Immunogenicity: Regulatory and Clinical Case Studies


Managing and predicting immune response from biological therapies can be challenging to the drug development scientist, especially as new constructs and immunotherapy approaches continue to be discovered. The regulatory approaches to ensuring safety of new products needs to take into account what has been learned in the clinic to date. This meeting will review case studies of clinical candidates in order to learn the most clinically relevant information for immunogenicity, and also share insights from regulators on winning approaches for ensuring safety of biologic drugs.

Case studies of clinical relevance of immunogenicity and regulatory strategies will include:

  • Review of current knowledge of immunogenicity
  • Linking immunogenicity and aggregation
  • Analyzing immunogenicity data
  • Translational immunogenicity to predict clinical response from preclinical data
  • Therapeutic use of Treg cells in autoimmunity
  • Clinical methods for enhancing immune function
  • Improved tools for predicting immune responses
  • Ensuring success and clinical safety of human regulatory T cells (Tregs) in immunotherapy
  • Developing successful immune modulatory strategies for Fc fusion proteins and other novel constructs

Scientists who wish to present their knowledge and expertise to their colleagues are asked to click here to submit an abstract.  Remember to specify the conference that you are interested in and please provide your full contact information.

The deadline for submission is Friday, September 25, 2015.

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program.  Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

For more details on the conference, please contact:

For partnering and sponsorship information, please contact:

Christina Lingham
Executive Director, Conferences
Phone: 781-972-5464
E: clingham@healthtech.com

Jason Gerardi
(Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781-972-5452
E: jgerardi@healthtech.com

Carol Dinerstein
(Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471
E: dinerstein@healthtech.com