Jo Anne Goodnight

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Lab to LifeNIH SBIR/STTR Funding
OpportuNIHtieS
National Institutes of Health

• Jo Anne Goodnight
• SBIR/STTR Program Coordinator
• Office of Extramural Research, NIH

October 11, 2007 Nebraska
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Topics to Discuss Today

• SBIR/STTR Program Overview
• NIH SBIR/STTR Program Specifics
• From a Knowledge-Based Economy to an
  Innovation-Based Economy Transitioning SBIR/STTR
  Medical Innovations to the Marketplace

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What Do These Medical Device Solutions Have in
Common?
Cardiac Assist, Inc.
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Entrepreneurial Audacity
Intellectual Rigor Hard Work Passion Mission
Entrepreneurship
NIH SBIR/STTR Funding
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Technology Entrepreneurship
Intralase - Femtosecond laser technology Design
Continuum - PediSedate sedation device for
children CardiacAssist - Tandem Heart
(Percutaneous Ventricular Assist Device) Xilas
Medical - TempTouch and GlideSoft are medical
devices that prevent the occurrence of foot
ulcers and amputations in people with
diabetes. ARISIL- Ear Popper is a non-surgical
device for treatment of middle ear effusion
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SBIR/STTR Program Overview
GENERAL FEATURES
SMALL BUSINESS INNOVATION RESEARCH (SBIR)
PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER
(STTR) PROGRAM The best way to predict the
future is to create it.
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SBIR Purpose and Goals
We in government must work in partnership with
small businesses to ensure that technologies and
processes are readily transferred to commercial
applications. Ronald Reagan, July 22, 1982.

• Stimulate technological innovation

• Use small business to meet Federal RD needs

• Foster and encourage participation by minorities
  and disadvantaged persons in technological
  innovation

• Increase private-sector commercialization
  innovations derived from Federal RD

Small Business Innovation Development Act of
1982 P.L. 106-554 (Signed 12/21/2000 extends
program through 09/30/2008)
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STTR Purpose and Goals

• Stimulate and foster scientific and technological
  innovation through cooperative research and
  development carried out between small business
  concerns and research institutions

• Foster technology transfer between small business
  concerns and research institutions

Small Business Research and Development
Enhancement Act of 1992 P.L. 107-50 (Program
reauthorized through 09/30/2009)
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SBIR/STTR 3-Phase Program
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The Life Science Innovation Lifecycle
SBIR
Adapted from Innovation Lifecycle of Richard
Seline, New Economy Strategies The life science
innovation lifecycle is marked by more challenges
and more unique industry relationships than those
of most other industry clusters, because of
numerous clinical trials, regulatory hurdles and
patent applications. The 21st Century Life
Science Roadmap, Texas Healthcare Bioscience
Institute
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SBIR/STTR Tip of the RD Iceberg
SBIR/STTR Set-Aside Percentage 2.8
Extramural Research/Development Budget
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SBIR Eligibility Criteria

• Organized as for-profit U.S. business
• Small 500 or fewer employees, including
  affiliates
• PD/PIs primary employment must be with small
  business concern at time of award and for
  duration of project period
• At least 51 U.S.- owned by individuals and
  independently operated or
• At least 51 owned and controlled by another
  (one) business concern that is at least 51 owned
  and controlled by one or more individuals

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STTR Eligibility Criteria

• Applicant is Small Business Concern
• Formal Cooperative RD Effort
• Minimum 40 by small business
• Minimum 30 by U.S. research institution
• U.S. Research Institution
• College or University other non-profit
  research organization Federal RD center
• Intellectual Property Agreement
• Allocation of Rights in IP and Rights to Carry
  out
• Follow-on RD and Commercialization

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SBIR and STTR Critical Differences

• Research Partner
• SBIR Permits partnering
• 33 Phase I and 50 Phase II
• STTR Requires partnering with Research
  Institution
• Small business (40) and U.S. research
  institution (30)

• Principal Investigator
• SBIR Primary (gt50) employment must be with
  small business concern
• STTR PI may be employed by either research
  institution or small business concern

Award is always made to Small Business Concern
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Land of Opportunities

• Providing incubator facilities on university
  property
• Taking equity position (e.g., 5) in commercial
  ventures
• Investing funds in new companies.
• Providing technical and business services to new
  firms (e.g., alumni, business school) .
• Entering into joint ventures with private
  entities.

