Past Event
日期
2024 年 9 月 3 - 5 日
地点
Boston, MA
World Bispecific Summit
2024 年 9 月 5 日 | 1:00-1:30pm ET
Dose optimization strategies for bispecific T-cell engagers in oncology
John Burke, PhD
|VP, QSP Consultancy
- The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies to maximize the efficacy of a drug as well as the safety and tolerability.
- Mechanistic modeling approaches, such as Quantitative Systems Pharmacology (QSP), support this effort by enabling the selection of a more targeted clinical starting and efficacious dose in oncology.
- We will present case studies where we developed QSP models in collaboration with our partners to predict efficacious dose and determine First-in-Human starting dose.
