Jo Anne Goodnight - PowerPoint PPT Presentation


Title: Jo Anne Goodnight


1
"Lab to Life"
National Institutes of Health
NIH SBIR/STTR Funding OpportuNIHtieS
  • Jo Anne Goodnight
  • SBIR/STTR Program Manager
  • Office of Extramural Research, NIH

9th Annual NIH SBIR/STTR Conference Feb 26-27,
2007 ? Las Vegas, NV
2
Topics to Discuss Today
  • SBIR / STTR Program Overview
  • NIH SBIR / STTR Program Specifics
  • Whats New?
  • Communicating with NIH
  • Transitioning to the Marketplace
  • Selling/Marketing to NIH

3
What Do These Solutions Have in Common?
Cardiac Assist, Inc.
4
Entrepreneurial Audacity
Intellectual Rigor Hard Work Passion Mission
Entrepreneurship
NIH SBIR/STTR Funding
5
Technology Entrepreneurship
Intralase - Femtosecond laser technology Design
Continuum - PediSedate sedation device for
children CardiacAssist - Tandem Heart
(Percutaneous Ventricular Assist
Device) Cyberkinetics Neurotechnology -
BrainGateTM - Communication interfaces to restore
limb movement to those with spinal cord injury,
stroke, ALS (Lou Gehrig's disease), etc. GlycoFi
- Biotherapeutics
6
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.
7
Program Descriptions
  • Small Business Innovation Research (SBIR)
  • Set-aside program for small business
  • concerns to engage in Federal RD --
  • with potential for commercialization.
  • Small Business Technology Transfer (STTR)
  • Set-aside program to facilitate cooperative
  • RD between small business concerns and
  • U.S. research institutions --
  • with potential for commercialization.

2.5
0.3
8
SBIR / STTR Program Mission
Supporting scientific excellence and
technological innovation through the investment
of Federal research funds in critical American
priorities to build a strong national economy
one small business at a time.
9
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)
10
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)
11
(No Transcript)
12
SBIR/STTR 3-Phase Program
13
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
14
SBIR Eligibility Checkpoints
  • Organized for-profit U.S. business
  • 500 employees or fewer, including affiliates
  • PD/PIs primary employment must be with small
    business concern at time of award and for
    duration of project period

15
SBIR Eligibility Checkpoints
  • Small business concern must be
  • 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

16
STTR Eligibility Checkpoints
  • Applicant is Small Business Concern
  • (Subsidiaries are NOT eligible for STTR
    program)
  • 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

17
Ownership And Control
got questions?
  • Contact the SBA Size Specialists
  • Request an eligibility determination
  • http//www.sba.gov/size/indexcontacts.html

18
Performance of Research Activities
All research/RD must be performed in its
entirety in the U.S.
  • Rare cases to conduct testing of specific
    patient populations outside U.S. is allowable
  • Travel to scientific meeting in foreign country
    is allowable
  • Foreign consultants/collaborators are allowable,
    but must perform consulting in U.S.

19
Fee/Profit
  • Up to 7 of total direct and FA costs may be
    requested for fee
  • Must be requested and justified in application
  • Only SBC eligible -- no contracts, consortium or
    other third party are eligible for fee
  • Fee not a cost

20
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

21
NIH SBIR / STTR Program Specifics
22
Transforming Medicine Through Innovation
The NIH SBIR/STTRProgram Specifics
Lab to Life Improving the Health of Americans
23
NIH Mission
Improve human health through biomedical and
behavioral research, research training and
communications.
24
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

25
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
26
HHS SBIR/STTR Funding
640M
Propose a Realistic and Appropriate Budget
for the Research Take Home Message 1
27
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
28
SBIR/STTR Program Updates
Whats New?
  • Receipt Dates
  • Multiple PD/PI SBIR and STTR
  • Appendix Instructions
  • Pilot Manufacturing Assistance Program

New!
Reminders
  • Electronic Submission
  • Funding Opportunity Announcements (FOA)
    Solicitations

29
Solicitations and Receipt Dates
  • SBIR/STTR Omnibus Grant Solicitation Parent FOAs
  • (NIH, CDC, and FDA)
  • Release January
  • Standard Receipt Dates April 5, Aug 5, Dec 5
  • (AIDS/AIDS-related May 1, Sept 1, Jan 2) No
    Change
  • SBIR Contract Solicitation (NIH, CDC)
  • Release August November receipt date
  • NIH Guide for Grants and Contracts
  • Release Weekly Receipt dates specified in
    each FOA

SBIR PA-07-280 and STTR PA-07-281
New!
30
Multiple PD/PIs
Important Links
New!
Multiple Principal Investigators Web
Site http//grants2.nih.gov/grants/multi_pi/
NOT-OD-06-069 Multiple PI Implementation
Update http//grants2.nih.gov/grants/guide/notice
-files/not-od-06-069.html How to Write a Grant
Application Multiple PI Leadership Plan
http//www.niaid.nih.gov/ncn/grants/write/write_p2
.htm Examples of Project Leadership Plans for
Multiple PI Grant ... http//grants2.nih.gov/grant
s/multi_pi/sample_leadership_plans.pdfNOT-OD-06-
074 Reminder for Applicants Considering the
Multiple PI http//grants2.nih.gov/grants/guide/n
otice-files/NOT-OD-06-074.html
31
Multiple PI Initiative Why?
Rationale and Background
  • Multiple PD/PI (MPI) represents an NIH Roadmap
    initiative (http//nihroadmap.nih.gov/interdiscipl
    inary/) and responds to a Federal-wide directive
    to formally allow more than one PD/PI
  • Offers new approaches to maximize the potential
    of team science efforts
  • MPI model will supplement -- not replace --
    traditional single PD/PI model

