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设计高价值药物研发计划:From Concept to First-in-Human (FIH)

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 this 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

Who should watch

  • Professionals at emerging biotechs and small pharmaceutical companies
  • Translational researchers and clinical pharmacologists involved in FIH planning and execution
  • Drug development leaders seeking to optimize early-stage decision-making and program value
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