THE NCI SMALL BUSINESS PROGRAMS: SUPPORTING CANCER START-UPS - NCI SBIR Development Center - FreeMind ...
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THE NCI SMALL BUSINESS
PROGRAMS: SUPPORTING CANCER
START-UPS
NCI SBIR Development Center
Deepa Narayanan
Program Director
January 14, 2020
KEY TOPICS
• NIH SBIR & STTR Overview
• SBIR Development Center
• Funding Opportunities (FY 2020 NCI SBIR
Contracts, and NCI Phase IIB Bridge Awards)
• Supporting Funding & Non-Funding Resources
• Application Tips
2
@NCISBIR
CONGRESSIONALLY MANDATED
Set Aside
FY11 FY19
Small Business Innovation Research (SBIR)
Set-aside program for small business concerns to engage in
Federal R&D with the potential for commercialization 2.5% 3.2%
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 0.3% 0.45%
with the potential for commercialization
Federal agencies with an extramural R&D budget > $1B
~$1.14B in FY2019 at NIH
~$173M in FY2019 at NCI
3
@NCISBIR
NIH = 27 Institutes & Centers
The Office of the Director (OD)
National Institute National Institute National Institute National Institute National Institute
on Aging on Alcohol Abuse of Allergy & of Arthritis & National Cancer of Child Health &
& Alcoholism Infectious Diseases Musculoskeletal & Institute (NCI) Human Development
(NIA) (NIAAA) (NIAID) Skin Diseases (NIAMS) (NICHD)
National Institute on National Institute National Institute National Institute National Institute National Eye
Deafness & Other of Dental and of Diabetes & on Drug Abuse of Environmental Institute
Communication Craniofacial Digestive & Kidney Health Sciences
Disorders (NIDCD) Research (NIDCR) Diseases (NIDDK) (NIDA) (NIEHS) (NEI)
National Institute National Institute National Institute National Institute
National Heart, National Human
of General of Mental Health of Neurological of Nursing Research
Lung, & Blood Genome Research
Medical Sciences Disorders &
Institute (NHLBI) Institute (NHGRI)
(NIGMS) (NIMH) Stroke (NINDS) (NINR)
National Institute on National Center National Center National Institute
Fogarty
Minority Health & for Complementary for Advancing National Library of Biomedical
International
Health Disparities & Integrative Health Translational Sciences of Medicine (NLM) Imaging &
Center (FIC)
(NIMHD) (NCCIH) (NCATS) Bioengineering (NIBIB)
NIH Clinical Center for Information Center for Scientific No funding
Center (CC) Technology (CIT) Review (CSR)
authority 4
@NCISBIR
Why Seek SBIR/STTR Funding
• Provides seed funding for innovative technology development
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
• Provides recognition, verification, and visibility
• Helps provide leverage in attracting additional funding or support
(e.g., venture capital, strategic partner)
5
@NCISBIR
SBIR – STTR: Critical Differences
SBIR STTR
Permits research institution partners Requires research institution partners
(e.g., universities) (e.g., universities)
Small business concern may outsource Minimum 40% of the work should be conducted by
~33% of Phase I activities and 50% of the small business concern (for profit), and minimum
Phase II activities of 30% by a U.S. research institution (non-profit)
ELIGIBILITY: The PD/PI’s primary ELIGIBILITY: IP Agreement providing necessary IP
employment (i.e., >50%) MUST be with the rights to the SBC in order to carry out follow-on R&D
SBC for the duration of the project period and commercialization
PI primary employment not stipulated (min.10% effort
to project)
6
@NCISBIR
Eligibility
✓ Applicant must be a Small Business Concern (SBC)
Award always
✓ Organized for-profit U.S. business made to
small business
✓ 500 or fewer employees, including affiliates
✓ ˃ 50% U.S.- owned by individuals and independently operated
OR
˃ 50% owned and controlled by another (one) business concern that is ˃ 50% owned and
controlled by one or more individuals
OR (SBIR ONLY)