32
Leadership Plan
  • A Leadership Plan must accompany application
  • Rationale for having multiple PD/PIs
  • Decision making process
  • Allocation of funds or resources (when desired)
  • Process for resolving conflict
  • PD/PIs roles and administrative, technical, and
    scientific responsibilities for project

33
Review of Multiple PD/PI Applications
  • Minimal modification of standard review criteria
  • Relationship, roles, and responsibility of
    collaborating PD/PIs will be assessed as part of
    Approach
  • Qualification of all PD/PIs will be assed under
    Investigators
  • If multiple environments are employed, their
    quality will be assessed under Environment
  • Details provided in SF424 (RR) Review Section

34
NIH Interaction With PD/PI Team
  • SBC must designate a primary point of contact - a
    Contact PD/PI
  • This individual is listed first on application
    and will be indicated on all documents.
  • SBIR Contact PD/PI must meet 51 employment
    requirement
  • STTR Contact PD/PI must be associated with
    applicant/awardee small business concern
  • Contact PD/PI has no extra authority or
    responsibility other than serving as a contact
    point for project
  • Grantee SBC may, at time of a non-competing
    application, request another member of leadership
    team to assume role of Contact PD/PI

35
SBIR/STTR Multiple PD/PI Employment
  • SBIR Primary employment of Contact PD/PI must
    be with SBC (Phase I and Phase II).
  • STTR First PD/PI listed must be affiliated with
    applicant SBC and will serve as Contact PD/PI.
    Contact PD/PI may be from SBC or single,
    partnering research institution.
  • Note STTR Contact PD/PI must have a formal
    appointment with or commitment to SBC, which must
    be in form of an official relationship between
    parties, but need not include salary or other
    form of remuneration.

36
NIH SBIR/STTR 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
37
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

Take Home Message 2
38
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
39
Does My Technology Fit In NIH?
See our Mission Statement!
Solutions to Real Problems. that affect Real
People.
No requirement to find an identical topic match.
Take Home Message 3
40
Synergy Innovations, Inc. (NH) (HD36154)
Product Smart Variable Geometry
Socket" Technology A series of water-filled
bladders, passive pumps, and valves compensate
for volumetric changes of the residual limb.
Outcome Consistent and precise fit, which
lowers the need for, and cost of, continued
rehabilitation and greatly improves the quality
of life for lower-limb amputees. Importance of
SBIR The conceptualization, development, and
commercialization of this device.
. the SBIR mechanism is a unique source of
support for biomedical engineers and
entrepreneurs. - Dr. Robert Dean, President
, Synergy Innovations Inc.
41
NovaRx (CA) (1R44CA105964)
  • Product Vaccine for Glioma (Brain Cancer)
  • Technology
  • TGF-ß antisense technology blocks the production
    of TGF-Beta by the cancer cells.
  • Replaces autologous tumor cells with allogeneic
    tumor cells (other peoples tumor cells) that may
    be used "off the shelf" to treat a large number
    of patients
  • Importance of SBIR 2.2 million SBIR award (4
    years) will help fund pivotal Phase II/III
    clinical trial.
  • SBIR Funding Critical in establishing the
    feasibility of developing a whole-cell vaccine
    for the treatment of gliomas.

Allogeneic Glioma Vaccine using TGF-beta knockouts
42
ARISIL (NY) (1R44DC003613 )
Product Ear Popper Technology Development of a
safe, simple, non-surgical device to drain the
middle ear of fluid and restore hearing. Uses of
Device Treating such common conditions as Otitis
Media, Aerotitis/Barotitis (caused by rapid
elevation changes), and Eustachian Tube
Dysfunction in children and adults. Importance
of SBIR Critical in establishing the
feasibility of developing a device that may
replace surgery and drugs for draining middle ear
fluid.
43
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
44
Gap Funding Programs
Phase I
Phase II
Phase III
45
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

46
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?
47
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?

48
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

49
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!
50
Technical Assistance Program
Transitioning to the Marketplace
Phase I
Phase II
Phase III
51
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.

52
Technical Assistance Program
(TAP)
Commercialization Assistance Program
Niche Assessment Program
New!
Pilot Manufacturing Assistance Program
53
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

54
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)
55
Congratulations!
The check is in the mail
(almost)
56
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

57
Key to the NIH Application, Review, and Award
Process
Communication
Take Home Message 4
58
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

59
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
60
NIH Review Staff
  • Scientific Review Administrator.
  • Point of contact during review process
  • Recruitment/Assignment of Reviewers
  • Concerns about I/C Assignment or Review

Review
61
NIH Grants Management Staff
  • Pre-Award Steps
  • Post-Award Advice/Guidance

Award
62
NIH SBIR/STTR Program Coordinator
Guidance and Advice.... Success Stories
63
NIH Could Be Your First Customer!
Small Business Licensing and Procurement
Opportunities
Did You Know?
64
Little Known Facts
Small Business Licensing and Procurement
Opportunities
  • 1. NIH is a major (possibly largest) U.S.
    consumer of bioscience research reagents and
    instruments.
  • NIH employs 17,000 Intramural staff scientists
  • Laboratories spread across the nation (Bethesda
    campus housing majority of labs)
  • 2. There are many mechanisms and avenues for
    selling products and services to the NIH.
  • GSA Schedule
  • Blanket Purchase Agreement with NIH -- Goods and
    services into the NIH stockroom
  • - If the goods and services from a biotech
    company are superior quality, an NIH scientist
    can justify buying sole source

