“ Novel Technology Development: What To Do When That Lightbulb Goes On ”

1. “Novel Technology Development: What To Do When That Lightbulb Goes On”

2. Clinical Translational Sciences Institute • Novel Clinical and Translational Methodologies(Drs. Valdes, Eaton, Keynton) • Goals are to facilitate: • Identification of novel technologies • Partnering with industry • Development of novel training programs • Transitioning initiatives into clinical research and medical applications

3. Clinical Translational Sciences Institute Novel Clinical and Translational MethodologiesSpecific Aims: Aim 1. Enhance the efficiency of discovery-to-clinical practice Aim 2. Catalyze development of novel science and technology-based discoveries at UofL Aim 3. Develop new programs to attract and train junior faculty scientists in translational research

4. Clinical Translational Sciences Institute Idea(discovery) Application Is path linear? Is path downhill?

5. Clinical Translational Sciences Institute NCTM Core(catalyst) Enzymology 101 Idea(discovery) Application

6. 2) Confusion 1) Discovery 3) Protection NCTM 6) Application 5) Funding 4) Organization

7. 2) Confusion (eliminate) Center for Environmental Geneticsand Integrative Biology (CEGIB) Integrated Health Sciences Facilities Core Biomarker Applications Research Applications(mechanistic studies) Assessment of Health/Disease Clinical Applications(prevention, diagnosis, prognosis)

8. Clinical Translational Sciences Institute Mr. James Zanewicz&Dr. Holly Clark Office ofTechnology Transfer 3) Protection

9. James R. Zanewicz, J.D., L.L.M.&Holly S. Clark, Ph.D. Office ofTechnology Transfer

10. UofL’s Office of Technology Transfer •Where to find us: Office of Technology Transfer MedCenter 3 201 East Jefferson Street, Suite 215 Tel. 502-852-2965 • http://louisville.edu/thinker/ • Who we are: James Zanewicz, Director Cassie Carmichael Melea East Matthew Hawthorne Holly S. Clark Christopher Shaw Christopher Fick Sandra Foster Eric Castlen Libby Kinberger Charlene Williams Brittany Curfew

11. THE OFFICE OF TECHNOLOGY TRANSFEROTT Review, Protect and Commercialize UofL Research. Protect Intellectual Property. Option and License Agreements with Companies. Review, Draft and Audit IP Agreements. MTAs Confidentiality Agreements. Anything with IP issues: Grants, Purchases, etc. Compliance with Funding Agencies. For more information:http://louisville.edu/thinker/ Tel: 502-852-2965

12. Reporting a Discovery/Invention When? ►Tell OTT about anything that may be a great research development, a valuable research tool, or merely a cool idea. ► LET US KNOW BEFORE YOU PUBLISH OR PRESENT * How? http://louisville.edu/thinker/for-faculty-and-staff Click on “Research Disclosure”

14. Assessment Process Research Disclosure submitted to OTT Docket New RDF Assign to Technology Manager Market Potential IP Protection • Meet with Inventor(s): • Invention • Stage of development • Publications • Market Potential • Potential Licensees • Utility/ application • IP Protection • Evaluate for: • Inventorship • Ownership • Invention • Funding Support • Supporting Docs • Publications • Market Potential • IP Protection Develop Business Strategy

15. Commercializing UofL Research Marketing; finding a partner (OTT and the inventor) Licensingto an Established Company Maybe the inventor wants tostart a company…

16. EVPR’s PROOF OF CONCEPT GRANT AWARDfor Research Disclosures Submitted to OTT http://louisville.edu/thinker/for-faculty-and-staff/proof-of-concept-grant-program.html $50,000 per quarter. Awarded every 3 months. For Early-Stage UofL Technologies

17. Take Home Message For all of your UofL IP needs… Call OTT James R. Zanewicz, J.D., LL.M. Holly Symonds Clark, Ph.D. Office of Technology Transfer University of Louisville MedCenter3, Suite 215 Tel: 852-2965 James.Zanewicz@louisville.edu holly.symonds.clark@louisville.edu

18. Clinical Translational Sciences Institute 4) Organization Mr. Steve Gailar Metacyte

19. From the Mind to the Marketplace Presented by: Steve Gailar President & CEO MetaCyte is a for-profit subsidiary of the UofL Foundation.

20. MetaCyte History Is now operating as a for-profit subsidiary of the UofL Foundation MetaCyte Business Lab, LLC • Is a health and life science incubator • Was founded in 2002 by: • Jewish Hospital HealthCare Services, Inc. • Norton Healthcare, Inc. • UofL Health Care • University of Louisville

21. Not Your Parent’s Incubator! MetaCyte creates “investment grade” start-up life science companies Think of MetaCyte as a “manufacturing” company whose products are life science and healthcare technology start-ups. We proactively identify raw material from the University of Louisville and turn that raw material into products—life science and healthcare technology start-ups. MetaCyte’s customers are professional investors in life science and healthcare technology companies.

22. Our Goal — Create Fundable Companies MetaCyte takes an equity position in its portfolio companies at creation • We do our homework: • What is the market opportunity and who is already in it? • What do clinicians think about the technology? • What is the status of intellectual property? • Are there reimbursement issues? • What will the business model be? • What are the financial requirements? • What are the business/technical milestones important to investors? • And, importantly, what about the scientific founder?

