Tufts CSDD Quarterly Update

Selected excerpts from recent articles

The Atlantic
July/August 2010
No Refills

If companies have really stopped caring about R&D, why is it that according to Joseph DiMasi, an economist at Tufts who specializes in the pharmaceutical industry, spending on R&D is 11 times what it was 30 years ago?

Investors.com
August 20, 2010
Lilly's Alzheimer Flop Prods Collaboration

[According to] Kenneth Kaitin, head of the Tufts University Center for the Study of Drug Development, "We don't know if amyloids are the heart of the problem," he told IBD.

Los Altos Town Crier
August 17, 2010
Clinical trials benefit from gift of participation

There are many important questions to answer before joining a clinical trial. "The Gift of Participation: A Guide to Making Informed Decisions about Volunteering for a Clinical Trial" (Jerian Publishing, 2007) is a good place to start. Author Ken Getz is a senior research fellow at the Tufts Center for the Study of Drug Development and founder of the non-profit Center for Information and Study on Clinical Research Participation.

Boston.com (Boston Globe)
August 16, 2010
Sanofi seeks efficiencies with new model

"The fully independent [industry] unit, operating under the parent company umbrella, is a break from the traditional big pharma business model and represents companies' interest in duplicating the flexibility and cost-efficiencies of small biotech and biotech-like companies,'' said Ken Kaitin, director of the Center for the Study of Drug Development at Tufts University. "The dual goals are, first, to have science rather than business drive development decisions, and second, to lower costs by keeping overhead and resource demands to a minimum.''

Medical News Today
August 9, 2010
Complexity Of Clinical Trials Mitigated By Therapeutic Expertise

Research recently completed by the Tufts Center for the Study of Drug Development linked clinical study complexity to increased research costs. Tufts researchers found, for example, the median number of procedures per clinical trial increased by 49% between 2000-03 and 2004-07. The total effort required to complete those procedures grew by 54%.

Bloomberg
August 5, 2010
Pfizer May Gain as U.S. Devises Speedy Alternative to Animal Safety Tests

About 30 percent of potential drugs that pass animal testing make it through the first two of three phases of human trials usually needed for U.S. regulatory approval. Almost a third of those medicines typically fail in the final phase, according to Joseph DiMasi, a researcher at Tufts University in Boston, Massachusetts, and Henry Grabowski, of Duke University in Durham, North Carolina, in a 2003 study published in the Journal of Health Economics.

Nature Medicine
August 2010
After Avandia, some seek split in drug approval and monitoring

Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development in Boston, sees significant improvements in the safety evaluation process at the FDA, particularly in the area of safety monitoring. ... "The FDA is now going to be looking into what your plan is once the drug has entered the market, which isn't a bad idea," Kaitin says.

Science
July 30, 2010
Is Pharma Running Out of Brainy Ideas?

[A] report, commissioned by IOM for the June meeting and prepared by the Tufts Center for the Study of Drug Development, identified 1747 drugs in development for a much longer list of disorders, including degenerative diseases like multiple sclerosis and neurological conditions like epilepsy. Indeed, the Tufts report suggests that the pipeline has expanded rapidly for many conditions in recent years. ... Moreover, when CNS drugs fail, they tend to do so in late-stage clinical trials, after a significant investment has been made, says Kenneth Kaitin, director of the Tufts center.

Investors.com
July 14, 2010
Drug Approval Process Slowing As FDA Seeks To Stress Safety

Drug developers themselves can help speed the process, says Kenneth Kaitin, director of the Tufts Center. One suggestion is to share scientific information so they don't repeat each other's mistakes, he says. "It used to be they'd rather fail alone than share in success," Kaitin said. That's starting to change. A dozen companies are sharing Alzheimer's research data, he says. They're networking more because they realize failure is more likely if they don't.