Tufts CSDD Quarterly Update

Selected excerpts from recent articles

Wall Street Journal
June 17, 2010
New Effort Launched for Clinical Drug Trials

Methods for patient recruitment have improved over time with more companies making use of recruitment specialists or patient databases, but "there is a lot of hype," said Ken Getz, a senior research fellow at the Tufts Center who isn't involved in the New York collaboration. Sometimes an approach works for one study and not another, he said.

Fox Business: John Stossel's Blog
June 10, 2010
Protecting Us to Death

There is data to suggest that clinical trials are becoming more difficult to conduct, require more complex screening criteria, more data to be gathered, all at greater expense. The Tufts Center for the Study of Drug Development documents many of these trends, the most recent being the complexity of screening and data collection.

Fierce Biotech IT.com
May 31, 2010
GSK's Avandia trial faces recruitment battle

Researchers from the Tufts Center for the Study of Drug Development find that a rise in the eligibility criteria for acceptable subjects makes it hard to recruit volunteers, while an increase in the complexity of trials - thanks to the growing number of procedures per protocol - makes it hard to keep them. The more complex protocols lengthen trial timelines, discouraging subjects from participating to the end.

Xconomy
May 5, 2010
Tough Challenges for Clinical Trials

Kenneth Kaitin, director of [Tufts CSDD] says the increasing complexity [of clinical trials] comes from a number of factors, chief among them that the types of products being developed today tend to be geared towards more chronic and challenging indications. "Therefore the trials tend to be more complex," he says.

Bloomberg
April 30, 2010
Dendreon Approval Sparks New Era for Cancer Vaccines

Food and Drug Administration approval of Provenge "will definitely inform the clinical development programs of other companies" working on vaccine treatments for cancer, said Janice Reichert, a senior research fellow at the Tufts Center for the Study of Drug Development in Boston.

Kansas City Business Journal
April 16, 2010
Federal report: Competition will reduce cost of biologics

It could take as long as 10 years and $200 million to develop a biosimilar, according to the commission. The average cost to develop a biologic is about $1.2 billion, and it can be done in about eight years, according to the Tufts Center for the Study of Drug Development.

NPR: Martketplace Morning Report
April 13, 2010
Patent Reform Could Strengthen Biotech

Tufts CSDD Director, Kenneth Kaitin, in an interview with reporter Kerry Grens of Marketplace, states, "Investors are looking for assurance that there will be adequate protection of intellectual property; if not then the risk of development becomes much greater. There are a lot of small companies that, even though they have a product in development that shows signs of success, are just running out of money."

MedpageToday.com
April 12, 2010
FDA Hears Testimony on Prescription Drug User Fee Act

Two decades ago, the drug companies had to wait an average of three years for the FDA to review their applications; in 2008, the wait was just 1.5 years, said Christopher Milne, MPH, JD, associate director of the Tufts Center for the Study of Drug Development in Boston.

PRWeb.com
April 12, 2010
ClearTrial Unveils New Product Release at Partnerships in Clinical Trials Conference 2010

"Our ongoing research indicates that clinical research protocols are being conducted in more global locations at the same time that they are increasingly more complex and demanding," said Kenneth Getz, Senior Research Fellow at the Tufts Center for the Study of Drug Development. "These factors present significant challenges to the industry as it strives to achieve higher levels of efficiency and productivity."

Investor's Business Daily
April 9, 2010
If It's The Only Cure, It's Going To Cost You

Christopher-Paul Milne, associate director of the Tufts University Center for the Study of Drug Development, boils the characteristics of specialty drugs down to five elements.

FierceBiotechIT.com
April 6, 2010
Tufts' Getz sees opportunity in regulatory affairs' rising workload

"The increased volume of global work combined with limited capacity is creating much higher demand for, and pressure on, regulatory affairs professionals," says Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development.

Boston.com
April 6, 2010
Tufts: New approaches to drug development needed

Drug development alliances and partnerships may be the best approach to bring new drugs to market, according to a panel of pharmaceutical and biotech industry leaders recently convened by the Tufts Center for the Study of Drug Development.

Boston.com
April 5, 2010
In the Search for Cancer Drugs, Mice Get New Role

There are about 850 cancer drugs in clinical development, according to the Tufts Center for the Study of Drug Development, a 70 percent increase in three years.