Interactive workshop with participants from academia, industry, and the regulators exploring the opportunities and challenges in tumour agnostic cancer drug development.
Sessions discussed the successes and failures of previous trials in this area, explored trial design, and discussed biomarker development for patient stratification.
LEARNING OBJECTIVES
- To understand the current landscape of tumour agnostic drug development
- To be able to discuss suitable trial designs to deliver such studies
- To develop an understanding of biomarker development and the need for agnostic tumour registrations
- To understand the regulatory environment around these registrations
TARGET AUDIENCE
The target was a multidisciplinary audience of academia representatives, EU and US regulatory bodies (EMA, FDA, National Agencies), the pharmaceutical industry, HTAs, and patient advocates.