Dr. Shanshan Bi received her Ph.D. degree in Pharmaceutics from Peking University. She is a member of the Quantitative Pharmacology Professional Committee, Chinese Pharmacological Society.

Dr. Bi is currently the Vice General Manager, Head of Beijing Office at Linking Truth Technology (LTT) Co., Ltd.. Before joining LTT, she was the head of Clinical Pharmacology at RemeGen responsible for the ClinPharm strategy to support clinical development of RemeGen’s pipeline including antibody-drug conjugates and fusion protein products. Prior to RemeGen, Dr. Bi worked at Pfizer China and Janssen Pharmaceutical R&D as a ClinPharm lead and also a pharmacometrician to support global and China projects.

About 17-year clinical pharmacology related experience, including over 12-year industry experience, especially in clinical development of innovative drugs (participated in ~40 Phase 1/2/3 clinical trials). Expertise in early clinical development of innovative drugs, development of clinical pharmacology strategy, early clinical study design and reporting, population PK/PD analysis, modeling and simulation, preparation of clinical pharmacology summary documents for IND/BLA fillings.  Familiar with the regulatory requirements in China, with experience in supporting regulatory submissions/approvals.

博士，毕业于北京大学药学院，现担任中国药理学会定量药理学专业委员会委员。主要研究兴趣为模型与仿真及PK/PD分析方法在新药研发中的应用。

2021年6月至今，就职于北京领初医药科技有限公司，任副总经理、北京办负责人。为创新药公司提供产品在其全生命周期中所涉及的临床药理学服务，涉及从首次人体试验到向监管部门提交新药申报资料的准备；构建整体临床药理学开发策略；I/II/III期方案中临床药理学部分设计等。

曾在荣昌生物（烟台）股份有限公司担任临床药理部负责人，主要从事抗体偶联药物，融合蛋白类生物大分子的临床药理与定量药理研究，治疗领域包括肿瘤，自身免疫以及眼科疾病。先后就职于辉瑞（中国）研究开发有限公司定量药理学和临床药理学部门，主要从事辉瑞中国罕见病领域和抗感染领域大、小分子的早期及晚期开发与研究工作，并支持上市后产品的说明书更新以及临床再评价。2014年-2017年就职于强生旗下杨森制药公司的临床药理学部门，从事临床药理及定量药理学的相关工作，涉及抗病毒、抗肿瘤及抗凝药物，并支持多款产品在国内的成功获批。