University Perspectives on Innovation: September 28, 2005 BMES-IDEA meeting

1. University Perspectives on Innovation:September 28, 2005BMES-IDEA meeting William R. Brody President, The Johns Hopkins University

2. Subtitle: Bill Brody’s Recipe for Successful Entrepreneurship –Top 10 Do’s and Don’ts

3. Disclaimer Caution: The views expressed in this presentation represent those of William R. Brody and should not be construed to represent the official position of The Johns Hopkins University, which, in any event, doesn’t have an official position, because no one can really speak for the entire university

4. Achtung! The material presented herein, other than that stolen (or borrowed) by the author is the subject of a pending patent application by the author. Any use, reproduction, quotation, or other use of this material without first obtaining a license (or material transfer agreement) from William R. Brody and The Johns Hopkins University Office of Technology Licensing is expressly verboten. Such license negotiations shall not take longer than 36 months to complete.

5. Technology Transfer: Started in 1884 • 1876 Johns Hopkins University Founded • In 1879 Johns Hopkins chemistry professor Ira Remsen discovers saccharin. • In 1884 assistant Constantin Fahlberg patents it.

6. Early Approach to Patenting • While at U. Chicago in 1942, Russell Morgan invents the x-ray phototimer • The University sells the patent for $1 to GE • Morgan moves to Johns Hopkins • U of C solicits Mrs. Morgan for donation

7. The “Mertonian Tradition” --Open Science • In 1970 Nobelists Dan Nathans and Hamilton Smith publish discovery of restriction enzymes • “It never even occurred to us” to seek a patent

8. The Bayh-Dole Act of 1980 • Intended to promote the commercialization of government-sponsored research • Prompted by low rate of licensing patents from government research (many of which were defense-related) • Intent was not to create a new revenue stream for universities (though that effect was seen as a possible benefit)

9. Technology Transfer Revenue Growth U.S. Universities Gross Licensing Revenue – FY1991 to FY2000 Source: AUTM Licensing Survey FY2000

10. Universities Vary Widely in Generating Licensing Income Source: AUTM Licensing Survey FY2000

11. Why is this? • Success in patent licensing requires one ‘big hit’ -- akin to winning the jackpot at Las Vegas • One big hit makes the licensing portolio profitable – this drives tech transfer offices to focus on the potential home run • Must identify the one potential big hit from a sea of possible invention disclosures

12. Picking Winners -- how good are we? • John Simpson • Julio Palmaz • Paul Bottomley

13. Cardiac Surgery as a model for innovationDevelopment of Valve Replacement Surgery • Dr. Charles P. Bailey – First successful mitral valve commissurotomy, June 10, 1949 -no company • Dr. C. Walton Lillehei – VSD closure using cross-circulation (1954) -Medtronic • Dr. Richard DeWall – Heart Lung Machine using Bubble Oxygenator (1955) -Bentley Labs • Dr. Albert Starr – First successful mitral valve replacement with Starr-Edwards ball-valve prosthesis, August 25, 1960. -Edwards Laboratories

14. Cardiac Surgery as a model for innovation: Many Companies Spawned • Edwards Laboratories Shiley Laboratories • Bentley Laboratories Pacesetter (Siemens) • Medtronic Hancock Labs • Advanced Cardiovascular Systems (Guidant) • Boston Scientific Cordis (J&J) • St. Jude Medical Ventritex

15. So you want to start a company? • Idea • Intellectual property • Investment Capital • Management Team • Define your personal objectives • Make money? • Get your idea into clinical practice • Win a Nobel Prize • Stay at the university & get tenure • Move into the commercial sector

16. How to Avoid Making Mistakes

17. Recipe for SuccessMedical StartupsTop 10 List • 510 K rather than PMA • Recurring revenue stream • Significant barrier to entry • Low development cost • Cost effective/less invasive/safer/better = must be clearly evident

18. Recipe for SuccessMedical StartupsTop 10 List • New or rapidly emerging market with no dominant competitor • Avoid Inventor’s Paranoia • Don’t serve two masters (conflict of commitment) • Minimize Conflict of Interest • Be Lucky

19. Louis Pasteur: “Chance favors the prepared mind.”

20. Advice to the entrepreneur: When you have become successful, give generously back to your university (and if you didn’t go to a university in the United States, please donate to Johns Hopkins University)

21. The End

22. References • On the Take, Jerome P. Kassirer, M.D. (2005, Oxford University Press) • Universities in the Marketplace, Derek Bok (2003, Princeton University Press) • Los Angeles Times: articles on conflict of interest among NIH senior scientists by David Willman, December 7, 2003 and December 22, 2004

23. COI Dilemma (as stated by Kassirer) • “Where does the line exist between advancing the cause of science and the betterment of patient care on the one hand, and the pecuniary interests of the physicians collaborating with industry to produce these advances on the other?”

24. “I cannot be bought” • “Thre is little doubt that substantial sums of money induce physicians to drift across the line, and as they do, financial conflicts of interest can cause great damage.” – J.P. Kassirer

25. Effects of Funding Source on Study Outcome • Study on thromboembolic complications of 3rd generation contraceptive agents by Richard Smith in British Medical Journal • Funded by public money (e.g., NIH): showed thromboembolic complications occurred with 3rd generation contraceptive agents • Funded by pharma: No complications recorded

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