Corporate and Foundation Relations

DRUG SAFETY TALK DRAWS AUDIENCE FROM ACADEMIA, INDUSTRY AND GOVERNMENT


	Ross Prentice (left) and Marvin Zelen at this year's Harvard-Schering Plough Workshop. Dr. Prentice, professor of Biostatistics at the University of Washington's School of Public Health and Community, was the recipient of the 2005 Marvin Zelen Leadership Award. Photo courtesy of the HSPH Department of Biostatistics.

Biostatisticians play a vital role in public health by applying statistical science to analyze problems and further biomedical research. One area where the field can make a big impact is in the quantitative evaluation of risks associated with exposure to new drugs, and in the monitoring of drug safety, the topic of this year's annual Harvard-Schering Plough Workshop.

More than 175 representatives from academic institutions, pharmaceutical companies and federal regulatory agencies traveled to the Harvard School of Public Health for the two-day event this past June.

In the wake of the withdrawal of painkiller Vioxx from the marketplace, the ongoing controversy over other Cox-2 inhibitors, and the increasing visibility of drug safety in the news, there certainly was a lot to talk about. Speakers representing Harvard University, Schering-Plough, the U.S. Food and Drug Association, Pfizer, GlaxoSmithKline Research and Development, the University of Washington and Duke University discussed topics ranging from clinical trials to post-marketing surveillance.

"Because it’s organized through Harvard, we’re able to get really top people from the FDA to come, top people from industry. We can exchange ideas in an unbiased setting,” said Louise Ryan.

Robert O'Neill, director of the Office of Biostatistics at the FDA's Center for Drug Evaluation and Research, spoke about areas in which statistics can aid the FDA's efforts to modernize the techniques and methods used to evaluate the safety, efficacy, and quality of pharmaceuticals.

Diverse Perspectives and Wide-ranging Discussion
“It would be very hard for FDA officials to go and visit at a pharmaceutical industry and explore the kinds of topics that we’re able to explore at the workshop. Because it’s organized through Harvard, we’re able to get really top people from the FDA to come, top people from industry. We can exchange ideas in an unbiased setting,” said Louise Ryan, a professor in HSPH’s Biostatistics department and the head of this year’s planning committee. The workshop's academic setting provides a neutral environment that’s conducive to a wide-ranging discussion between professionals with diverse perspectives, she said.

The workshop is the signature piece of an agreement formalized in 1992 between the school’s Biostatistics department and the Schering-Plough Research Institute. In addition to the company’s annual giving to the school, the partnership involves collaborative research, faculty exchanges, and joint planning of the workshop.

“It’s been positive for Schering-Plough to be associated with such a high-caliber workshop,” said Ken Koury, group director, Statistics, at the Schering-Plough Research Institute, and a member of the planning committee.

Besides its benefits to the company, the relationship with Harvard School of Public Health also has helped the career development of individual researchers at Schering-Plough, he said.

The partnership has also been educational for faculty members and students at HSPH.

“It has helped us understand the regulatory process better," Ryan said. "I think that it also was very good for the department in terms of appreciating the high quality work that goes on in the pharmaceutical industry,” she said.

Numerous graduate students and junior faculty from the department have received funding from Schering-Plough to support their research and training, Ryan said. This has been particularly important for foreign students, who are ineligible for federal training grants. Students also have met with Schering-Plough scientists, shared research findings, and worked as interns.

A report on this year's conference from Harvard Public Health NOW.