˃ 50% owned by multiple venture capital operating companies, hedge funds, private equity
firms, or any combination of these 7
@NCISBIR
Three-Phase Program
NCI SBIR PHASE IIB
FAST-TRACK
BRIDGE AWARD
(PH I & II)
PHASE II NCI SBIR PHASE IIB BRIDGE AWARD Phase III
PHASE I
CROSSING THE VALLEY OF DEATH
Crossing the Valley of Death
• Technology validation & • Commercialization stage
DIRECT TO PHASE II clinical translation • Use of non-SBIR/STTR
• Follow-on funding for SBIR funds
• Proof-of-Concept • Research & Development Phase II awardees from any
• Up to $400K over • Commercialization plan federal agencies
6 to 12 months required • Expectation that applicants
• Up to $2M over will secure substantial 3rd
2 years party investor funds
• $4M over 3 years
@NCISBIR
NIH SBIR/STTR BUDGET LIMITS
Standard Award Hard Cap Waiver Cap
INSTITUTE
SPECIFIC
Phase I $150,000 $252,131 NCI: $400,000
Phase II $1.0M ~$1.68M NCI: $2.0M
Waiver topics:
https://sbir.nih.gov/sites/default/files/NIH_Topics_for_Budget_Waivers.pdf
9
@NCISBIR
NCI Waiver Topics
• Therapeutics (e.g., Small Molecules, Biologics, Radiomodulators, and Cell-based Therapies
• In Vitro and In Vivo Diagnostics (e.g., Companion Diagnostics and Prognostic Technologies)
• Imaging Technologies (e.g., Agents, Devices, and Image-Guided Interventions)
• Devices for Cancer Therapy (e.g., Interventional Devices, Surgical, Radiation and Ablative Therapies)
• Agents for Cancer Prevention (e.g., Vaccines, but not “Technologies for Cancer Prevention”)
• Development of Low Cost Technologies for Global Health
• Development of Digital Health Tools
10
@NCISBIRNCI SBIR Development Center
NCI SBIR - CORE ACTIVITIES
CENTRAL GUIDANCE OUTREACH
OVERSIGHT
• Administer all 400+ SBIR/STTR • Help applicants prepare for • Attend conferences and
awards at the NCI application, resubmission, and workshops & visit state-based
discuss funding options organizations and universities to
raise awareness of the program
FUNDING NETWORKING TRAINING
• Maintain a network of investors, • Provide entrepreneurship training,
• Seed emerging technology areas and facilitate connections between as well as webinars on key topics
by developing targeted funding NCI SBIR portfolio companies and such as IP, regulatory strategy, and
opportunities either as grants or potential investors/strategic how to build a strong team
contracts partners
12
@NCISBIRNCI SBIR Program Staff Let’s discuss your project!
Send Specific Aims to ncisbir@mail.nih.gov
Michael Weingarten, MA
Director Andrew J. Kurtz, PhD
Lead Program Director
NCI SBIR Development Center
Biologics, Small Molecules, Nanotherapeutics, Molecular Diagnostics
Nancy Kamei, PhD
Greg Evans, PhD
Program Director
Lead Program Director Cancer Therapeutics
Cancer Biology, E-Health, Epidemiology, Research Tools
Patricia Weber, DrPH Jian Lou, PhD
Program Director Program Director
Digital Health, Therapeutics, Biologics, FRAC Workshop In-Vitro Diagnostics, Theranostics, early-stage drug development, Bioinformatics,
Investor Initiatives
Deepa Narayanan, MS Amir Rahbar, PhD, MBA
Program Director Program Director
Imaging, Clinical Trials, Radiation Therapy, Investor Initiatives, FRAC Workshop In-Vitro Diagnostics, Biologics, Therapeutics, Proteomics
Ming Zhao, PhD Jonathan Franca-Koh, PhD, MBA
Program Director Program Director
Cancer Diagnostics & Therapeutics, Cancer Control & Prevention, Molecular Imaging, Cancer Biology, Biologics, Small Molecules, Cell Based Therapies, Bridge Award
Bioinformatics, Stem Cells
Christie Canaria, PhD Ashim Subedee, PhD
Program Manager Program Director
Cancer/Biological Imaging, Research Tools, Devices, I-Corps at NIH, Scientific Cancer Therapeutics and Diagnostics, Imaging, Cancer Prevention and Control,
Communications Digital Health, Investor Initiatives
Kory Hallett, PhD Monique Pond, PhD
Program Manager Program Director
Monoclonal Antibodies, Immunotherapy, Biologics, and Program Analysis Cancer Therapeutics, Biologics, Regulatory
