NCI SBIR & STTR: Funding & Resources for the Translation of Innovative Cancer Technologies

Transcription

1 NCI SBIR & STTR: Funding & Resources for the Translation of Innovative Cancer Technologies December 12, 2013, Deepa Narayanan NCI SBIR Development Center

2 Today s Presentation Application Overview & Eligibility The NIH SBIR/STTR Programs The NCI SBIRDevelopment Center: Special Initiatives at NCI SBIR Award Funding Opportunities Practical Strategies on Applying

3 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

4 Congressionally Mandated Programs Set Aside (FY14) 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 28% 2.8% 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 S t id t f ilit t ti R&D b t 0.40% ~$700M annually at NIH ~$110M annually at NCI 4

5 Reasons to Seek SBIR/STTR Funding One of the largest sources of early stage 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 Funding is non-dilutive capital Projects undergo NIH s rigorous scientific peer review Can be a leveraging tool to attract other funding

6 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 51% U.S.- owned by individuals and independently operated * OR 51% owned and controlled by another (one) business concern that is 51% 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 6

7 STTR Eligibility Applicant is a Small Business Concern Formal Cooperative R&D Effort Minimum 40% by small business concern 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 Should provide the necessary IP rights (to the SBC) in order to carry out follow-on R&D and commercialization i Principal Investigator s primary employment may be with either the Small Business Concern or the research institution 7

8 SBIR & STTR: Three-Phase Program Proof of Concept of study $150,000 over 6 months (SBIR) or 1 year (STTR) Commercialization stage Use of non SBIR/STTR funds Fast Track Application Phase I Phase II Combined Phase I & II FEASIBILITY DEVELOPMENT Phase III COMMERCIALIZATION Research & Development e e Commercialization plan required $1 million over 2 years * Hard caps on award sizes: $225,000 for Phase I; $1.5 million for Phase II Note: Actual funding levels may vary by topic. 8

9 SBIR vs. STTR: Which Program is Best for You? Principal Investigator Research Partner SBIR Primary employment must be with small business Permits partnering Small business must do 67% Phase I, 50% Phase II STTR PI may be employed by either small business or research institution, and must commit minimum of 10% effort to project Requires partnering with US research institution Small business min. 40%, Research institution min. 30% Small Business Concern is ALWAYS the Applicant/Awardee Organization Funding rates vary annually based primarily on application numbers The best choice is the fit for your budget and leadership structure

10 The NIH SBIR/STTR Programs

11 NIH = 27 Institutes & Centers 24 Participants in the SBIR/STTR Program Office of Research Infrastructure Programs (ORIP) The Office of the Director (OD) National Institute on Aging (NIA) National Institute on Alcohol Abuse & Alcoholism (NIAAA) National Institute of Allergy & Infectious Diseases (NIAID) National Institute of Arthritis & Musculoskeletal & Skin Diseases (NIAMS) National Cancer Institute (NCI) National Institute of Child Health & Human Development (NICHD) National linstitute t on National linstitute t National linstitute t National Institute National linstitute t Deafness & Other of Dental and of Diabetes & on Drug Abuse of Environmental Communication Craniofacial Digestive & Kidney Health Sciences Disorders (NIDCD) Research (NIDCR) Diseases (NIDDK) (NIDA) (NIEHS) National Eye Institute (NEI) National Institute of General Medical Sciences (NIGMS) National Heart, Lung, & Blood Institute (NHLBI) National Human Genome Research Institute (NHGRI) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders & Stroke (NINDS) National Institute of Nursing Research (NINR) National Institute on Minority Health & Health Disparities (NIMHD) National Center for Complementary & Alternative Medicine (NCCAM) Fogarty International Center (FIC) National Center for Advancing Translational Sciences (NCATS) National Library of Medicine (NLM) National Institute of Biomedical Imaging & Bioengineering (NIBIB) NIH Clinical Center (CC) Center for Information Technology (CIT) Center for Scientific Review (CSR) No funding authority 11

12 NIH SBIR/STTR P Ch Program Changes SBIR/STTR Reauthorization Act of 2011

13 Set-aside is Increasing FY SBIR Set-aside STTR Set-aside % 0.30% % 0.35% % 0.35% 2014 (current) 28% 2.8% 0.40% % 0.40% % 0.45% % 0.45% 13

14 New Provisions in Current Omnibus Grant Solicitations 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). Hard caps on award sizes (Ph I $225k, Ph II $1.5M) Applicants can request $5000 in Technical Assistance, beyond award cap. If requested, cannot participate in NIH Technical Assistance Programs.

