2014 Overview of the NCI Small Business
Programs: Grant and Contract Funding
Opportunities to Bring Cancer Science to
the Market
Greg Evans, PhD
Team Leader
Cancer Imaging/Biology/Control
NCI SBIR Development Center
A
Tuesday July 22, 2014
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
2
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
3
Congressionally-Mandated Programs
 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
Set Aside $$
FY14
FY17
2.8%
3.2%
0.40%
0.45%
 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
~$757 M in FY14 at NIH
~$119 M in FY14 at NCI
4
Increase in Set-Aside and in
NCI SBIR/STTR Budget (2013 estimate)
FY
SBIR Setaside
STTR Setaside
Estimated
Combined
NCI 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
* Assumes flat NIH overall budget
5
NIH = 27 Institutes & Centers
24 Participate in the SBIR/STTR Program
Office of Research
Infrastructure Programs
(ORIP)
The Office of the Director (OD)
(NIA)
National Institute
on Alcohol Abuse
& Alcoholism
(NIAAA)
National Institute
of Allergy &
Infectious Diseases
(NIAID)
National Institute on
Deafness & Other
Communication
Disorders (NIDCD)
National Institute
of Dental and
Craniofacial
Research (NIDCR)
National Institute
of Diabetes &
Digestive & Kidney
Diseases (NIDDK)
National Institute
on Drug Abuse
National Institute
of General
Medical Sciences
(NIGMS)
National Heart,
Lung, & Blood
Institute (NHLBI)
National Human
Genome Research
Institute (NHGRI)
National Institute
of Mental Health
National Center
for Complementary
& Alternative
Medicine (NCCAM)
Fogarty
International
Center (FIC)
National Institute
on Aging
National Institute on
Minority Health &
Health Disparities
(NIMHD)
NIH Clinical
Center (CC)
National Institute
of Arthritis &
Musculoskeletal &
Skin Diseases (NIAMS)
(NIDA)
(NIMH)
National Center
for Advancing
Translational Sciences
(NCATS)
Center for Information
Technology (CIT)
National Cancer
Institute (NCI)
National Institute
of Child Health &
Human Development
(NICHD)
National Institute
of Environmental
Health Sciences
(NIEHS)
National Eye
Institute
National Institute
of Neurological
Disorders &
Stroke (NINDS)
National Institute
of Nursing Research
National Library
of Medicine (NLM)
Center for Scientific
Review (CSR)
(NEI)
(NINR)
National Institute
of Biomedical
Imaging &
Bioengineering (NIBIB)
No funding
authority
6
FY2013 SBIR/STTR Funding Levels
Agency/Institute
SBIR
STTR
SBIR+STTR
NIH
$620M
$80M
$717M
NCI
$97M
$13M
$110M
← The annual SBIR/STTR budget
for each participating Institute
or Center (IC) is proportional
to the total annual budget
appropriation for that IC
NIGMS
NIDDK
7
NCI SBIR/STTR Active Portfolio:
Pipeline of 400+ Vetted Projects
Health IT &
Software Tools
12%
Tools for
Basic Research
7%
Therapeutics
33%
In Vitro
Diagnostics
21%
Imaging
20%
Devices for
Cancer Therapy
7%
8
Reasons to Seek SBIR/STTR Funding
• 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
9
SBIR Eligibility Requirements
•
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
10
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
11
SBIR and STTR Programs
(Critical Differences)
SBIR
STTR
• Permits research institution partners (e.g., universities)
• Small business concern may outsource ~33% of Phase I
activities and 50% of Phase II activities
• 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)
Award always made to small business
12
NCI Has Multiple Small Business Solicitations
Know the Application Deadlines
 SBIR & STTR Omnibus Solicitations for Grant Applications
Release: January
Receipt 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: Weekly
Receipt Dates: Various
http://grants.nih.gov/grants/guide
13
NCI SBIR/STTR Budget Distribution
Administrative Supplements
NIH Technical Assistance Programs
Contracts
Grants
14
NCI Offers Three SBIR/STTR Award Stages
PHASE I – R41, R43 Grant, or Contract
• Feasibility Study
• $300K over < 12 months (rarely 18-24 months
PHASE II – R42, R44 Grant, or Contract
• Full Research/R&D
• $2.0M over 2-3 years
• Commercialization plan required
Phase IIB Bridge Award
PHASE III
• Commercialization Stage
$1M per year for 3
years, with matching $$
(also NHLBI, NINDS)
• Use of non-SBIR/STTR Funds
15
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.
