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1 COLUMBIA UNIVERSITY Technology Transfer- An Overview Dr
COLUMBIA UNIVERSITY Technology Transfer- An Overview Dr. Michael Cleare Executive Director Science and Technology Ventures

2 Historical Development
Founded as King’s College under British Royal Charter, 5th college in American Colonies - Medical Faculty established, 1st in colonies Re-chartered as Columbia College School of Mines established, predecessor to School of Engineering and Applied Sciences School of Architecture established, 4th in U.S. Schools of Nursing, Architecture and Social Work, 1st in U.S.; Barnard College and Teachers College become affiliates; College of Physicians and Surgeons established Re-named Columbia University School of Journalism, 1st in U.S. Columbia-Presbyterian Medical Center created, 1st integrated medical research, education and clinical care facility in U.S. Lamont Geological Observatory established, now Lamont-Doherty Earth Observatory Columbia Earth Institute established

3 University Leadership
Board of Trustees President Provost Academic VPs and Deans Executive VP for Research Senior Executive Vice President University-wide Strategic Initiatives Innovation and Knowledge Transfer- (Science and Technology Ventures) Administration School and Departmental Initiatives Research Institutes and Centers Tenure Process Pedagogy and Curriculum Multidisciplinary Program Development Research Institutes and Centers Sponsored Research

4 Key Mechanisms for Transferring Academic Knowledge to Industry
Faculty contacts and consulting Published papers, talks at meetings, patents and applications Columbia graduates STV industry contacts Deals- Licensing/Spin Outs STV web site (

5 Before Bayh- Dole “Science - The Endless Frontier” (1945) Expansion of federally funded research investments since 1950s Recognition of unrealized public benefit and commercial potential from research results from federally funded research (28,000 patents, < 5% licensed)

6 Bayh-Dole Act (Patent and Trademark Act of 1980)
Non-profits can obtain title to inventions made with federal funding (e.g. National Institute of Health grants) Bayh-Dole places obligations on non-profits, including: Disclose the existence of inventions Seek patent protection for inventions Diligent commercialization Annual reports on commercialization efforts Exclusive licensee must manufacture substantially in U.S. Preference for small businesses as licensee Share revenue with inventors Net revenue used for educational and research mission

7 Bayh- Dole Provisions encourage collaboration with industry to
promote the utilization of inventions; universities must file patents on inventions they elect to own; government retains non- exclusive license and march- in rights.

8 Bayh-Dole Act - Key ProgramRequirements
Disclosure to Agency Election of Title Within 2 years of disclosure File Application Designate U.S. Funding Source Occasional Reporting Inventor Shares

9 SCIENCE & TECHNOLOGY VENTURES MISSION STATEMENT
- Transfer inventions and innovative knowledge to outside organizations for the benefit of society on a local and global basis - Whenever appropriate this is to be carried out at going commercial rates so discretionary funds are brought into the university to improve educational and research activities and capabilities

10 Science and Technology Ventures Principal Activities
Work with faculty members to identify and patent new inventions Facilitate research collaborations between faculty members and industry License inventions and technology developed in University laboratories Established Companies Start-ups Provide support to licensees and start-ups Incubator Compliance with government regulations, reporting.

11

12 (“Pushing back the Frontiers”)
UNIVERSITIES - A MODIFIED CORE MISSION THE NEW INTERFACE UNIVERSITY Academic Research (“Pushing back the Frontiers”) Teaching Scholarship (“Human Capital”) Interdisciplinary Initiatives Translational Res./Tech Transfer Economic Dev.(local, natl., global) Spin offs/jobs/GDP Focused short courses. Corporate/Government Rels Agencies, Alternative Funding Interactions with Society (“Reducing to Practice”)

13 Columbia Intellectual Capital
Over $600 million in research support annually 23,000 students (7,000 u/grads); Graduate Researchers 3,000 faculty, plus 4,000 researchers, clinicians, part-time 74 Nobel Prizes awarded ( ) World-class medical center 500 patents 250 Invention Reports reviewed annually Many Inter-Institutional Relationships

