PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, and Proteome Sciences plc (LSE: PRM), a leading provider of protein biomarker discovery, validation, and assay development services, today announced the formation of an alliance focused on enhancing PAREXEL's biomarker capabilities for early phase clinical development. PAREXEL is using Proteome Sciences' PS Biomarker Services™ protein and peptide biomarker capabilities to support biopharmaceutical companies in making earlier assessments of new compounds in development. Proteome Sciences will assist PAREXEL early phase experts in helping biopharmaceutical companies advance biomarker discovery and qualification within clinical trials. This expanded capability allows PAREXEL to offer its customers mass spectrometric and pharmacokinetic assays for protein and peptide compounds.
"Biomarker analyses are anticipated to become increasingly important in clinical trials to understand the biological activity and safety profile of candidate therapies. Our early phase experts are focused on helping customers make better decisions faster about their compounds in development. Biopharmaceutical companies benefit from our bioanalytical and biomarker capabilities to generate reproducible and reliable data that can be interpreted for pharmacokinetic or pharmacodynamic purposes," said Michelle Middle, MB ChB, Corporate Vice President and Worldwide Head of Early Phase, PAREXEL International. "Our alliance with Proteome Sciences reinforces our commitment to provide customers with significant expertise to help them select relevant biomarkers for their development programs, interpret results, and determine implications for their therapies."
Christopher Pearce, Chief Executive of Proteome Sciences said: "We are very pleased to have PS Biomarker Services selected by PAREXEL as a preferred provider of protein and peptide biomarker services. We believe that the current regulatory requirements for biomarkers in drug development and diagnostics coupled with the need for fast, flexible and cost effective workflows have meant that specialist services will be increasingly required. Our ISO 9001:2008 facility in Frankfurt, Germany was designed to provide expert protein biomarker discovery and validation and for the development of rapid mass spectrometric-based assays to service the growing requirements of the biopharmaceutical industry."
PAREXEL early phase experts provide deep scientific insights and a broad portfolio of biomarkers and non-routine laboratory analysis. With its alliance partners, PAREXEL helps biopharmaceutical companies select and interpret the right biomarkers. PAREXEL provides access to key biomarkers in major disease categories, including oncology, hematology, neurology, cardiology, infectious diseases, endocrinology, respiratory, gastroenterology, urology, and immunology. The Company's early phase units offer fully validated analytical methods, including a broad scope of cellular and soluble biomarker analysis capabilities, and bioanalytical services for qualitative and quantitative drug, metabolite, and biomarker analysis in a variety of matrices.
PAREXEL continuously develops new analytical methods for clients, and has a database with more than 500 internally developed and validated analytical methods, which adhere to ICH and FDA guidelines. PAREXEL's bioanalytical lab provides routine safety testing and clinical chemistry and hematology analysis. The lab offers state-of-the-art chromatographic systems, including 18 LC-MS/MS instruments for use during PK sample analysis and well-equipped immunochemistry facilities for biomarker analysis. The laboratory has been audited by FDA and WHO among other audits.
PAREXEL's early phase services provide fully integrated solutions from First in Man through Proof of Concept and help biopharmaceutical companies generate better and faster go/no-go decisions about their compounds, and strive to return solid, reproducible outcomes to succeed in later-phase trials. PAREXEL's early phase capabilities include a full scope of early phase studies, specialized trial design, state-of-the-art technologies, hospital-based resources, and scientific expertise as well as vast experience in the neurology, cardiology, respiratory, and metabolism/endocrine therapeutic areas. With early phase unit locations across three continents, PAREXEL provides rapid study start-up and access to diverse patient populations in addition to healthy volunteers. For more information about PAREXEL's early phase capabilities visit: https://www.parexel.com/
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