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.

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
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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