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University-Business Partnership Opportunities

• Own small firms (assign someone else PI)
• Principal Investigator
• (with official permission from university)
• Senior Personnel on SBIR/STTR
• Consultants on SBIR/STTR
• Subcontracts on SBIR/STTR
• University facilities provide analytical
• and other service support

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UNIVERSITY AND INDUSTRYTwo diverse cultures
Industry Researchers are from MARS
University Researchers are from Venus
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SBIR/STTR Participating Agencies

• DOD SBIR/STTR
• HHS SBIR/STTR
• NASA SBIR/STTR
• DOE SBIR/STTR
• NSF SBIR/STTR
• DHS SBIR /STTR
• USDA SBIR
• DOC SBIR
• ED SBIR
• EPA SBIR
• DOT SBIR

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NIH SBIR / STTR Program Specifics
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NIH Mission
Improve human health through biomedical and
behavioral research, research training and
communications.
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Bridging the Discovery to Development Gap
SBIR/STTR Programs Are Fully Integrated Within
NIH Research Agenda

• Improve human health through prevention,
  detection, diagnosis and treatment of disease
  or disability
• Speed process of discovery
• Reduce cost of medical care
• Improve research tools/ reduce cost of research
• Increase health knowledge base

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Organizational Structure of NIH
Office of the Director
http//www.nih.gov/icd
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute on Aging
National Institute of Child Health and
Human Development
National Institute of Allergy and Infectious
Diseases
National Institute of Dental and Craniofacial Rese
arch
National Institute of Diabetes and Digestive
and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health
Sciences
National Institute on Deafness and
Other Communication Disorders
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders
and Stroke
National Institute of General Medical Sciences
National Institute of Nursing Research
National Center on Minority Health and Health
Disparities
National Institute of Biomedical Imaging and
Bioengineering
National Center for Complementary and
Alternative Medicine
National Library of Medicine
Fogarty International Center
National Center for Research Resources

No funding authority
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NIH Institute/Center SBIR/STTR Budget
Allocations (FY2007)
Extramural RD Set-Asides SBIR 2.5 STTR
0.3
580.7M (SBIR) 70.0M (STTR)
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Features of NIH SBIR/STTR Program Snapshot

• SBIR and STTR Program
• Single Solicitation for grants Same topics
• Investigator-initiated research ideas
• Contract Solicitation Closes Nov. 5
• NIH Guide for Grants and Contracts

• External Peer Review
• Experts from Academia and Industry
• 5 Criteria Significance, Approach,
• PI(s), Innovation, Environment

• Gap Funding Programs
• No-Cost Extensions
• Phase I/Phase II Fast Track
• Competing Renewal Phase II awards
• Administrative Supplement Awards

• Multiple Receipt Dates
• April 5, August 5, December 5
• May 7, September 7, January 7 (AIDS)

• Multiple Award Mechanisms
• Grants, Contracts, Cooperative Agreements

• Technical Assistance Programs
• Ph I Technology Niche Assessment
• Ph II Commercialization Assistance
• Both Pipeline to Partnerships (P2P)

• Budget and Project Period
• 100K/6 months (Ph I) 750K/2 yrs (Ph II)
• Deviations where scientifically appropriate for
  success of the project.

