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Business of Bio Series Bringing Science to the Market: The National Cancer Institute SBIR & STTR Program Wednesday, September 15 10:00am-Noon.

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Presentation on theme: "Business of Bio Series Bringing Science to the Market: The National Cancer Institute SBIR & STTR Program Wednesday, September 15 10:00am-Noon."— Presentation transcript:

1 Business of Bio Series Bringing Science to the Market: The National Cancer Institute SBIR & STTR Program Wednesday, September 15 10:00am-Noon

2 Business of Bio Series Welcome Jim Hughes Vice President, Office of Research & Development University of Maryland

3 Business of Bio Opening Remarks Dr. Curt Civin Founding Director, Center for Stem Cell Biology & Regenerative Medicine University of Maryland School of Medicine

4 Business of Bio Presentation Michael Weingarten Director, National Cancer Institute SBIR Development Center

5 Presentation Dr. Ali Andalibi Program Director & Branch Chief, National Cancer Institute SBIR Program

6 Bringing Science to the Market: The NCI SBIR Program University of Maryland BioPark September 15, 2010 Michael Weingarten Director, NCI SBIR Development Center

7 Todays 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 7

8 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

9 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

10 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 Doesnt 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

11 SBIR Eligibility Applicant must be a Small Business Concern (SBC) Organized for-profit U.S. business 500 or fewer employees, including affiliates PD/PIs 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 OR At least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals 11

12 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 Investigators primary employment may be with either the Small Business Concern or the research institution 12

13 NIH SBIR/STTR Omnibus Solicitations for Grant Applications Release: January Receipt Dates: April 5, August 5, and December 5 Solicitation of the NIH & CDC for SBIR Contract Proposals Release: August Receipt Date: Early November See NIH Guide for various other Program Announcements (PAs) and Requests for Application (RFAs), i.e. other grants Release: Weekly Receipt Dates: Various Multiple Funding Solicitations 13

14 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 NCIs SBIR budget is now invested in contracts. Approximately $11M in new contract funding opportunities just announced.

15 SBIR Portfolio Summary (Active as of July ) Grants & Contracts -- $110M budget ClassificationTopic Area Phase 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) Cancer Control & Epidemiology 12% Software, Bioinformatics & eHealth 10 (2)25(5) Educational Tools & Other 4 (1)17 (4) Total (480) 246 (51)234 (49)

16 16

17 17 NCI SBIR Phase II Bridge Award

18 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

19 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 19

20 Example: How the Bridge Award Would Apply in the Area of Drug Development Phase I & Phase II SBIR Commercialization NDA Review Clinical Trials Safety Review 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 Investment SBIR Bridge Award 20

21 Example: How the Bridge Award Would Apply in the Area of Drug Development Commercialization NDA Review Clinical Trials Safety Review Preclinical Development (Lead Development, Animal Studies, File IND) Target Identification & Validation Private Investment Phase I & Phase II SBIR SBIR Bridge Award 2nd Year 1/3 of funds 3rd Year 1/3 of funds 1 st Year 1/3 of funds Milestones reached? Matching Funds? YES STOP NO YES STOP NO Milestones reached? Matching Funds? Milestones reached? Matching Funds? SBIR Bridge Award 21

22 Six Bridge Awards in FY2009 CompanyTitle First-Year Total Costs All-Year Total Cost Estimate Altor BiosciencesBifunctional T Cell Receptor Based Immunotherapeutics$1,000,000$2,969,291 Gamma Medica-IdeasMolecular Breast Imaging to Guide Early-Stage Patient Care$1,000,000$3,000,000 Guided TherapeuticsSpectroscopic Evaluation of Cervical Cancer$1,000,000$2,517,125 Koning CorporationKoning Cone Beam Breast CT$999,861$2,986,453 OptosonicsPhotoacoustic CT for Preclinical Molecular Imaging$1,000,000$2,997,247 Lpath TherapeuticsCommercialization of ASONEP for the Treatment of Cancer$1,000,000$3,000,000 Total$5,999,861$17,470,116 22

23 Third-party Investment Cumulative for 6 Bridge Awards Made in FY 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

24 24 New Approach for Managing SBIR at NCI

25 SBIR Development Center 25 Old SBIR Management Model at NCI Awards were managed by 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 NCIs 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.

26 SBIR Development Center Staff Ali 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

27 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

28 2010 NCI SBIR Investor Forum hosted by San Jose BioCenter 2010 Investor Forum: November 9, Stanford, CA 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 NCIs top companies Exclusive one-on-one meetings 28 "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

29 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.

30 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

31 Michael Weingarten Director SBIR Development Center Phone:

32 Ali Andalibi, PhD Program Director, NCI SBIR Development Center The NCI SBIR Program Applications September 15, 2010

33 2010 NCI SBIR Contract Funding Opportunities

34 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)

35 SBIR/STTR Omnibus Grant Solicitation Release: January Receipt Dates: April 5, August 5, and December 5 SBIR Contract Solicitation (NIH, CDC) Release: Early August 2010 Receipt Date: Early November 2010 NIH Guide for Grants and Contracts Release: Weekly Receipt Dates: Various For more information visit: NIH Issues Multiple SBIR Solicitations

36 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

37 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

38 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

39 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.

40 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.

41 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.

42 Submitting an Application

43 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

44 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 companys business strategy one that has a high potential for success?

45 Key #1 Start 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

46 Consider your companys 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 ( Key #2 Consider Your Companys Strengths and Weaknesses

47 Key #3 Always 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

48 Key #3 Always 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

49 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

50 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

51 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

52 More Information on NCI SBIR & STTR Website

53 Ali Andalibi, Ph.D. Program Director NCI SBIR Development Center Phone:

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