Parexel Newsletter : Issue 3 - December 2008

PAREXEL - Expertise that makes the Difference

Issue No.3

December 2008

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Industry News: Clinical Trial Starts for Oncology

FDA-Regulated Clinical Trial Starts for Oncology Continue to Climb
• As measured by new commercial IND submissions to the FDA's Center for Drug Evaluation and Research (CDER), clinical trial starts for new oncology drugs grew by 13% in 2007.

Events

We invite you to visit PAREXEL at these upcoming industry events. Events are a great way to get to know our experts, discuss your outsourcing challenges, and learn how PAREXEL’s global reach, technology and expertise can help your organization..

Cover Story: Industry Agreement Advances Molecular Imaging in Clinical Trials

Advanced imaging technologies such as positron emission tomography (PET) have revolutionized the practice of medicine, allowing physicians to view biologic activity at the molecular level in the human body through the use of radiopharmaceuticals, bioluminescence agents, and other imaging biomarkers.

Expert Profile:

Denis Miller, M.D. Senior Medical Director and Oncology/Hematology Therapeutic Area Team Leader Clinical Research Services Group PAREXEL International

Dr. Miller joined PAREXEL International in 2006 following a long and distinguished career in oncology and hematology research and clinical development. His experience encompasses clinical care and teaching in an academic environment; clinical research for a non-profit foundation; and drug development for the pharmaceutical industry. Dr. Miller has worked on numerous research and clinical development.

Best Practices: Proof of Concept studies help companies save time and money while reducing risk

Nearly 43 percent of Phase III clinical trials fail to meet their primary objectives, according to the 2008 Bio/Pharmaceutical Source Book. Given that each failure costs tens of millions of dollars and years of development time, this is a sobering statistic. No biopharmaceutical or medical device company can afford such a devastating outcome in today’s highly competitive marketplace and challenging economy. Yet the failures continue to occur with disheartening regularity.