A Prescription for R&D Refills


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Product Description

According to the Outlook 2010 report from the Tufts Center for the Study of Drug Development (CSDD), worldwide sales for all drugs coming off patent from 2009 through 2012 will exceed $88 billion. Drug developers and the U.S. Food and Drug Administration have worked hard to speed up the drug-development process; total average clinical time dropped by 10% from 1992 through 2007, even as trials became more complex, while average approval times declined by nearly 60%. Despite these improvements, it still takes an average of more than $1 billion and 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, the report found.
“The simple fact is that product launches are not keeping pace with patent expirations,” says Tufts CSDD Director Kenneth Kaitin. “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…

R&D, Biotech Hit Hard by Downturn

Bob Webber, Bioclinica – Many life-sciences ­companies are eager to benefit from SharePoint capabilities, but may be unsure how its capabilities can be leveraged in the highly ­regulated world of clinical trial management.
Bill Gwinn, i3 – There are several ways to measure and describe investigators: location, ­experience, hosptial affiliation, age and gender, foreign ­languages spoken, adverse actions, and specialty.
Lori Shields, Medidata – The overarching need to stay within budget remains, yet it will be ­important to be aware that the cost of executing clinical trials
is definitely on the rise.
Jon DeVries, Merge Healthcare – Perceptions of imaging technology are changing — imaging is increasingly viewed as one of the most ­powerful cost-savings strategies to measure and monitor the effects of the drug or device under evaluation.

Thought Leaders
David Apelian, M.D., Ph.D. Senior VP, Research & ­Development and Chief Medical Officer, GlobeImmune Inc., a private biopharmaceutical company developing novel treatments for infectious diseases and cancer. For more information, visit
Nathaniel A. Brown, M.D. Chief Medical Officer and Senior VP, Clinical Development, Presidio Pharmaceuticals Inc., a specialty pharmaceutical company dedicated to the discovery and development of small-molecule antiviral therapeutics for novel and validated targets. For more information, visit
Simon Craw, Ph.D. VP, UniStemCell, International Stem Cell Corporation (ISCO), a developer of parthenogenesis stem-cell ­technology that promises to advance the field of regenerative medicine by addressing the problem of immune rejection. For more information, visit
Jeffrey Kasher, Ph.D. VP for Global Clinical Development, Eli Lilly and Company, a global healthcare and pharmaceutical company. For more information, visit
Kenneth I. Kaitin. Director, Tufts Center for the Study of Drug Development (CSDD), an independent nonprofit research group affiliated with Tufts University, which offers analyses and commentary on pharmaceutical issues. For more information, visit
Maria Smith. Global Head, Operations — Affiliate Management, Product Development, Roche, a research-focused healthcare company with combined strengths in pharmaceuticals and diagnostics. For more information, visit
Douglas Winship. VP of Regulatory Operations, Catalyst ­Pharmaceutical Partners Inc., a specialty pharmaceutical company ­developing and commercializing prescription drugs for the treatment of drug addiction. For more information, visit