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Business of Bio SeriesBringing Science
to the Market: The National Cancer Institute
SBIR & STTR ProgramWednesday, September 15
10:00am-Noon
Business of Bio SeriesWelcome
Jim HughesVice President,
Office of Research & Development
University of Maryland
Business of Bio Opening Remarks
Dr. Curt CivinFounding Director,
Center for Stem Cell Biology &
Regenerative MedicineUniversity of Maryland
School of Medicine
Business of Bio Presentation
Michael WeingartenDirector,
National Cancer InstituteSBIR Development Center
PresentationDr. Ali Andalibi
Program Director & Branch Chief,
National Cancer InstituteSBIR Program
Bringing Science to the Market:The NCI SBIR Program
University of Maryland BioParkSeptember 15, 2010
Michael WeingartenDirector, NCI SBIR Development Center
Today’s Presentation• Program overview
• Strategic move to targeted solicitations
• Helping Companies Bridge the “Valley of Death”– SBIR Phase II Bridge Award
• A New Approach to Managing SBIR– NCI Investor Forum– Regulatory Assistance Program
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Congressional Goals1. 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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Percent of NCI and NIH Budget
9
2.5%
0.3%
Set Aside
~$110 million annually at the NCI~$650 million annually at the NIH
SBIR: Set-aside program for small business concerns to engage in Federal R&D with the potential for commercialization
STTR: Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with potential for commercialization
• One of the largest sources of early stage of life sciences funding in the country.
• A stable and predictable source of funding
• Intellectual property rights are retained by the small business concern
• Not a loan – no repayment is required
• Doesn’t impact stock or shares in any way (no dilution of capital)
• Provides recognition, verification and visibility
• Can be a leveraging tool to attract other funding (VC, etc.)
Reasons to Seek SBIR & STTR Funding
SBIR Eligibility
Applicant must be a Small Business Concern (SBC)
Organized for-profit U.S. business
500 or fewer employees, including affiliates
PD/PI’s primary employment (i.e., >50%) must be with SBC at the time of award and for duration of the project period
At least 51% U.S.- owned by individuals and independently operated
ORAt least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals
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STTR Eligibility
Applicant is a Small Business Concern
Formal Cooperative R&D Effort
• Minimum 40% by small business
• Minimum 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 SBC 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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NIH 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: AugustReceipt Date: Early November
See NIH Guide for various other Program Announcements (PAs) and Requests for Application (RFAs), i.e. other grants
Release: WeeklyReceipt Dates: Various
Multiple Funding Solicitations
13
NCI Has Moved to More Targeted Funding Opportunities
• Goal is to improve success in commercialization by focusing on more directed research.
• Invest in the technology priorities of NCI that also have greatest potential for commercialization
• Catalyze targeted technology development and draw private sector investment in specific areas– Approximately 20% of NCI’s SBIR budget is now invested in contracts.
Approximately $11M in new contract funding opportunities just announced.
