Contact Information: Contact: Tufts Center for the Study of Drug Development Charlene Neu 617-636-2187 Business Communication Strategies Peter Lowy 617-734-9980
Drug Companies Still Under Pressure to Increase Pace of Development, According to Tufts Center for the Study of Drug Development
BOSTON, MA--(Marketwire - January 6, 2010) - Although drug developers are improving R&D
efficiency, in part by terminating more unpromising drugs earlier in
development, their continued success will depend on how well they partner
with other firms at specific points on the development spectrum, according
to the Tufts Center for the Study of Drug Development.
"Developers have made important progress in reducing R&D times, but because
only three in 10 new drugs, on average, generate sufficient revenue to
sustain R&D, pharmaceutical and biotech firms are under great and growing
pressure to generate revenue to bring more products to market," commented
Tufts CSDD Director Kenneth I Kaitin in connection with the release today
of the Tufts Center's Outlook 2010 report on pharmaceutical and
biopharmaceutical trends.
"The simple fact is that product launches are not keeping pace with patent
expirations," he added.
According to Tufts CSDD, worldwide sales for all drugs coming off patent
from 2009 through 2012 will exceed $88 billion. Currently, it costs, on
average, more than $1 billion and takes more than seven years from the
start of clinical trials to conduct the necessary studies and win approval
to market a new drug in the United States.
Kaitin noted that while new technologies and improved protocol designs are
helping to improve R&D efficiency, "Future success for many sponsors will
depend on their ability to collaborate with other drug companies, and how
well they engage and partner with outside service providers."
Among the near-term trends cited in the Tufts CSDD's Outlook 2010 report
are the following:
* More firms will focus on improving clinical protocol design -- to help
reduce trial costs and speed development cycles -- to mitigate a trend
toward increased protocol complexity.
* After the U.S. Congress concludes the current health care reform debate,
a more activist Food and Drug Administration will focus on a regulatory
pathway for follow-on biologics approvals, over-the-counter product and
drug safety, foreign facility inspections, preventable deaths from chronic
diseases, and vaccine manufacturing capacity.
* Clinical development time for novel protein products, which now averages
seven years, is unlikely to decrease due to disease complexity, growth of
study protocols that lengthen studies, and difficulty recruiting and
retaining volunteers.
* Off-label prescribing of biopharmaceuticals in the U.S. will be subject
to increased economic scrutiny, such as comparative effectiveness
assessments, drug utilization reviews, and prior authorization.
* A tougher global operating environment that is forcing marginal research
sites to exit clinical development will ultimately create a less fragmented
global development landscape; higher performing research investigators will
be available to partner with sponsors.
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 the Tufts
CSDD Impact Report, a bi-monthly newsletter providing analysis and insight
into critical drug development issues.