13
@NCISBIRSupporting Staff
Patti Swayne Julienne Willis
Innovation Coordinator Program Specialist
Kehui Zhang
Tamar Boghosian
Program Analyst
Program Analyst
Lisa Yeom Bryce Geiling
Communications Specialist Communications Specialist
Brittany Connors
Investor Relations Coordinator
@NCISBIRNCI SBIR/STTR Portfolio
Major Portfolio Areas
(2018)
~475 Total Projects
15
@NCISBIR2018 Economic Impact Study – Goals
1. Quantify the contribution of the NCI SBIR/STTR program
to the U.S. economy
2. Determine key patient and societal impacts resulting from
technologies funded by the NCI SBIR/STTR program
Test Cohort
• 690 Phase II SBIR/STTR grant awards
• Awards made between 1998 – 2010
• 444 Companies
• $787 Million
Study timeline: September 2017 – September 2018
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@NCISBIREconomic Impact
247 110
products products
commercially currently in
available development
sbir.cancer.gov/impact
17
@NCISBIRECONOMIC IMPACT
https://sbir.cancer.gov/impact
18NCI SBIR/STTR Funding Model
CONTRACTS
GRANTS
(SBIR ONLY)
Areas of interest
NCI scientific
Omnibus Solicitation: & technology
Contractto commercial
Investigator initiated Topics sector
priorities
• 3 receipt dates (January,
April, September)
• R&D scope is defined by the NIH
Targeted Solicitation:
• New topics once per year
Focused/NCI gap/
priority areas • Set-aside of funds for each topic
• May NOT have conversations with program
• Variable receipt dates staff to discuss proposal ideas
• Pre-award contract negotiations 19Funding Opportunities
Grant Funding Opportunities
TITLE SBIR FOA STTR FOA DUE DATES
PA-19-272 (General) PA-19-270 (General)
Omnibus Solicitation
PA-19-273 (Clinical Trial) PA-19-271 (Clinical Trial)
SBIR Technology Transfer
PA-18-705 (SBIR only)
(technology transfer out of NIH intramural labs)
Illuminating the Druggable Genome (IDG) PA-19-034 PA-19-033 September 5;
Cancer Prevention, Diagnosis, and Treatment January 6;
PAR-18-801 PAR-18-802 April 6
Technologies for Low-Resource Settings
SBIR IMAT (Innovative Molecular Analysis
PAR-18-303 (SBIR only)
Technology)
Development of Highly Innovative Tools and
PA-17-147 PA-17-148
Technology for Analysis of Single Cells
Phase IIB Bridge Award RFA-CA-19-047 (SBIR only) Summer 2020
Commercialization Readiness Pilot (CRP) Program PAR-19-334 (Ph II SBIR only)
Administrative Supplement PA-18-591 Rolling
Administrative Supplement Diversity in Research PA-18-837 Rolling
@NCISBIRSpecial Grant Funding Opportunities II: SBIR Innovative Molecular Analysis
Technology (IMAT) Development for Cancer Research and Clinical Care
One Solicitation (Phase I, Phase II, Fast-Track), Expiring January 8, 2021
• SBIR
• PAR-18-303 -- Clinical Trial Not Allowed
NCI only- for early stage work on
highly innovative diagnostics and
research tools
Deadlines: September 5, January 5, April 5
22Special Grant Funding Opportunities I: Cancer Prevention,
Diagnosis, and Treatment Technologies for Low-Resource Settings
Two Solicitations (Phase I, Phase II, Fast-Track), Expiring January 6, 2021
• SBIR
• PAR-18-801 -- Clinical Trial Optional
• STTR
• PAR-18-802 -- Clinical Trial Optional
Research may be conducted in low-
resource settings within, or outside
of the US in these programs, with
justification
Deadlines: September 5, January 5, April 5
23NCI SBIR Phase IIB – Bridge Awards
FAST-TRACK
(PH I & II) Non-SBIR/STTR Funds
PHASE PHASE PHASE
NCI SBIR PHASE IIB BRIDGE AWARD
I II III
CROSSING THE VALLEY OF DEATH
Commercialization
• Provides up to $4M from NCI over 3 years
• Technology validation and clinical translation
• Open to any NIH-funded Phase II awardees with projects relevant to NCI mission
• Accelerates commercialization by incentivizing partnerships with third-party investors &
strategic partners earlier in the development process
• Competitive preference and funding priority to applicants that can raise substantial
