THE NCI SMALL BUSINESS PROGRAMS: SUPPORTING CANCER START-UPS

NCI SBIR Development Center

Deepa NarayananProgram Director

January 14, 2020

KEY TOPICS

@NCISBIR

• 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

CONGRESSIONALLY MANDATED

@NCISBIR

3

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

Set AsideFY11 FY19

2.5% 3.2%

0.3% 0.45%

~$1.14B in FY2019 at NIH~$173M in FY2019 at NCI

NIH = 27 Institutes & Centers

The Office of the Director (OD)

National Institute

on Alcohol Abuse

& Alcoholism

(NIAAA)

National Institute

of Arthritis &

Musculoskeletal &

Skin Diseases (NIAMS)

National CancerInstitute (NCI)

National Institute

on Aging

(NIA)

National Institute

of Child Health &

Human Development

(NICHD)

National Institute

of Allergy &

Infectious Diseases

(NIAID)

National Institute

of Diabetes &

Digestive & Kidney

Diseases (NIDDK)

National Institute

of Dental and

Craniofacial

Research (NIDCR)

National Institute

on Drug Abuse

(NIDA)

National Institute

of Environmental

Health Sciences

(NIEHS)

National Institute on

Deafness & Other

Communication

Disorders (NIDCD)

National Eye

Institute

(NEI)

National Human

Genome Research

Institute (NHGRI)

National Heart,

Lung, & Blood

Institute (NHLBI)

National Institute

of Mental Health

(NIMH)

National Institute

of Neurological

Disorders &

Stroke (NINDS)

National Institute

of General

Medical Sciences

(NIGMS)

National Institute

of Nursing Research

(NINR)

No funding

authority

National Institute on

Minority Health &

Health Disparities

(NIMHD)

National Library

of Medicine (NLM)

National Center

for Complementary

& Integrative Health

(NCCIH)

Fogarty

International

Center (FIC)

National Institute

of Biomedical

Imaging &

Bioengineering (NIBIB)

National Center

for Advancing

Translational Sciences

(NCATS)

Center for Information

Technology (CIT)

Center for Scientific

Review (CSR)

NIH Clinical

Center (CC)

@NCISBIR

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Why Seek SBIR/STTR Funding

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• 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)

@NCISBIR

SBIR – STTR: Critical Differences

SBIR STTR

Permits research institution partners

(e.g., universities)

Requires research institution partners

(e.g., universities)

Small business concern may outsource

~33% of Phase I activities and 50% of

Phase II activities

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)

ELIGIBILITY: The PD/PI’s primary

employment (i.e., >50%) MUST be with the

SBC for the duration of the project period

ELIGIBILITY: IP Agreement providing necessary IP

rights to the SBC in order to carry out follow-on R&D

and commercialization

PI primary employment not stipulated (min.10% effort

to project)

@NCISBIR

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7

Eligibility

✓ Applicant must be a Small Business Concern (SBC)

✓ Organized for-profit U.S. 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

Award always

made to

small business

@NCISBIR

Three-Phase Program

• Proof-of-Concept

• Up to $400K over

6 to 12 months

• Research & Development

• Commercialization plan

required

• Up to $2M over

2 years

• Commercialization stage

• Use of non-SBIR/STTR

funds

PHASE II NCI SBIR PHASE IIB BRIDGE AWARDCROSSING THE VALLEY OF DEATH

FAST-TRACK

(PH I & II)

NCI SBIR PHASE IIB

BRIDGE AWARD

• Technology validation &

clinical translation

• Follow-on funding for SBIR

Phase II awardees from any

federal agencies

• Expectation that applicants

will secure substantial 3rd

party investor funds

• $4M over 3 years

Crossing the Valley of Death

@NCISBIR

PHASE I Phase III

DIRECT TO PHASE II

NIH SBIR/STTR BUDGET LIMITS

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@NCISBIR

Standard Award Hard Cap Waiver Cap

$150,000 $252,131 NCI: $400,000

$1.0M ~$1.68M NCI: $2.0M

Phase I

Phase II

INSTITUTE SPECIFIC

Waiver topics: https://sbir.nih.gov/sites/default/files/NIH_Topics_for_Budget_Waivers.pdf

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

@NCISBIR

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NCI SBIR Development

Center

NCI SBIR - CORE ACTIVITIES

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CENTRALOVERSIGHT• Administer all 400+ SBIR/STTR

awards at the NCI

GUIDANCE

• Help applicants prepare for application, resubmission, and discuss funding options

OUTREACH

• Attend conferences and workshops & visit state-based organizations and universities to raise awareness of the program

