National Institutes of Health SMALL BUSINESS FUNDING OPPORTUNTIES

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National Institutes of Health SMALL BUSINESS
FUNDINGOPPORTUNTIES
Peter C. Preusch, Ph.D. SBIR/STTR Program
Coordinator National Institute of General Medical
Sciences National Institutes of Health Department
Health and Human Services
The Southeast SBIR Conference April 19, 2003,
Atlanta, GA
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National Institutes of Health
Our Mission Improve human health through
biomedical and behavioral research, research
training and communications.
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THE NIH CULTURE
In its mission to protect and improve human
health, the NIH conducts and supports basic,
applied, and clinical and health services
research to understand the processes underlying
human health and to acquire new knowledge to help
prevent, diagnose, and treat human diseases and
disabilities.
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Whats New?

• Application
• PHS 398 Common grant form
• Receipt Date Postmark Date
• Product Development Plan ALL Phase II
• and
  Fast Track

• Commercialization Assistance Programs
• NCI Phase II Pilot
• Competing Continuation Applications

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SBIR/STTR Participating Agencies
TOTAL 1.6 B FY 2003

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

(estimate) NIH 500 M SBIR 30 M STTR
530 M Total CDC 9.0 M SBIR FDA
0.8 M SBIR AHRQ 2.1 M SBIR
HHS SBIR/STTR
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NATIONAL INSTITUTES OF HEALTHSBIR/STTR FUNDING
RATES for FISCAL YEAR 2002
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499 M SBIR/STTR
335
63
48
81
Success Rate ()
880
44
33
25
27
17
0
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NIH SBIR/STTR PROGRAM FEATURES and NUANCES
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Key NIH Grant Facts

• Eligibility is determined at the time of award
• -corporate eligibility, PI employment status
• The PI is required to have expertise to oversee
  
• project scientifically and technically (not a
  PhD)
• Applications may be submitted to different
  agencies for similar work ( not multiple awards)
• Its a grant, not a loan - no repayment
• Indirect as well as indirect costs awarded
• Its yours to keep - equipment, IP rights
• Invention reporting requirements

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DOES MY TECHNOLOGY FIT THE NIH?
NIH Mission Statement
Improve human health through biomedical and
behavioral research, research training, and
communications.
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National Institutes of Health
Office of the Director
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 Diabetes and Digestive
and Kidney Diseases
National Institute of Dental and Craniofacial Rese
arch
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 Library of Medicine
National Center for Complementary and
Alternative Medicine
National Center on Minority Health and Health
Disparities
National Institute of Biomedical Imaging and
Bioengineering
Fogarty International Center
National Center for Research Resources
Center for Information Technology
Center for Scientific Review
Clinical Center
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RESEARCH AREAS
Our ideas . Your ideas

• SBIR/STTR Grant Solicitation
• SBIR Contract Solicitation
• NIH Guide for Grants and Contracts
• Strategic Plans of ICs - IC web sites
• http//www.nih.gov/icd/

• Investigator-initiated RD

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SBIR/STTR Omnibus Solicitationhttp//grants.nih.g
ov/grants/funding/sbirsttr1/index.pdf

• Mission statement
• General areas of research
• Topics of interest
• Other Research Topics Within the Mission of
  the IC

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Research AreasNIH Guide http//grants.nih.gov/g
rants/guide/index.html
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Examples of Cross-Cutting Areas of Interest...or
Buzzwords de Jour

• Biodefense
• Biosensors
• Nanotechnologies
• Bioinformatics
• Proteomics/Genomics
• Biosilicon devices
• Biocompatible materials
• Acousto-optics and opto-electronics
• Imaging technologies
• Genetically engineered proteins

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Research Funded by NIH https//www-commons.cit.nih
.gov/crisp/

• Abstracts of funded projects
• Identify potential collaborators

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NIH Application, Review and Award Process
PHS 398 Common Grant Application Form Receipt
Dates postmark by Dec 1, Apr 1, or Aug 1 Phase I
(No Appendix allowed) Phase II (Product
Development Plan required) Fast-track (Product
Development Plan required) Receipt and Referral -
Cover Letter Recommended Study Section Assignment
- Expertise/Conflicts Mulitple IC assignment -
ARAs, Response to PA/RFA Summary of Review in 6-8
weeks (Revise if Necessary) Award Decisions in 6
months (depends on budget and on YOU!)
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REVIEW CRITERIA (Phase I)

