Short Course: Comparability of Biologicals

Instructors:
Mayumi Holly, Tune Therapeutics
Nadine Ritter, Global Biotech Experts, LLC
Mark Schenerman, University of Maryland, Baltimore County

The CGTP Pre-Conference Short Course takes place on Sunday, June 6, 2027, from 09:00-17:00 EDT at the Bethesda North Marriott Hotel & Conference Center and is offered in-person only. The CGTP Pre-Conference Short Course offers a comprehensive overview of comparability in biological products, including key topics such as manufacturing changes, lifecycle management, and patient safety. The morning session will cover global regulatory guidance, including ICH Q5E, WHO guidelines, and regional perspectives from the FDA, EMA, and PMDA, alongside scientific and technical considerations like analytical similarity, clinical requirements, and risk-based approaches. The afternoon session will feature applied case studies on cell and gene therapies, therapeutics (monoclonal antibodies), and vaccines, highlighting unique challenges like autologous versus allogeneic products and process impact. We encourage professionals of all levels, from early-career to senior level, to participate in this opportunity.

The Cell & Gene Therapy Products (CGTP) Symposium takes place on June 8-10, 2027. You do not need to be registered for the Symposium to participate in the Short Course. We highly encourage attendees to participate in both the Symposium and Short Course to maximize their CGTP learning experience. 

View Short Course Program     View CGTP Registration Fees

Note: Registration for the Short Course is not included in the Symposium registration fee. The Short Course requires an additional registration, which can be added to your Symposium registration at the time of purchase. For additional information on pricing, view Registration Fees.