FUNDING

• Seed emerging technology areas by developing targeted funding opportunities either as grants or contracts

TRAINING

• Provide entrepreneurship training, as well as webinars on key topics such as IP, regulatory strategy, and how to build a strong team

NETWORKING

• Maintain a network of investors, and facilitate connections between NCI SBIR portfolio companies and potential investors/strategic partners

@NCISBIR

NCI SBIR Program Staff

Greg Evans, PhD

Lead Program Director

Cancer Biology, E-Health, Epidemiology, Research Tools

Michael Weingarten, MA

Director

NCI SBIR Development Center

Jian Lou, PhD

Program Director

In-Vitro Diagnostics, Theranostics, early-stage drug development, Bioinformatics,

Investor Initiatives

Deepa Narayanan, MS

Program Director

Imaging, Clinical Trials, Radiation Therapy, Investor Initiatives, FRAC Workshop

Amir Rahbar, PhD, MBA

Program Director

In-Vitro Diagnostics, Biologics, Therapeutics, Proteomics

Ming Zhao, PhD

Program Director

Cancer Diagnostics & Therapeutics, Cancer Control & Prevention, Molecular Imaging,

Bioinformatics, Stem Cells

Jonathan Franca-Koh, PhD, MBA

Program Director

Cancer Biology, Biologics, Small Molecules, Cell Based Therapies, Bridge Award

Kory Hallett, PhD

Program Manager

Monoclonal Antibodies, Immunotherapy, Biologics, and Program Analysis

Andrew J. Kurtz, PhD

Lead Program Director

Biologics, Small Molecules, Nanotherapeutics, Molecular Diagnostics

Patricia Weber, DrPH

Program Director

Digital Health, Therapeutics, Biologics, FRAC Workshop

Christie Canaria, PhD

Program Manager

Cancer/Biological Imaging, Research Tools, Devices, I-Corps at NIH, Scientific

Communications

Let’s discuss your project!

Send Specific Aims to ncisbir@mail.nih.gov

Ashim Subedee, PhD

Program Director

Cancer Therapeutics and Diagnostics, Imaging, Cancer Prevention and Control,

Digital Health, Investor Initiatives

Monique Pond, PhD

Program Director

Cancer Therapeutics, Biologics, Regulatory

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@NCISBIR

Nancy Kamei, PhD

Program Director

Cancer Therapeutics

Supporting Staff

@NCISBIR

Julienne Willis

Program Specialist

Lisa Yeom

Communications Specialist

Kehui Zhang

Program Analyst

Bryce Geiling

Communications Specialist

Tamar Boghosian

Program Analyst

Brittany Connors

Investor Relations Coordinator

Patti Swayne

Innovation Coordinator

NCI SBIR/STTR Portfolio

@NCISBIR

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Major Portfolio Areas

(2018)

~475 Total Projects

2018 Economic Impact Study – Goals

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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

@NCISBIR

Economic Impact

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sbir.cancer.gov/impact

247

products

commercially

available

110

products

currently in

development

@NCISBIR

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ECONOMIC IMPACT

https://sbir.cancer.gov/impact

NCI SBIR/STTR Funding Model

NCI scientific & technologypriorities

Areas of interest to commercial

sector

CONTRACTS

(SBIR ONLY)GRANTS

Omnibus Solicitation:Investigator initiated

• 3 receipt dates (January, April, September)

Targeted Solicitation:Focused/NCI gap/

priority areas

• Variable receipt dates

Contract Topics

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• R&D scope is defined by the NIH

• New topics once per year

• Set-aside of funds for each topic

• May NOT have conversations with program staff to discuss proposal ideas

• Pre-award contract negotiations

Funding Opportunities

Grant Funding OpportunitiesTITLE SBIR FOA STTR FOA DUE DATES

Omnibus SolicitationPA-19-272 (General)

PA-19-273 (Clinical Trial)

PA-19-270 (General)

PA-19-271 (Clinical Trial)

September 5;

January 6;

April 6

SBIR Technology Transfer

(technology transfer out of NIH intramural labs)PA-18-705 (SBIR only)

Illuminating the Druggable Genome (IDG) PA-19-034 PA-19-033

Cancer Prevention, Diagnosis, and Treatment

Technologies for Low-Resource Settings PAR-18-801 PAR-18-802

SBIR IMAT (Innovative Molecular Analysis

Technology)PAR-18-303 (SBIR only)

