Final ProgramCPSA 2012
Transforming Drug Discovery & Development Through Innovation:
Past, Present and Future
October 1 - 4, 2012
Sheraton Bucks County Hotel
Langhorne, PA
Session Synopsis
Wednesday, 10:15 am - 11:45 am
Innovation in Regulated Bioanalysis: Yes, It's Happening!
Discussion Leader: Shane Needham, Alturas Analytics & Naidong Weng, Janssen
The principles of GLP are now well established to ensure the quality of analytical data. The question is whether regulatory compliance hinders innovation in science. Our session, "Innovation in Bioanalysis - Yes it is Happening!", chaired by Shane Needham, Alturas and Naidong Weng, Janssen, will provide presentations that demonstrate there is science in compliance. Kicking off the session will be a presentation discussing the history, present and future of innovation in processes and procedures to make the bioanalytical lab more compliant and efficient (Science and Process in Regulatory Bioanalysis by Roger Hayes, MPI). Presentations on compliance when using high-resolution mass spectrometry and microflow and nanoflow to improve LC-MS/MS assays will be discussed (Regulation Does Not Hamper Innovation: Incorporating New Technologies and New Approaches into Regulated Bioanalysis by Anne Aubry, BMS, and Microflow LC/MS/MS in Regulated Bioanalysis - Is It Possible? by Shane Needham, Alturas). Speakers will also discuss using "fit for purpose" methods when appropriate to analyze protein biomarkers (Innovative Bioanalytical Approach for Protein Biomarkers by Wenying Jian, Janssen).
Presentations:
Science and Process in Regulated Bioanalysis
Roger Hayes, MPI Research
Innovative Bioanalytical Approach for Protein Biomarkers
Wenying Jian, Janssen
Regulation Does Not Hamper Innovation: Incorporating New Technologies and New Approaches Into Regulated Bioanalysis
Anne-Françoise Aubry, Bristol-Myers Squibb
Microflow LC/MS/MS in Regulated Bioanalysis - Is It Possible?
Shane Needham, Alturas Analytics
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