日期： 2025 年 10 月 14 日, 星期二
时间： 10:00 am – 10:30 am (UK)
概述
Designing and preparing for FIH studies is a pivotal stage in early drug development. Success depends on strategic planning and collaboration across clinical pharmacology, DMPK, translational medicine and clinical operations. In the live webinar, experts will share how to design a high-value development program from concept to FIH by leveraging biomarkers, advanced modeling, and real-time PK/PD approaches. You’ll gain insights into adaptive, data-driven strategies that maximize therapeutic potential, accelerate decision-making, and increase the likelihood of clinical success. Case studies will illustrate how Model-Informed Drug Development (MIDD) is applied in real time to guide FIH trials.
What you will learn
- Using biomarkers to assess therapeutic potential and guide early clinical decisions
- Strategies to design a high-value development program with real time PK/PD modeling in FIH studies
- Apply Model-Informed Drug Development (MIDD) through real-world case studies
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VP, Global Head, Clinical Pharmacology & Translational Medicine
Certara 药物开发解决方案
Dr. Tong Zhu 拥有超过 25 年专注于转化医学、早期开发及临床药理学的丰富经验，对药物研发领域有着深厚的专业知识。对药物研发领域有着深厚的专业知识。她曾负责领导 Astellas 线粒体生物学重点战略，通过全球合作，帮助识别和开发针对线粒体生物学的创新药物。在 Astellas 近 14 年的职业生涯中，她曾在临床药理学与探索性开发部门担任过多个领导职务。加入 Astellas 之前，Dr. Zhu 在雅培全球药物研发部门（现为 AbbVie）的临床药理学和药物代谢动力学团队中担任了重要职位。
Vice President. 临床药理学与转化医学
Certara 药物开发解决方案
Dr. Offman 拥有 20 多年的药物开发经验，于 2017 年加入 Certara，负责 Certara 临床药理学和转化医学部门的转化药代动力学和药效学工作。Dr. Offman has supported the development of several oncology products including Asparlas (calaspargase pegol), Oncaspar (pegasparaginase) and brigatinib (Alunbrig), and was instrumental in the approval of RedHill Biopharma’s Talicia for H. pylori infection. Prior to joining Certara, Dr. Offman was responsible for clinical pharmacology and pharmacometrics at Celerion, leading study design, data analysis and interpretation for clinical pharmacology studies including first-in-human, drug-drug interactions, mass balance and special population trials. Prior to joining Certara, Dr. Offman oversaw biopharmaceutics and scientific affairs for Genpharm, a subsidiary of Merck KGaA as well as Mylan. Additionally, as a clinical pharmacologist, Dr. Offman has supported development and approval of Epanova (Omthera), XHANCE (Optinose) and Austedo (Auspex).
Vice President, Clinical Pharmacology and Translational Medicine, Certara
A pharmacist by training, William has a MSc in Toxicology and a PhD in Pharmacokinetics and Metabolism. He has 25 years of experience in Pharmaceutical companies and PK/Tox laboratories. Before joining Certara, William worked for pharmaceutical companies, headed up the Clinical PK/PD and Pharmacometrics department of a global CRO and was Senior PK assessor at the MHRA where he provided PK and PD assessments, interacting with non-clinical, pharmaceutical, medical assessors and with Company staff using appropriate CHMP and ICH guidelines. As a Member of the Modelling and Simulation Working Group to provide support to the European Medicines Agency’s scientific committees and working parties on modelling and simulation and more general methodological discussions and qualification procedures regarding modelling and simulation, he advised pharmaceutical companies on good clinical pharmacology trial design, adequacy of data, appropriate analyses and other pharmacokinetic issues relating to license applications, at company meetings.
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