third-party funds (i.e., ≥ 1:1 match)
24
@NCISBIR2019 SBIR Bridge Evaluation
The 21 Bridge Award recipients leveraged $51M in NCI funding with ~$220M in third-party funds
secured during the Bridge Award period for a ratio of:
4 third-party dollars to 1 NCI dollar
Sources of Matching Funds Average Investments by Technology Area
$30.60
Other
4%
$17.06
VC
Strategic
$ (MM)
41%
$13.30
Partner
$10.62
$9.70
35%
$6.78
$2.56
$2.43
$2.35
Angel DE V I CE DI A G NO S T I C DRUG / B I O L O G I C
20%
NCI Funding Award-Relevant Fundraising Follow-On
25
@NCISBIRCommercialized Bridge Projects
Company Product Status
Nexus 128 3D Photoacoustic Computed Tomography (PAT) for Commercialized by Endra
Optosonics preclinical molecular imaging Life Sciences
Commercialized in US and
Gamma Medica LumaGEMTM Molecular Breast Imager several other countries
Commercialized in US and
Koning KBCT, cone beam Computed Tomography Breast Imager
several other countries
Advanced Cell Commercialized, Acquired
RNAScope In-Situ Hybridization Technology
Diagnostics by Biotechne
Guided Commercialized
LuViva® advanced cervical scan
Therapeutics internationally
MEMS-VCSEL Swept-Source Laser Engine for Optical Coherence
Praevium Commercialized by
Tomography/Microscopy (OCT/OTM) Volumetric Imaging of Tissue
Research ThorLabs
Pathology
Wilson Wolf
G-RexTM cell culture device to improve TIL production and reduce cost Commercialized
Manufacturing
Corvida Medical Halo®, a Closed System Transfer Device (CSTD) for Chemotherapy Commercialized
26
@NCISBIRGrant vs. Contract
GRANT CONTRACT
Investigator-defined within the
Scope of the proposal Defined by the NIH (focused)
mission of NIH
NIH Center for Scientific Review NCI DEA (target 50% business
Peer Review Locus
(CSR) reviewers)
Questions during May speak with any Program MUST contact the contracting
solicitation period? Officer officer
Receipt Dates 3 times/year for Omnibus Only ONCE per year
Set-aside of funds for
NO YES
particular areas?
If proposal scores well during peer
Based on score during peer
Basis for Award review, must then negotiate to
review
finalize deliverables with NIH
One final report (Phase I); Kick-off presentation, quarterly
Reporting
Annual reports (Phase II) progress & final reports
@NCISBIRContract Topics
Grants R&D Contracts
180
160 15%
20% ($24M)
140 ($31M)
Millions
25%
120
24% ($34M)
31% ($29M)
100 ($37M)
36%
80 ($38M)
60
40
20
0
FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 FY 2018
28
@NCISBIRPast Contract Topics on SBIR.Cancer.gov
29
@NCISBIRAdministrative Supplement
PURPOSE BUDGET
Funds may be available for administrative supplements to meet • As appropriate
increased costs that are within the scope of the approved award, but
were unforeseen when the new or renewal application or grant progress • Check with your Program Director
report for non-competing continuation support was submitted.
IMPORTANT POINTS
• Aims that help with commercialization efforts are
encouraged.
FOA
• No peer review, Programmatic Review is required.
• Decisions based on merit, programmatic balance & available
funds
ELIGIBILITY
•Must have an active SBIR/STTR Phase I or Phase II grant.
•Project duration shouldn’t exceed the project period of the
parent award.
•Applications can be submitted on a rolling basis
https://grants.nih.gov/grants/guide/pa-files/PA-18-591.htmlDiversity Supplement
PURPOSE BUDGET
Improve the diversity of the research workforce by recruiting and • Application budgets are limited to no more than the amount of
supporting students, postdoctorates, and eligible investigators from the current parent award, and must reflect the actual needs of
groups that have been shown to be underrepresented in health-related the proposed project.
research or in the SBIR program.
IMPORTANT POINTS
• Strongly encouraged to discuss with Program Director
FOA
• No peer review, Programmatic Review is required.