15 New Provisions NOT Yet Implemented No switching between SBIR and STTR mechanisms Applicants cannot yet apply for Phase II SBIR funding based on Phase I STTR award or vice versa. No direct to Phase II applications Pilot FOAs when implemented. Why not? NIH is currently updating its electronic systems and forms for these provisions.

16 NIH Reauthorization website

17 SBIR/STTR Funding Opportunities 17

18 Multiple Funding Solicitations Know the Application Deadlines 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 the NIH Guide for other Program Announcements (PA s) and Requests for Application (RFA s), i.e. grants Release: Weekly Receipt Dates: Various t / t / id 18

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20 The NCI SBIR Development Center 20

21 Pipeline of 400+ vetted projects Cancer Control and Epidemiology 8% Cancer Biology 13% Cancer Therapeutics 36% In Vitro Diagnostics 18% Cancer Imaging Technologies 16% Devices for Cancer Therapy 9%

22 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% Projects by Cancer Site 18% 6% 7% 2% 3% 3% 3% 0 1% 1% 1% 6% 4% 3% 4% 6% 3% 2% 25% Cancer Site Bladder Bone Brain Breast Cachexia Cervical Colorectal Esophageal Head & Neck Cancer Leukemia Liver Lung Lymphoma Ovarian Pancreatic Prostate Skin Other Cancer Sites Other/Platform

23 NCI SBIR Development Center Program Directors Michael Weingarten, MA Director NCI SBIR Development Center Greg Evans, PhD Lead Program Director Cancer Biology, E-Health, Epidemiology, Research Tools Andrew J. Kurtz, PhD Lead Program Director Biologics, Small Molecules, Nanotherapeutics, Molecular Diagnostics, Bridge Award Patricia Weber, DrPH Program Director Digital Health, Therapeutics, Biologics, SBIR Investor Forum, FRAC Workshop Deepa Narayanan, MS Program Director Cancer Imaging, Clinical Trials, Radiation Therapy, SBIR Investor Forum, FRAC Workshop Ming Zhao, PhD Program Director Cancer Diagnostics & Therapeutics, Cancer Control & Prevention, Molecular Imaging, Bioinformatics, Stem Cells Jian Lou, PhD Program Director In-Vitro Diagnostics, Theranostics, early-stage drug development, Bioinformatics, FRAC Workshop Todd Haim, PhD Program Director Small Molecules, Biologics, Immunotherapeutics, Theranostics, SBIR Investor Forum, FRAC Workshop Amir Rahbar, PhD, MBA Program Director In-Vitro Diagnostics, Biologics, Therapeutics, Proteomics, SBIR Investor Forum Jennifer Shieh, PhD Program Director Digital Health, Bioinformatics, Evaluation, SBIR Investor Forum, FRAC Workshop

24 New Activities of NCI Development Center Development Center staff are responsible for: Conducting regular outreach events to help recruit more focused, commercially-minded SBIR applicants Coaching applicants on developing stronger applications Identifying key priority areas for NCI & developing funding opportunities based on those Providing oversight and active management of projects Mentoring and guiding companies throughout the award period Facilitating matchmaking with potential third-party investors and strategic partners 24

25 NCI SBIR Grant Funding Opportunities

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27 Multiple Funding Solicitations Know the Application Deadlines SBIR & STTR Omnibus Solicitations for Grant Applications Release: January Receipt Dates: April 5, August 5, and December 5 See the NIH Guide for other Program Announcements (PA s) and Requests for Application (RFA s), i.e. grants Release: Weekly Receipt Dates: Various Solicitation of the NIH & CDC for SBIR Contract Proposals Release: August sign up for the list to get notified! Receipt Date: Early November t / t / id

28 NCI Program Announcements Innovative Health IT for Broad Adoption by Healthcare Systems & Consumers (PA ) Goal: Accelerate development & commercialization of evidence-based consumer health IT to (1) Prevent or reduce the risk of cancer (2) Facilitate patient-provider provider communication (3) Improve disease outcomes in consumer & clinical settings o Receipt date: April 5, August 5, December 5 through 2015 Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (SBIR-IMAT, PAR ) 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. o Receipt date: November and May through 2016 Development of Highly Innovative Tools and Technology for Analysis of Single Cells (PA ) Goal: Development of next-generation tools to better define cell heterogeneity in situ, with substantially increased sensitivity, selectivity, spatiotemporal p resolution, scalability or non- destructive analysis of multiple global or functional measures of single cells. o Receipt date: April 5, August 5, December 5 through 2015

