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Bioassays 2015
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Monday, March 23, 2015 - Tuesday, March 24, 2015

Sheraton Silver Spring Hotel, Silver Spring, MD


Bioassays 2015: Scientific Approaches & Regulatory Strategies

Thank you to all who participated and helped make Bioassays 2015 a success!  
Mark your calendars now for Bioassays 2016: April 4 - 5, 2016 at the Sheraton Silver Spring Hotel, Silver Spring, MD.  


On behalf of the Scientific Organizing Committee and CASSS, we are excited to welcome you to Bioassays 2015: Scientific Approaches & Regulatory Strategies and look forward to your participation and input March 23 - 24, 2015 at the Sheraton Hotel in Silver Spring, Maryland. Hold this date on your calendar and plan to join us at Bioassays 2015 for what will surely be an informative conference on the current thinking, strategies, lessons learned, method development and standardization approaches and technologies used for bioassays. 

The CASSS Bioassays meeting  has established itself as a premier conference and unique opportunity for participants and opinion leaders to discuss and debate current regulatory and industry topics regarding bioassays. Bioassays are a critical component of the analytical control strategies for biologics and other complex molecules. The ability of an assay to characterize and demonstrate biological activity is essential and developing such bioassays is becoming more difficult as biologic drugs are engineered to be more complex and/or have multiple modes of action. Companies are continuously challenged with developing assays that are biologically relevant for the analysis of multiple potential mechanisms. Bioassays are also used for lot release, stability, comparability and characterization studies, which requires that the assays be robust and, in most cases, suitable for a QC lab.  

Bioassays 2015 is structured to encourage attendee interaction. Each session includes case study presentations followed by a panel discussion allowing for lively dialogue between attendees from academia, industry and regulatory agencies. 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 US FDA, Health Canada and various European agencies has been strong each year. In addition, an exhibitor showcase 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. 

Bioassays 2015 will have four major focus sessions that will be rich in case studies and scientific discussion:

   • Bioassays for cell and gene therapy products
   • Bioassays to support commercialization of drug products
   • Bioassay challenges during product globalization
   • Advances in bioassay technologies and platforms

We are sure you will find Bioassays 2015 to be informative and productive, and that it will provide you with current perspectives on bioassays. We look forward to seeing you in Silver Spring, Maryland in March 2015! 


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