DAY 1
Session 1: Opportunities & challenges with clinical trial design for early & accelerated development plans
- Jaap Verweij (Erasmus MC) – Introduction to opportunities and challenges with Clinical Trial Design
- Blanca Garcia Ochoa (EMA SAWP, AEMPS) – Current challenges and opportunities with CTs in oncology – a regulatory agency point of view
- Stefan Schwoch (Lilly) – Current challenges and opportunities with CTs in oncology – an industry point of view
- Axel Hanauske (Lilly) – Innovations and combinations for novel anticancer strategies
- Irene Braña (Vall d’Hebron Institute of Oncology, VHIO) – Present on Basket of Baskets or other clinical trials to show relevance of innovative trial design today
- Volker Wacheck (Lilly) – Innovative Oncology Study Designs – industry experience and case studies
Session 2: Innovative clinical trial designs to accelerate development & approval
- Dominik Heinzmann (Roche) – Possibilities and risks associated with directly moving from Phase I to Phase III: An opportunity for adaptive designs?
- Olivier Collignon (Luxembourg Institute of Health, seconded national expert to the EMA) – Current statistical considerations and regulatory perspectives on the planning of basket/umbrella trials and on the integration of historical controls
- Paolo Bruzzi (National Cancer Research Institute Genoa) – Heterogenous populations: subgroup analyses for survival benefit (and enrichment potential)
DAY 2
Session 3: Innovative clinical trial designs to accelerate development & approval (continued)
- Jorge Camarero (AEMPS) – Data requirements from early trials in the context of an MAA
- Jan Gross (Merckgroup) – A snapshot on the regulatory environment of accelerated developments
Session 4: A new framework for planning, conducting and interpreting clinical trial results: Estimands
- Frank Bretz (Novartis) – How the ICH E9 addendum around estimands may impact our clinical trials
- Steven Teerenstra (MEB and University Medical Center Nijmegen) – Expectations and advice from regulators how to use the new framework of estimands in clinical trials
- Kaspar Rufibach (Roche) – Treatment effect measures for time-to-event endpoints – Estimands and beyond
Session 5: Opportunities and challenges when implementing PHC concepts into clinical trial designs
- Rosa Giuliani (SAG-O EMA, San Camillo Forlanini Hospital Rome) – A clinical/regulatory perspective on experience so far with biomarkers in EU approvals – Outlook and Challenges
- Heinz Zwierzina (Medical University Innsbruck) – Treatment decision making based on molecular phenotyping
- Claudia Dollins (Merckgroup) – Impact of clinical trial design on potential IVD regulatory claims