Post on 15-Jan-2016
Greg Evans, PhDTeam Leader
Cancer Imaging/Biology/Control
NCI SBIR Development Center
2014 Overview of the NCI Small Business Programs: Grant and Contract Funding
Opportunities to Bring Cancer Science to the Market
Tuesday July 22, 2014 A BioAustin/ Austin Chamber of Commerce
Today’s Presentation
SBIR and NIH Background Information
Company-Initiated SBIR/STTR Grant Applications- 3 DEADLINES PER YEAR
Targeted NCI SBIR Funding Opportunities• New Contract Topics Published Once Per Year in August- DEADLINE IN NOVEMBER• 3 Narrowly-Focused Grant Program Announcements Ending 2014-2016
SBIR Phase IIB Bridge Grant Program- 3rd Stage and Largest Award• Requirement for Matching Funds
Initiatives (Beyond Funding) to Facilitate Commercialization
Tips for a Successful NCI SBIR Application
NCI SBIR Development Center
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Congressional Goals
1. Stimulate technological innovation
2. Use small business to meet Federal R&D needs
3. Increase private-sector commercialization innovations derived from Federal R&D
4. Foster participation by minority and disadvantaged persons in technological innovation
Small Business Innovation Development Act of 1982
Small Business Technology Transfer Act of 1992
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Congressionally-Mandated Programs
2.8%
0.40%
Set Aside $$
~$757 M in FY14 at NIH~$119 M in FY14 at NCI
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Small Business Innovation Research (SBIR)Set-aside program for small business concerns to
engage in Federal R&D with the potential for commercialization
Federal agencies with an extramural R&D budget > $100M
Small Business Technology Transfer (STTR)Set-aside program to facilitate cooperative R&D between small
business concerns and U.S. research institutions with the potential for commercialization Federal agencies with an extramural R&D budget > $1B
3.2%
0.45%
FY14 FY17
FY SBIR Set-aside
STTR Set-aside
Estimated CombinedNCI Budget (Millions)*
2011 2.5% 0.30% $110
2012 2.6% 0.35% $115
2013 (just ended)
2.7% 0.35% $120
2014 2.8% 0.40% $125
2015 2.9% 0.40% $130
2016 3.0% 0.45% $135
2017 3.2% 0.45% $140
Increase in Set-Aside and in NCI SBIR/STTR Budget (2013 estimate)
* Assumes flat NIH overall budget5
NIH = 27 Institutes & Centers24 Participate in the SBIR/STTR Program
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The Office of the Director (OD)
National Instituteon Alcohol Abuse
& Alcoholism(NIAAA)
National Instituteof Arthritis &
Musculoskeletal &Skin Diseases (NIAMS)
National CancerInstitute (NCI)
National Instituteon Aging
(NIA)
National Instituteof Child Health &
Human Development(NICHD)
National Instituteof Allergy &
Infectious Diseases(NIAID)
National Instituteof Diabetes &
Digestive & KidneyDiseases (NIDDK)
National Instituteof Dental andCraniofacial
Research (NIDCR)
National Instituteon Drug Abuse
(NIDA)
National Instituteof Environmental Health Sciences
(NIEHS)
National Institute onDeafness & OtherCommunication
Disorders (NIDCD)
National EyeInstitute
(NEI)
National HumanGenome ResearchInstitute (NHGRI)
National Heart,Lung, & Blood
Institute (NHLBI)
National Instituteof Mental Health
(NIMH)
National Instituteof Neurological
Disorders &Stroke (NINDS)
National Instituteof General
Medical Sciences(NIGMS)
National Instituteof Nursing Research
(NINR)
No funding authority
National Institute on Minority Health &Health Disparities
(NIMHD)
National Libraryof Medicine (NLM)
National Centerfor Complementary
& AlternativeMedicine (NCCAM)
FogartyInternationalCenter (FIC)
National Instituteof Biomedical
Imaging & Bioengineering (NIBIB)
National Centerfor Advancing
Translational Sciences(NCATS)
Center for InformationTechnology (CIT)
Center for ScientificReview (CSR)
NIH ClinicalCenter (CC)
Office of Research Infrastructure Programs
(ORIP)
FY2013 SBIR/STTR Funding Levels
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Agency/Institute SBIR STTR SBIR+STTR
NIH $620 M $80 M $717 M
NCI $97 M $13 M $110 M
NIDDKNIGMS
← The annual SBIR/STTR budget for each participating Institute or Center (IC) is proportional to the total annual budget appropriation for that IC
Therapeutics33%
Devices for Cancer Therapy
