Event Outline
The CDDF Annual Conference, scheduled on 3 – 5 February 2025 focussed on highly relevant topics in the development of anti-cancer drugs and offers constructive discussions with highly competent leaders in fields central to oncology drug development (patient advocates, regulators from the FDA, EMA and EU national agencies, health technology assesors, academic researchers and pharmaceutical industry). It took a deep dive into the efforts to increase diversity, representativity and inclusion, in clinical trials as well as the latest discussions on endpoints in oncology drug development. Presentations and panel discussions updated the audience on innovative clinical trial designs and on controversial topics in diagnostics. Finally, the EU health technology assessment process was reviewed with a focus on overcoming inequalities, Joint EMA/HTA scientific advice and patient participation.
Learning Objectives
- Session 1 (Joint CDDF/AAADV): Explore the open questions relating to diversity in clinical trial participation and discuss US and EU regulatory perspectives.
- Session 2: Understand the current debate on the use of endpoints in cancer drug development, the controversial perspectives on currently used endpoints as well as examples of the development of new endpoints.
- Session 3: Examine innovative clinical trial designs, incl. single arm trials and real-world data, in regulatory guidance development, case studies and academic analysis.
- Session 4: Discover and engage in the discussion of controversial topics on diagnostics in the developmen of anti-cancer treatments, incl. precision cancer diagnostics, regulatory guidance of laboratory-developed tests, an update on IVDR regulation.
- Session 5: Review the EU health technology assessment process and discuss inequalities of the approval process in the EU, understand lessons learned in the Joint EMA/HTA scientific advice process, and discuss the impact of patient participation in HTA processes.