29 NCI SBIR Contract Funding Opportunities

30 NCI SBIR Targeted Contract Solicitations NCI scientific & technology priorities Areas of interest to the commercial sector, based on market opportunity Contract topics in NCI priority areas with strong potential for commercial success $37,406 $38,174 NCI SBIR contracts (thousands) $12,387 13% $7,757 13% 8% $16,665 17% $25,020 $26,102 25% 24% 17% 8% 33% 25% 35% % of total NCI SBIR Fiscal Year

31 SBIR Contracts vs. Grants Scope of the proposal SBIR Grants Investigator-defined within the mission of NIH SBIR Contracts Defined (narrowly) by the NIH Questions during May speak with any MUST contact the contracting solicitation period? Program Officer officer Receipt Dates 3 times/year for Omnibus Only ONCE per year Reporting Set-aside funds for particular areas? Program Staff Involvement One final report (Phase I); Annual reports (Phase II) No Low Kickoff presentation, quarterly progress reports, final report, commercialization plan Yes High

32 SBIR Contracts vs. Grants Peer Review Locus SBIR Grants SBIR Contracts NIH Center for Scientific NCI Division i i of Extramural Review (CSR) Activities (DEA) Review Sections Basis for Award Sections review applications for different programs in similar topic areas Peer review score Program relevance & balance Specific sections for each single topic Peer review score Program relevance & balance Negotiation of technical deliverables Budget Fast Track Ph I & II are considered as a single application with a single score Ph I & II are considered separate proposals; they are reviewed and scored independently

33 FY14 NCI Contract Funding Topics Therapy & Diagnosis 326 Development of Novel Therapeutic Agents that Target Cancer Stem Cells 327 Rf Reformulation lti of FildCh Failed Chemotherapeutic ti Drugs 331 Development of a Biosensor Based Core Needle Tumor Biopsy Device 332Development ofradiation Modulators for Use During Radiotherapy Advancing Cancer Research 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 Specific Phospho Threonine Protein Standards for Use in Cancer Assays Health IT 333 Software Tools for the Development of Environmental Measures Related to Cancer Health Behaviors and Resources 33

34 Funding Opportunity Summary PHS HHS, NIH, and CDC SBIR Program Solicitation ONE proposal receipt date per year: Published August 29, 2013; original deadline November 13 EXPIRED Receipt Date: November 25, 2013, 4:30 PM ET RFP can be found at: Amendment: More info about NCI s topic areas:

35 NCI SBIR Investor Forum Exclusive opportunity for some of the most promising NCI-funded companies to showcase their technologies In 2012, 18 top SBIR funded companies presented Over 200 life science investors & leaders 150+ one on one meetings 2010 Investor Forum: 8 out of 14 presenting companies closed deals valued at over $230M

36 2010 Investor Forum Results 8 out of the 14 presenting companies have closed deals valued at over $230M Zacharon, a company focused on developing therapeutics for rare diseases and cancer, finalized a major partnership with Pfizer worth up to $200M Lpath closed a $4.9 Million Equity Financing round to fund continued development of two drug candidates MagArray closed a strategic partnership deal with IMRA America for $10M to continue development of its cancer diagnostic platform ImaginAb raised $12.5M in a Series A round to engineer antibodies into in vivo PET imaging agents for targeted molecular diagnostics.

37 Workshop on Federal Resources to Accelerate Commercialization Bringing together NCI SBIR/STTR awardees to move funded technologies from bench to bedside May 7, 2013 at NCI Shady Grove Speakers from FDA, CMS, USPTO, and White House OSTP Panels on other sources of federal funding, resources & collaborative programs at NIH, and unique life science investment organizations One-on-one meetings with program directors and speakers

38 NCI SBIR Phase IIB Bridge Award g p g p 38

39 NCI SBIR Phase IIB Bridge Award Phase I FEASIBILITY Phase II DEVELOPMENT NCI SBIR Phase IIB Bridge Award CROSSING THE VALLEY OF DEATH Phase III COMMERCIALIZATION Provides up to $1M per year for up to 3 years Open to any NIH-funded Phase II awardees with projects relevant to NCI mission Accelerates commercialization by incentivizing partnerships with thirdparty 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)

40 Partnership Benefits for Third-Party Investors Opportunity to partner with small businesses to develop & commercialize: 1. Technologies that have been vetted by NIH peer-review, AND 2. Projects for which substantial proof-of-concept data already exists Opportunity to share in the early-stage investment t risk with the NCI 40

41 13 Bridge Awards (to date) NCI Total $32,401,156 Third Party Investments $76,100,756 Leverage > 2 to 1 Venture Capital: 1/3 Strategic Partners: 1/3 Individuals & Other: 1/3 41