23. MetaCyte Business Model

24. MetaCyte Growth

25. Venture Capital Sources We Tap

26. Contact MetaCyte Steve Gailar President & CEO MetaCyte Business Lab, LLC 201 East Jefferson Street, Suite 125 Louisville, Kentucky 40202 Phone: (502) 569-1020 x309 Fax: (502) 569-1021 sgailar@metacyte.biz

27. Clinical Translational Sciences Institute Dr. Steve Koenig UofLSBIR/STTR Experience 5) Funding

28. Venture Capital Instant Money Ownership Expectations Funding Rounds Business Development Federal & State Funding Development Time Grant Dependency Control Ownership Industry Parntership Business Models Choices – work interest and return on investment?

29. MCS Device - Project Funding Support National Institutes of Health – Heart, Lung, & Blood Institute SBIR 2R44HL083586-02A1 (Koenig) 8/1/2008 –7/31/2010 NIH-SBIR Phase II $1,440,170 Development of a Counterpulsation Therapy Device The major goals are to (1) complete engineering development and surgical procedures, (2) demonstrate reliability and hemocompatablity, and (3) demonstrate safety and biocompatibility of a novel counterpulsation device (CPD) to treat early stage heart failure. 1R43HL088760-01 (Koenig) 4/1/2009 –3/31/2011 NIH-SBIR - Phase II $1,580,486 Portable pneumatic driver for counterpulsation therapy The major goals of this project are to (1) complete engineering development, (2) demonstrate reliability and hemocompatablity, and (3) demonstrate safety and biocompatibility of a portable pneumatic driver for a novel counterpulsation device (CPD) to treat early stage heart failure. 1R43HL083586-01 (Koenig) 6/1/2006 – 1/31/2007 NIH-SBIR Phase I $172,749 A counterpulsation device to promote myocardial recovery The major goal of this project is to develop a novel 30ml, pneumatic counterpulsation device that will be cannulated to the subclavian artery to promote myocardial recovery by reducing ventricular workload and augmenting myocardial perfusion. 1R43HL088760-01 (Koenig) 8/1/2007 –7/31/2008 NIH-SBIR - Phase I $268,790 Portable pneumatic driver for counterpulsation therapy The major goal of this project is to develop a pneumatic driver for a 30-ml chronic counterpulsation device and compare acute physiologic responses to a clinical IABP in a large animal model. • Kentucky Science and Technology Corporation • KSTC-xx-DCIS-xxx (Koenig) 10/1/2008 –9/30/2009 • Kentucky Science and Technology Corp $500,000 • Implantable Sensing and Triggering System • The major goal of this project is to develop and test sensors and electronics for reliable measurement of ECG to be used a triggering system to time inflation and deflation of the membrane for a novel counterpulsation device (CPD) to treat heart failure. Testing will be conducted in a mock flow loop, and acute and chronic large animal model during hypertensive, hypotensive, and heart failure test conditions. • KSTC-184-512-07-011 (Koenig) 3/1/2007 –12/31/2007 • Kentucky Science and Technology Corp $100,000 • Counterpulsation device to promote myocardial recovery • The major goal of this project is to test a novel counterpulsation device (CPD) in three chronic 30-day CPD implant studies. The state of Kentucky provides grant support to match NIH SBIR phase I award to acquire additional preliminary data beyond the scope of the phase I award to support NIH SBIR phase II applications. • KSTC-02-DCIS-021 (Koenig) 10/1/2008 –2/28/2009 • Kentucky Science and Technology Corp $100,000 • Counterpulsation device to promote myocardial recovery • The major goal of this project is to complete two one-week and two 30-day chronic CPD implant experiments with portable pneumatic driver. The state of Kentucky provides grant support to match NIH SBIR phase I award to acquire additional preliminary data beyond the scope of the phase I award to support NIH SBIR phase II applications. • *Budget Tips $$$$$$$ • Ask for as much funding as you can justify • Request Indirect Costs (28%) • Request Fee (7%)

30. NIH-SBIR Phase I Application Helpful Hints • Strategy - submissions • Tell-a-story • Less is More (graphics) • Innovation • Ready for Testing • Lots of Preliminary Data • Reasonable Goals • Clinical Application • Preliminary Commercialization Plan

31. NIH-SBIR Phase II Application Helpful Hints • Accomplish/Exceed Phase I objectives • Commercialization Plan • Consider Industry Partner • Demonstrate high probability of success/product • Challenge/Solution • Define achievable metrics • Personnel and Resources • Budget Justification

32. Clinical Translational Sciences Institute 1) Discovery 6) Application Integration of Key Initiatives

33. Clinical Translational Sciences Institute Professor Fellowships Student Developing an Entrepreneurial Faculty

34. Clinical Translational Sciences Institute Bioengineered Technologies Drug Design & Development CTFP Pharmacogenomics & Personalized Therapeutics Computational Methods in Bioinformatics Biomarker Discovery & Validation (Programs to be developed) Developing Clinical Translational Sciences Postdoctoral Fellowship Programs

35. Clinical Translational Sciences Institute Entrepreneurial Faculty (centered on scholarship) • Challenges: • Time & Effort (how gauged?) • Promotion & Tenure? • Recognition for Scholarly Accomplishments?(Disclosures; patents applied or issued; industry contracts; Fed SBIR/STTR funding; spin-out companies; other activities....) • Alignment is necessary (one of CTSI’s goals)

36. Questions&Discussion “Novel Technology Development: What To Do When That Lightbulb Goes On”