• Research objectives must be within the original scope of the
peer reviewed and approved project,
ELIGIBILITY
•Must have an active Phase I or Phase II or Fast Track grant.
•The project and budget periods must be within the currently
approved project period for the existing parent award.
•Applications can be submitted on a rolling basis
https://grants.nih.gov/grants/guide/pa-files/pa-18-837.htmlCommercialization Readiness Pilot Program-Technical
Assistance
PURPOSE BUDGET
Aims to facilitate the transition of previously funded SBIR and STTR • $250,000 total costs for NCI
Phase II and Phase IIB projects to the commercialization stage by
providing additional support for technical assistance not typically SCOPE
supported through Phase II or Phase IIB grants or contracts. • Funds can be requested for help with regulatory,
reimbursement or IP Strategy.
APPLICATION DUE DATES
• Design and planning for a clinical trial including
• Jan 5, April 5, September 5 administrative tasks
• Technical assistance associated with manufacturing.
FOA
• Other technical assistance offered through a third-party
technical assistance provider, including market research.
• And more ….check with your Program Director
ELIGIBILITY
•Must have active or completed NCI SBIR (Phase II and Phase
IIB) or STTR (Phase II) awards.
REVIEW
•Peer Review with Special Emphasis Panel at CSR
•Decisions based on peer review, merit, programmatic
balance & available funds
https://grants.nih.gov/grants/guide/pa-files/par-19-334.htmlHow can NCI help translate your ideas to the marketplace?
NIH and NCI Assistance
Non-Federal Funds
NCISBIR
SBIR Ph I SBIR Ph II Ph IIB Bridge
Commercialization
CROSSING THE
VALLEY OF DEATH
I-Corps at NIH
NCI-Managed
NCI Investor Initiatives
Application NCI Peer Learning and Networking Webinar
Assistance
Program NCI Resources for Commercialization Workshops
CEO Roundtable
Connecting Awardees to Regulatory Experts (CARE)
NIH-Managed
Niche Assessment
Program
Commercialization
Assistance Program https://sbir.cancer.gov/resources
@NCISBIRNIH/NCI Applicant Assistance Program (AAP)
NIH AAP PROGRAM NOT PROVIDED
Phase I Preparation Support and Review Grant Writer
Specific Aims Page Review and Advice Development of Research Plan
Register small business for
Submission Process Coaching
you, apply to NIH for you
• AAP is FREE!
• For companies
Sign up for our mailing list at
without previous NIH https://sbir.cancer.gov
SBIR/STTR award to receive an alert for future cohorts!
• Short, simple
application
35
@NCISBIRI-CORPS at NIH
• Intensive Entrepreneurial Immersion course aimed at
providing teams with skills and strategies to reduce
commercialization risk
• Curriculum emphasizes Reaching out to Customers to
test hypotheses about the market(s) for the technology
• Teams are expected to conduct over 100 interviews in
8 weeks
#ICorpsNIH
• Format is focused on Experiential Learning
• NCI SBIR designed, launched, and manages the
program for NIH
• 21 Institutes at NIH and CDC participate (FY2019)
36
@NCISBIRI-CORPS AT NIH #ICorpsNIH
Benefits to Translational Researchers
• Teaches the researcher how to build a business model around their technology
• Goal is to actively investigate where the technology can provide greatest impact and
largest benefit in the life sciences ecosystem
37
@NCISBIRInvestor Initiatives
Exclusive opportunity for some of our most promising
NCI-funded companies to showcase their technologies
If selected, companies…
• Receive coaching on presentation & pitching
• Get chances to present at top conferences (e.g. BIO, RESI, AdvaMed, & many more!)
