Wednesday, July 20, 2011

Leadership, flexibility key for biomedical innovation

Author: Arlen D Meyers, MD, MBA

Last year marked the 30th anniversary of the Bayh-Dole Act. Enacted on Dec 12, 1980, the Patent and Trademark Act Amendments of 1980 created a uniform patent policy among the many federal agencies that fund research, enabling small businesses and not-for-profit organizations, including universities, to retain title to inventions made under federally funded research programs. This legislation was co-sponsored by Sens. Birch Bayh of Indiana and Robert Dole of Kansas.

Since passage of the act, university technology transfer offices have blossomed and academic entrepreneurial activities have continued to grow. For example, at my university, the University of Colorado, 94 companies have been created in the past 16 years based on intellectual property from CU. In addition, in FY 2009, there were 258 invention disclosures, 204 patent application filings and licensing revenue of $4.4 million.

There are significant barriers to faculty and staff participating in commercializing their ideas, inventions and discoveries. The barriers to faculty and staff participation in commercialization efforts are substantial and include:

1. increasing clinical, teaching and administrative demands on faculty time;
2. little value placed on commercial R & D efforts;
3. lack of recognition for commercialization efforts;
4. a gap in understanding the differences between academic or community-based practice and industrial culture;
5. departmental impediments to physician-industry cooperation—for example, not granting time off from clinical activities, limitations on consulting time or complicating consulting agreement contracts;
6. a perception that the academic culture of "publish or perish" conflicts with a commercial culture to keep findings secret until patented;
8. lack of knowledge, skills and abilities to participate in more complicated aspects, such as spinout formation;
9. weak internal and external networks that leave faculty and staff unaware of the commercial opportunities available and the accomplishments of their colleagues;
10. lack of departmental leadership or acceptance of the importance of academic entrepreneurship;
11. an increasingly rigid regulatory and oversight environment overseeing potential physician-industry conflict of interest, and
12. lack of innovation management systems in the community setting to capture, assess and develop products and services with market potential.

In addition, there are major differences in the clinical and basic research culture versus the corporate world.

Take the approach to research, for example. Basic, clinical or translational researchers tend to be science-focused problem solvers, looking to unlock the mysteries of nature. Corporate research tends to be more project-driven, based on a clearly identified unmet market need with a bottom-line-driven sense of urgency lacking in a noncorporate environment. Likewise, while there are provisions and guidelines for bioentrepreneurs who want to publish and protect their ideas, "publish or perish" sometimes conflicts with the "patent and protect" corporate mentality.

The clash of cultures is not just in academic settings. As more nonacademic doctors become employees of hospitals, community-based healthcare organizations such as academic medical centers will want to monetize the intellectual property of their physician employees. This becomes even more of an issue as private investors buy hospitals and look for more nonclinical revenue streams.

Creating an ecosystem that generates biomedical innovation will be a continuing challenge for hospital administrators and medical staffs both in academia and the community. Those that do it right stand to gain a competitive market advantage, generate nonclinical revenue and win the war for talent.

About the author:

Arlen Meyers, MD, MBA , President and CEO of the Society of Physician Entrepreneurs, is Professor of Otolaryngology, Dentistry and Engineering at the University of Colorado Denver. He is the cofounder of four companies and is a consultant to several life science, IT and investment firms. Dr. Meyers is a former Harvard-Macy Fellow, a National Library of Medicine Fellow, a Fulbright Scholar and was names as one of the 50 most influential healthcare executives of 2011 by Modern Healthcare Magazine.

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