Developing treatments for rare diseases poses many challenges including but not limited to patient enrollment, clinical trial designs, poor understanding of the disease process and natural history, limited understanding of clinically meaningful endpoints, etc. Model-informed drug development (MIDD) became an essential tool to integrate knowledge from various sources and utilize modeling & simulation strategies to gain unique insight and accelerate drug development. In this webinar, we will discuss the clinical pharmacology and regulatory considerations for rare disease drug development, and the applications of MIDD approaches in rare disease drug development with a focus on physiologically based pharmacokinetic (PBPK) methodologies. We will discuss several examples where PBPK modeling has been successfully used to support development and regulatory approvals.

Presenter:
Xinyuan (Susie) Zhang, Ph.D.
Vice President, Regulatory Strategies
Physiologically Based Pharmacokinetics (PBPK) Solutions

Please note: this webinar will be conducted in Mandarin on the Xiaoeknow platform. To attend, participants will need the Wechat app.