Development of Highly Innovative Tools and

Technology for Analysis of Single CellsPA-17-147 PA-17-148

Phase IIB Bridge Award RFA-CA-19-047 (SBIR only) Summer 2020

@NCISBIR

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

Special Grant Funding Opportunities II: SBIR Innovative Molecular Analysis Technology (IMAT) Development for Cancer Research and Clinical Care

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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

Special Grant Funding Opportunities I: Cancer Prevention, Diagnosis, and Treatment Technologies for Low-Resource Settings

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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

NCI SBIR Phase IIB – Bridge Awards

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@NCISBIR

PHASEI

PHASEII

PHASEIII

NCI SBIR PHASE IIB BRIDGE AWARDCROSSING THE VALLEY OF DEATH

FAST-TRACK

(PH I & II)

• 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)

Non-SBIR/STTR Funds

Commercialization

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2019 SBIR Bridge Evaluation

VC41%

Angel20%

Strategic Partner

35%

Other4%

Sources of Matching Funds

$2.3

5

$2.4

3

$2.5

6

$10.6

2

$6.7

8

$17.0

6

$9.7

0

$13.3

0

$30.6

0

DEVICE DIAGNOSTIC DRUG/BIOLOGIC$

(M

M)

NCI Funding Award-Relevant Fundraising Follow-On

Average Investments by Technology Area

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

@NCISBIR

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Commercialized Bridge Projects

Company Product Status

OptosonicsNexus 128 3D Photoacoustic Computed Tomography (PAT) for

preclinical molecular imaging

Commercialized by Endra

Life Sciences

Gamma Medica LumaGEMTM Molecular Breast ImagerCommercialized in US and

several other countries

Koning KBCT, cone beam Computed Tomography Breast ImagerCommercialized in US and

several other countries

Advanced Cell

DiagnosticsRNAScope In-Situ Hybridization Technology

Commercialized, Acquired

by Biotechne

Guided

TherapeuticsLuViva® advanced cervical scan

Commercialized

internationally

Praevium

Research

MEMS-VCSEL Swept-Source Laser Engine for Optical Coherence

Tomography/Microscopy (OCT/OTM) Volumetric Imaging of Tissue

Pathology

Commercialized by

ThorLabs

Wilson Wolf

ManufacturingG-RexTM cell culture device to improve TIL production and reduce cost Commercialized

Corvida Medical Halo®, a Closed System Transfer Device (CSTD) for Chemotherapy Commercialized

@NCISBIR

Grant vs. Contract

GRANT CONTRACT

Scope of the proposalInvestigator-defined within the

mission of NIHDefined by the NIH (focused)

Peer Review Locus NIH Center for Scientific Review

(CSR)

NCI DEA (target 50% business

reviewers)

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

Set-aside of funds for

particular areas?NO YES

Basis for AwardBased on score during peer

review

If proposal scores well during peer

review, must then negotiate to

finalize deliverables with NIH

ReportingOne final report (Phase I);

Annual reports (Phase II)

Kick-off presentation, quarterly

progress & final reports

@NCISBIR

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Contract Topics

0

20

40

60

80

100

120

140

160

180

FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 FY 2018

Mill

ion

s

Grants R&D Contracts

36%($38M)

31%($37M)

24%($29M)

25%($34M)

20%($31M)

15%($24M)

@NCISBIR

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@NCISBIR

Past Contract Topics on SBIR.Cancer.gov

Administrative Supplement

https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html

•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

ELIGIBILITY

IMPORTANT POINTS

• Aims that help with commercialization efforts are encouraged.

• No peer review, Programmatic Review is required.

• Decisions based on merit, programmatic balance & available funds

• As appropriate

• Check with your Program Director

BUDGET

Funds may be available for administrative supplements to meet increased costs that are within the scope of the approved award, but

were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted.

PURPOSE

FOA

https://grants.nih.gov/grants/guide/pa-files/pa-18-837.html

•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

ELIGIBILITY

IMPORTANT POINTS

• Strongly encouraged to discuss with Program Director

• No peer review, Programmatic Review is required.

• Research objectives must be within the original scope of the peer reviewed and approved project,

• Application budgets are limited to no more than the amount of the current parent award, and must reflect the actual needs of the proposed project.

BUDGET

Improve the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented in health-related research or in the SBIR program.

PURPOSE

FOA

Diversity Supplement

https://grants.nih.gov/grants/guide/pa-files/par-19-334.html

•Must have active or completed NCI SBIR (Phase II and Phase IIB) or STTR (Phase II) awards.

ELIGIBILITY

SCOPE

• Funds can be requested for help with regulatory, reimbursement or IP Strategy.