• Significance (Real Problem/Real People)
• Approach (Research Design, Feasible)
• Innovation (New or Improved?)
• Investigators (PI and team)
• Environment (Facilities/Resources)
• Protection of Human Subjects
• Animal Welfare
• Budget

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REVIEW CRITERIA (Phase II)

• See Previous Slide
• Demonstrated Feasibility in Phase I
• Product Development Plan
• High Degree of Commercial Potential based on PDP
  
• Protection of Human Subjects
• Animal Welfare
• Budget

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REVIEW CRITERIA (Amended)

• See Previous Slide(s) as appropriate
• Responses to comments from the previous review
• Appropriateness of improvements in the revised
  application

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APPLICATION TO AWARD TIMELINE
2-tiered review process
SBIR/STTR Scientific/Technical Adv
Council Est.Award Receipt
Dates Peer Review Board Review
Date Apr 1 June/July Sept/Oct
Nov Aug 1 Oct/Nov Jan/Feb
Mar Dec 1 Feb/March May/June
July
90-Day pre-award costs are allowable At your
own risk..
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NIH SBIR FAST-TRACK Bridging the Funding Gap
Phase I Completed Submit satisfactory Phase I
Final Report
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Key to the NIH Application, Review, and Award
Process
Communication
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NIH Program Staff

• Before you apply...
• Assess the fit with IC and NIH
• Whats New PAs/RFAs
• Assist in finding collaborators
• Review Issues Dos and Donts
• Define product and focus application

Application
Review
Award
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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 Program Staff

• After the review...
• What the rating means (numeric vs. )
• Strengths and weaknesses
• Likelihood of funding
• Next steps

If at first you dont succeed.
Revise and resubmit
Application
Review
Award
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NIH Grants Management Staff

• Pre-Award Steps
• Post-Award Advice Guidance

Award
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WHY THE AWARD MAY BE DELAYED

• Human Subject Issues (OHRP)
• IRB and Assurances
• http//ohrp.osophs.dhhs.gov/index.htm
• Helen Gordon hgordon_at_osophs.dhhs.gov
• Animal Welfare Issues (OLAW)
• IACUC (Animal Involvement)
• http//grants.nih.gov/grants/olaw/olaw.htm
• EIN (Entity Identification Number)
• http//www.irs.gov
• Third Party Involvement
• Contracts, Consortia, Consultants

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From the Test Tube to the Medicine Cabinet

• Small BUSINESS Innovation Research
• Think very early about your commercialization
  pathway
• HOW will you commercialize? WHO will buy
  it?
• Research Research. Research
• Market will willingly accept your idea NO
• Business Planning is CRITICAL to the Companys
  Commercialization Plan

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http//www.fda.gov/cder/handbook/Develop.gif

• NDA Contains
• Pre-clinical studies
• Human clinical studies
• Manufacturing Details
• Labeling Info
• Other Info

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From the Test Tube to the Medicine Cabinet

• Few small companies have all the resources
  necessary to develop their ideas into a
  marketable state.
• Majority of profitable and innovative products
  require third parties to supply
• Advice
• Development funding
• Technology know-how
• Design or marketing expertise
• Manufacturing capability

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Commercialization Issues

• Phase II to Phase III Sources of Funding
• Clinical evaluation and FDA approvals
• Drug, Device, Biological, Diagnostics
• cGMP and GLP Facilities
• Partnerships and Strategic Alliances
• Corporate Goals and/or Exit Strategies
• Company sells product or service itself
• Company sells or licenses idea

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Pilot Commercialization Assistance Program (NCI)

• Goal Teach business skills to help mature
  SBIR/STTR-developed technologies (move them
  forward into marketplace)
• Focus
• Business plan development
• Opportunity forum (marriage broker)
• Contractor Dawnbreaker

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Development of Technical Assistance Menu

• Assistance with
• Developing Product Development Plan
• Developing business plans
• Valuing a technology
• Risk assessment
• Market assessment
• IND filings
• Manufacturing issues

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Future Directions at NIH to Assist Companies in
Commercialization

