The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).

Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.

The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.

This audio conference covers:

• Development of a risk assessment strategy
• Minimum expectations of immunogenicity methods
• Timelines for implementation & execution of effective immunogenicity programs
• Phase and risk appropriate design of sample sampling
• Productive integration of immunogenicity results into clinical trials
• Case studies of late phase immunogenicity programs of relevant biopharmaceuticals

About the speaker:

Ana T. Menendez, Ph.D. is Senior Director of Biotechnology at Catalent, a full-service solution provider to the biopharmaceutical industry. Dr. Menendez joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and was responsible for the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody – toxin conjugate that was approved in 2000.

Dr. Menendez obtained her Ph.D. in Microbiology/Immunology from NY Medical College. She is an international speaker and course instructor on Immunogenicity and Bioassay Method Development and Validation.

Who should attend?

• Regulatory Affairs
• Quality Assurance & Quality Control
• Clinicians
• Scientists
• Toxicologists
• Pharmacologists
• Clinical Research Associates
• Laboratory personnel