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How You Can Compete Successfully

• Understand our mission.
• Review research topics in FOAs.
• If no topic match, remember Other areas within
  our mission are acceptable.
• Contact NIH Staff to discuss your idea.
• Give yourself ample time to prepare your
  application.
• Propose innovative ideas with scientific and
  technical merit.

http//grants.nih.gov/grants/funding/sbir.htm
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Finding / Identifying Funding Opportunities
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Identifying NIH Funding Opportunities

• SBIR/STTR Grant Opportunities
• Omnibus Solicitation
• Search the Suggested Topics
• Search Previous Awards for Suggested IC
• Targeted Opportunities
• SBIR Contract Opportunities
• Other NIH Funding Opportunities (NIH Guide to
  Grants Contracts)
• Other Agency SBIR/STTR Opportunities

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SBIR/STTR Omnibus Grant Solicitation
Omnibus Solicitation of the NIH, CDC and FDA for
SBIR/STTR Grant Applications

• SBIR Parent Funding Opportunity Announcement
  (PA-07-280)
• STTR Parent Funding Opportunity Announcement 
  (PA-07-281)
• SBIR/STTR Program Descriptions and Research Topics

NIH (23 ICs) SBIR STTR
FDA SBIR only
CDC SBIR only
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NIH SBIR/STTR Research Topics

• Missions of Awarding Components
• Suggested technical topics
• Broad Descriptions
• Program Descriptions
• Trans-NIH Opportunities

200 pages of topics!
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NIH SBIR/STTR Parent Solicitation Contains Broad
Research Topics
Examples from 200 pages of topics!
Our Ideas Biodefense Biosensors Nanotechnologies
Bioinformatics Diagnostic and Therapeutic
Devices Telehealth
Biosilicon devices Biocompatible
materials Acousto-optics / opto-electronics Imagin
g devices Genetically engineered
proteins Proteomics / Genomics
http//grants.nih.gov/grants/funding/sbirsttr1/200
7-2_SBIR-STTR-topics.doc
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NIH SBIR/STTR Research Topics
Your Ideas (a.k.a. I cant find a topic match)

• Investigator-initiated RD projects

Angioscopes to Zebrafish

• Research projects related
• to NIH mission

• Other areas of research within mission of an
  awarding component

Key Take Home Message
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Searching the NIH Guide
Office of Extramural Research home
pagehttp//grants2.nih.gov/grants/oer.htm
Select Funding Opportunities in the NIH Guide for
Grants and Contracts
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Searching the NIH Guide
Office of Extramural Research home
pagehttp//grants2.nih.gov/grants/oer.htm
Select Funding Opportunities in the NIH Guide for
Grants and Contracts
The Advanced Search feature provides a lot of
options to narrow your search.
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NIH CRISP Search Medical Device
21 hits
9 different ICs
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What Does This Tell You?

• Ideas of possible ICs to target
• Fit with IC suggested topic?
• Does it fit an ICs mission?
• Investigator-initiated?
• Potential collaborators/partners

NEXT STEP? Contact NIH Program Staff
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NIH Guide for Grants and Contracts Targeted PAs
RFAs
http//grants.nih.gov/grants/funding/sbir_announce
ments.htm

• RFA-AA-07-009 Medications Development for the
  Treatment of Alcoholism (SBIR)
• PA-07-042 Image-Guided Cancer Interventions
  (SBIR)
• PAR-07-160 Innovations in Biomedical
  Computational Science and Technology (SBIR)
• PA-06-013 Manufacturing Processes of Medical,
  Dental,
• Biological Technologies (SBIR)

Parallel STTR
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RFA-AA-06-006 Medications Development for the
Treatment of Alcoholism
Objective Development of medications for
alcohol abuse and dependence

• Unique Features
• Special single receipt date (April 25, 2007)
• Letter of Intent Receipt Date (March 25, 2007)
• Flexible budget and project durations
• Ph I -- 2 yrs, 200K total costs per year
• Ph II 2 yrs, 500K total costs per year
• 2M committed for 3-6 Phase I, Phase II,
  Competing Renewals

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PAR-07-160 Innovations in Biomedical
Computational Science and Technology
Objective To support research and development
of tools and approaches for computing data

• Unique Features
• Special receipt dates (Feb, May, Sept 2007 Jan,
  May, Sept 2008 Jan 2009)
• Trans-NIH opportunity
• Flexible budget and project durations
• Phase I 2 yrs, 150K total costs per year
• Phase II 3 yrs, 750K total costs per year
• Parallel Announcement (PAR-07-161)

