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News & Press: General News

2018 Year In Review

Sunday, January 20, 2019  
Posted by: Stephanie Flores
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CASSS continued to grow and strengthen its global community in 2018, with participation up 9% over the prior year.  We attribute the growth to focusing on what matters most to our members: interactions with regulatory agencies and industry colleagues from around the globe; and the opportunity to explore and learn about new and emerging trends and challenges in the field of biopharmaceutical development.  

Two key accomplishments in 2018 were a 30% increase in regulatory agencies joining CASSS, and the successful launch of a symposium dedicated specifically to unique manufacturing, quality and regulatory considerations for Cell & Gene Therapy Products in July.

Since the start, CASSS symposia and forums have consistently been valued and supported by the U.S. Food and Drug Administration. Representatives serve on the scientific organizing committees, give presentations and participate in both formal and informal discussions throughout CASSS’ portfolio of meetings.  This interaction benefits both the agency and industry through valuable insights and greater understanding of issues that need more attention and exposure to new trends and technologies. Given the global nature of the industry, CASSS is working to expand that interaction to health authorities around the globe.  In 2018 we reached 346 regulatory participants from 26 countries, up from 20 in 2017.


Regulatory Participation Map

The second area of accomplishment was the successful launch of the Cell & Gene Therapy Products (CGTP): Manufacturing, Quality and Regulatory Considerations conference in July 2018.  The meeting was punctuated by an opening keynote by Peter Marks, Director, Center for Biologics Evaluation and Research, FDA, followed later by the announcement by Denise Gavin, CBER, FDA, of six new guidances released by the agency.  Attendees remarked on the useful insights they gained about various approaches that companies are taking and differences between the US and European regulatory perspectives.

CGTP 2019 is currently being planned for June 10 – 12, 2019 in Bethesda, MD.  Find out more about this, and all of CASSS’ 2019 portfolio at

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