7%Imaging
20%
In Vitro Diagnos-tics21%
Tools forBasic Research
7%
Health IT & Software Tools12%
NCI SBIR/STTR Active Portfolio: Pipeline of 400+ Vetted Projects
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• Provides seed funding for innovative technology development
• Provides recognition, verification and visibility
• Helps provide leverage in attracting additional funding or support (e.g., venture capital, strategic partner)
Not a Loan
No repayment is required
Doesn’t impact stock or shares in any way (i.e., non-dilutive)
• Intellectual property rights retained by the small business
Reasons to Seek SBIR/STTR Funding
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• Applicant is a Small Business Concern (SBC)
• Organized for-profit U.S. business
• 500 or fewer employees, including affiliates
• PI’s primary employment (>50%) must be with the SBC at time of award & for duration of project
• > 50% U.S.- owned by individuals and independently operated*
OR
• > 50% owned and controlled by other business concern/s that is/are > 50% owned and controlled by one or more individuals*
OR
• > 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these *
*Formerly >= 51%; *New rule starting 1/28/13, NIH SBIR only
SBIR Eligibility Requirements
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STTR Eligibility
Applicant is a Small Business Concern
Formal Cooperative R&D Effort
• 40% by small business
• 30% by U.S. research institution
U.S. Research Institution: College or University; Non-profit research organization; Federally-Funded R&D Center (FFRDC)
Intellectual Property Agreement
• Allocation of IP rights (to SBC) and rights to carry out follow-on R&D and commercialization
Principal Investigator’s primary employment may be with either the Small Business Concern or the research institution
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SBIR
SBIR and STTR Programs(Critical Differences)
Award always made to small business
• Permits research institution partners (e.g., universities)• Small business concern may outsource ~33% of Phase I
activities and 50% of Phase II activities
STTR
• Requires research institution partners (e.g., universities)• Minimum 40% of the work should be conducted by the
small business concern (for profit), and minimum of 30% by a U.S. research institution (non-profit)
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SBIR & STTR Omnibus Solicitations for Grant Applications
Release: JanuaryReceipt Dates: April 5, August 5, and December 5
Solicitation of the NIH & CDC for SBIR Contract Proposals
Release: typically early August Receipt Date: only once per year, typically early November
See the NIH Guide for other Program Announcements (PA’s) and Requests for Application (RFA’s), i.e. grants
Release: WeeklyReceipt Dates: Various
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NCI Has Multiple Small Business SolicitationsKnow the Application Deadlines
http://grants.nih.gov/grants/guide
NCI SBIR/STTR Budget Distribution
Grants
Contracts
Administrative Supplements NIH Technical Assistance Programs
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PHASE II – R42, R44 Grant, or Contract• Full Research/R&D• $2.0M over 2-3 years • Commercialization plan required
PHASE III• Commercialization Stage• Use of non-SBIR/STTR Funds
PHASE I – R41, R43 Grant, or Contract• Feasibility Study • $300K over < 12 months (rarely 18-24 months
Phase IIB Bridge Award
NCI Offers Three SBIR/STTR Award Stages
$1M per year for 3 years, with matching $$
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(also NHLBI, NINDS)
New Provisions in Current Omnibus Grant Solicitations, Enacted in Last 2 Years
• SBIR/STTR applicants must register at the SBA Company registry at SBIR.gov.
• VC-backed companies (VCOC, hedge fund, private equity firms) CAN NOW apply (NIH SBIR only).
• Applicants can request $5000 in Technical Assistance, beyond award cap. If requested, cannot participate in NIH Technical Assistance Programs.
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• FY15 allows switching between STTR and SBIR mechanisms• Applicants may apply for Phase II SBIR funding based on
Phase I STTR award or vice versa.