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PA-07-042 Image-Guided Cancer Interventions
Objective To support the development and
clinical validation of systems for image-guided
interventions (IGIs) for cancer

• Unique Features
• Flexible budget and project durations
• Ph I -- 2 yrs, 150K total costs per year
• Ph II 3 yrs, 1M total costs per year (projects
  with clinical evaluation)
• Ph II 3 yrs, 750K total costs per year
  (projects without clinical evaluation)

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PA-06-036 NIDA Phase II SBIR Competing Renewal
Awards
Objective To provide support for existing,
promising compounds through the next step of drug
discovery and development

• Unique Features
• Continuation of Phase II award
• Flexible budget and project durations
• 3 yrs, 750K total costs per year
• SBIR only -- May exceed 50 subcontracting rule
  (must be well justified)

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NIH Review Process
Submits SBIR/STTR Grant Application to
NIH Electronically
2-3 months after submission
2-3 months after review
IC Staff Prepare funding Plan for IC Director
Grantee Conducts Research
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Common Problems with Applications

• Inadequately defined test of feasibility
• Diffuse, superficial, or unfocused research plan
• Lack of sufficient experimental detail
• Questionable reasoning in experimental approach
• Uncritical approach
• Failure to consider potential pitfalls and
  alternatives
• Lack of innovation
• Unconvincing case for commercial potential or
  societal impact
• Lack of experience with essential methodologies
• Unfamiliar with relevant published work
• Unrealistically large amount of work proposed

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NIH SBIR/STTR Success RatesFiscal Year 2006
355
640 M SBIR/STTR
41.4
26
10
41
153
Success Rate ()
684
26.0
25
21.4
19.8
19.4
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Gap Funding Programs
Phase I
Phase II
Phase III
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Gap Funding Options

• No-Cost Extension (Ph I or Ph II)
• Extension in time with no additional funds
• Phase I / Phase II Fast Track
• Simultaneous submission / concurrent review
• Administrative / Competitive Supplements
• Discuss with your Program Director
• Phase II Competing Renewal Award
• Maximum of 1M/yr for 3 years
• Response to IC-specific FOA or Parent FOA

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Bridging the Phase I - II Funding Gap
NIH SBIR/STTR FAST-TRACK
Phase I Phase II
(Simultaneous Submission and Concurrent Review)
Program Staff assess completion of specific aims
and milestones
Completion of Phase I
Go? No Go?
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Important Considerations
NIH SBIR Fast-Track Review Option

• Convincing preliminary data
• Clear, measurable, achievable milestones
• Well-conceived Commercialization Plan
• Letters of Phase III support/interest?
• Track record for commercializing?

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Phase II Competing Renewal Award
Purpose

• To take existing, promising compounds or devices
  developed under a Phase II through the next step
  of drug discovery / medical device refinement and
  development

• Provide additional Phase II research support to
  continue assessing and improving devices or
  conducting preclinical studies of drugs or
  devices that ultimately require
• clinical evaluation
• approval of a Federal regulatory agency
• refinements to medical equipment (DME) designs

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Phase II Competing Renewal Award
Eligibility

• SBIR Phase II awardee
• Promising pharmacologic agents or devices have
  already been identified (or developed) and some
  preclinical pharmacology has been conducted
• Response to an NIH Funding Opportunity
  Announcement
• Generally, 750k-1M/year for up to 3 years

Contact your Program Director to discuss!
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Congratulations!
The check is in the mail
(almost)
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NIH SBIR/STTR Award Process Avoid Delays

• Human Subject Issues (OHRP)
• - IRB and Assurances
• - http//ohrp.osophs.dhhs.gov/index.htm
• Animal Welfare Issues (OLAW)
• - IACUC (Animal Involvement)
• - http//grants.nih.gov/grants/olaw/olaw.htm
• Third Party Involvement
• - Contracts, Consortia, Consultants

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Deploying Medical Device Innovations to the
Marketplace (a.k.a. Phase III)
Transitioning to the Marketplace
Phase I
Phase II
Phase III
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Biotech RD Companies Faced With Unique Challenges

• High intense capital needs (gt1B) to see a
  product from idea to market.
• Unusually long development time (5-12 yrs) for
  clinical evaluation and FDA approval.
• Exceptionally high burn rate for investment
  funds.
• Significant investments by venture capital
  entities, many of which are not owned at least
  51 by natural persons.
• Multiple rounds of financing required.

