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CBI forum tackles drug safety issues

Experts who gathered at MIT last week to try to solve the problems inherent in the way America makes medicine were offered a real-world illustration of the high stakes involved as jurors deliberated in the Vioxx case.

The very next day, Aug. 19, a Texas jury awarded a whopping $229 million in punitive damages to the widow of a man who died after taking the prescription painkiller for his arthritis.

On Aug. 18, hundreds of biomedical professionals, academic experts and doctors attended a daylong forum titled "New Medicines: Can Innovation and Safety Coexist?" The forum was the first major open event held by the new MIT Center for Biomedical Innovation (CBI), a new Institute-wide collaboration of faculty from the MIT Schools of Engineering, Management, and Science, the Harvard-MIT Division of Health Sciences & Technology (HST), and their counterparts from government and industry.

The program was launched this summer to bring key players from business, government and academia together to find efficient and safe ways to move advances in the life sciences from the laboratory to the public.

Alice Gast, MIT's associate provost and vice president for research, spoke during the day's luncheon of the promise CBI holds for improving the pharmaceutical industry.

"It couldn't be a more exciting time," she said. "The challenges in the air are to me as electrifying as Sputnik was in its time, when MIT stepped up to the plate and designed the Apollo guidance computer system; or the tensions of World War II when the famed 'Rad Lab' brought an interdisciplinary team to develop radar… Why is CBI so important? It is our Rad Lab for health care."

In the day's keynote panel discussion, titled "Defining the Challenges Surrounding Innovation and Safety," panelists spoke of risks associated both with introducing and not introducing a drug to market. For example, additional phases of testing add delays and costs that might harm the patients whom the drugs could potentially help.

"We want to continue to develop drugs that help the majority, but how do we do that while protecting the minority?" asked Dr. Robert Spiegel, senior vice president of medical affairs and chief medical officer at Schering-Plough Research Institute.

With strict FDA regulations, the United States is slow to approve drugs for public use. The rigorous clinical trials required are both expensive and time consuming. When things go wrong and courts award huge damages, as in the Vioxx case, it becomes even more difficult for companies to be innovative.

"We can have innovation and we can have safety, but it comes at a price," said panelist Una Ryan, who is president and CEO of Avant Immunotherapeutics Inc. and chair of the Massachusetts Biotechnology Center.

Other keynote panelists included Ernst Berndt, the Louis B. Seley Professor of Applied Economics at the MIT Sloan School of Management, and Dr. John Fallon, chief physician executive and senior vice president at Blue Cross Blue Shield of Massachusetts. CBI Executive Director and Professor of Practice Dr. Frank Douglas moderated the panel.

State Rep. Jack Hart (D-Boston) and former Massachusetts House Speaker Thomas M. Finneran, who is now president of the Massachusetts Biotechnology Council, also spoke during the event.

The forum--co-sponsored by Merck Research Laboratories and Gene Logic Inc.-- was held in conjunction with the fourth annual "Celebration of Biotechnology in Kendall Square."

The celebration, which has come to be known as the "Biobash," recognizes the extraordinary number of biotech companies that have grown up around MIT in the Kendall Square area of Cambridge. This year's "Biobash" was sponsored by CBI, the Harvard-MIT Division of Health Sciences and Technology and the MIT Entrepreneurship Center. More than 700 biotechnology professionals and MIT and Harvard affiliates attended the event.

"We want to accelerate the growth of the Kendall Square cluster and make this 'the place to be' for any ambitious player in the biotech revolution," said Kenneth Morse, senior lecturer and managing director of the MIT Entrepreneurship Center. "MIT's world-renowned, unique competitive advantage is our ability to work across schools and disciplines. The challenges of the biotech revolution are all interdisciplinary."

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