16
Newest Provisions Implemented
• 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
17
SBIR/STTR Success Rates NIH-Wide
Number of
Number of
Success
Applications Applications
Rate
Reviewed
Awarded
Fiscal
Year
SBIR/STTR
Phase
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
Total Funding
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
Number of
Success
Applications Applications
Rate
Reviewed
Awarded
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
7-10 months
Due Date
Scientific
Review
Council
Review
Award Date
(earliest)
April 5
August 5
December 5
July
October
March
October
January
May
December
April
July
20
NCI Has Multiple Small Business Solicitations
Know the Application Deadlines
 SBIR & STTR Omnibus Solicitations for Grant Applications
Release: January
Receipt 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: Weekly
Receipt Dates: Various
http://grants.nih.gov/grants/guide
21
Annual Solicitation for NCI SBIR Contract Topics
Areas of interest to the
commercial sector,
based on market
opportunity
NCI scientific &
technology
priorities
Contract topics in NCI priority areas with strong
potential for commercial success
$37,406
$25,020
13%
2007
25%
$7,757
13% 17%
8%
2008
2009
NCI SBIR contracts
(thousands)
$26,102
$16,665
$12,387
$38,174
24%
17%
33%
35%
25%
2012
2013
% of total NCI SBIR
8%
2010
2011
Fiscal Year
22
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
Reporting
One 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
23
2013 NCI Contract Topics- last year
http://sbir.cancer.gov/funding/contracts
Therapy & Diagnosis
•
•
•
•
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
Advancing Cancer Research
• 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
Health IT
• 333 Software Tools for the Development of Environmental Measures
Related to Cancer Health Behavior and Resources
24
NCI Has Multiple Small Business Solicitations
Know the Application Deadlines
 SBIR & STTR Omnibus Solicitations for Grant Applications
Release: January
Receipt 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: Weekly
Receipt Dates: Various
http://grants.nih.gov/grants/guide
25
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/
26
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/
28
NCI Offers Three Award Stages
PHASE I – R41, R43 Grant, or Contract
• Feasibility Study
• $225K over 9-12 months (rarely 24)
PHASE II – R42, R44 Grant, or Contract
• Full Research/R&D
• $1.5M over 2-3 years
• Commercialization plan required
Phase IIB Bridge Award
PHASE III
• Commercialization Stage
$1M per year for 3
years, with matching $$
(also NHLBI, NINDS)
• Use of non-SBIR/STTR Funds
29
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…”
30
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
31
16 NCI Phase IIB Bridge Awards (to date)
$20,000,000
$15,000,000
$10,000,000
$5,000,000
$0
NCI Total
$37,160,051
Third-Party Investments
$82,502,379
Leverage
> 2 to 1
Venture Capital:
Strategic Partners:
Individuals & Other:
1/3
1/3
1/3
32
NCI SBIR Investor Forums- 2009, 2010, 2012, and 2014
33
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?
Approach
• Are design and methods well-developed and
appropriate? Are problem areas addressed?
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?
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!
35
NCI SBIR Development Center
Staff
Michael Weingarten, MA
Director
NCI SBIR Development Center
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
Patricia Weber, DrPH
Program Director
Digital Health, Therapeutics, Biologics, SBIR
Investor Forum, FRAC Workshop
Jian Lou, PhD
Program Director
In-Vitro Diagnostics, Theranostics, early-stage drug
development , Bioinformatics, FRAC Workshop
Deepa Narayanan, MS
Program Director
Cancer Imaging, Clinical Trials, Radiation Therapy, SBIR
Investor Forum, FRAC Workshop
Ming Zhao, PhD
Program Director
Cancer Diagnostics & Therapeutics, Cancer Control &
Prevention, Molecular Imaging, Bioinformatics,
Stem Cells
Christie Canaria, PhD
AAAS Science & Technology Policy Fellow
Policy, Outreach, Success Stories, Scientific
Communications, 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 Director
In-Vitro Diagnostics, Biologics, Therapeutics, Proteomics,
SBIR Investor Forum
Jennifer Shieh, PhD
Program Director
Digital Health, Bioinformatics, Research Tools,
Evaluation, SBIR Investor Forum, FRAC Workshop
36
Managing NCI’s SBIR/STTR Portfolio
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
37
NCI SBIR Outreach Travel in Calendar 2012
San Diego,
CA
$3.0M for the commercialization of ASONEP™, a firstin-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-ofcare 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
38
National and Regional Conferences Attended by NCI
SBIR in Calendar 2012
• 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
39
More Information on
NCI SBIR & STTR Website
Connect with
us
on LinkedIn
Follow us
on Twitter:
@NCIsbir
http://sbir.cancer.gov
40
http://sbir.cancer.gov
Greg Evans, Ph.D.
Team Leader, Cancer Imaging/Biology/Control
NCI SBIR Development Center
Phone: 240-276-5245
evansgl@mail.nih.gov
41