This workshop is aimed at all relevant stakeholders in cancer drug development, patients, academic researchers, regulatory agencies and pharmaceutical companies. It will address the latest developments in the use of endpoints in cancer drug development. It focuses on the assessment within the context of other data from clinical trials and looks to define a problem-solving, multi-stakeholder approach to the future development of endpoints. The workshop will focus on discourse-inducing presentations and interactive panel discussions.
- Understanding of past achievements and current challenges in the definition and assessment of endpoints
- Assess the challenges and possible solution in the assessment of time-to-event endpoints
- Updated knowledge on novel endpoints, like measurable residual disease or circulating tumour nucleotides, and possible pathways for validation
- Understanding of strategies to improve the use and overcome obstacles in the use of patient-reported outcomes in cancer drug development
- Develop awareness for the use of endpoints in expedited regulatory pathways.
- Address the current challenges with the definition and contextualisation of endpoints in drug development and commercialisation
- Focus on a problem-solving aspect through debates and multi-stakeholder panel discussions.
The target is a multidisciplinary audience of academia representatives, EU and US regulatory bodies (EMA, FDA, National Agencies), pharmaceutical Industry, HTAs and patient advocates.