Lab Views Newsletter July 2008

FDA Advisory Committee on Cardiovascular Safety
The FDA Endocrinology and Metabolic Drugs Advisory Committee recently voted to recommend that the FDA require pharma companies to establish cardiovascular safety evidence for new diabetes medicines. How will this impact the clinical trials industry? Joel Morganroth, MD, Chief Scientist at eResearch Technology, told Applied Clinical Trials that in the area of cardiovascular testing, "A core ECG laboratory can provide consistent and accurate evaluation of changes from baseline in 12-lead ECG morphology (such as new myocardial infarction pattern) plus identification of interval changes (e.g. QT prolongation and risk for sudden death from an arrhythmia) signals of which may be lost or be falsely positive using site interpreted ECGs. Site interpreted ECG data has so much variability and inaccuracies that core laboratory analysis, like other critical research endpoints, should always be employed."
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Enterprise-Wide LIMS for Pharma/Biotech Manufacturing
August 4, 2008
The Westin Hotel|Philadelphia, PA

5th Annual Congress: Partnering with Central Labs, Cardiology and Imaging Labs Europe
September 10-11, 2008
Courtyard Marriott Brussels|Belgium

2nd Annual Kinase Inhibitors
October 21-22, 2008
World Trade Center|Boston, MA

Maureen Loftus
- IBT Laboratories' new president and COO.

Yi Zhu
- ACR Image Metrix adds clinical research project manager.

Patrice Hugo, PhD
- MDS Pharma Services' Vice President of Scientific Affairs for its global central labs network.

Sally Warner, Medical Director, Medical Imaging Group for Perceptive Informatics, discusses "The Role of Labs in Imaging Components for Diabetes Trials" in our podcast series titled Challenges & Solutions in Diabetes. Click here to listen.

Parexel has expanded global clinical logistics for centralized coordination of clinical study supplies, lab services, and more.

Cordium Links' joint venture brings central and core lab services to China.

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