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治疗药物的免疫安全评估中的挑战和差距:IQ DruSafe调查

Mark Collinge¹, Haley Neff-LaFord², Surekha Akella³

¹Pfizer Inc., Groton, CT, USA.

Regulatory toxicology and pharmacology : RTP

|April 20, 2024

概括

免疫安全评估面临着新疗法带来的挑战. 行业调查突出显示,需要更新指导方针,改进非临床模型,以及改进将研究结果转化为临床环境.

科学领域:

免疫毒理学和免疫安全科学
由新模式和免疫瘤学推动的进步.

背景情况:

免疫毒理学的快速发展需要更新的评估策略.
在当前的免疫安全评估,工具应用和数据解释方面,行业面临着挑战.

研究的目的:

了解当前免疫安全评估中的关键挑战,科学差距和局限性.
评估T细胞依赖抗体反应 (TDAR) 和细胞因子释放试验 (CRA) 的行业需求,工具,监管反和实践.

主要方法:

开发了一项调查,并分发给行业专业人士.
该调查重点关注当前的做法,挑战以及监管反的影响.

主要成果:

受访者认为现有的ICH S8指南对于当前的免疫调节剂和新模式是不够的.
确定的差距包括非临床评估的临床翻译和缺乏相关的非临床物种/模型.

结论:

显然需要更新ICH S8指南,以满足行业对新疗法的需求.
诸如体外模型,微生理系统和人性化小鼠模型等新兴领域对未来的免疫毒性评估充满希望.

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