• Design and planning for a clinical trial including administrative tasks

• Technical assistance associated with manufacturing.• Other technical assistance offered through a third-party

technical assistance provider, including market research.• And more ….check with your Program Director

• $250,000 total costs for NCI

BUDGET

Aims to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance not typically supported through Phase II or Phase IIB grants or contracts.

PURPOSE

FOA

Commercialization Readiness Pilot Program-Technical Assistance

•Peer Review with Special Emphasis Panel at CSR•Decisions based on peer review, merit, programmatic balance & available funds

REVIEW

• Jan 5, April 5, September 5

APPLICATION DUE DATES

How can NCI help translate

your ideas to the marketplace?

NIH and NCI Assistance

@NCISBIR

SBIR Ph I SBIR Ph IINCISBIR

Ph IIB BridgeCommercialization

CROSSING THE

VALLEY OF DEATH

I-Corps at NIH

Non-Federal Funds

Niche Assessment

Program

Commercialization

Assistance Program

NCI Investor Initiatives

NCI Resources for Commercialization Workshops

NC

I-M

anag

ed

NIH

-Man

age

d

NCI Peer Learning and Networking WebinarApplication

Assistance

Program

CEO Roundtable

Connecting Awardees to Regulatory Experts (CARE)

https://sbir.cancer.gov/resources

NIH/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

Submission Process CoachingRegister small business for

you, apply to NIH for you

@NCISBIR

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Sign up for our mailing list at https://sbir.cancer.gov

to receive an alert for future cohorts!

• AAP is FREE!

• For companies

without previous NIH

SBIR/STTR award

• Short, simple

application

I-CORPS at NIH

@NCISBIR

• 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

• Format is focused on Experiential Learning

• NCI SBIR designed, launched, and manages the

program for NIH

• 21 Institutes at NIH and CDC participate (FY2019)

#ICorpsNIH

36

I-CORPS AT NIH

@NCISBIR

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

#ICorpsNIH

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Investor Initiatives

38

@NCISBIR

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

AP

PLI

CA

TIO

N Jan/Feb 2020

Open to Phase I awardees (2018 or later) & Phase II awardees (2016 or later)

Short Application

REV

IEW

March/April 2020

Review by > 50 investors & strategic partners

SELE

CTI

ON May 2020

Approximately 25-30 companies selected for presentations

MA

TCH

ING June 2020

Companies assigned to conferences

MEN

TOR

ING July-Sept 2020

Pitch Prep & Mentoring (pitch calls approx. 2 weeks prior to conference)

Executive Summaries

PR

ESEN

TATI

ON Sept 2020 - June

2021

Present at conferences

Investor Initiatives Program Format

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INVESTOR INITIATIVES – 2018-19

40

COMPANIES

“The value of the event was

mostly to extremely valuable”

36SHOWCASE EVENTS10

MEETINGS WITH INVESTORS &

STRATEGIC PARTNERS470+

97%

92%

“Investor Initiatives helped us

progress toward our goals”

Each company selected to present received pitch-coaching from

SBIR staff and/or external investors which added significant

value to the presenters

ACA Summit ∙ Advamed ∙ BIO ∙ BIO Investor Forum ∙ BioNetwork ∙ Life Sciences Summit ∙ Medical Alley ∙ PMWC ∙ RESI Boston ∙ RESI NY

Peer 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

@NCISBIR

41For more information contact Patricia Swayne: patti.swayne@nih.gov

Translational Resources (TRECS) WORKSHOP

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

Workshop on Translational Resources to Enhance Commercialization Success

@NCISBIR

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CEO Round Table

43

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-life startup issues.

• 2 pilot cohorts already ongoing• 2-3 hours once every 1-2 months

@NCISBIR

NEW

WHEN WHAT WHERE WHO

Applications open Early 2020.

Cohorts begin Spring/Summer 2020.

• Networking• Ongoing Mentoring

& Advice• Potential

Partnerships

In person or Virtual C-Level Executives of all awardees

10-12 participants per cohort

• Cohort 1: May - Oct 2019

• Pilot Program to encourage early communication between small businesses and CDRH

• Stay tuned for future cohorts

CARE Program

• Spring 2020

• Opportunity to meet one-on-one with regulators from FDA

• Educational panel presentations with speakers from FDA

TRECS Workshop

• Coming soon!