• Direct to Phase II applications for SBIR
Newest Provisions Implemented
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SBIR/STTR Success Rates NIH-Wide
Fiscal Year
SBIR/STTR PhaseNumber of
Applications Reviewed
Number of Applications
Awarded
Success Rate
Total Funding
2013 SBIR Fast Track 313 49 15.7% $13,981,386
2013 SBIR Phase I 3,738 495 13.2% $114,040,157
2013 SBIR Phase II 542 178 32.8% $136,348,846
2013 STTR Fast Track 42 12 28.6% $2,542,128
2013 STTR Phase I 583 109 18.7% $24,138,629
2013 STTR Phase II 72 19 26.4% $10,985,373
2013 FY TOTAL 5,290 862 16.3% $302,036,519
Success rates are defined as the percentage of reviewed grant applications that receive funding. 18
SBIR/STTR Success Rates – NCI 2013
NCI Program
Number of Applications
Reviewed
Number of Applications
Awarded
Success Rate
Total Funding
STTR Ph I 110 18 16.4% $4,460,889
STTR Ph II 8 1 12.5% $250,569
SBIR Ph I 548 52 9.5% $11,959,712
SBIR Ph II 128 24 18.8% $15,294,335
Success rates are defined as the percentage of reviewed grant applications that receive funding. 19
NIH Timeline for New Grant Applications
Due Date Scientific Review
Council Review
Award Date (earliest)
April 5 July October DecemberAugust 5 October January AprilDecember 5 March May July
7-10 months
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SBIR & STTR Omnibus Solicitations for Grant Applications
Release: JanuaryReceipt Dates: April 5, August 5, and December 5
Solicitation of the NIH & CDC for SBIR Contract Proposals
Release: typically early August Receipt Date: only once per year, typically early November
See the NIH Guide for other Program Announcements (PA’s) and Requests for Application (RFA’s), i.e. grants
Release: WeeklyReceipt Dates: Various
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NCI Has Multiple Small Business SolicitationsKnow the Application Deadlines
http://grants.nih.gov/grants/guide
Annual Solicitation for NCI SBIR Contract Topics
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NCI scientific & technologypriorities
Areas of interest to the commercial sector,
based on market opportunity
Contract topics in NCI priority areas with strong potential for commercial success
13%8%
17%25%
NCI SBIR contracts(thousands)
% of total NCI SBIR
2007 2008 2009 2010 2011 2012 2013Fiscal Year
13%8%
17%25% 24%
33%35%$12,387
$7,757
$16,665
$25,020
$38,174
$26,102
$37,406
NCI SBIR Contracts vs. Grants: What's the difference?
SBIR Grants SBIR Contracts
Scope of the proposal
Investigator-defined within the mission of NIH Defined by the NIH (focused)
Questions during solicitation period?
May speak with any Program Officer
MUST contact the contracting officer
Receipt Dates 3 times/year for Omnibus Only ONCE per year
Peer Review Locus NIH Center for Scientific Review (CSR)
NCI Division of Extramural Activities
Basis for Award Peer review score/ Program assessment
Peer review score/negotiation of technical deliverables, budget
ReportingOne final report (Phase I);Annual reports (Phase II)
Kickoff presentation, quarterly progress reports, final report, commercialization plan
Set-aside funds for particular areas? No Yes
Program Staff Involvement Low High
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2013 NCI Contract Topics- last year
Therapy & Diagnosis
Advancing Cancer Research
• 326 Development of Novel Therapeutic Agents that Target Cancer Stem Cells • 327 Reformulation of Failed Chemotherapeutic Drugs• 331 Development of a Biosensor-Based Core Needle Tumor Biopsy Device• 332 Development of Radiation Modulators for Use During Radiotherapy
• 328 Validation of 3D Human Tissue Culture Systems that Mimic the Tumor Microenvironment
• 329 Proteomic Analysis of Single Cells Isolated from Solid Tumors• 330 Generation of Site-Specific Phopho-Threonine Protein Standards for
Use in Cancer Assays
http://sbir.cancer.gov/funding/contracts
Health IT• 333 Software Tools for the Development of Environmental Measures
Related to Cancer Health Behavior and Resources24
SBIR & STTR Omnibus Solicitations for Grant Applications
Release: JanuaryReceipt Dates: April 5, August 5, and December 5
Solicitation of the NIH & CDC for SBIR Contract Proposals
Release: typically early August Receipt Date: only once per year, typically early November
See the NIH Guide for other Program Announcements (PA’s) and Requests for Application (RFA’s), i.e. grants
Release: WeeklyReceipt Dates: Various
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NCI Has Multiple Small Business SolicitationsKnow the Application Deadlines
http://grants.nih.gov/grants/guide
Development of Highly Innovative Tools and Technology for Analysis of Single Cells (PA-13-140)
Goal: Development of next-generation tools to better define cell heterogeneity in situ, with substantially increased sensitivity, selectivity, spatiotemporal resolution, scalability or non-destructive analysis of multiple global or functional measures of single cells.
