Greg Evans, PhD Team Leader Cancer Imaging/Biology/Control NCI SBIR Development Center 2014 Overview of the NCI Small Business Programs: Grant and Contract

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


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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


Reviewed


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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21




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







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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: [email protected]

http://commonfund.nih.gov/Singlecell/

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mailto:[email protected]

http://commonfund.nih.gov/Singlecell/

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: [email protected]

http://sbir.cancer.gov/funding/technology 27


http://sbir.cancer.gov/funding/technology

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: [email protected]

http://sbir.cancer.gov/resource/hit/

28


http://sbir.cancer.gov/resource/hit/

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


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

[email protected]

http://sbir.cancer.gov

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Documents

Greg Evans, PhD Team Leader Cancer Imaging/Biology/Control NCI SBIR Development Center 2014 Overview of the NCI Small Business Programs: Grant and Contract