SBIR Portfolio Summary (Active as of July 1
2010) Grants & Contracts -- $110M budget
Classification Topic AreaPhase I
(% of portfolio)
Phase II(% of portfolio)
Therapeutics
31%
Biologics 28 (6%) 19 (4%)
Small molecules 59 (12) 18 (4)
Nanotechnology-based therapeutics 15 (3) 9 (2)
Devices for Cancer Therapy
9%
Surgical interventions 4 (1) 3 (1)
Ablative technologies 6 (1) 3 (1)
Radiation Therapy 12 (2) 15 (3)
Imaging Technologies
19%
Image-guided interventions 4 (1) 10 (2)
New imaging technologies 28 (6) 49 (10)
Diagnostics
24%In vitro diagnostics 63 (13) 53(11)
Cancer Biology
6%Research Tools 13 (3) 13 (3)
Cancer Control & Epidemiology
12%
Software, Bioinformatics & eHealth 10 (2) 25(5)
Educational Tools & Other 4 (1) 17 (4)
Total (480) 246 (51) 234 (49)
http://sbir.cancer.gov
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NCI SBIR Phase II Bridge Award
SBIR & STTR: Three-Phase Program
* Note: Actual funding levels may differ by topic. 18
PHASE I – R41, R43–Feasibility Study –$150K and 6-month (SBIR) *–or 12-month (STTR) Award
PHASE II – R42, R44• Full Research/R&D• $1 million and 2-year Award (SBIR & STTR) *• Commercialization plan required
PHASE III• Commercialization Stage• Use of non-SBIR/STTR Funds
Phase II Bridge Award
Follow-on to SBIR Phase II–Helps early-stage companies cross the “Valley of Death” by:
• Facilitating partnerships with third-party investors & strategic partners• Incentivizing third-party investments earlier in the development process
NCI is sharing in the investment risk with other investors
Incentive Structure–Gives competitive preference and funding priority to
applicants that can raise third-party funds (i.e., 1:1 match)• Affords NIH the opportunity to leverage millions in external resources• Provides valuable input from third-party investors in several ways:
1. Rigorous commercialization due diligence prior to award
2. Commercialization guidance during the award
3. Additional financing beyond the Bridge Award project period
SBIR Phase II Bridge Award
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Example: How the Bridge Award Would Apply in the Area of Drug Development
Phase I & Phase II SBIR
CommercializationNDAReview
ClinicalTrials
SafetyReview
Preclinical Development(Lead Development, Animal Studies, File IND)
Target Identification& Validation
SBIR Bridge Award addresses the problem by bridging the “Valley of Death”
SBIR Bridge Award allows NIH to share investment risk by incentivizing investors or strategic partners to evaluate projects and commit funds much earlier
Private InvestmentSBIR Bridge Award
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Example: How the Bridge Award Would Apply in the Area of Drug Development
CommercializationNDAReview
ClinicalTrials
SafetyReview
Preclinical Development(Lead Development, Animal Studies, File IND)
Target Identification& Validation
Private InvestmentPhase I & Phase II SBIR
SBIR Bridge Award
2nd Year1/3 of funds
3rd Year1/3 of funds
1st Year1/3 of funds
Milestones reached?Matching Funds?
YES
STOP
NO
YES
STOP
NOMilestones reached?Matching Funds?
Milestones reached?Matching Funds?
SBIR Bridge Award
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Six Bridge Awards in FY2009
Company TitleFirst-Year
Total CostsAll-Year Total Cost Estimate
Altor Biosciences Bifunctional T Cell Receptor Based Immunotherapeutics $1,000,000 $2,969,291
Gamma Medica-Ideas Molecular Breast Imaging to Guide Early-Stage Patient Care $1,000,000 $3,000,000
Guided Therapeutics Spectroscopic Evaluation of Cervical Cancer $1,000,000 $2,517,125
Koning Corporation Koning Cone Beam Breast CT $999,861 $2,986,453
Optosonics Photoacoustic CT for Preclinical Molecular Imaging $1,000,000 $2,997,247
Lpath Therapeutics Commercialization of ASONEP for the Treatment of Cancer $1,000,000 $3,000,000
Total $5,999,861 $17,470,116
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Third-party InvestmentCumulative for 6 Bridge Awards Made in FY2009
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Traditional Venture Capital $17,000,000
Strategic Partners $18,000,000
Other Investment Firms $5,500,000
Individuals/Other $10,000,000
Investor Total (3 yrs) $50,500,000
NCI Total (3 yrs) $17,470,116
Leverage>2.8 to
1
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New Approach for Managing SBIR at NCI
SBIR Development Center
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Old SBIR Management Model at NCI
• Awards were managed by 40-50 people who each spent a small amount of their time on SBIR
• Few of these NCI program directors had significant industry experience or commercialization expertise
New Development Center at NCI
• Team of 9 program directors and one center director
• Exclusively focused on management & administration of NCI’s SBIR/STTR portfolio
• Center staffed by program directors with both industry experience and scientific expertise so they can mentor companies on strategy.
• Center staff interacts actively with NCI program staff. This includes assigned division liaisons.
