In a few short years, "Bioassays" has quickly established itself as a unique opportunity for participants to gain current regulatory and industry insight regarding bioassays. Bioassays are part of the foundation upon which analytical control strategies for biologics and other complex molecules are built. The ability of an assay to characterize and demonstrate biological activity is essential. Biologic drugs may have complex and/or multiple modes of action. Companies are continuously challenged with developing assays that are biologically relevant for the analysis of these different mechanisms. These methods are used for lot release, stability, and/or characterization. Therefore, these methods must be robust and in many cases, suitable for a QC lab.
Bioassays 2013 is structured to encourage attendee interaction. Each session includes a panel discussion following case study presentations allowing for lively dialogue between attendees from academia, industry and regulatory agencies on each session topic. As in previous years, we expect this format to result in additional focus on the technical and regulatory details of the topic. Regulatory participation from the FDA and European agencies has grown each year. In addition, an exhibitor and poster reception at the end of Day One will give attendees the opportunity to present additional topics and continue the day's discussion in an informal setting.
We are sure you will find Bioassays 2013 to be informative, productive and that it will supply you with current perspectives on bioassays. We look forward to seeing you in Rockville!