42 NIH Resources for Translational Technology

43 NIH Technology Assistance Programs for SBIR/STTR Awardees Niche Assessment Program (NAP) For Phase I SBIR/STTR awardees Market analysis report Commercialization Assistance Program (CAP) For Phase II SBIR/STTR awardees Mentoring program $5000 technical assistance supplement Beyond award cap Submit request in SBIR/STTR application budget page If requested, cannot take part in NAP or CAP

44 Collaborative Programs at NIH Provide access to resources, not funding Different application & review process from grants Open to projects from academia or industry

45 Collaborative Programs at NIH NCI Experimental Therapeutics (NExT) Program next deadline February 15 NCI Clinical Assay Development Program (CADP) cancer, next deadline February 15 NCI PREVENT Program resources/programs/prevent Next tdeadline dli April il7 NCATS Bridging Interventional Development Gaps (BrIDGs) diseases/bridgs/bridgs.html Register by December 16 for January 10 submission NCATS Therapeutics for Rare & Neglected Diseases (TRND) diseases/trnd/trnd.html p// / / / /

46 What Does It Take to Get Funded? Practical Strategies/ Tips on Applying

47 The Grant Application Process Omnibus April 5 August 5 December months after submission 9-12 months after submission Decide to Apply Build the Application Submit the Application Peer Review Review the Summary Statement Receive the Award Resubmit

48 Deciding to Apply

49 The Grant Application Process Omnibus April 5 August 5 December months after submission 9-12 months after submission Decide to Apply Build the Application Submit the Application Peer Review Review the Summary Statement Receive the Award Resubmit

50 Federal Funding: Not Easy Money SBIR/STTR awards are highly competitive (It was not always like that) Resubmissions have become the norm Funding success rate around 10 15% Your competitors are smart, skilled, accomplished, and hail from top institutions Lots of great ideas Solution: Prepare a strong application Solution: Use help

51 When is an SBIR/STTR application appropriate? Innovative solution to significant unmet clinical need Significant commercial potential Leverages company/founder expertise Need funding to produce feasibility data Need funding for development Start up: Too early for private investment Established SBC: No resources to try new approach, but board supports SBIR

52 When NOT to Apply Chasing solicitations why not? Chasing cool technologies Need cash urgently SBIRs take 8 16 months or more to get and you must start with Phase I (~$225K) Incremental upgrade: no change to clinical paradigm Me too product matching thi competitor s capabilities Basic research still required to demonstrate commercial and clinical feasibility

53 Understand the Application Process Receiving the Deciding to Building the Submitting the Summary Apply application application Statement Resubmission Receiving the award Start early (Key #1) Strong proposals take time to develop NIH Timeline for New Applications 6-9 months Take care of the administrative registrations (See SF424). Start this at least 2 months before deadline!? > Electronic Submission Carefully read the Solicitation Due Date Scientific Council Award Date Need time to fill the gaps Review Review (earliest) Assemble a strong scientific team April 5 July October December Get access to equipment and other August 5 October January April resources December 5 March May July Get letters of support

54 Before You Write an Application Consider your company s strengths Consider your company s weaknesses Review similar, currently funded NIH projects NIH Project RePORTER Contact NIH Program Director in advance (at least 1 month before due date!) to discuss your specific aims and receive feedback

55 Search Previous Awards

56 Search Previous Awards

57 Building the Application

58 SF424 Application Guide

59 Key #2 Take Time to Refine the Vision Start informal discussions to clarify the product vision Potential customers Technical experts Potential investors & commercialization partners Seek help early in process Experienced dsbir applicants Academic collaborators with grant experience Professional grant writers Engage with SBIR Program Staff a short summary and request review of specific aims

60 Key #3 Build the Right Team Choose the Principal Investigator (PI) Consider building multi PI team Multidisciplinary proposals PI lacks certain types of necessary expertise Must appoint Contact PI (SBIR, > 50% of time w/ business) Partner to fill the gaps Academic collaborations Consultants Other companies Use SBIR application as engagement tool Academic researchers understand grants Business executives understand product development and marketing

61 Key #4 Reviewers Only See the Application Specific Aims (1 page) Focal point of the application Highlight the technology s major strengths Describe goals of the application be specific Quantitativeperformance milestones What is the problem you are uniquely able to solve? What is the unmet medical need? Research Strategy Provide background information Provide detailed technical plan to achieve Specific Aims Propose realistic scope/budget/timeline Preliminary data not required in Ph I, but often powerful Describe potential pitfalls and alternative angles of attack

62 Key #4 Reviewers Only See the Application Other application components Letters of support Necessary from consultants and collaborators Powerful from clinicians, end users, and potential investors/partners Phase II Commercialization Plan (12 pages) Cover Letter Not seen by reviewers Used to request dual assignment Used to request and justify a specific study section Biosketches for all senior and key personnel (< 4 pages each) Budgets for each project period Separate budgets for each subcontract Descriptions of facilities and equipment Human subject research section (if applicable) Vertebrate animals section (if applicable) Other information as required

63 Key #5 Run Your Own Peer Review before you submit 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 Ask all collaborators to review the application Recruit independent, technically trained laymen as readers Do they understand it? Are they excited?