14 R&D expenditures at U.S. universities FY 1992-02
$31.7Bn AUTM Licensing Survey: FY 2002

15 Industry-sponsored R&D expenditures U. S
Industry-sponsored R&D expenditures U.S. universities and colleges, FY92-02

16 TECHNOLOGY TRANSFER FLOW CHART
FEDERAL FUNDS $400 M TECHNOLOGY TRANSFER FLOW CHART EXTERNAL MARKETING INPUT GOVERNMENT AGENCIES INVENTION REVIEWS COMMERCIALIZATION IP MINING IDENTI- FICATION PRIORITIZATION STRATEGY, TACTICS LICENSE V START UP . TECHNICO/MARKETING INVENTION BRIEFS (2-3 WEEKS) REPORTS STV OUTSIDE COUNSEL/CONSULTANTS MORE DATA MORE DATA SHELVE SPECIALIST TECHNICAL INPUT STATE/ INDUSTRIAL OTHERS $210 M IP PORTFOLIO PATENTS COPY RIGHT STV LICENSE/ SPINOUT OTHER/ PARTNERSHIPS ADANDON REPORT GOVERNMENT AGENCIES. ETC. DEALS FOREIGNS CIPS $$ SUCCESS % BACK TO CU

17 STV Discovery and Commercialization in FY04
Research Expenditure- Federal, State, Industry, and University $610MM in Research Expenditure Faculty Member or Graduate Student Has a New Invention 240 Inventions Reported STV Decides to File A Patent 130 New US Patents Filed $10 MM/yr Investment (legal costs) License to Existing Companies License to Start-ups 60 Licenses Executed 9 Start-up/Small Companies Formed Market $109 MM of Income Generated 6 Start-ups Funded

18 US University Technology Transfer Productivity
$2.4M/per disclosure 123,230 Disclosures $267 B Research 42% 57,641 Patent Applications Assessment 21% 48% 61% FY 01 26,000 Issued Patents 22% 26,000 Active Agreements products Commercialization 3.5% 17% 4,320Start-Ups platforms AUTM Licensing Surveys FY91- FY02

19 Organizational Structure & Outputs
Executive Director, S&T Ventures New Ventures Strategic Partnerships Economic Development Patent Management 250 inventions annually 150 active license agreements 100 active research agreements Health Sciences Arts & Sciences / Engineering Go through chart: -Int. and ED new activities -Importance of research agreements 60+ startups created Patent pools, research: Karolinska ITRI -Imperial etc. Regional TBED strategies, state/local sponsors 500+ patents under management

20

21 Advantages of Working with Universities
Major source of new technologies Basic and pioneering research Leverage many existing academic - industry ties Ongoing relationship allows easy monitoring of opportunities Technology Transfer offices offer one stop shopping Research agreements, License Agreement, Research/License options Flexible deal making plus competitive research costs We strive to make integration easier across the board - Many T.T. directors with industry experience

22 Columbia Inventions Submitted to STV
248 236 207 208 189 182 151 155

23 Life Sciences Invention Reports by Department
120

24 STV Completed Agreements
149 148 148 84 113 90 93

25 Patent Applications Filed
YEAR TOTAL US TOTAL FOREIGN TOTAL APPLICATIONS FY 1996 108 48 156 FY 1997 111 85 196 FY 1998 104 81 185 FY 1999 109 102 211 FY 2000 118 60 178 FY 2001 173 131 304 FY 2002 190 270 460 FY 2003 232 443 FY 2004 121 252

26 Patent Applications Filed
STV Patent Applications and Agreements Sustained Strong Levels Over Time Patent Applications Filed 375 patents applications were filed in FY04 Slight decline in recent years reflects effort to control patent costs Agreements Completed Significant growth since reflects increased outreach to faculty and the market

27 The Virtuous Cycle UNIVERSITY NEW KNOWLEDGE TRANSFERRED BASIC RESEARCH
OUT OF UNIVERSITY FOR BENEFIT OF SOCIETY PRIME ACTIVITY- BASIC RESEARCH STATE $ UNIVERSITY TECHNOLOGY TRANSLATIONAL FEDERAL FUNDING $ (RETURN ON FEDERAL INVESTMENT) IP/KNOW HOW INDUSTRIAL $ LICENSE INCOME/ RESEARCH AGREEMENTS CORPORATE RELATIONSHIPS COMMERCIALIZATION LICENSED OUT AT GOING RATE TO ESTABLISHED COMPANIES & START UPS DISCRETIONARY FUNDS FOR EDUCATIONAL/ RESEARCH INITIATIVES INCOME TO UNIVERSITY $$ GRADUATES PRODUCTS/PROCESSES PROFITS-TAXES GDP ETC. JOBS EXPORTS RETURN ON FEDERAL INVESTMENT

28 Selected Products Benefiting from Columbia Inventions
SIPquest* * Chalfie’s GFP* * Arrow Catheter (Modak) CHO cell line (Chasin), not patented (1980 PNAS) Blackberry 7100 T (Im)*