65
Annual NIH Research Festival- Excellent
starting point for companies hoping to sell
products to NIH - Bethesda campus (Fall) - Ft.
Detrick campus (Spring) - Small-to-medium-sized
biotech companies - Attracts 6,000 NIH PhDs,
many of whom want the latest research tools
Small Business Licensing and Procurement
Opportunities
Did You Know?
66
The competition for SBIR Phase I and Phase II
awards satisfies competition requirements for
Phase III. - An agency is permitted to do a
Sole Source Justification and Approval for an
SBIR Phase III award that is derived from,
extends, or logically concludes efforts performed
under prior SBIR awards.
http//www.sba.gov/sbir/SBIR-PolicyDirective.pdf
10 U.S.C. 2304(b) (2) or 41
U.S.C. 253(b) (2)
Did You Know?
Small Business Licensing and Procurement
Opportunities
67
Ways to Market to HHS/NIH
  • Search the Federal Business Opportunities Web
    page (FedBizOpps) regularly (http//www1.fbo.gov/)
  • FedizOpps is single government point-of-entry for
    Federal procurement opportunities over 25,000.
    (Request for Proposals RFP)
  • Search NIH RFP Directory
  • Search Research Contracts Branches of NIH ICs
  • Familiarize yourself with HHS OSDBU Web site
  • Search the HHS Forecast
  • Attend Vendor Outreach Sessions (held monthly)
  • Understand what HHS will buy

68
FedBizOpps
Search by Procurement Classification Code A-
Research Development  
69
Search NIH Request for Proposals
Directory http//ocm.od.nih.gov/contracts/rfps/MAI
NPAGE.HTM
Search NIHs RFP Directory
70
Familiarize Yourself with HHS OSDBU Web Site
http//www.dhhs.gov/osdbu/
71
Management Services
What HHS Buys
  • Biomedical Research
  • Evaluations
  • Information Management
  • Conference Management
  • Data Collection
  • Data Analysis

72
Information Technology
What HHS Buys
  • Hardware
  • Software
  • Programming
  • Computer Repair
  • Data Entry
  • Systems Integration

73
Products
What HHS Buys
  • Equipment
  • Textile Goods
  • Office Supplies
  • Office Furniture
  • Chemicals
  • Paper Products
  • Laboratory Supplies

NIH Intramural Labs NIH Clinical Center
74
Search Forecast of HHS' Contracting
Opportunities FY 2007 (examples)
http//www.dhhs.gov/osdbu/publications/forecast.ht
ml
75
Attend Vendor Outreach Sessions
  • OSDBU hosts monthly Vendor Outreach Session
    (VOS)
  • Educate vendors on preferential procurement
    programs
  • Provide information effective marketing to HHS
  • Second Tuesday of each month (Jan Nov)
  • (900 12 noon).
  • FREE!

Schedule of Events http//www.hhs.gov/osdbu/event
s/
76
SBIR / STTR Toolbox
Information and Resources
77
Stay InformedList Servs
  • SBIR/STTR ListServ Mailings from Yours Truly
  • Send an e-mail to LISTSERV_at_LIST.NIH.GOV with
    following text in message body (not "Subject"
    line) subscribe SBIR-STTR your name
    (Example subscribe SBIR-STTR Jane Doe)
  • NIH Guide for Grants and Contracts (weekly
    edition)
  • http//grants.nih.gov/grants/guide/listserv.htm
  • NIH SBIR/STTR Notification
  • http//grants.nih.gov/grants/funding/listserv.htm

78
Helpful Links
  • NIH Small Business Funding Site
  • http//grants.nih.gov/grants/funding/sbir.htm
  • Computer Retrieval of Information on Scientific
    Projects (CRISP)
  • http//crisp.cit.nih.gov
  • Contacts at NIH
  • http//grants.nih.gov/grants/contacts.htm
  • National SBIR/STTR Resource Center
  • http//www.sbirworld.com

79
Getting Started NIH As Your Potential Customer
  • HHS OSDBU www.hhs.gov/osdbu - Forecast of
    Procurement/Contracting Opportunities Lists of
    Active Contracts How To Do Business Guide
  • GSA/FAS www.gsa.gov/fas
  • Federal Acquisition Regulations www.arnet.gov
  • FedBizOpps www.fedbizopps.gov - Single posting
    for all government requirements
  • CCR www.ccr.gov - Your company must be
    registered to do business and be paid by the
    Federal Government
  • Federal Procurement Data Center - www.fpdc.gov
  • Procurement Technical Assistance Center PTAC
    www.aptac-us.org

80
Preparing an SBIR/STTR Grant Application
  • Electronic Submission
  • http//era.nih.gov/ElectronicReceipt/prepare_ap
    p.htm
  • Finding the PHS398 elements in the SF424 (RR)
    (crosswalk)
  • Errors and warnings (validations)
  • Important Tips (PDF, etc.)
  • Prepare Application FAQs
  • Application Guide SF424 (RR)
  •  Sample Application Forms
  •  Application Examples
  •  Training video and handouts on SF424 (RR) form
  •  Grants.gov Application Package Demo

81
Preparing an SBIR/STTR Grant Application
  • http//grants1.nih.gov/grants/grant_tips.htm
  • http//grants1.nih.gov/grants/funding/sbir_policy.
    htm
  • http//www.niaid.nih.gov/ncn/grants/
  • http//deainfo.nci.nih.gov/EXTRA/EXTDOCS/gntapp.ht
    m
  • http//www.nlm.nih.gov/ep/Tutorial.html

