CPSA 2012
Transforming Drug Discovery & Development Through Innovation:
Past, Present and Future
October 1 - 4, 2012
Sheraton Bucks County Hotel
Langhorne, PA
Workshop Synopsis
Monday, 12:00 pm - 4:00 pm
Pharmaceutical Sciences Workshop: A Focus on Biomarkers
Sponsored by ACS-NJ Mass Spectrometry Discussion Group and Frontage Laboratories
Moderators: Ron Kong, PTC Therapeutics and Fangbiao Li, Merck
With the advancement of new technologies, molecular biomarker becomes one of the most important aspects in the pharmaceutical development. Biomarkers can give an indication of the probable effect of treatment on patients or the extent of disease stage. Biomarker is frequently used as a surrogate endpoint for evaluating efficacy and safety in early drug development studies, safety studies, and clinical development. This workshop focuses on the application of analytical technologies and methodologies in the identification and validation of molecular biomarkers during the drug development.
Presentations:
Biomarker Development and Validation–Our Practices and Experiences
Shawn Li, Ph.D.
Director, Biologics Services
Frontage Laboratories, Inc.
Biomarkers Utilization in Early Stage Development
Omar F. Laterza, Ph.D., DABCC
Director, Immunoassays and Mass Spectrometry
Clinical Development Laboratory
Merck Research Laboratories
Using Physiologically-based PK/PD Modeling to Impact Drug Development Decision Making
Emile Chen, Ph.D.
Director, Drug Metabolism and Pharmacokinetics, Modeling and Translational Biology
GlaxoSmithKline
Innovative Biomarker Assay for the Quantitation of D3 Creatinine and Creatinine Using LC-MS/MS
Michael Leonard, Ph.D.
Investigator
PTS-DMPK-BST
GlaxoSmithKline
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