I have always maintained that killing bad products early is crucial to long-term success. I can think of a couple of biotechs that need to read this report: <g>
Wednesday May 16, 7:59 am Eastern Time
Press Release
Quicker R&D Decisions Are Key to Improving Drug Success Rates, According to the Tufts Center for the Study of Drug Development
BOSTON--(BW HealthWire)--May 16, 2001--The sooner pharmaceutical companies terminate drugs in development that are unlikely to succeed -- either clinically or economically -- the better able those firms will be to finance the discovery and development of new drugs that will provide significant value, according to a recently completed study by the Tufts Center for the Study of Drug Development.
``Drug companies are becoming more efficient in developing new medicines that are eventually approved for marketing, and they're doing it by terminating research on unpromising compounds sooner rather than later,'' said Dr. Kenneth I. Kaitin, director of the Tufts Center. ``This is good practice, because the sooner unsuccessful compounds are terminated, the more quickly resources can be re-deployed to investigate other, potentially more promising compounds.''
He said that delayed product termination ``increases costs, clogs the research pipeline with compounds unlikely to achieve success, and disappoints stakeholders, including company shareholders, project teams, service providers, and patients.''
The study, done under the direction of Dr. Joseph A. DiMasi of the Tufts Center, examined data provided by 24 parent pharmaceutical firms worldwide on new chemical entities (NCE) investigated in human subjects anywhere in the world, or on NCEs for which the firm was the first to file a U.S. investigational new drug application. Current success rates were examined through the end of 1999.
Despite the good news, Kaitin noted that, ``Although limited commercial markets or insufficient return on investment are gaining ground as the primary reasons for terminating compounds, killing off compounds for economic reasons still tends to occur relatively late in development.''
The study found that:
Economic- and efficacy-related factors have become more prevalent as the primary reasons for terminating compounds.
Median time to research abandonment or marketing approval decreased from 4.9 years to 4.3 years over a 10-year period.
Attrition rates are greatest in Phase II of clinical development, where more than half of the investigated compounds failed.
Approval success rates vary by therapeutic class, with anti-infectives enjoying the greatest likelihood of eventually obtaining marketing approval.
About the Tufts Center for the Study of Drug Development
Based in Boston, Mass., and affiliated with Tufts University, the Tufts Center for the Study of Drug Development (www.tufts.edu/med/csdd) provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. The Tufts Center conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics throughout the year.
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Contact:
Business Communication Strategies
Peter Lowy, 781-326-9980
or
Tufts Center for the Study of Drug Development
Peg Hewitt, 617-636-2185
Note that ARQL believes that their new in silico ADMET software can kill bad compounds early. ADMET failures are the biggest reason for small-molecule drug failures.
Peter |