64 Know NIH Review Criteria Significance Approach Innovation Investigator Environment Commercialization Does the product address an important problem, and have commercial potential? Is there a market pull for the proposed product? Are design and methods well-developed and appropriate? Are problem Summary areas addressed? StatementAre 1 potential pitfalls and alternative approaches provided? 2 How novel 3 is the technology/product and the approaches 4 proposed to test its feasibility? 5 Impact Score: Are the 6 investigators, t collaborators and consultants 7 appropriately trained and capable 8 of completing all project tasks? 9 Does the scientific environment contribute to the probability of success? Facilities? Independence? Is the company s business strategy one that has a high potential for success?

65 Key #6 Identify Study Section Identify the most appropriate p Institute/Center Talk to a program director Identify the most appropriate study section BEFORE you submit your application and check after you re assigned See CSR website for study section descriptions See the list of study section members Do they have the right areas of expertise? Request and justify a study section in the cover letter

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67 Post Submission What s next? Receiving the Summary Statementt t Receiving the award 10-15% -Awards? 35-40% - Receive scores -Need resubmission (-01 applications only) 50% - Not discussed - Need resubmission (01 applications only)

68 If you are not funded the first time Rejection is painful, but there is feedback to work with Respond to the Summary Statement carefully Use peer review to improve your technology and presentation Discuss with your NIH Program Director Revise and resubmit Introduction Page: Response to reviewer critiques Request review by PO Be constructive not defensive Learn more about SBIR/STTR grants Explore opportunities to serve on NIH peer review panels Talk to successful applicants Understand review process and dynamics p//

69 Common Problems Reviewers did not understand your proposal Reason: Proposal is in the wrong study section Solution: Discuss study section selection with assigned NCI Program Director. Can you find a more appropriate study section? Reason: Proposal is not clearly written Solution: Improve your presentation Reason: Not enough data or specific enough description of the technology (e.g., chemical structure for lead compound) Solution: Don t rely on publications. Include any attributes that don t threaten IP.

70 Common Problems Reviewers say the proposal is not innovative Reason: Technology is not clearly differentiated Solution: Position technology relative to available alternatives Reason: Technology is a novel combination of existing approaches Solution: Emphasize need based novelty

71 Common Problems Reviewers ers feel the team is not qualified to handle the problem Strengthen your team by adding collaborators and consultants If PI has experience gaps, consider putting together a multi PI team Have ALL collaborators review the proposal

72 Common Problems Reviewers do not think you are working on significant problem Sell them on importance of the problem Be specific and quantitative Get a letter of support confirming the problem

73 Common Problems Reviewers are critical of the approach Respond to specific criticisms Revise your approach Have your approach reviewed by professionals similar to the y pp y p reviewers

74 Common Q1: SBIR or STTR? Reauthorization: Switching between phases will be allowed Is the true PI at the company or university? Junior postdocs as PI are sometimes questioned by reviewers Cost breakdown SBIR requires 2/3 work done by company in Ph I, 50% in Ph II STTR requires 40% done by company, 30% done by partner Success Rates should not be a major decision making factor Significant variance year to year so there is no answer to the question: g y y q Which is easier to get

75 Common Q2: Appropriate Budget and Cost Structure Total budget and time period should be determined by needs of the project (must fit legal land programmatic caps) Eligibility: Phase I SBC must do 2/3 of the work Determined by division of total costs between SBC and subawardee Fee for Service may count as SBC costs Intellectual work and analysis must be done by the company Indirect costs are a defining characteristic ofsubawards Consultants could be SBC costs Discuss with grants management officer

76 Common Q3 and Q4: Contract or Grant? Phase I or Fast Track? Isthe contract a true fit for the optimalproposal? proposal? Most cases: Phase I grant Fast Track could be good approach for: Late stage and/or clinical trial projects Companies that have already been awarded grants on that technology and are familiar with specificreviewer concerns Companies that have demonstrated track record of commercialization

77 NCI SBIR Development Center Phone: Follow us on Deepa Narayanan Program Director