Tufts CSDD Quarterly Update

Selected excerpts from recent articles

Pharmaceutical Executive
January 2010
A Fresh Look at the Industry's Future

Keynote speaker Ken Kaitin of the Tufts University Center for the Study of Drug Development said it best: Youth and experience can be a compelling combination - the booster shot for securing next stage innovations against an endlessly morphing profile of disease.

MSNBC.com
January 20, 2010
Orphan Drug Applications Doubled in 10 Years

The Tufts Center for the Study of Drug Development says the Food and Drug Administration granted orphan drug status to 425 experimental products between 2006 and 2008, up from 208 between 2000 and 2002.

BusinessWeek
January 6, 2010
Is Drug R&D in Jeopardy?

The layoffs might not slow drug introductions, says Kenneth Kaitin, director of Tufts University's Center for the Study of Drug Development. Increasingly, pharmaceutical companies are outsourcing R&D to universities and bioscience startups, which may have more expertise and work for less money. The recent job cuts will likely hasten more linkups to keep pipelines from running dry.

TheStreet.com
December 11, 2009
Glaxo, Wyeth Cut Costs With Trial Software

Three of 10 marketed drugs produce revenue that exceeds the $1.1 billion in average development costs, according to the Tufts Center for the Study of Drug Development.

Bio-IT World
December 8, 2009
Getz: Industry Trends Suggest More Trials will go to Top Sites

"Within five years, I think we'll see a totally different relationship between sponsors, CROs, and sites," says Kenneth Getz. "Not enough attention has been paid to the fundamental problem of public trust [of clinical research] and protocol design."

Financial Times
December 7, 2009
New Lease of Life

"Over the past eight years [of the previous administration], there was only a true, confirmed commissioner for three and a half years," says Kenneth Kaitin, director of the Center for the Study of Drug Development at Tufts University in Boston. "That was very little time for someone to serve as the face of the agency and articulate its views to the public and Congress. It was open season for the critics."

Washington Times
November 28, 2009
Volunteers for Drug Trials Hard to Find

"It's not lack of patient willingness but because many of the diseases being studied today involve smaller and more targeted populations - some for a specific [product] only shown to be needed in a smaller, more targeted subset," said Kenneth Getz, a Tufts University School of Medicine research fellow and founder/chairman of the Center for Information and Study on Clinical Research Participation... He also said that getting patients to learn about the trials is "a communications challenge," especially in the cluttered Internet age.

Medical News Alert
November 23, 2009
Gene Silencing to Boost Biological Drug Yields

Janice Reichert, senior research fellow at Tufts Center for the Study of Drug Development in Boston, Massachusetts, told Bloomberg that anything that can reduce the time it takes to produce from the cell line, or that improves the efficiency of the process would be a good thing... "CHOs are the default option for biotech drugs, they're the workhorse of the industry," she said.

The Scientist
November 6, 2009
Team of Rivals: Enlight Biosciences has a business model that's compelling enough to coax pharmaceutical companies to do something they rarely do-work together.

"If you know about this industry and how insular and proprietary it is, then these [large pharma consortia represent] very substantial changes in approach and strategy," says Ken Kaitin, director of the Tufts Center for the Study of Drug Development. ... "It is an industry that desperately needs a new strategy," says Kaitin. "They've been talking about this for two decades, but now it's an imperative."