Tufts Center for the Study of Drug Development

Faster approval: oncology drugs in the U.S., non-oncology drugs in the E.U.

Friday, September 7, 2012 10:45 AM

Approval times for new oncology drugs in the U.S. during the last decade were shorter than approval times for non-oncology products, while the reverse was the case in the E.U., according to a study recently completed by the Tufts Center for the Study of Drug Development.

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Study: U.S. provides faster access to oncology drugs than Europe

Thursday, July 12, 2012 11:01 AM

Cancer patients in the U.S. get faster access to more oncology drugs to treat their disease than patients in Europe, according to a recent study by the Boston-based Tufts Center for the Study of Drug Development.

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Transparency Life Sciences launches as first drug developer based on open innovation

Tuesday, January 31, 2012 02:15 PM

Transparency Life Sciences (TLS), the first drug development company based on open innovation, has officially launched, with the introduction of a prototype of its crowdsourced web platform that allows patients, physicians, researchers and other stakeholders to contribute to the design of clinical studies. 

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FDA drug approvals on the rise despite slow development time

Wednesday, May 11, 2011 01:02 PM

The FDA has passed nearly twice as many biopharmaceutical drug approvals in the last 10 years than it did in the 1990s, a news release from the Tufts Center for the Study of Drug Development (CSDD) has indicated, according to Mass High Tech.

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The economics of off-shoring clinical trials

Monday, May 9, 2011 01:11 PM

The drugs industry insists that the same strict standards apply to foreign trials as to those conducted domestically, according to a Reuters report.

"We have exactly the same protocol and exactly the same standards for our trials around the world,'' says Roche Holding chief executive Severin Schwan.  "Some years ago quality might have been a real concern. Today the situation is different. This is a reason why more trials are being conducted in emerging markets.''

Switzerland-based Roche, the world's largest maker of cancer drugs, is also conducting more trials overseas because the healthcare authorities in certain countries to see data collected from their own populations.

"I see this as an opportunity. A broader range of patients can take part in our trials and the patient population of our trials becomes ethnically more diverse ... If we do not include a certain portion of patients in our global trials, some countries might delay the approval of certain drugs,'' Schwan says.

However, for drug companies looking to globalize clinical trials, two factors are considered: time and money. The clock is always ticking down to the next drug patent expiration, and taking six months off drug development timelines can spell hundreds of millions of dollars of extra sales.

So, many in the industry are still working out just how much cheaper it really is to do clinical research in internationally.

In 2008, former GlaxoSmithKline chief executive Jean-Pierre Garnier published estimates in an article for the Harvard Business Review, stating a midsize company with 60,000 patients in clinical trials could save $600 million a year by switching 50% of its trials to low-cost places such as India and Latin America.

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Report: Some sponsors more prepared to lead the way in personalized medicine than others

Monday, April 18, 2011 08:05 AM

As the pharmaceutical industry’s investment in personalized medicine leads to development of an increasing number of targeted therapies, particularly for cancer patients, some drug sponsors have shown greater commitment and more structure in their approach than others, according to a new report by consulting firm Diaceutics.

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