• Resources webpage of key guidance documents applicable to small businesses

• Curated list of links to FDA educational webinars

NCI SBIR Website

CARE: Connecting Awardees with Regulatory Experts

44

@NCISBIR

NEW

CDRHDICE - Division of Industry and Consumer Education Phone: 1(800) 638-2041 or (301) 796-7100; Email: DICE@fda.hhs.gov

CDERSBIA - Small Business & Industry AssistancePhone: (866) 405-5367 or (301) 796-6707; Email: CDERSBIA@fda.hhs.gov

CBERMATTB - Manufacturers Assistance and Technical Training BranchPhone: 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

45

@NCISBIR

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

Conduct market research

Develop market entry strategy

Identify other uses of technology

Determine competitive advantages

Note: there might be changes in these programs in near future.

Website: https://sbir.nih.gov/nap

Application Period: October

Program Period: November-January

NIH-Managed Programs

NIH-Managed Programs

Commercialization Accelerator Program (CAP)

• Services provided by Larta, Inc.

• For Phase II Awardees

• Managed by NIH SBIR office

@NCISBIR

46

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

Other 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 Servicehttps://next.cancer.gov/experiment

alTherapeutics/form.htm

@NCISBIR

47

NCI Drug Development Consultation Service

• 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/

@NCISBIR

48

https://next.cancer.gov/experiment

alTherapeutics/form.htm

Other 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.)

@NCISBIR

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How do I get started?

@NCISBIR

What is NCI looking for?

51

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

@NCISBIR

Before you start writing the application…

52

Consider your company’s

strengths AND weaknesses

Review similar, currently-funded NIH SBIR/STTR

projects

Discuss your specific aims with

NIH Program Director

https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44

@NCISBIR

http://projectreporter.nih.gov

53

@NCISBIR

Tip #1 – Start Early

54

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

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Tip #2 – Refine Your Vision

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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

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Tip #3 – Draft a Clear Application

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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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Tip #3 – Draft a Clear Application (cont’d)

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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 (<4 pages each)

• Budgets for each project period & for each subcontract

• Detailed descriptions of facilities and equipment

• Human subject research section (if applicable)

• Vertebrate animals section (if applicable)

Budget Specifics

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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)

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SBIR Review Criteria – 5 scored

Does the product address an important problem, and have commercial potential?

Is there a market pull for the proposed product?

How novel is the technology/product and the approaches proposed to test its

feasibility? What is the competitive advantage?

Are the investigators, collaborators and consultants appropriately trained and

capable of completing all project tasks?

Are design and methods well-developed and appropriate? Are problem areas

addressed? Are potential pitfalls and alternative approaches provided?

Does the scientific environment contribute to the probability of success?

Facilities? Independence?

Significance

Innovation

Investigator

Approach

Environment

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@NCISBIR

SBIR Review Criteria – 5 scored

Does the product address an important problem, and have commercial potential?

Is there a market pull for the proposed product?

How novel is the technology/product and the approaches proposed to test its

feasibility? What is the competitive advantage?

Are the investigators, collaborators and consultants appropriately trained and

capable of completing all project tasks?

Are design and methods well-developed and appropriate? Are problem areas

addressed? Are potential pitfalls and alternative approaches provided?

Does the scientific environment contribute to the probability of success?

Facilities? Independence?

Significance

Innovation

Investigator

Approach

Environment

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Commercialization Is the company’s business strategy one that has a high potential for success?

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SBIR/STTR GRANTACADEMIC GRANT

Significance

(Knowledge increase)

Product

(optional)

Approach

(Appropriate

for discovery)

Innovation

(What could be/

theoretically possible)

Expertise/Team

(Discovery

Research)

Environment

SCIENCE

Expertise/Team

Phase I: Research and Development

Phase II: Commercial Development

PRODUCT

Science

(MANDATORY)

Significance

(Changing a paradigm)

Approach

(Product

Development)

Innovation

(Competitive

Advantage) Commercialization

Environment

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SBIR/STTR versus Academic Grants

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What if you are funded?

62

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What if you are not funded?

63

Rejection is painful, BUT…feedback is a roadmap for next steps!

@NCISBIR

What if you are not funded?

64

Rejection is painful, BUT…

• 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

feedback is a roadmap for next steps!

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Common Pitfalls – #1

65

• 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

What if the reviewers don’t believe you are

working on significant problem?

@NCISBIR

Common Pitfalls – #2

66

• 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!

What if the reviewers didn’t understand

your proposal?

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Common Pitfalls – #3

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• 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

What if the reviewers believe your team is

not well qualified?

NCI SBIR/STTR Success Rates

Resubmissions

versus

Original

applications

@NCISBIR

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Learn More!

https://sbir.cancer.gov

www.linkedin.com/company/nci-sbir-development-center

@NCIsbir

@NCISBIR

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THANK YOU

ncisbir@mail.nih.gov@NCIsbir