIR and STTR Grant application process for Life Science companies. This webinar was presented by Jerry Knotts of the California Coast Venture Forum.

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  • 1. Securing Funding for Life Science Companies: SBIR and STTR Grant General Information and Nuances Given by Jerry Knotts President, CCVF (CONTENT ADAPTED FROM AN NIH PRESENTATION)
  • 2. ABOUT SECUREDOCS SecureDocs is a virtual data room for sharing and storing sensitive documents both internally and with outside parties. AppFolio, Inc. Company Basics: Ò  Founded by the team that created and launched GoToMyPC and GoToMeeting Ò  Backed by leading technology companies and investors Ò  Web-based business software for financial and legal professionals
  • 3. ABOUT JERRY KNOTTS Ò  President, California Coast Venture Forum Ò  Mentor for LARTA Institute in support of the NIH-CAP and other initiatives Ò  Mentor and coach to entrepreneurs in life science and other industries Ò  BSEE (Electrical Engineering) from The Penn State University Ò  MBA from Auburn University
  • 4. POLLING QUESTION #1
  • 5. AGENDA v  Background - NIH v  Basics of the SBIR & STTR programs Definitions 3 Phase Program Eligibility v  SBIR/STTR programs Grant Review Process Grant Selection Criteria Timeline What’s New
  • 6. NIH MISSION IMPROVE HUMAN HEALTH through biomedical and behavioral research, research training and communications.
  • 7. NIH ORGANIZATION v  FY 2013 Funding Sources (23 Institutes & Centers) FIC NCATS NCCAM NCI NEI NHGRI NHLBI NIA NIAAA NIAID NIAMS NIBIB NICHD NIDA – NIDCD NIDCR NIDDK NIEHS – NIGMS NIMH NIMHD NINDS NINR NLM - Fogarty International Center National Center for Advancing Translational Sciences National Center for Complementary and Alternative Medicine National Cancer Institute National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Biomedical Imaging and Bioengineering National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute on Deafness and other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Disease National Institute of Environmental Health Sciences National Institute of General Medical Sciences National Institute of Mental Health National Institute on Minority Health and Health Disparities National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Library of Medicine
  • 8. NIH SBIR OBJECTIVES & FUNDING v  Objectives Stimulate Technology Innovation Strengthen Role of Small Business Increase Private Sector Commercialization Increase Small Business Participation v Funding (FY2012) –[1 Oct 2010 – 30 Sep 2011] SBIR $634 M STTR $85 M
  • 9. SBIR/STTR AWARD TYPES v  Multiple Mechanisms GRANTS, Contracts, Cooperative Agreements v  Award Amount and Project Period Ø  Phase I ~$150,000 Ø  Phase II ~$1,000,000 6 months 2 years Realistic and appropriate
  • 10. YOUR IDEAS v  Investigator-initiated R&D v  Research projects related to the NIH mission v  “Other” areas of research within the mission of an awarding component
  • 11. NIH IDEAS §  SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA) Release: January Open for entire Calendar Year §  SBIR Contract Solicitation (NIH, CDC) Release: August Open for ~ 3 months §  NIH Guide for Grants and Contracts Release: Weekly Open as noted
  • 12. HELP NIH MEET ITS MISSION Conduct innovative R/R&D that results in product, process, or service that will... v  Improve patient health v  Speed process of discovery v  Reduce cost of medical care/cost of research v  Improve research & communication tools
  • 13. DEFINITIONS v  Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in federal R&D -with potential for commercialization. v  Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization.
