Parexel Newsletter : Issue 1

PAREXEL - Expertise that makes the Difference

Issue No.1

February 2008

In This Issue

Industry News: CNS Trials

CNS Trials Almost 15% of ALL FDA-Regulated Clinical Trials in 2007--PAREXEL Report

Clinical studies for neurology drugs represented 8.9% percent of all FDA-regulated clinical trials in 2007, according to a new study released in PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook. The study also found that trials for psychiatric therapies comprised another 5.5% of studies regulated by the FDA.

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.

The Beginning of it All

Welcome to the first edition of the PAREXEL Newsletter. Published quarterly, each issue will focus on a significant industry topic, offering best practices, industry news and profiles an expert in the field should you have additional questions. We hope you find this a valuable resource. To subscribe to your own copy, simply click on the link provided. We appreciate your feedback - Please let us know your thoughts and any suggestions for upcoming issues.

Cover Story: Imaging and Neurodegenerative Diseases

Imaging technologies open new horizons for CNS research
The aging of the population in North America, Western Europe, and Japan is bringing increased research focus on Alzheimer’s disease (AD), Parkinson’s disease (PD), and other neurodegenerative disorders that affect significant numbers of older people. In the US alone, more than 4.5 million people are estimated to be afflicted by AD – about 10 percent of the population over 60. Some studies predict that the number of AD patients will reach 13 million by 2050 unless an effective AD treatment is discovered.

Expert Profile

James Vornov, M.D, Ph.D.
Senior Medical Director & CNS Therapeutic Area Team Leader
Clinical Research Services Group
PAREXEL International

Dr. Vornov brought nearly 20 years of experience in neuroscience and drug development to PAREXEL when he joined the company in 2006. An internationally recognized clinician and scientist, Dr. Vornov has worked in multiple central nervous system (CNS) therapeutic areas, having directed programs in Parkinson’s disease, stroke, neuropathic pain, diabetic and chemotherapy-induced peripheral neuropathies, and brain tumors.

Best Practices

Patient Recruitment
Patient recruitment is one of the biggest challenges facing the pharmaceutical industry today. With a growing number of potential new drugs entering clinical development, the competition for qualified patients is intensifying. Shortfalls in key recruitment milestones such as “last patient in” (LPI) can create costly delays at a time when sponsors are under pressure to reduce expenses and bring new products to market as quickly as possible.