82
Finding A Partner
  • CRISP Award Database
  • http//crisp.oit.nih.gov
  • NIH Collaboration Opportunities and Research
    Partnerships
  • http//grants.nih.gov/grants/funding/corp.htm
  • NIH Office of Technology Transfer
  • http//ott.od.nih.gov/

83
FDA Technical Assistance
Each Component of FDA has an Office to Provide
Technical Assistance to Manufacturers
  • Human Drug Products
  • Biological Products
  • Animal Drugs and Devices
  • Food Products and Cosmetics

84
FDA Technical Assistance
Human Drug Products Center for Drug Evaluation
and Research (CDER) Telephone Number
301.827.4573Fax Number 301.827.4577Fax-On-Deman
d 800.342.2722 or 301.827.0577 CDER Home Page
http//www.fda.gov/cderEmail Address
DIB_at_cder.fda.gov
85
FDA Technical Assistance
Biological Products Center for Biologics
Evaluation and Research (CBER) Telephone Number
301.827.2000 or 800.835.4709Fax Number
301.827.3843CBER Home Page http//www.fda.gov/cb
er Email Address Manufacturers Assistance
and Technical Training Team MATT_at_cber.fda.gov
Consumer Health Professional Assistance
OCTMA_at_cber.fda.gov
86
FDA Technical Assistance
Animal Drugs and Devices Center for Veterinary
Medicine (CVM) Telephone Number
301.827.3800Fax Number 301.594.1807CVM Home
Page http//www.fda.gov/cvm Email Address
fdacvm_at_informatics.vetmed.vt.edu
87
FDA Technical Assistance
Food Products and Cosmetics Center for Food
Safety and Applied Nutrition (CFSAN) Telephone
Number 301-436-2335Fax Number 301-436-2764
CFSAN Home Page http//vm.cfsan.fda.gov/list.htm
l Email Address OCO_at_cfsan.fda.gov
88
The Top 10
89
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
90
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
91
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

92
Top 10 Reasons
  • To make economic and societal contributions
  • for America

93
Real Solutions..Real Problems. Real People
Lab to Life
Todays Ideas
Tomorrows Discoveries
A Better Future for All Americans
Final Take Home Message
94
For More Information
www.nih.gov
http//grants.nih.gov/grants/funding/sbir.htm
Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone 301-435-2688 Fax
301-480-0146 Email jg128w_at_nih.gov
Kay Etzler SBIR/STTR Program Analyst Phone
301-435-2713 Fax 301-480-0146
Email etzlerk_at_od.nih.gov
95
NIH ICs and General Areas of Research
NCI -- cancer cause, prevention, detection,
diagnosis, treatment and control
NHLBI -- diseases of heart, blood vessels, lungs,
blood, and transfusion medicine
NIDCR -- understand, treat and prevent infectious
and inherited craniofacial-oral-dental diseases
and disorders
NINDS -- diagnosis, treatment, and prevention of
disorders of the nervous system, neuromuscular
apparatus, and special senses of touch/pain
NIDDK -- diabetes, endocrinology, and metabolic
diseases digestive diseases and nutrition
kidney, urologic and hematologic diseases
NIAID -- understand, treat and prevent
infectious, immunologic, and allergic diseases
96
NIH ICs and General Areas of Research
NIGMS -- basic biomedical research not targeted
to diseases or disorders recombinant DNA
technology
NICHD -- fertility, pregnancy, growth,
development, and medical rehabilitation
NEI -- blinding eye diseases, visual disorders,
mechanisms of visual function, preservation of
sight, requirements of the blind
NIEHS -- identification, assessment, and
mechanism of action of environmental agents that
are potentially harmful to human health
NIA -- biomedical, social, and behavioral aspects
of aging process prevention of age-related
diseases and disabilities promotion of better
QOL for older Americans
97
NIH ICs and General Areas of Research
NIAMS -- arthritis/rheumatic diseases, connective
tissue diseases, musculoskeletal and skin
disorders
NIDCD -- normal mechanisms diseases, and
disorders of hearing, balance, smell, taste,
voice, speech and language
NIMH -- understanding, treating, preventing
behavioral and mental disorders (including HIV
prevention, neuro-AIDS research)
NIDA -- treatment of drug addiction behavioral
strategies for treatment medication training in
drug abuse treatment techniques drug abuse
treatment
NIAAA -- treatment and prevention of alcoholism
and alcohol-related problems
NINR-- understand effects of acute and chronic
illness, improving QOL, approaches to promote
health and prevent disease, improving clinical
environments
98
NIH ICs and General Areas of Research
NIHGRI -- efforts toward achieving the goals of
the Human Genome Project (Science vol. 262,
pp.43-46 Oct. 1, 1993)
NCRR -- RD in instrumentation and specialized
technologies for biomedical research RD in
comparative medicine discovery-oriented software
for science education
NCCAM -- complementary and alternative treatment,
diagnostic, and prevention modalities,
disciplines and systems education and public
information patient management botanical
products research-related issues (e.g., models,
methods)
NLM -- innovative methods, systems, and services
for managing health knowledge and information
View by Category
About This Presentation
Title:

Jo Anne Goodnight

Description:

... Life Science Innovation ... 'The life science innovation lifecycle is marked by more ... The 21st Century Life Science Roadmap, Texas Healthcare ... – PowerPoint PPT presentation