  • 14. SBIR/STTR: 3-PHASE PROGRAM v PHASE I ➜  ➜  Feasibility Study $150K and 6-month (SBIR) or 12-month (STTR) Award v PHASE II ➜  ➜  Full Research/R&D $1 M and 2-year Award (SBIR/STTR) v PHASE III ➜  ➜  Commercialization Stage Use of non-SBIR/STTR Funds
  • 15. SBIR PROGRAM ELIGIBILITY CHECKPOINTS v  Organized for- profit U.S. Small Business v  At least 51% U.S.- owned and independently operated v  Small Business located in the U.S. v  P.I.’s primary employment with small business during project v  Intellectual Property Agreement
  • 16. STTR PROGRAM ELIGIBILITY CHECKPOINTS v  Applicant is Small Business Concern v  Formal Cooperative R&D Effort ➜  Minimum - 40% by Small Business ➜  Minimum - 30% by U.S. Research Institution ➜  Option - 30% by Third Party v  U.S. Research Institution ➜  College or University; ➜  Other non-profit research organization; ➜  Federal R&D center v  Intellectual Property Agreement ➜  Allocation of Rights in IP ➜  Rghts to Carry out Follow-on R&D and Commercialization
  • 17. SBIR/STTR PROGRAMS PI DIFFERENCES v Principal Investigator (PI) SBIR: Primary (>50%) employment must be with small business Research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Primary employment not stipulated [PI can be from research institution and/or small business concern* must have permission from research institution] Requires research institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)] *Varies Among Agencies
  • 18. REVIEW PROCESS FOR RESEARCH GRANT Small Business Idents NIH item Submits SBIR/STTR Grant Application to NIH Applicant Initiates Research Idea ~2-3 months after submission ~2-3 months after review Grantee Conducts Research IC Allocates Funds NIH Center for Scientific Review Assign to IC and IRG Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Staff Prepare funding Plan for IC Director
  • 19. PHASE I REVIEW CRITERIA v  v  v  v  v  v  Overall Impact ( On Research Fields) Significance (Real Problem/Real People) Innovation (New or Improved?) Approach (Research Design, Feasible) Investigators (PI and team) Environment (Facilities/Resources) … Protection of Human Subjects … Animal Welfare … Budget
  • 20. PHASE II REVIEW CRITERIA v  Same as Phase I v  Demonstrated Feasibility in Phase I v  Commercialization Plan v  High Degree of Commercial Potential based on plan
  • 21. NIH SBIR “FAST-TRACK” BEST OPTION FOR EVERYONE? No! v  Convincing preliminary data? v  Clear, measurable, achievable milestones? v  Well-conceived Commercialization Plan? v  Letters of Phase III support/interest? v  Track record for commercializing? Speak with Program Staff Prior to Submission
  • 22. SBIR STANDARD VS “FAST-TRACK” Standard application, review, award process 7-9 months Phase I 7-9 months Phase II 6 months 24 months Fast-Track review option Phase I + Phase II 7-9 months Simultaneous submission/review 6 months Phase II Satisfactory Phase I Final Report
  • 23. APPLICATION, REVIEW, AND AWARD TIMELINE SBIR/STTR Receipt Dates Apr 5 Aug 5 Dec 5 Scientific/Technical Peer Review June/July Oct/Nov Feb/March Adv Council Board Review Sept/Oct Jan/Feb May/June 7 to 9 months 90-Day pre-award costs are allowable: At your own risk….. Awd Date Dec Apr July
  • 24. WHAT’S NEW? v  Electronic Filing v  Phase Iib – Competing Continuations v  Technical Assistance Programs
  • 25. PHASE IIB COMPETING CONTINUATIONS v Goal: Provide additional research funds to move already identified drugs or devices requiring regulatory approval into clinical trials v Stipulations: Available only to Phase II grantees preparing for clinical trials Focus -- Diagnostics, devices, tissue engineering, drug development Funding level: up to $1M per year for max - 3 years IC must have announced the opportunity Speak with Program Staff Prior to Submission
  • 26. TECHNICAL ASSISTANCE PROGRAMS (Phase I Awardees) Identify other uses of technology Pilot Niche Assessment Determines competitive advantages Develops market entry strategy (Phase II Awardees) Commercialization Assistance (CAP) Business & strategic planning Builds alliances and investor partnerships
  • 27. UNIVERSITY PARTNERSHIPS v  Consultants on SBIR/STTR v  Subcontracts on SBIR/STTR Applicant must be the small business! v  Senior Personnel on SBIR/STTR v  Principal Investigator (with official permission from University) v  Own small firms (assign someone else PI)
  • 28. http://grants.nih.gov/grants/funding/sbir.htm •  Alerts •  Solicitations •  Targeted Research Opportunities •  Sample Application •  Award Information •  Collaborative Opportunities •  Success Stories
  • 29. Q&A Jerry Knotts, jeknotts@ccvf.org