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Technical Assistance Program
(TAP)
Commercialization Assistance Program
Niche Assessment Program
New!
Pilot Manufacturing Assistance Program
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What is TAP?

• Discretionary technical assistance and/or
  training in
• Strategic/business planning
• FDA requirements
• Technology valuation
• Patent and licensing issues
• Manufacturing issues
• Getting closer to the customer, market, and
  competition
• Systematic approach to developing business
  strategies
• Individualized assistance/mentoring/consulting

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Technical Assistance Programs

• Commercialization
• Assistance

Business strategic planning Builds alliances
and investor partnerships
(Phase II awardees)
Partnership with NIST MEP Centers Help make
better manufacturing and operational decisions
Manufacturing Assistance
(Phase II awardees)
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Transitioning to the Marketplace
NIH Pipeline to Partnerships
Technology Showcase Potential partners search for
technologies of interest Facilitates matchmaking
between NIH SBIR/STTR awardees and potential
strategic partners and investors
(Ph I and Ph II awardees)
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Pipeline to Partnerships (P2P)
http//www.ott.nih.gov/p2p/index.asp
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Pipeline to Partnerships (P2P)
http//www.ott.nih.gov/p2p/index.asp
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Pipeline to Partnerships (P2P)
http//www.ott.nih.gov/p2p/index.asp
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Key to the NIH Application, Review, and Award
Process
Communication
Key Take Home Message
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NIH Program Staff Pre-Application

• Assess the fit
• Whats New FOAs -- PAs/RFAs
• Assist in finding collaborators
• Review Issues Dos and Donts
• Define product and focus application

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NIH Program Staff Post Review

• Discuss outcome of peer review
• Review Summary Statement
• What the rating means (numeric vs. )
• Strengths and weaknesses
• Likelihood of funding
• Next steps

If at first you dont succeed.
Revise and resubmit
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NIH Review Staff

• Scientific Review Administrator.
• Point of contact during review process
• Recruitment/Assignment of Reviewers
• Concerns about I/C Assignment or Review

Review
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NIH Grants Management Staff

• Pre-Award Steps
• Post-Award Advice/Guidance

Award
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NIH SBIR/STTR Program Coordinator
Guidance and Advice.... Success Stories
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Top 10 Reasons
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Top 10 Reasons
10. Over 2.2 Billion available- annually
9. NOT A LOAN - no repayment
8. Provides recognition, verification and
visibility
7. Potential leveraging tool to
attract venture capital/other sources of
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Top 10 Reasons
6. Foster partnerships (universities, large
corporations) that enhance competitiveness of
small businesses in marketplace
5. Creates jobs / stimulates local and state
economies stronger National Economy
4. Provides seed money to fund high risk
projects
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Top 10 Reasons
3. Intellectual property rights are normally
retained by the small business

• 2. Small business concerns are recognized as
  
• a unique national resource of technological
• innovation creating AND sustaining

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Top 10 Reasons

• Opportunity to make economic and societal
  contributions
• to America

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Real Solutions..Real Problems. Real People
Lab to Life
Todays Ideas
Tomorrows Discoveries
A Better Future for All Americans
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For More Information
www.nih.gov
http//grants.nih.gov/grants/funding/sbir.htm
Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone [phone] Fax
301-480-0146 Email jg128w_at_nih.gov
Kay Etzler SBIR/STTR Program Analyst Phone
301-435-2713 Fax [phone]
Email etzlerk_at_od.nih.gov