29 Successful Licenses Co-Transformation (Axel et al.)- Process of inserting a gene into a eukaryotic cell (usually CHO cell line developed by Dr. Larry Chasin) to cause the cell to reliably produce large amounts of a therapeutic protein licensed to 20 companies Xalatan (Bito)- Prostaglandin-based drug for treating Glaucoma licensed to Pharmacia (now Pfizer) Antibody Technology (Joint with Stanford - Morrison et al) licensed to Centocor (Johnson & Johnson) Digital Compression Technology (Anastassiou) Founding member of MPEG LA, Patent Licensing Pool Partnership

30 Products from Columbia Technology
TPA Degrading blood clots EPO Stimulate red blood cell production Herceptin Breast cancer Factor VIII/IX Clotting factors for hemophiliacs Pulmozyme Cystic fibrosis DVD’s Digital compression (MPEG 2) LCD Screens Sequential Lateral Solidification LED’s White/blue light emitting diodes

31 Commercialization of Academic Research Plays a Major Role in the Economy
Funding for university research exceeded $30 billion in 2000 Gross license income in 2000 totaled $1.26 billion from over 9,059 licenses Estimated $40bn of US economic activity attributed to results of academic licensing, supporting 270,000 jobs Since 1980, 3,400 new companies were formed based on licenses from academic institutions Sales of products-417 in raised $5bn in taxes NIH report estimates 15x return on funding (2000) NSF 1998, AUTM 1999,2000. ($mm) Bayh-Dole Act 1980

32 US University Technology Transfer Trends*
License income of $1.25 billion to US universities (CU share >10%) Median income for the twenty largest research universities was $7MM (Avg=$17MM). New Licenses: 3,739 new licenses executed (up 15%), 32% of licenses with large companies (>500 FTEs), 450 new companies launched Active licenses: 26,000 licenses active (up 14%), 22% with product sales *Data from AUTM 2002 survey

33 University Policy- Distribution of License Revenues
GROSS INCOME 1-$125, > $ 125,000 STV EXPENSES/ DEVELOPMENT FUND % % NET INCOME Up to $100, >$100,000 INVENTOR % % INVENTOR’S RESEARCH % * 20.0% * UNIVERSITY % % DEPARTMENT % * SCHOOL % * * CAP APPLIES

34 Criteria for Licensing to Start-ups
Higher potential ROI than licensing opportunity Broad basis for multiple products Ideally a disruptive technology likely to be adopted in near term Development work and proof of principle required to attract licensees Best (often only) route to exploitation Faculty member must have requisite contacts, drive and abilities Must meet current investor criteria Business model, quality management interest, alignment of interests, large market size Low risk of negative public relations relating to technology and stakeholders

35 STV Approach to Spinouts
Low up front money, patent costs reimbursed License fee phased in line with milestones and/or funding rounds Case by case balance of equity & royalties, strategic decision based on business and the IP’s likely productization STV support before and after first round of Funding Columbia portfolio company status

36 Best Practices for Adding and Retaining Value in Spinouts
Help on business plan-staff experience/business school Make introductions to potential mgmt (VC Network) Introduce faculty members to each other, eg. molecular biologists to chemists Introduction to venture community-extensive networks Lower up front fees in exchange for equity Bundle IP with complementary inventions at other universities, both domestic and international Add experts to SAB, take a board observer seat, lend world class expertise- “the halo effect” Pay patent costs, stretch dates of reimbursement Facilitate turnarounds Why focus on University IP for spinouts?

37 New Ventures Revenues*
66 Companies to Date Current Companies 9 Companies Formed in FY Public** 15 Portco Licenses Producing Royalties & Fees 5 Investing in Research MPEG as percentage of total income declined 33% over last two years, showing increased breadth NV portfolio now accounts for 10% of STV income Need significant growth in portco royalties in ‘05 and ’06 to continue overall upward trend $12.5MM $7.1M $10.6M $10.7M Nephros, Co-Therix, Memy, Sentigen, Corixa, Pharmacopeia/Accelrys, Progenics, Aton, Call Street, Genpath, Nexell went under * MPEG Revenues decreased from 78% in ’02, to 67% in ’03, to 45% in ‘04 ** 7 still trade, 4 acquired, 1 went under

38 Summary on University Startups
Universities help to launch startups when they are realistic businesses Startups should provide fair value for the technology and reward risks by university Equity is only part of the deal value, not the driver Companies need to recognize the complexity in university policies Both sides need to be creative and flexible, and have fun throughout the negotiation Outstanding management at the earliest stages makes all the difference Even failed startups can benefit Columbia

