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.
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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. He has particular expertise in the rapid transition of compounds from the laboratory to proof of concept through the use of critical path technologies such as neuroimaging biomarkers, pharmacokinetic and pharmacodynamic modeling, and clinical trial simulation. He also has broad experience in clinical pharmacology, and has worked with the US Food and Drug Administration on registration strategies for CNS diagnostics and therapeutics.
As Senior Medical Director and CNS Therapeutic Area Team Leader for PAREXEL, Dr. Vornov oversees all of the company’s CNS-related clinical services and projects. “What I enjoy most about my work is being able to draw on expertise from across our global organization – from imaging to clinical to regulatory affairs – to help companies of all sizes bring their CNS products to market,” Dr. Vornov said. “I get to work with a wide variety of talented people who contribute their experiences to the team, so we all learn from each other. And I have the opportunity to participate in many different projects – from the earliest stages of development through pivotal trials and post approval – in a therapeutic area where there is a tremendous unmet medical need for effective therapies for a number of disorders, such as Alzheimer’s disease and Parkinson’s diseases. It’s very rewarding work.”
Before joining PAREXEL, Dr. Vornov was Senior Medical Director, Experimental Medicine at MGI Pharma in Baltimore, MD. He was Director of Clinical Pharmacology, Experimental Medicine, and Clinical Development at Guilford Pharmaceuticals in Baltimore prior to its merger with MGI Pharma. Dr. Vornov, who holds M.D. and Ph.D. degrees from the Emory University School of Medicine, also had a distinguished career in academic research and education. He served for 10 years on the faculty of Johns Hopkins School of Medicine in the departments of Neurology and Neuroscience, where he pursued basic research in the mechanisms of neuronal cell death, while also maintaining a clinical practice in neurology, focused on stroke. He is Board Certified in neurology.