Number of Views:55
Avg rating:3.0/5.0
Slides: 87
Provided by: goo119
Category:
Tags: anne | goodnight

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: Jo Anne Goodnight


1
"Lab to Life"
National Institutes of Health
NIH SBIR/STTR Funding OpportuNIHtieS
  • Jo Anne Goodnight
  • SBIR/STTR Program Manager
  • Office of Extramural Research, NIH

9th Annual NIH SBIR/STTR Conference Feb 26-27,
2007 ? Las Vegas, NV
2
Topics to Discuss Today
  • SBIR / STTR Program Overview
  • NIH SBIR / STTR Program Specifics
  • Whats New?
  • Communicating with NIH
  • Transitioning to the Marketplace
  • Selling/Marketing to NIH

3
What Do These Solutions Have in Common?
Cardiac Assist, Inc.
4
Entrepreneurial Audacity
Intellectual Rigor Hard Work Passion Mission
Entrepreneurship
NIH SBIR/STTR Funding
5
Technology Entrepreneurship
Intralase - Femtosecond laser technology Design
Continuum - PediSedate sedation device for
children CardiacAssist - Tandem Heart
(Percutaneous Ventricular Assist
Device) Cyberkinetics Neurotechnology -
BrainGateTM - Communication interfaces to restore
limb movement to those with spinal cord injury,
stroke, ALS (Lou Gehrig's disease), etc. GlycoFi
- Biotherapeutics
6
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.
7
Program Descriptions
  • Small Business Innovation Research (SBIR)
  • Set-aside program for small business
  • concerns to engage in Federal RD --
  • with potential for commercialization.
  • Small Business Technology Transfer (STTR)
  • Set-aside program to facilitate cooperative
  • RD between small business concerns and
  • U.S. research institutions --
  • with potential for commercialization.

2.5
0.3
8
SBIR / STTR Program Mission
Supporting scientific excellence and
technological innovation through the investment
of Federal research funds in critical American
priorities to build a strong national economy
one small business at a time.
9
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)
10
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)
11
(No Transcript)
12
SBIR/STTR 3-Phase Program
13
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
14
SBIR Eligibility Checkpoints
  • Organized for-profit U.S. business
  • 500 employees or fewer, including affiliates
  • PD/PIs primary employment must be with small
    business concern at time of award and for
    duration of project period

15
SBIR Eligibility Checkpoints
  • Small business concern must be
  • 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

16
STTR Eligibility Checkpoints
  • Applicant is Small Business Concern
  • (Subsidiaries are NOT eligible for STTR
    program)
  • 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

17
Ownership And Control
got questions?
  • Contact the SBA Size Specialists
  • Request an eligibility determination
  • http//www.sba.gov/size/indexcontacts.html

18
Performance of Research Activities
All research/RD must be performed in its
entirety in the U.S.
  • Rare cases to conduct testing of specific
    patient populations outside U.S. is allowable
  • Travel to scientific meeting in foreign country
    is allowable
  • Foreign consultants/collaborators are allowable,
    but must perform consulting in U.S.

19
Fee/Profit
  • Up to 7 of total direct and FA costs may be
    requested for fee
  • Must be requested and justified in application
  • Only SBC eligible -- no contracts, consortium or
    other third party are eligible for fee
  • Fee not a cost

20
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

21
NIH SBIR / STTR Program Specifics
22
Transforming Medicine Through Innovation
The NIH SBIR/STTRProgram Specifics
Lab to Life Improving the Health of Americans
23
NIH Mission
Improve human health through biomedical and
behavioral research, research training and
communications.
24
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

25
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
26
HHS SBIR/STTR Funding
640M
Propose a Realistic and Appropriate Budget
for the Research Take Home Message 1
27
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
28
SBIR/STTR Program Updates
Whats New?
  • Receipt Dates
  • Multiple PD/PI SBIR and STTR
  • Appendix Instructions
  • Pilot Manufacturing Assistance Program

New!
Reminders
  • Electronic Submission
  • Funding Opportunity Announcements (FOA)
    Solicitations

29
Solicitations and Receipt Dates
  • SBIR/STTR Omnibus Grant Solicitation Parent FOAs
  • (NIH, CDC, and FDA)
  • Release January
  • Standard Receipt Dates April 5, Aug 5, Dec 5
  • (AIDS/AIDS-related May 1, Sept 1, Jan 2) No
    Change
  • SBIR Contract Solicitation (NIH, CDC)
  • Release August November receipt date
  • NIH Guide for Grants and Contracts
  • Release Weekly Receipt dates specified in
    each FOA

SBIR PA-07-280 and STTR PA-07-281
New!
30
Multiple PD/PIs
Important Links
New!
Multiple Principal Investigators Web
Site http//grants2.nih.gov/grants/multi_pi/
NOT-OD-06-069 Multiple PI Implementation
Update http//grants2.nih.gov/grants/guide/notice
-files/not-od-06-069.html How to Write a Grant
Application Multiple PI Leadership Plan
http//www.niaid.nih.gov/ncn/grants/write/write_p2
.htm Examples of Project Leadership Plans for
Multiple PI Grant ... http//grants2.nih.gov/grant
s/multi_pi/sample_leadership_plans.pdfNOT-OD-06-
074 Reminder for Applicants Considering the
Multiple PI http//grants2.nih.gov/grants/guide/n
otice-files/NOT-OD-06-074.html
31
Multiple PI Initiative Why?
Rationale and Background
  • Multiple PD/PI (MPI) represents an NIH Roadmap
    initiative (http//nihroadmap.nih.gov/interdiscipl
    inary/) and responds to a Federal-wide directive
    to formally allow more than one PD/PI
  • Offers new approaches to maximize the potential
    of team science efforts
  • MPI model will supplement -- not replace --
    traditional single PD/PI model

