Belle Van Rosmalen
Director, Medical Development Eli Lilly
Seminars
Wednesday 1st October 2025
9:00 am Formulating Innovative & Patient Centred Phase 3 Trials to Improve Results for Translating More Drugs to Clinic
- Designing Phase III MASH trials to integrate robust methodologies and evaluating efficacy and safety across diverse patient populations, accelerating the path to regulatory approval to bring therapies to patients faster
- Incorporating non-invasive testing throughout Phase III trials to reduce patient burden and enhance data collection efficiency, leading to more comprehensive and patient-friendly assessments of treatment response
- Implementing patient retention strategies to ensure sustained participation in long-term Phase III studies, providing more complete and reliable data for demonstrating durable treatment benefits
Wednesday 1st October 2025
1:15 pm Roundtable Discussion: Adapting Trial Methodologies to Reflect Real-World MASH Populations to Broaden Treatment Applicability
- Implementing more inclusive trial designs that incorporate diverse patient populations to ensure trial results are generalizable to a broader range of MASH patients to lead to more effective and equitable treatment strategies
- Utilizing real-world data (RWD) and patient registries to provide valuable insights into disease progression and treatment outcomes in routine clinical practice to complement traditional trial data and enhance the development of patient-centred treatment approaches
- Exploring novel endpoints beyond traditional histology to capture the full spectrum of MASH-related outcomes, including patient-reported quality of life and long-term complications to facilitate the development of therapies that address the holistic needs of MASH patients
