分析部会

治療用タンパク質の免疫原性 5月3日〜4日

安全性や効能への影響という点で、免疫原性は、現在も生物製剤業界にとっての大きな懸念材料となっています。この学会は、免疫原性を促す要因、予測ツールの開発、この問題を克服するためのアプローチなどに焦点を絞り込んだもので、前臨床評価および臨床評価の戦略、リスク評価、規制面の問題や指針などに関する専門家の提言も紹介されます。

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5月3日, 木曜日

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

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