32
Leadership Plan
  • A Leadership Plan must accompany application
  • Rationale for having multiple PD/PIs
  • Decision making process
  • Allocation of funds or resources (when desired)
  • Process for resolving conflict
  • PD/PIs roles and administrative, technical, and
    scientific responsibilities for project

33
Review of Multiple PD/PI Applications
  • Minimal modification of standard review criteria
  • Relationship, roles, and responsibility of
    collaborating PD/PIs will be assessed as part of
    Approach
  • Qualification of all PD/PIs will be assed under
    Investigators
  • If multiple environments are employed, their
    quality will be assessed under Environment
  • Details provided in SF424 (RR) Review Section

34
NIH Interaction With PD/PI Team
  • SBC must designate a primary point of contact - a
    Contact PD/PI
  • This individual is listed first on application
    and will be indicated on all documents.
  • SBIR Contact PD/PI must meet 51 employment
    requirement
  • STTR Contact PD/PI must be associated with
    applicant/awardee small business concern
  • Contact PD/PI has no extra authority or
    responsibility other than serving as a contact
    point for project
  • Grantee SBC may, at time of a non-competing
    application, request another member of leadership
    team to assume role of Contact PD/PI

35
SBIR/STTR Multiple PD/PI Employment
  • SBIR Primary employment of Contact PD/PI must
    be with SBC (Phase I and Phase II).
  • STTR First PD/PI listed must be affiliated with
    applicant SBC and will serve as Contact PD/PI.
    Contact PD/PI may be from SBC or single,
    partnering research institution.
  • Note STTR Contact PD/PI must have a formal
    appointment with or commitment to SBC, which must
    be in form of an official relationship between
    parties, but need not include salary or other
    form of remuneration.

36
NIH SBIR/STTR 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
37
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

Take Home Message 2
38
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
39
Does My Technology Fit In NIH?
See our Mission Statement!
Solutions to Real Problems. that affect Real
People.
No requirement to find an identical topic match.
Take Home Message 3
40
Synergy Innovations, Inc. (NH) (HD36154)
Product Smart Variable Geometry
Socket" Technology A series of water-filled
bladders, passive pumps, and valves compensate
for volumetric changes of the residual limb.
Outcome Consistent and precise fit, which
lowers the need for, and cost of, continued
rehabilitation and greatly improves the quality
of life for lower-limb amputees. Importance of
SBIR The conceptualization, development, and
commercialization of this device.
. the SBIR mechanism is a unique source of
support for biomedical engineers and
entrepreneurs. - Dr. Robert Dean, President
, Synergy Innovations Inc.
41
NovaRx (CA) (1R44CA105964)
  • Product Vaccine for Glioma (Brain Cancer)
  • Technology
  • TGF-ß antisense technology blocks the production
    of TGF-Beta by the cancer cells.
  • Replaces autologous tumor cells with allogeneic
    tumor cells (other peoples tumor cells) that may
    be used "off the shelf" to treat a large number
    of patients
  • Importance of SBIR 2.2 million SBIR award (4
    years) will help fund pivotal Phase II/III
    clinical trial.
  • SBIR Funding Critical in establishing the
    feasibility of developing a whole-cell vaccine
    for the treatment of gliomas.

Allogeneic Glioma Vaccine using TGF-beta knockouts
42
ARISIL (NY) (1R44DC003613 )
Product Ear Popper Technology Development of a
safe, simple, non-surgical device to drain the
middle ear of fluid and restore hearing. Uses of
Device Treating such common conditions as Otitis
Media, Aerotitis/Barotitis (caused by rapid
elevation changes), and Eustachian Tube
Dysfunction in children and adults. Importance
of SBIR Critical in establishing the
feasibility of developing a device that may
replace surgery and drugs for draining middle ear
fluid.
43
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
44
Gap Funding Programs
Phase I
Phase II
Phase III
45
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

46
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?
47
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?

48
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

49
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!
50
Technical Assistance Program
Transitioning to the Marketplace
Phase I
Phase II
Phase III
51
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.

52
Technical Assistance Program
(TAP)
Commercialization Assistance Program
Niche Assessment Program
New!
Pilot Manufacturing Assistance Program
53
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

54
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)
55
Congratulations!
The check is in the mail
(almost)
56
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

57
Key to the NIH Application, Review, and Award
Process
Communication
Take Home Message 4
58
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

59
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
60
NIH Review Staff
  • Scientific Review Administrator.
  • Point of contact during review process
  • Recruitment/Assignment of Reviewers
  • Concerns about I/C Assignment or Review

Review
61
NIH Grants Management Staff
  • Pre-Award Steps
  • Post-Award Advice/Guidance

Award
62
NIH SBIR/STTR Program Coordinator
Guidance and Advice.... Success Stories
63
NIH Could Be Your First Customer!
Small Business Licensing and Procurement
Opportunities
Did You Know?
64
Little Known Facts
Small Business Licensing and Procurement
Opportunities
  • 1. NIH is a major (possibly largest) U.S.
    consumer of bioscience research reagents and
    instruments.
  • NIH employs 17,000 Intramural staff scientists
  • Laboratories spread across the nation (Bethesda
    campus housing majority of labs)
  • 2. There are many mechanisms and avenues for
    selling products and services to the NIH.
  • GSA Schedule
  • Blanket Purchase Agreement with NIH -- Goods and
    services into the NIH stockroom
  • - If the goods and services from a biotech
    company are superior quality, an NIH scientist
    can justify buying sole source

