OATP1A2 and P-gp expression level dependent transport of zolmitriptan and fexofenadine across MDCKII monolayers

Outsourcing and Standardization of Global Studies Joseph F. Bower Ph.D., MBA Covance Laboratories, Inc. The global biologics drug market continues to expand and increase its portion of the global pharmaceutical market. While biologics only accounted for 15% of the global pharmaceutical market’s revenue in 2012; the top three drugs in 2012 were all biologics. This portion will rapidly increase as Biosimilars and other new technology platforms (ADC, Gene Therapy) begin to hit the global market. In addition, the regulatory landscape is continuously evolving and becoming much more challenging to navigate. Therefore, it is imperative that companies partner with providers who have experience and expertise in supporting biotherapeutics across multiple global clinical trials as well as those who have a strong global presence. Case studies will be reviewed to highlight challenges faced with cross validating immunoassays across multiple global sites to support clinical trials. These will identify strategic approaches and outcomes and highlight lesson learned precipitating a strategy to ensure your approach consistently delivers quality bioanalytical results from site to site. Speaker: Joseph F. Bower Ph.D., MBA Executive Director Immunochemistry Services Covance Laboratories, Inc Mobile: 571.423.8213 Presentation only No poster