SBIR Development Center StaffAli Andalibi, PhD (Branch Chief)Previous•NSF – SBIR Program Director, Medical Biotechnology•House Ear Institute – Scientist & Director, New Technology and Project Development•Trega Biosciences, Inc. – Research Scientist
Michael Weingarten, MA (Director)Previous•NASA – Program Manager, NASA Technology Commercialization Program
Greg Evans, PhD (Branch Chief)Previous•NHLBI/NIH – Program Director, Translational and Multicenter Clinical Research in Hemoglobinopathies•NHGRI/NIH – Senior Staff Fellow
David Beylin, MS (Program Director)Previous•X/Seed Capital Management, LLC, Consultant•Naviscan PET Systems, Inc., Vice President, Research
Andrew J. Kurtz, PhD (Program Director)Previous•NIH – AAAS Science & Technology Policy Fellow•Cedra Corporation – Research Associate, Bio-Analytical Assays and Pharmacokinetics Analysis
Deepa Narayanan, MS (Program Director)Previous•Naviscan PET Systems, Inc., Director, Clinical Data Management (Oncology Imaging & Clinical Trials)•Fox Chase Cancer Center, Scientific Associate (Molecular Imaging Lab)
Natalia Kruchinin, PhD (Program Director)Previous•QIAGEN, Inc. – Molecular Diagnostics Applications Manager•Motorola, Inc. – Senior Scientist, Gene Expression Assays
Jian Lou, PhD (Program Director)Previous•Johnson & Johnson – Research Scientist, Target Validation & Biomarker Development•Lumicyte, Inc. – Director, Molecular Biology Systems Analysis
Patti Weber, DrPH (Program Director)Previous•International Heart Institute of Montana –Tissue Engineering and Surgical Research•Ribi ImmunoChem Research, Inc. – Team Leader, Cardiovascular Pharmacology
Todd Haim, PhD (Program Analyst / AAAS Fellow)Previous•National Academy of Sciences – Christine Mirzayan Science and Technology Policy Fellow•Pfizer Research Laboratories – Postdoctoral Fellow, Cardiac Pathogenesis & Metabolic Disorders
New Activities of Center
• Active outreach to bring in a new class of commercially viable applicants
• Coaching companies on developing stronger applications• Active management of projects and better oversight• Mentor and guide companies throughout the award period• When appropriate, matchmaking with investors
2010 NCI SBIR Investor Forum hosted by San Jose BioCenter
2010 Investor Forum: November 9, Stanford , CAhttp://sbir.cancer.gov/investorforum/
Featured Small Businesses• Exclusive opportunity for ~ 15 NCI awardees to showcase their
companies to investors• Present to and network with the top investors & strategic
partners in the country• Participate in panel discussion with successful Bridge awardees
and their investors
Investors• Opportunity to evaluate NCI’s top companies • Exclusive one-on-one meetings
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"The Forum was a great opportunity to get exposed to new companies in oncology." - Ankit Mahadevia, M.D., MBA, Life Sciences Associate, Atlas Venture
"I was very impressed with your choice of companies.The mix of stages was ideal." - Sarah Bodary, Ph.D., Venture Partner, SV Life Sciences
2009 NCI SBIR Investor Forum Outcomes
• One company raised $30M to fund clinical trials of a new generation of oral antifolates
• One company developed relationships with big pharma that led to the launch of a new drug screening service they are offering.
• One company developed relationships with a VC that is going to lead their next round of venture financing.
• Several other companies are going thru due diligence.
Regulatory Assistance
Goal
– Provide Phase II awardees access to regulatory consultants to accelerate the FDA approval process for drugs, biologics and devices
Path
– Provide appropriate Phase II awardees ≥30 hours of consulting time and activities, including:
1. A preliminary conversation with the company regarding the writing of a regulatory plan
2. Review and editing of the regulatory plan
3. Post review discussion 30
Ali Andalibi, PhDProgram Director, NCI SBIR Development
Center
The NCI SBIR ProgramApplications
September 15, 2010
2010 NCI SBIR Contract Funding Opportunities
Contracts vs. Grants What's the difference?