• Competing Continuation Phase II application
• Currently only by Special Announcement
• Response to NIH Program Announcement
• Previous Phase II Awardees
• Advance Phase II compounds through next step of
  drug discovery and development
• Clinical issues and regulatory approvals
• Up to 800,000 total costs per year
• Up to 3 years

http//grants.nih.gov/grants/guide/pa-files/PA-02-
173.html
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Implantable Replacement Heart
A Few Advances to Write Home About...
AbioCorTM
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NIH SBIR/STTR Program Coordinator
Guidance and Advice.... Success Stories
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One Companys Recipe for Commercial Success
Measurement of Hemodialysis Access Flow
Recirculation (NIDDK Grant)

• Patient Monitor for use in hemodialysis clinics
• offering novel diagnostic measurement
  capabilities to the nephrologist
• incorporated in the National Kidney Foundation
  Guidelines for Patient Care.

Transonic Systems Inc. Ithaca NY
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One Companys Recipe for Commercial Success
(cont.)

• Submit SBIR projects that match companys
  corporate product portfolio
• SBIR incorporated into companys strategic plan
• Products the company wants to develop and market
  on its own, if it had adequate financial
  resources
• Products that utilize companys core competencies

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One Companys Recipe for Commercial Success
(cont.)

• Develop SBIR task list to include essential
  commercialization milestones
• Delivery of prototypes to, and validation studies
  with independent researchers
• FDA Clearance data gathering and FDA submission
• End-product of Phase II must be ready to be
  marketed

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One Companys Recipe for Commercial Success
(cont.)

• Keep the commercialization under companys
  control
• Develop products that they want to market
  themselves.
• (Third-party distribution channels only develop
  after new product becomes successful.)
• Phase II collaborators expected to publish. to
  give new products a first commercial exposure
• Pre-show products at scientific meetings

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Examples of NIGMS Funded Projects

• Todd R. Quackenbush Continuum Dynamics, Inc.
• Fast Method for DNA Simulations on Parallel
  Computers
• Jonathan W. Greene Combichem, Inc.
• Statistical Analysis of Large Scale Screening
  Data
• Richard D. Powell Nanoprobes, Inc.
• Combined Fluorescent and Gold Immunoprobes
• Erik M. Schaefer Promega Corporation
• Technologies for Studying Protein Prenylation
• Alan Greener Stratagene
• Optimization of Proteolytic Cleavage Affinity

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More Example of NIGMS Funded Projects

• Gerald Frost Nanoptics, Inc.
• High Efficiency Fiber Image Guide for Endoscopes
• Sandra J. Frawley Medical Decision Associates,
  Inc.
• Graphically Driven Clinical Advice Programs
• James A. Hayward Clear Solutions, Inc.
• Hyaluronate Biomaterials for Tissue Engineering
• Gregory P. Crawford Critical Concepts, Inc.
• Mathematical Physiology Simultor for Medical
  Education
• Jane Aldrich Lakeside Biotechnology, Inc.
• Vectors and Methods for Marker Free Transgenic
  Plants

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More Example of NIGMS Funded Projects

• Jeanne Dietz-Band Oncor, Inc.
• Telomeric DNA Probes for Clinical Diagnostics
• James R. Hudson, Jr. Research Genetics, Inc.
• Multiplexed Microsatellite Genetic Linkage
  Markers
• Ronald M. Cook, Biosearch Technologies, Inc.
• Pharmaceutical Scale Synthesis of
  Oligonucleotides
• Clement E. Furlong Rhizogenics Corp
• Bacterial-Based Protein Producing Bioreactors
• Stuart M. Nemser Compact Membrane Systems, Inc.
• Membrane Oxygenators for Enhancing Bioreactors

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FOR MORE INFORMATION
Visit the NIH Small Business Funding
Opportunities Website
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For more information

• Small Business Guide to FDA
• http//www.fda.gov/ora/fed_state/small_business/sb
  _guide/intro.html
• Cross-agency website
• http//www.sbirworld.com/sbir

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Mark Your Calendars Now!!!
5th Annual NIH SBIR/STTR Conference June 2-3,
2003 Natcher Conference Center NIH
Campus Bethesda, MD
Registration and other details SOON available
at http//grants.nih.gov/grants/funding/sbir.htm
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Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone [phone] Fax
301-480-0146 Email jg128w_at_nih.gov