• Affiliated with the Single Cell Analysis Program (SCAP) through the NIH Common Fund• New analytical measures and manipulations of cellular contents, structure and activity beyond those currently available• First-in-class and/or cross-cutting techniques
Next receipt dates: Aug 5, Dec 5 through 2015
Contact Dr. Xing-Jian Lou: loux@mail.nih.gov
http://commonfund.nih.gov/Singlecell/
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Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (SBIR-IMAT, PAR-13-327)
Goal: To support the development, maturation, and dissemination of novel and potentially transformative next-generation technologies through an approach of balanced but targeted innovation in support of clinical, laboratory, or epidemiological research on cancer.
• Molecular and cellular analytical technologies for cancer detection and/or characterization in vitro, in situ, or in vivo
Next receipt dates: November and May through 2016
Contact Dr. Amir Rahbar: rahbaram@mail.nih.gov
http://sbir.cancer.gov/funding/technology 27
Innovative Health IT for Broad Adoption by Healthcare Systems & Consumers (PA-12-196)
Goal: Accelerate development & commercialization of evidence-based consumer health IT to:
• Prevent or reduce the risk of cancer• Facilitate patient-provider communication• Improve disease outcomes in consumer & clinical settings
• Phase II or Fast-Track applications only• Strong applicants will have a partnership with large business
(e.g. commercial IT firm, EMR vendor, healthcare systems, etc.)
Next receipt dates:
August 5, December 5 through 2014
Contact Dr. Patricia Weber: weberpa@mail.nih.gov
http://sbir.cancer.gov/resource/hit/
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PHASE II – R42, R44 Grant, or Contract• Full Research/R&D• $1.5M over 2-3 years • Commercialization plan required
PHASE III• Commercialization Stage• Use of non-SBIR/STTR Funds
PHASE I – R41, R43 Grant, or Contract• Feasibility Study • $225K over 9-12 months (rarely 24)
Phase IIB Bridge Award
NCI Offers Three Award Stages
$1M per year for 3 years, with matching $$
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(also NHLBI, NINDS)
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Strategy
Competing Renewal Program for SBIR Phase II Awards
• Provides additional NIH funding to extend selected projects
• Involves another peer-review cycle to evaluate progress & future plans
• Accelerates commercialization by incentivizing partnerships with third-party investors & strategic partners earlier in the development process
How does NCI accomplish this goal?
• NCI gives competitive preference and funding priority to applicants that can raise substantial third-party funds (i.e., ≥ 1:1 match)
“…Applicants are expected to leverage their previous NIH SBIR support, as well as the opportunity to compete for additional NCI funding under
this [funding announcement], to negotiate and attract third-party financing needed to advance a product or technology toward
commercialization…”
Important Features of Phase IIB Bridge Award
• Eligibility• Current Phase II awards & and those that ended within the last 2 years
• Cancer-related Phase II projects initially funded by other NIH institutes
• Ad Hoc Peer Review Committee to Evaluate Technical and Commercial Merits
• Reviewers are academics, clinicians, industry professionals, venture capitalists
• Emphasizes important commercialization considerations such as intellectual property (e.g., patents) and strategy for gaining FDA approval
• Requires complete disclosure of applicant’s SBIR commercialization history
Third-Party Fundraising plan
• Preferred Types of Funds: Cash, liquid assets, convertible debt
• Sources of Funds: Another company, venture capital firm, individual “angel” investor, foundation, university, state or local government, or any combination
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16 NCI Phase IIB Bridge Awards (to date)
Venture Capital: 1/3
Strategic Partners: 1/3
Individuals & Other: 1/3
NCI Total $37,160,051
Third-Party Investments $82,502,379
Leverage > 2 to 1
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Know NIH SBIR/STTR Grant Review Criteria
Significance• Does the product address an important
problem, and have commercial potential? Is there a market pull for the proposed product?
Innovation• How novel is the product and the approaches
proposed to test its feasibility?
Investigator• Is the investigator appropriately trained
and capable of managing the project?
Approach• Are design and methods well-developed and
appropriate? Are problem areas addressed?
Environment• Does the scientific environment contribute to the
probability of success? Is the environment unique?