39 Value of STV’s Portfolio of New Ventures has Increased Over Time
Since its inception, STV has been involved in 66 start-ups, in many cases taking an equity stake 50 companies still active 15 currently produce income through royalties, equity payments and milestone fees 5 are investing in sponsored research at Columbia University 2004 was an extremely positive year for creating shareholder exits 7 companies acquired, went public or announced exit events, for a total of $8 million (estimate) in income to Columbia over FY04 and FY05 Compared to 5 such events over past 19 years Latest valuation for STV’s private equity is $40 million

40 STV Portfolio Companies Public Transactions in 2004
Seven portfolio companies went public or announced their acquisition by a publicly traded company in 2004 12 out of STV’s 50 companies created exits for Shareholders Columbia income from these transactions will be ~$8MM * Skinetics Biosciences Sirna Therapeutics (Nasdaq: RNAI) acquired Skinetics $2MM+milestones Topical hair removal December 2004 * announced acquisition Smarts $260MM Storage management December 2004 acquired Aton $150MM+ milestones Treatment of cancer March 2004 FactSet Research Systems(NYSE-FDS) acquired Call Street Inc. $7MM Wall street notes on conference calls May 2004 Cotherix Inc $30MM (NASDAQ:CTRX) Treatments for Pulmonary disease November 2004 Memory Pharmaceuticals $35MM (NASDAQ:CTRX) Treatments for CNS disease April 2004 Nephros Inc $12.6MM (AMEX:NEP) Treatments for end stage renal disease September2004

41 Executed Agreements with New Portfolio Companies
10 9 9 7 5 5 4 Quality not quantity

42 Columbia Contributes to Success of Startup
GROWTH STV ACTIVITIES License IP - balance equity and royalties Add experts to SAB, grad students STV board observer IP bundling with other institutions Ongoing basic research Business plan Seed funding- proof of principle Introductions to investors, mgmt. SBIR proposals STV-led turnarounds Invest in patent, evaluate commercial opportunities Collaborate with other faculty/industry Inventor makes Discovery SOURCE OF FUNDS: USE OF FUNDS: Government grants Basic research Government, company sponsors Applied research SBIR, angels, seed VC Prototypes, models “proof of concept” Early stage VC Product development

43 Lessons Learned from Startups
Carefully evaluated balance of royalties, fees and equity maximizes return In some cases Columbia should agree to equity split with scientific founder before company’s inception. Launch startup when there is a realistic business plan Startups should provide fair value and reward risks undertaken by university Outstanding management at the earliest stages is vital

44 Startup Policies No sponsored research allowed from company if faculty member holds equity No management role for faculty, most act as Chief Scientific Advisor one day per week Sell equity as soon as possible post-IPO STV takes board observer seats in exceptional cases

45 COMMON UNIVERSITY TECHNOLOGY TRANSFER ISSUES
Effect on traditional university role. Return on federal investment: Scientific, cash, equity, societal Conflicts of interest situations - rules & management General availability of technologies - e.g. research tools/targets. Deal structure - Going commercial rate? - Back v front loading - Start ups; equity, royalties, license fees, research - Small v large companies. Timeliness/Responsiveness: internal & external Global Issues - Provisions for poor countries - Patent status/enforceability

46 What is Next in Technology Transfer?
Technology gap funding increasingly common as Universities seek to maximize returns Industry university partnerships Humanitarian considerations Increasing number of high quality startups Proof of concept gap funding enabling more and better opportunities Young tenured faculty more interested in startups

47 Innovation Gap Funding
Private Funding VALUE Proof of Concept Funding Gap Public R&D Funding Product Development and Marketing Technology Value Captured Validation Basic Research/ Discovery Feasibility Technology Development Funding Sources Gov’t and Company Grants SBIR, angels, seed VC Columbia Gap Fund STV Pre-Seed Fund Early stage VC TIME STV Licenses Technology

48 Models to Bridge the Proof of Concept Gap at Universities
Government funded seed funds - University Challenge Seed Fund - UK, STTR program - US Philanthropy funded interdisciplinary drug discovery centers - Broad Institute - MIT /Harvard Venture-backed specialty investment companies /incubators- Synecor - Duke, Frazier Health Care, Guidant, GE Medical, Delphi and Deutsche Bank University Seed Funds- There are over 60 universities with some kind of seed funding available, ranging from granting small amounts of money to advance research projects, to venture capital funds, with endowment capital, that invest exclusively in university spinouts.

