ANALYTICAL STREAM

3rd Annual

Immunogenicity of Protein Therapeutics May 3 - 4

Immunogenicity continues to be a major concern for the biologics industry regarding its impact on safety and efficacy. This event examines factors that contribute to immunogenicity, development of predictive tools, and approaches to overcome this problem. It also presents expert advice on pre-clinical and clinical assessment strategies, risk assessment and regulatory considerations and guidance.

Day 1 | Day 2

THURSDAY, MAY 3

12:00 pm Registration

Predictive Methods For Immunogenicity

1:30 Chairperson's Opening Remarks

1:40 Beyond in silico: Advancing Pre-Clinical Immunogenicity Testing

Jack Ragheb, M.D., Ph.D., Principal Investigator, Immunology, Therapeutic proteins, CDER/FDA - Biography

"Humanized" mice that fully recapitulate the human hematopoietic system may permit direct in vivo assessment of human immunogenicity to a therapeutic protein. This session will describe the nature, limitations, utility, and predictive value of in vitro and in vivo model systems. Case studies will illustrate how pre-clinical data and a risk-based assessment may help inform the probability of immunogenicity in humans.

2:10 Amgen's Perspective on Immunogenicity Prediction Tools and Efforts

Theresa J. Goletz, Ph.D., Senior Personalized Healthcare Leader, Clinical Immunology, Amgen, Inc. - Biography

Sponsored by
2:40 Sponsored Presentation Speaker to be Announced

2:55 Sponsored Presentation (Opportunity Available)

3:10 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00-5:00 Problem Solving Breakout Discussions

Day 1 | Day 2