65
Annual NIH Research Festival- Excellent
starting point for companies hoping to sell
products to NIH - Bethesda campus (Fall) - Ft.
Detrick campus (Spring) - Small-to-medium-sized
biotech companies - Attracts 6,000 NIH PhDs,
many of whom want the latest research tools
Small Business Licensing and Procurement
Opportunities
Did You Know?
66
The competition for SBIR Phase I and Phase II
awards satisfies competition requirements for
Phase III. - An agency is permitted to do a
Sole Source Justification and Approval for an
SBIR Phase III award that is derived from,
extends, or logically concludes efforts performed
under prior SBIR awards.
http//www.sba.gov/sbir/SBIR-PolicyDirective.pdf
10 U.S.C. 2304(b) (2) or 41
U.S.C. 253(b) (2)
Did You Know?
Small Business Licensing and Procurement
Opportunities
67
Ways to Market to HHS/NIH
  • Search the Federal Business Opportunities Web
    page (FedBizOpps) regularly (http//www1.fbo.gov/)
  • FedizOpps is single government point-of-entry for
    Federal procurement opportunities over 25,000.
    (Request for Proposals RFP)
  • Search NIH RFP Directory
  • Search Research Contracts Branches of NIH ICs
  • Familiarize yourself with HHS OSDBU Web site
  • Search the HHS Forecast
  • Attend Vendor Outreach Sessions (held monthly)
  • Understand what HHS will buy

68
FedBizOpps
Search by Procurement Classification Code A-
Research Development  
69
Search NIH Request for Proposals
Directory http//ocm.od.nih.gov/contracts/rfps/MAI
NPAGE.HTM
Search NIHs RFP Directory
70
Familiarize Yourself with HHS OSDBU Web Site
http//www.dhhs.gov/osdbu/
71
Management Services
What HHS Buys
  • Biomedical Research
  • Evaluations
  • Information Management
  • Conference Management
  • Data Collection
  • Data Analysis

72
Information Technology
What HHS Buys
  • Hardware
  • Software
  • Programming
  • Computer Repair
  • Data Entry
  • Systems Integration

73
Products
What HHS Buys
  • Equipment
  • Textile Goods
  • Office Supplies
  • Office Furniture
  • Chemicals
  • Paper Products
  • Laboratory Supplies

NIH Intramural Labs NIH Clinical Center
74
Search Forecast of HHS' Contracting
Opportunities FY 2007 (examples)
http//www.dhhs.gov/osdbu/publications/forecast.ht
ml
75
Attend Vendor Outreach Sessions
  • OSDBU hosts monthly Vendor Outreach Session
    (VOS)
  • Educate vendors on preferential procurement
    programs
  • Provide information effective marketing to HHS
  • Second Tuesday of each month (Jan Nov)
  • (900 12 noon).
  • FREE!

Schedule of Events http//www.hhs.gov/osdbu/event
s/
76
SBIR / STTR Toolbox
Information and Resources
77
Stay InformedList Servs
  • SBIR/STTR ListServ Mailings from Yours Truly
  • Send an e-mail to LISTSERV_at_LIST.NIH.GOV with
    following text in message body (not "Subject"
    line) subscribe SBIR-STTR your name
    (Example subscribe SBIR-STTR Jane Doe)
  • NIH Guide for Grants and Contracts (weekly
    edition)
  • http//grants.nih.gov/grants/guide/listserv.htm
  • NIH SBIR/STTR Notification
  • http//grants.nih.gov/grants/funding/listserv.htm

78
Helpful Links
  • NIH Small Business Funding Site
  • http//grants.nih.gov/grants/funding/sbir.htm
  • Computer Retrieval of Information on Scientific
    Projects (CRISP)
  • http//crisp.cit.nih.gov
  • Contacts at NIH
  • http//grants.nih.gov/grants/contacts.htm
  • National SBIR/STTR Resource Center
  • http//www.sbirworld.com

79
Getting Started NIH As Your Potential Customer
  • HHS OSDBU www.hhs.gov/osdbu - Forecast of
    Procurement/Contracting Opportunities Lists of
    Active Contracts How To Do Business Guide
  • GSA/FAS www.gsa.gov/fas
  • Federal Acquisition Regulations www.arnet.gov
  • FedBizOpps www.fedbizopps.gov - Single posting
    for all government requirements
  • CCR www.ccr.gov - Your company must be
    registered to do business and be paid by the
    Federal Government
  • Federal Procurement Data Center - www.fpdc.gov
  • Procurement Technical Assistance Center PTAC
    www.aptac-us.org

80
Preparing an SBIR/STTR Grant Application
  • Electronic Submission
  • http//era.nih.gov/ElectronicReceipt/prepare_ap
    p.htm
  • Finding the PHS398 elements in the SF424 (RR)
    (crosswalk)
  • Errors and warnings (validations)
  • Important Tips (PDF, etc.)
  • Prepare Application FAQs
  • Application Guide SF424 (RR)
  •  Sample Application Forms
  •  Application Examples
  •  Training video and handouts on SF424 (RR) form
  •  Grants.gov Application Package Demo

