Sessions:
US (EST)：10:00-11:00am, October 16, 2025
EMEA (GMT)：10:00-11:00am, October 21, 2025
APAC (JST)：10:00-11:00am, October 23, 2025
Summary
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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Vice President. Clinical Pharmacology & Translational Medicine
Certara Drug Development Solutions
Dr. Offman has over 20 years of drug development experience and joined Certara in 2017 where he leads translational pharmacokinetic and pharmacodynamic efforts in Certara’s Clinical Pharmacology & Translational Medicine group. 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).
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