Prix Galien: Night at the Museum

More than 500 representatives of Big Pharma joined a select roster of Nobel prize winners, key regulatory officials, and trade association leaders at the New York Museum of Natural History on October 16 with one purpose in mind: to recognize the latest innovations in new drugs and medical devices that support, improve, and lengthen the lives of patients worldwide. A highlight of the evening was the presentation of the Prix Galien's 2012 Pro Bono Humanitarian Award to Francis Collins, MD, Director of the National Institutes of Health, for his record in advocating higher ethical standards in the conduct of medical research, particularly in improving the design, execution, and application of clinical trials to ensure safe and appropriate use of new treatments. Collins was presented the award by 1986 Nobel Peace Prize recipient and author Elie Wiesel, whose forthcoming book, Open Heart, documents his personal encounter with the practical results of the trial process as a coronary bypass patient last year.

Fred Hassan, chair of Bausch and Lomb and former CEO of Schering Plough.

The award ceremony's product honorees included Bristol-Myers Squibb's Yervoy (ipillumab), as Best Biotechnology Product, for treatment of melanoma; Merck's Victrelis (boceprevir), and Vertex's Incivek (telaprevir) both of which won for Best Pharmaceutical Agent, for treatment of hepatitis C; and Edwards Lifesciences' SAPIEN Transcatheter Heartvalve and Medtronics Melody Transcatheter Pulmonary Valve, as Best Medical Technology Product. This year was the first time Prix Galien's award committee of seven nobelists recognized innovation in medical devices, a decision that was made due to the expanding and complementary role that devices play in the treatment of disease.

Pharm Exec editor-in-chief Bill Looney (left) and Pharm Exec EAB member and head of JBL Asssociates Montreal, Bernard Lachapelle (right).

FDA Commissioner Margaret Hamburg delivered the evening's keynote address, which centered on her personal commitment to promoting innovation through metrics built around the FDA's program initiatives to foster "smart regulation" rather than the pursuit of the bureaucratic status quo. Hamburg, along with European Medicines Agency Executive Director Guido Rasi, also participated in panel discussions at the 3rd annual Prix Galien Forum of policy experts held earlier in the day at the Alexandria Center for Life Sciences in lower Manhattan.

Chair of the Prix Galien committee and former chairman of Merck, Roy Vagelos.

In their comments to attendees, both leaders confirmed the expanding role of the regulator in an era of globalization, with Hamburg noting that the FDA today is not only assessing a drug around the traditional metrics of safety and efficacy, but on performance—under real market conditions—as well.

Clark Herman is Pharm Exec's Associate Editor. He can be reached at cherman@advanstar.com.