Grant applications in any area within the mission of the awarding components identified in the SBIR/STTR Omnibus Grant Solicitations
Contract proposals are accepted only if they respond specifically to a research topic within the Contract Solicitation
Contract topics are much more targeted, narrowly focused
3 receipt dates per year for company-initiated SBIR/STTR Grant Applications (Phase I or Phase II) submitted under Omnibus
Only 1 receipt date per year for NCI SBIR Contract Proposals
All grant applications and contract proposals MUST be received in response to a published NIH funding opportunity announcement (FOA)
SBIR/STTR Omnibus Grant SolicitationRelease: JanuaryReceipt Dates: April 5, August 5, and December 5
SBIR Contract Solicitation (NIH, CDC)Release: Early August 2010Receipt Date: Early November 2010
NIH Guide for Grants and ContractsRelease: WeeklyReceipt Dates: Various
For more information visit:http://sbir.cancer.gov
NIH Issues Multiple SBIR Solicitations
NCI SBIR Contract Funding Opportunities
Development of Anticancer Agents
Companion Diagnostics: Predictive and Prognostic Tests Enabling Personalized Medicine in Cancer Therapy Innovative
Development of a Molecular Diagnostic Assay to Detect Basal-like Breast Cancer Alternative Biospecimen Stabilization and Storage Solutions
Radioprotector/Mitigator Development to Decrease Normal Tissue Injury During Radiotherapy
Development of Molecular Pharmacodynamic Assays for Targeted Therapies
Development of Devices for Point of Care Analysis of Circulating Tumor Cells Development of Glycosylation-Specific Research Reagents (Antibodies and Aptamers)
Algorithms for Automated Quantitative Imaging of Tumor Microenvironment
NCI SBIR Contract Funding Opportunities
Systems for Automated Storage, Analysis, and Reporting of Objective Behavioral Exposures
Methods and Tools for Quantitatively Measuring Non-Coding RNAs in Cancer Early Detection, Prediction, and Diagnosis
Low-Field Electron Paramagnetic Resonance Imaging Device to Optimize Development of Anti-Angiogenic Therapeutics in Cancer Animal Models (NIH TT)
A New Type of Vaccine for Prevention of HIV Infection and HIV-Associated Cancers (NIH TT)
Therapeutics and Theranostics Based on Nanotechnology
Nanotechnology Sensing Platforms for Improved Diagnosis of Cancer
Development of Clinical Automated Multiplex Affinity Capture Technology for Detecting Low Abundance Cancer-related Proteins/Peptides
Development of Quantitative Multiple Reaction Monitoring Mass Spectrometry Assays for the Detection of Cancer Related Aberrant Proteins/Peptides
NCI SBIR Contract Funding Opportunities
Systems for Automated Storage, Analysis, and Reporting of Objective Behavioral Exposures
Development of Blood-based Methods for the Detection of Cancer Recurrence in Post-Therapy Breast Cancer Patients
Novel Digital X-ray Sources for Cancer Imaging Applications
Development of Innovative Algorithms/Software for Processing & Analysis of In Vivo Images in Oncology
Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging, and Treatment
Development of Anticancer Agents
Budget: $200,000 for Phase I; $1,500,000 for Phase II
Number of Anticipated Awards: 5
Receipt Date: November 8, 2010
Project Goal and Major Focus:
To support critical pre-IND research for small companies developing
candidate therapeutic agents of interest.
Work scope may include animal efficacy testing, structure activity
relationships (SAR), medicinal chemistry, formulation, production of GMP
bulk drug and clinical product, as well as pharmacokinetic,
pharmacodynamic, and toxicological studies.
Development of Devices for Point of Care Analysis of Circulating Tumor Cells
Budget: $200,000 for Phase I; $1,000,000 for Phase II; FT Accepted
Number of Anticipated Awards: 4
Project Goal and Major Focus:
The short term goal is to demonstrate the technical viability of the proposed
approach to detect, isolate, or eliminate CTCs in an experimental setting.