49 Effective University Technology Transfer Needs:
Summary Effective University Technology Transfer Needs: Clear Title (e.g. Bayh Dole) University’s Commitment Office with Critical Mass, Appropriate Experience Supply of Excellent Research This can provide: Value to Society and Economy Discretionary Funds to University Retention/Recruitment Incentive

50 Academic Partnerships – STV Partnerships
Develop collaboration with other academic research centers around the world - joint research, licensing and start-ups Many new inventions are complex and research is multi-center- genomics, proteomics and new digital technologies Collaboration brings together more knowledge and skills to make major new developments, allowing for more rapid development and greater success Encourages earlier collaboration of commercial partners University collaborators include: Stanford, Cold Spring Harbor, Oxford, Pasteur, McGill, Karolinska, ITRI

51 Rationale Complexity of technology-no one Institution will have all the answers Provides another option to exploit IP/technology Affords leverage through access to partners’ marketing network- cross marketing Unlocks new funding sources Enables transfer of know how/best practices Develops broader relationships Internationally

52 STV Partnerships’ Mission
To develop and manage external collaborations with academic/technology development organizations and to commercialize Columbia/partner IP for the benefit of society and Columbia

53 Strategy Identify areas of Research strength at Columbia which are complemented at another institution Increase value by combining existing technology/IP into a more valuable package for licensing Facilitate joint research, increase funding, create more valuable joint IP, license technology to obtain better deals from industry

54 ITRI-Taiwan Research Foundry- industry/government funded
SLS Agreement executed- LCD/OLED flat panel displays – PDAs/cellphones//automotive Framework agreement drafted for IP specific deals/ joint research collaborations/IP pooling Major Agency/Research Agreement over next several years- SLS Help Desk for Taiwan industry, will license to major players- AU Optronics/Toppoly License agreements in negotiation

55 Imperial/Exploit Alliance
Tripartite Alliance formed 2003 between Columbia, Imperial College London and Exploit, Singapore Intent is to bundle technology/IP and form joint research collaborations for licensing Bioinformatics (Functional Genomics) is first project, with Diabetes/obesity area under consideration Cardiac Pacemaker (joint IP) strategy in development

56 Karolinska Institute, Stockholm
Stem cells, neurology, cancer identified as key areas for collaboration with Columbia Joint gender specific research potential(cardiovascular/ osteoporosis/ CNS/ Diabetes) Institutional connection through Dean’s Office, Health Sciences Division, Columbia

57 McGill University, Montreal
Areas for collaboration-nanotechnology, metals, sensors, cancer, parasitology, display/”smart” electric grid technology Facilitated Faculty contact on Biosensors Canadian Consulate/Consultant meetings -possible collaborations with Alberta, Toronto, Waterloo, Vancouver

58 Ireland Dublin-UCD/DCU/Trinity contacts-MOU signed with DCU
Investigated EE collaboration potential Genomics and high throughput screening also pursued Science Foundation Ireland relationship with Columbia established

59 Ben Gurion University, Israel
Two research areas identified-tissue necrosis/drug delivery Potential collaboration on vaccine (smallpox) and antibodies research and funding (joint project-Homeland Security funding) with Columbia start-up company Weizmann and Technion discussions initiated

60 Stanford University Radioprotection (cellular level), microarrays, bomb detection and network security of interest Columbia Radiation /Physiology/Cellular Biophysics Faculty reviewing information Photonics area a possibility Bioarrays for viral/infectious disease detection – Joint IP

61 China Visit in November’03 with CUMC personnel
Meetings with Ministry of Science and Technology, Academy of Sciences, Peking Union Medical College and Fudan University (Shanghai) Public Health Initiatives- SARS- ongoing Teachers’ College hosted NAEA delegation of top University administrators- STV Partnerships ran week long research management/Tech transfer seminar for group Hosted Zhejiang IP delegation in December ‘03

62 Successful Deal- Lilly
Lilly/Columbia/British Diabetes Association/Pasteur Institute Multi-year deal researching genetic basis of diabetes $25 MM in corporate funding Complexities of culture and legal frameworks overcome, all partners benefited

63 CSFs for International Collaborations
Focused, dedicated resources Identification of true research synergy Faculty relationships-identify/facilitate Commercial/legal/licensing framework defined up front Pragmatic approach to funding/resource challenges Sense of urgency

64 Corporate Outreach Integrated Business Development strategy
Coordinate across Life Sciences/Physical Sciences Contacts Database Presentation to highlight platform capabilities at Columbia Incent “Proof of Concept” funding approach for industry


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