分析部门

治疗用蛋白质的免疫原性 5月3日～4日

免疫原性在对安全性和效能的影响上，现在仍为生物制剂业界的一大隐忧。本学会聚焦在促使免疫原性的因素、预测工具的开发、克服此问题的方法等，并也介绍前临床评价以及临床评价的策略、风险评价、法规面的问题和方针等相关专家的建议。

第1天 | 第2天

5月3日, 星期四

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

第1天 | 第2天