The long term goal is to develop Point of Care (POC) devices and methods of
circulating tumor cell (CTC) detection, enumeration, isolation, removal and
subsequent genetic and proteomic analysis for better cancer diagnosis,
prognosis and treatment.
The major focus is to develop clinical tools rather than tools for basic
research.
A New Type of Vaccine for Prevention of HIV Infection and HIV-Associated Cancers (SBIR Technology Transfer)
Budget: $300,000 for Phase I; $2,500,000 for Phase II
Number of Anticipated Awards: 1
Project Goal and Major Focus:
This is an SBIR Technology Transfer topic, whereby intramural inventions are
licensed to qualified small businesses with the intent that those businesses
develop these inventions into commercial products that benefit the public.
The ultimate goal of this NCI SBIR project is to accelerate the development of
efficacious vaccines that can activate broadly neutralizing anti-HIV-1 antibody
(bnAb) precursor germline B-cells and elicit anti-HIV-1 bnAbs.
The short term goals of this topic are to test the in vivo immunogenic potential
of the identified potential primary HIV immunogen in an innovative animal
model and identify one or more candidate primary immunogens.
Submitting an Application
Keys to a Strong Application
• Significant, innovative, and focused science
• Significant product and/or commercial potential
• A product-focused application is more likely to have support of business reviewers
• A project with sound financial projections is more likely to attract a partner
• Translational research/clinical applications projects should involve the appropriate collaborators
• Physicians
• Microbiologists
• Statisticians
Know NIH Review Criteria
Significance• Does the study address an important problem
and have commercial potential?
Innovation • Are there novel concepts or approaches? Are the aims original and innovative?
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?
Key #1Start Application Process Early
• Start developing your application as early as possible. You need time to develop a strong proposal.
• Seek help of experienced applicants early in process
• Assemble a strong scientific team– If you have a weakness or gap in expertise, fill it early
• Consider your company’s strengths
– Try to exploit those strengths to address a specific NIH Program initiative
• Consider your weaknesses too
– It is rare that a small company will have all the necessary expertise for a strong application
– If you have no track record of commercialization, consider getting a partner who does
• Partner with other companies or academics to fill gaps• Review similar, currently funded projects using NIH Research Portfolio
Online Reporting Tools (http://report.nih.gov)
Key #2Consider Your Company’s Strengths and Weaknesses
Key #3Always Consider the Reviewers
• Who is going to review your application?– All members of the Review Panel will score your application
– The primary reviewer, as well as the two or three others will have read your application and will be leading its discussion
– Combination of academic and industry reviewers
Key #3Always Consider the Reviewers
• What are they looking for?– Readable and understandable application
• Do not assume they will know everything you know• You understand your application best so convey it to them• Clear and concise language, “lay summary”
– Clear plan for Phase I, II and commercialization– Feasible methods– Appropriate objective tests of success for each Specific Aim– Promising preliminary data are very influential– Solid letters of support for commercialization
Key #3 Always Consider the Reviewers
• Read your material critically as if you were the Reviewer– What are the weaknesses?– Point out potential difficulties, do not hide them– Suggest ways to address them or provide rationale– Recruit an independent reader
• Provide alternative methods if a particular approach is not successful
• Help the Reviewer write his/her critique
Key #3 Always Consider the Reviewers
• Be realistic about your goals– Provide a feasible timetable for key objectives
• Be realistic about your budget– Ask Program Director for early guidance
• Have you honestly assessed the commercial viability of your technology?
• Do you have a talented professional to be a PI?
• Is the PI supported by the right team? Does he or she have the time?
• Do you have the resources to write the grant application or contract proposal?
• Do you have the resources and capabilities to execute?
• Do you have the business resources needed for a successful launch?
Application Checklist
More Information onNCI SBIR & STTR Website
http://sbir.cancer.gov
Ali Andalibi, Ph.D. Program Director
NCI SBIR Development CenterPhone: 301-496-9686
http://sbir.cancer.gov