Commercialization• Is the company’s business strategy one that has
a high potential for success? 34
Other Tips for a Strong Application
• Significant, innovative, and focused science
• Make the SBIR/STTR application product-focused, as distinct from an R01
• Generate preliminary data, if possible
• Enlist appropriate collaborators (e.g., cancer biologists, clinicians, statisticians), and include letters of support
• Explain the key issues and controversies in the product space; describe the competition and your value proposition
• Identify any unanswered questions, and then contact NCI SBIR program staff for help
• Write clearly
• Prepare your application early!
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NCI SBIR Development Center Staff
Greg Evans, PhD Lead Program Director
Cancer Imaging, Cancer Biology, Cancer Research Tools, E-Health, Epidemiology
Andrew J. Kurtz, PhD Lead Program Director
Biologics, Small Molecules, Nanotherapeutics, Molecular Diagnostics, Bridge Award
Michael Weingarten, MA Director
NCI SBIR Development Center
Deepa Narayanan, MS Program Director
Cancer Imaging, Clinical Trials, Radiation Therapy, SBIR Investor Forum, FRAC Workshop
Jian Lou, PhD Program Director
In-Vitro Diagnostics, Theranostics, early-stage drug development , Bioinformatics, FRAC Workshop
Patricia Weber, DrPH Program Director
Digital Health, Therapeutics, Biologics, SBIR Investor Forum, FRAC Workshop
Todd Haim, PhD Program Director
Small Molecules, Biologics, Immunotherapeutics, Theranostics, SBIR Investor Forum, FRAC Workshop
Amir Rahbar, PhD, MBA
Program DirectorIn-Vitro Diagnostics, Biologics, Therapeutics, Proteomics,
SBIR Investor Forum
Jennifer Shieh, PhD
Program DirectorDigital Health, Bioinformatics, Research Tools,
Evaluation, SBIR Investor Forum, FRAC Workshop
Ming Zhao, PhD
Program DirectorCancer Diagnostics & Therapeutics, Cancer Control &
Prevention, Molecular Imaging, Bioinformatics,
Stem CellsChristie Canaria, PhDAAAS Science & Technology Policy FellowPolicy, Outreach, Success Stories, Scientific
Communications, SBIR Investor Forum, FRAC Workshop
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Managing NCI’s SBIR/STTR Portfolio
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Old Management Model
• Awards were managed by 40-50 program staff from across the NCI who each spent a small percentage of their time on SBIR
• Program directors had significant technical expertise but typically had no industry experience or commercialization expertise
New SBIR Development Center
Goal: Enhance commercialization success of SBIR-funded projects
• 10-member management team exclusively focused on the administration of NCI’s SBIR/STTR portfolio
• Center staffed by program directors with industry experience and a broad range of technical expertise
• Center collaborates with staff from across other NCI divisions to integrate the small business initiatives with the Institute’s priorities
• Center is developing a range of new initiatives to help small businesses
San Diego, CA
$3.0M for the commercialization of ASONEP™, a first-in-class monoclonal antibody against the angiogenic growth factor S1P
Oriental, NC$3.0M for the development of a photoacoustic computed tomography (CT) scanner for preclinical molecular imaging
Norcross, GA$2.5M for the development of LightTouch®, a point-of-care device for cervical cancer screening
Northridge, CA
$3.0M for the development of a novel molecular breast imaging technique to guide early-stage patient care
Miramar, FL
$3.0M for the development of ALT-801, a fusion protein consisting of IL-2 coupled with a soluble T-cell receptor fragment that recognizes a specific form of processed p53 antigen
West Henrietta, NY
$3.0M for the development of a cone beam breast CT scanner
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NCI SBIR Outreach Travel in Calendar 2012
National and Regional Conferences Attended by NCI SBIR in Calendar 2012
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• NIH SBIR Conference
• Radiological Society of North America (RSNA)
• Society of Nuclear Medicine (SNMA)
• American Association of Cancer Research (AACR)
• Personalized Medicine World Conference
• Mobile Health Summit
• Partnering for Cures
• Biotechnology Industry Organization (BIO)
• Mid-Atlantic BIO
• JP Morgan Biotech Investment Conference
More Information onNCI SBIR & STTR Website
http://sbir.cancer.gov40
Follow us on Twitter:@NCIsbir
Connect with us
on LinkedIn
Greg Evans, Ph.D. Team Leader, Cancer Imaging/Biology/Control
NCI SBIR Development CenterPhone: 240-276-5245
evansgl@mail.nih.gov
http://sbir.cancer.gov
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