• Executive Summaries are shared with many top investors
Even if not selected, companies…
• Receive a review of their application by some of the top investors in the country
38
@NCISBIRInvestor Initiatives Program Format
Jan/Feb 2020 March/April May 2020 June 2020 July-Sept 2020 Sept 2020 - June
MENTORING
PRESENTATION
MATCHING
REVIEW
APPLICATION
SELECTION
Open to Phase I 2020 Approximately Companies Pitch Prep & 2021
awardees (2018 Review by > 50 25-30 companies assigned to Mentoring (pitch Present at
or later) & Phase investors & selected for conferences calls approx. 2 conferences
II awardees strategic partners presentations weeks prior to
(2016 or later) conference)
Executive
Short Application Summaries
39INVESTOR INITIATIVES – 2018-19
36 COMPANIES
97%
10 SHOWCASE EVENTS
ACA Summit ∙ Advamed ∙ BIO ∙ BIO Investor
Forum ∙ BioNetwork ∙ Life Sciences Summit ∙
Medical Alley ∙ PMWC ∙ RESI Boston ∙ RESI NY
“Investor Initiatives helped us
progress toward our goals”
470+ MEETINGS WITH INVESTORS &
STRATEGIC PARTNERS 92%
Each company selected to present received pitch-coaching from “The value of the event was
SBIR staff and/or external investors which added significant mostly to extremely valuable”
value to the presenters
40Peer Learning Webinar Series
Peer Learning and Networking (PLAN) Webinar Series
• Goal is to improve peer learning and & provide more networking opportunities
• 2 - 4 presenting companies share their experience and expertise and discuss
potential areas of collaborations
• 2 - 4 webinars per year
NCI SBIR PLAN Webinar Series
I-Corps at NIH – Lessons Learned
Building an Effective Translational Team
Do’s and Don’ts for Successful Phase IIB Bridge
IP Strategies – How to Build a Strong IP Portfolio
For more information contact Patricia Swayne: patti.swayne@nih.gov
41
@NCISBIRTranslational Resources (TRECS) WORKSHOP
Workshop on Translational Resources to Enhance Commercialization Success
Next Workshop: May 2020 in Rockville, MD
https://sbir.cancer.gov/programseducation/TRECS2018
• Open to active awardees
• Speakers from FDA, CMS, NSF, pharma, med-tech, VCs and across NIH
• Panels on other sources of federal funding, resources & collaborative
programs at NIH, and unique life science investment organizations
• Over 300 One-on-one meetings with program directors and speakers
• Networking and Brainstorm sessions with other SBIR peers and NIH staff
42
@NCISBIRCEO Round Table
CEO Roundtable Pilot Program
• Platform for founders/CEOs/other C-Level Executives of NCI
SBIR-funded startups to mentor and advise each other on real- NEW
life startup issues.
• 2 pilot cohorts already ongoing
• 2-3 hours once every 1-2 months
Applications open • Networking
In person or Virtual C-Level Executives
Early 2020. • Ongoing Mentoring
of all awardees
& Advice
Cohorts begin • Potential
10-12 participants
Spring/Summer 2020. Partnerships
per cohort
WHEN WHAT WHERE WHO
43
@NCISBIRCARE: Connecting Awardees with Regulatory Experts
DICE - Division of Industry and Consumer Education
CDRH Phone: 1(800) 638-2041 or (301) 796-7100; Email: DICE@fda.hhs.gov
SBIA - Small Business & Industry Assistance NEW
CDER Phone: (866) 405-5367 or (301) 796-6707; Email: CDERSBIA@fda.hhs.gov
MATTB - Manufacturers Assistance and Technical Training Branch
CBER Phone: 240-402-8020 or 1-800-835-4709; Email: Industry.Biologics@fda.hhs.gov
NCI SBIR supports awardee interactions with FDA and encourages
communication with regulators early on in the technology development process
• Cohort 1: May - Oct 2019 • Spring 2020 • Coming soon!
• Pilot Program to encourage early • Opportunity to meet one-on-one • Resources webpage of key guidance
communication between small with regulators from FDA documents applicable to small
businesses and CDRH • Educational panel presentations businesses
• Stay tuned for future cohorts with speakers from FDA • Curated list of links to FDA
educational webinars
CARE Program TRECS Workshop NCI SBIR Website
44
@NCISBIRNIH-Managed Programs
Niche Assessment Program (NAP)
• Service provided by Foresight S&T
• For Phase I Awardees
• First come, first serve (up to 200 companies/year)
• Managed by NIH SBIR office
Application Period: October
Conduct market research Program Period: November-January
Develop market entry strategy Website: https://sbir.nih.gov/nap
Identify other uses of technology
Determine competitive advantages
Note: there might be changes in these programs in near future. 45
@NCISBIRNIH-Managed Programs
Commercialization Accelerator Program (CAP)
• Services provided by Larta, Inc.
