January 27, 2011
Translational Science Expected to Play a Growing Role in Creating New Drugs
BOSTON —Jan. 27, 2011 — To produce drug candidates at the pace needed to remain competitive, pharmaceutical and biotech companies increasingly are using translational science to make decisions about what targets to pursue and how to allocate resources, according to a panel of pharmaceutical and biotech industry leaders and academics recently convened by the Tufts Center for the Study of Drug Development.
"Traditional drug development approaches still have utility, but they likely won't produce enough new drugs fast enough," said Tufts CSDD Director Kenneth I Kaitin. "Translational science offers an important step forward by helping to shorten the time needed to develop solutions in human health and disease based on new, basic research discoveries."
Driving the need to bring new prescription drugs to market faster, according to Kaitin, is the high cost of development—currently about $1.3 billion to develop and gain regulatory approval for each product—as well as the pending expiration of patents on dozens of top-selling drugs in the next few years.
"The encouraging news is that developers are engaging in a wide range of strategies to change the way they operate, including greater use of development partnerships, mergers and acquisitions, and in- and out-licensing agreements, in addition to implementing new approaches to portfolio optimization and development," Kaitin said.
The executives, who met as part of the Tufts CSDD Executive Forum Roundtable, also agreed that:
* Universities and research hospitals will continue to help identify breakthroughs in basic research that may translate into clinical development opportunities, but validating new technologies and identifying specific markets for discoveries made in academic settings remains a key challenge.
* Biomarker development, critical to moving development rapidly from discovery validation to clinical validation, needs to start early in drug development and needs to be actively governed.
* Advances in computers, telecommunication, and imaging technologies hold promise as emerging tools in translational science.
SCHEDULED TUFTS CSDD EXECUTIVE FORUM ROUNDTABLES
Upcoming Tufts CSDD Executive Forum Roundtable meetings will focus on the following topics:
Feb. 24, 2011 — Managing Global Investigative Sites for Peak Operational Efficiency
May 19, 2011 — Management Implications of the Global Regulatory Environment
Sept. 15, 2011 — Designing and Maintaining Successful Innovation Partnerships
Nov. 3, 2011 — Strategies to Optimize Performance and Manage Pipeline Risk
To learn more, call 617-636-2170.
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
Robert Chung — 617-636-2187
Business Communication Strategies
Peter Lowy —617-734-9980