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 facilities in The Netherlands, the United States and Central and Eastern Europe, PRA offers over 275 beds for patient and subject studies worldwide. Our global teams can meet the needs of any Phase I study design required in the industry today.
PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.
We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.
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