81
Preparing an SBIR/STTR Grant Application
  • http//grants1.nih.gov/grants/grant_tips.htm
  • http//grants1.nih.gov/grants/funding/sbir_policy.
    htm
  • http//www.niaid.nih.gov/ncn/grants/
  • http//deainfo.nci.nih.gov/EXTRA/EXTDOCS/gntapp.ht
    m
  • http//www.nlm.nih.gov/ep/Tutorial.html

82
Finding A Partner
  • CRISP Award Database
  • http//crisp.oit.nih.gov
  • NIH Collaboration Opportunities and Research
    Partnerships
  • http//grants.nih.gov/grants/funding/corp.htm
  • NIH Office of Technology Transfer
  • http//ott.od.nih.gov/

83
FDA Technical Assistance
Each Component of FDA has an Office to Provide
Technical Assistance to Manufacturers
  • Human Drug Products
  • Biological Products
  • Animal Drugs and Devices
  • Food Products and Cosmetics

84
FDA Technical Assistance
Human Drug Products Center for Drug Evaluation
and Research (CDER) Telephone Number
301.827.4573Fax Number 301.827.4577Fax-On-Deman
d 800.342.2722 or 301.827.0577 CDER Home Page
http//www.fda.gov/cderEmail Address
DIB_at_cder.fda.gov
85
FDA Technical Assistance
Biological Products Center for Biologics
Evaluation and Research (CBER) Telephone Number
301.827.2000 or 800.835.4709Fax Number
301.827.3843CBER Home Page http//www.fda.gov/cb
er Email Address Manufacturers Assistance
and Technical Training Team MATT_at_cber.fda.gov
Consumer Health Professional Assistance
OCTMA_at_cber.fda.gov
86
FDA Technical Assistance
Animal Drugs and Devices Center for Veterinary
Medicine (CVM) Telephone Number
301.827.3800Fax Number 301.594.1807CVM Home
Page http//www.fda.gov/cvm Email Address
fdacvm_at_informatics.vetmed.vt.edu
87
FDA Technical Assistance
Food Products and Cosmetics Center for Food
Safety and Applied Nutrition (CFSAN) Telephone
Number 301-436-2335Fax Number 301-436-2764
CFSAN Home Page http//vm.cfsan.fda.gov/list.htm
l Email Address OCO_at_cfsan.fda.gov
88
The Top 10
89
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
90
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
91
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

92
Top 10 Reasons
  • To make economic and societal contributions
  • for America

93
Real Solutions..Real Problems. Real People
Lab to Life
Todays Ideas
Tomorrows Discoveries
A Better Future for All Americans
Final Take Home Message
94
For More Information
www.nih.gov
http//grants.nih.gov/grants/funding/sbir.htm
Jo Anne Goodnight NIH SBIR/STTR Program
Coordinator Phone 301-435-2688 Fax
301-480-0146 Email jg128w_at_nih.gov
Kay Etzler SBIR/STTR Program Analyst Phone
301-435-2713 Fax 301-480-0146
Email etzlerk_at_od.nih.gov
95
NIH ICs and General Areas of Research
NCI -- cancer cause, prevention, detection,
diagnosis, treatment and control
NHLBI -- diseases of heart, blood vessels, lungs,
blood, and transfusion medicine
NIDCR -- understand, treat and prevent infectious
and inherited craniofacial-oral-dental diseases
and disorders
NINDS -- diagnosis, treatment, and prevention of
disorders of the nervous system, neuromuscular
apparatus, and special senses of touch/pain
NIDDK -- diabetes, endocrinology, and metabolic
diseases digestive diseases and nutrition
kidney, urologic and hematologic diseases
NIAID -- understand, treat and prevent
infectious, immunologic, and allergic diseases
96
NIH ICs and General Areas of Research
NIGMS -- basic biomedical research not targeted
to diseases or disorders recombinant DNA
technology
NICHD -- fertility, pregnancy, growth,
development, and medical rehabilitation
NEI -- blinding eye diseases, visual disorders,
mechanisms of visual function, preservation of
sight, requirements of the blind
NIEHS -- identification, assessment, and
mechanism of action of environmental agents that
are potentially harmful to human health
NIA -- biomedical, social, and behavioral aspects
of aging process prevention of age-related
diseases and disabilities promotion of better
QOL for older Americans
97
NIH ICs and General Areas of Research
NIAMS -- arthritis/rheumatic diseases, connective
tissue diseases, musculoskeletal and skin
disorders
NIDCD -- normal mechanisms diseases, and
disorders of hearing, balance, smell, taste,
voice, speech and language
NIMH -- understanding, treating, preventing
behavioral and mental disorders (including HIV
prevention, neuro-AIDS research)
NIDA -- treatment of drug addiction behavioral
strategies for treatment medication training in
drug abuse treatment techniques drug abuse
treatment
NIAAA -- treatment and prevention of alcoholism
and alcohol-related problems
NINR-- understand effects of acute and chronic
illness, improving QOL, approaches to promote
health and prevent disease, improving clinical
environments
98
NIH ICs and General Areas of Research
NIHGRI -- efforts toward achieving the goals of
the Human Genome Project (Science vol. 262,
pp.43-46 Oct. 1, 1993)
NCRR -- RD in instrumentation and specialized
technologies for biomedical research RD in
comparative medicine discovery-oriented software
for science education
NCCAM -- complementary and alternative treatment,
diagnostic, and prevention modalities,
disciplines and systems education and public
information patient management botanical
products research-related issues (e.g., models,
methods)
NLM -- innovative methods, systems, and services
for managing health knowledge and information
About PowerShow.com