January 5, 2012
Drug Companies Are Taking Steps to Improve R&D Productivity
BOSTON — Jan. 5, 2012 — Although drug companies are pursuing innovative approaches to increase the pace and reduce the cost of drug development, the greatest advances will come from better coordination with development partners and improved clinical trial design, according to the Tufts Center for the Study of Drug Development.
"The next few years will show how well the research-based pharmaceutical and biopharmaceutical industry, not just large pharma, has been able to adapt and innovate," said Tufts CSDD Director Kenneth I Kaitin. "The good news is that many companies are embracing new approaches to drug development that have the potential to improve R&D productivity, including novel partnership agreements with academic medical centers and other drug companies."
He made his comments in connection with the release today of the Tufts CSDD Outlook 2012 report on pharmaceutical and biopharmaceutical trends.
The need to improve R&D productivity—creating more drugs more quickly and at lower cost—is being driven, in part, by the scheduled expiration of patents for dozens of high revenue-earning drugs over the next five years.
According to Tufts CSDD, greater R&D productivity will flow from R&D partnerships, the concentration of internal company resources on fewer, rather than more, disease areas, and improved investigative site management, among other tactics.
Near-term trends highlighted in Outlook 2012 include the following:
* Regulatory agencies, especially in the U.S. and Europe, operating under tight budgets, will be challenged to balance their obligations to protect public health and safety while taking steps to help reduce approval bottlenecks.
* Many drug sponsors will re-assess their global footprint with an eye to better manage rising costs and reduce inefficiencies associated with clinical trials in emerging regions that lack sufficient support infrastructure.
* Personalized medicine and targeted therapeutics, a major R&D focus for many biotechnology and pharmaceutical firms, will be a key driver of studies of small molecule drugs and biopharmaceuticals, especially anticancer agents, over the next decade.
* U.S. payers will increasingly question whether the benefits of new cancer drugs are worth the cost, and will look to refine their reimbursement policies for personalized medicines.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
Contacts: Tufts Center for the Study of Drug Development
Sandra Peters — 617-636-2185