• For Phase II Awardees
• Managed by NIH SBIR office
Offers technical assistance in:
o Strategic/business planning
o FDA requirements
o Technology valuation
o Manufacturing issues
o Patent and licensing issues
Facilitates investor partnerships
Individualized mentoring/consulting
46
@NCISBIROther NIH/NCI Resources
NCI Experimental Therapeutics (NExT) Program
https://next.cancer.gov/
• Goal is to facilitate milestone driven
progression of new anticancer drugs
and imaging agents towards clinical
evaluation and registration
• Not a grant but NCI allocates various
contract and grant resources toward
the implementation and development
of submitted projects
• Consultation Service
https://next.cancer.gov/experiment
alTherapeutics/form.htm
47
@NCISBIRNCI Drug Development Consultation Service
https://next.cancer.gov/experiment
alTherapeutics/form.htm
• A focused consultation service provided by staff from the NCI Developmental Therapeutics
Program and Cancer Imaging Program - extensive experience in preclinical development of small
molecule, biological or imaging drugs for cancer
• Investigators from academia or small biotech companies can request this consultation service
• Typically a 1-hour call
• Request a consultation via the link above; simple form to complete
• Consultation call may help with:
• Drug discovery strategy
• Design of non-clinical safety studies
• Manufacturing plan
• IND plan
• FDA communication
• Superior application for supplemental drug development services to NCI NExT:
https://next.cancer.gov/
48
@NCISBIROther NIH/NCI Resources
NCI PREVENT Cancer Preclinical Drug Development Program
https://prevention.cancer.gov/major-programs/prevent-cancer-preclinical
• Partner with successful applicant to help them move their novel cancer preventive chemical or
biological agents and biomarkers from the lab bench towards IND filing, proof-of principle clinical
testing, and registration or validation
Nanotechnology Characterization Laboratory
https://ncl.cancer.gov/
• Services for researchers and companies
developing nanotechnology focused technologies
(therapeutics, diagnostics, imaging, etc.)
49
@NCISBIRHow do I get started?
What is NCI looking for?
Innovative solution to significant unmet clinical need
Solution that has significant commercial potential
Proposals are encouraged from
Start-up companies too early for
private investment
Established small businesses
seeking to pursue new projects
51
@NCISBIRBefore you start writing the application…
Consider your Review similar, Discuss your
company’s currently-funded specific aims with
strengths AND NIH SBIR/STTR NIH Program
weaknesses projects Director
https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44
52
@NCISBIRhttp://projectreporter.nih.gov
53
@NCISBIRTip #1 – Start Early
Strong proposals take time to develop
• Carefully read the funding solicitation and allow time
to address all of the key requirements
• Gain access to equipment, facilities, other resources
• Assemble a strong scientific team
• Obtain letters of support from collaborators
Complete the administrative registrations
• Start at least 2 months before deadline
• See SF424 application guide (grants.gov,
eRA Commons)
• http://sbir.nih.gov – see Electronic Submission
54
@NCISBIRTip #2 – Refine Your Vision
Start informal discussions to clarify the product vision
• Technical experts, potential customers, investors,
commercialization partners, and other stakeholders
Seek help from others with experience and insights
• Current/prior SBIR grantees
• Academic collaborators with grant writing experience
• Professional grant writers*
• Engage with SBIR program staff for the most up-to-date
information on agency priorities, current NIH policies, etc.
Carefully consider the study design
• Identify strategies to mitigate risk
• Present alternative approaches if problems are encountered
55
@NCISBIRTip #3 – Draft a Clear Application
Specific Aims (1 page): Grab their attention!!
• Focal point of the application
• Highlight the technology’s major strengths
• Describe goals of the application (be specific)
• Include quantitative performance milestones
• Describe the unmet need that you are addressing
Research Strategy
• Provide background information
• Provide detailed technical plan to achieve the Specific Aims
• Propose a project scope within the budget and time constraints
• Preliminary data not required (Ph I), but needed to be competitive
• Describe potential pitfalls and alternative angles of attack
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@NCISBIRTip #3 – Draft a Clear Application (cont’d)
Other application components
• Letters of support
• Necessary from consultants and collaborators
• Helpful endorsements from clinicians, end-users, investors
• Phase II Commercialization Plan (12 pages)
• Bio-sketches for all senior/key personnel (Budget Specifics
TOTAL COST BUDGETS
• SBIR Budgets are defined by total cost.
