First in Human (FIH) Dose Selection: from Basic Concepts to Novel Considerations

First-in-Human (FIH) Dose Selection is a key consideration in the drug development of new promising drug candidates. Such estimation involving cross functional expertise and collaborations is essential for the design of efficient and successful Phase 1 clinical trials. FIH dose is based on the Regulatory requirements and the concept and strategy differ depending on drug modality, from small molecules to innovative biotherapeutics.

The GMP FIH workshop will provide insights of the FIH dose estimation for synthetic and biologic molecules such as bispecific mAbs, antibody drug conjugate, RNA therapeutics or CAR-T cell therapies with illustrated case studies. Challenges and future considerations will also be discussed.

This workshop will be held in Paris 75012 on Oct, 17th 2023. Seats are available here.