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PRA Early Phase Leaders to Speak at Bioanalysis Forum
Date:6/21/2011

RALEIGH, N.C., June 21, 2011 /PRNewswire/ -- PRA, a leading Clinical Research Organization, announces that two bioanalytical experts from our Early Development Services (EDS) group will speak at the European Bioanalysis Forum being held 21-22 June 2011 in Brussels, Belgium.

On day one of the meeting, Dr. Nico van de Merbel, Scientific Director of PRA's bioanalytical laboratory in The Netherlands, will host a session titled, "The Use of Internal Standards for Macromolecule Quantification by LC-MS: Lessons Learned from Small Molecule Assays." The presentation will compare possible approaches for using internal standards in LC-MS based macromolecule assays. It also will explore each approach's analytical performance and practical utility.

Dr. Martin Nemansky, who also serves as Scientific Director of our Netherlands lab, will present, "Sense and Nonsense of Quantitative Analysis of Biologics - or Why Should We Care?" on day two. The discussion will examine critical questions concerning novel biologics, new batches of biologics and the development of biosimilars. The discussion will also evaluate a variety of assay methods for their functionality within the development and registration process of large molecule drugs.

Dr. van de Merbel's field of expertise is the bioanalytical application of chromatographic methods (HPLC, LC-MS/MS) for small molecules. At PRA, he oversees the development and validation of chromatographic methods for small molecules in biological samples. Dr. Nemansky has specialized expertise in the application of biochemical and immunological methods for the bioanalysis of large molecules. This field includes method development, validation and quantitative determination of large molecule drugs, anti-drug antibodies, biomarkers and endogenous compounds.

PRA EDS is an international group helping pharmaceutical and biotechnology clients in our Phase I development programs. Through our harmonized clinical and laboratory facil
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