• Subcontracting is limited.
• Know the rules and the criteria.
Can request a 7% Fee
Company Profit
Of total budget
Technical Assistance Money ($6,500 for Phase I; $50,000 for Phase II)
Example: regulatory consultant
Caveat: if requested, company cannot participate in NIH Technical
Assistance Programs (CAP, Niche)
58
@NCISBIRSBIR Review Criteria – 5 scored
Does the product address an important problem, and have commercial potential?
Significance
Is there a market pull for the proposed product?
Are design and methods well-developed and appropriate? Are problem areas
Approach addressed? Are potential pitfalls and alternative approaches provided?
How novel is the technology/product and the approaches proposed to test its
Innovation feasibility? What is the competitive advantage?
Are the investigators, collaborators and consultants appropriately trained and
Investigator
capable of completing all project tasks?
Does the scientific environment contribute to the probability of success?
Environment Facilities? Independence?
59
@NCISBIRSBIR Review Criteria – 5 scored
Does the product address an important problem, and have commercial potential?
Significance
Is there a market pull for the proposed product?
Are design and methods well-developed and appropriate? Are problem areas
Approach addressed? Are potential pitfalls and alternative approaches provided?
How novel is the technology/product and the approaches proposed to test its
Innovation feasibility? What is the competitive advantage?
Are the investigators, collaborators and consultants appropriately trained and
Investigator
capable of completing all project tasks?
Does the scientific environment contribute to the probability of success?
Environment Facilities? Independence?
Commercialization Is the company’s business strategy one that has a high potential for success?
60
@NCISBIRSBIR/STTR versus Academic Grants
ACADEMIC GRANT SBIR/STTR GRANT
Expertise/Team Expertise/Team
(Discovery Phase I: Research and Development
Research) Phase II: Commercial Development
Approach Approach
(Appropriate (Product
Environment
for discovery) Development) Environment
SCIENCE PRODUCT
Significance
Product Significance
Science (Changing a paradigm)
(optional) (Knowledge increase)
(MANDATORY)
Innovation
Innovation
(What could be/
(Competitive
theoretically possible) Commercialization
Advantage)
61
@NCISBIRWhat if you are funded?
62
@NCISBIRWhat if you are not funded?
Rejection is painful, BUT… feedback is a roadmap for next steps!
63
@NCISBIRWhat if you are not funded?
Rejection is painful, BUT… feedback is a roadmap for next steps!
• Revise and resubmit the application
• Introduction Page: Response to
reviewer critiques
• Be constructive, NOT defensive
• Learn more about SBIR/STTR grants
• Talk to successful applicants
• Understand review process and
dynamics – http://csr.nih.gov
64
@NCISBIRCommon Pitfalls – #1
What if the reviewers don’t believe you are
working on significant problem?
• Consider reviewer comments from their point of view and their knowledge of
current clinical practice (or relevant sector/customer segment)
• Address reviewer comments in an evidence-based fashion
• Be specific and quantitative when providing data to support your claims
• Obtain additional letters of support from stakeholders who can confirm the
magnitude of the problem AND the potential impact of your solution
65
@NCISBIRCommon Pitfalls – #2
What if the reviewers didn’t understand
your proposal?
• Possible Reason: Proposal is not clearly written
Solution: Improve your presentation; check for spelling or grammatical
errors, make sure figures are clearly labeled, etc.
• Possible Reason: Not enough data, or vague descriptions of the technology
Solution: Present key data in the application; reference publications to
save space, but show the most important figures!
66
@NCISBIRCommon Pitfalls – #3
What if the reviewers believe your team is
not well qualified?
• Provide more background on your team members’ qualifications
• Strengthen your team by adding collaborators and consultants
• Consider including a management plan/strategy that describes who is
completing which aspects of the work, and how they are qualified
• For multidisciplinary projects, consider a multi-PI team
67
@NCISBIRNCI SBIR/STTR Success Rates
Resubmissions
versus
Original
applications
68
@NCISBIRLearn More!
https://sbir.cancer.gov @NCIsbir
www.linkedin.com/company/nci-sbir-development-center
69
@NCISBIRTHANK YOU
ncisbir@mail.nih.gov
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