SESSION 1: SURROGATE ENDPOINTS AND MRD
- Overview of requirements for surrogate endpoint adoption by CHMP/EMA
- Overview of validated methods and thresholds used to assess MRD in MM
SESSION 2: CURRENTLY AVAILABLE DATA: HOW TO DEFINE THE OPTIMAL DATA
SET FOR VALIDATION?
- Walter Gregory (University of Leeds, UK) – Overview of two published meta-analyses
- In-depth look at specific data-sets; which ones meet requirements? / Individual data ‘owners’/cooperative groups
- Spain: Bruno Paiva (University of Navarra, Spain)
- UK: Roger Owen (St James’s Institute of Oncology Leeds, UK)
- Italy: Stefania Oliva (University of Turin, Italy)
SESSION 3 : THE REGULATORS’ VIEW
- Walter Gregory (University of Leeds, UK) – Clinical Development Strategy for validation of MRD as a surrogate endpoint
SESSION 4: MRD AS A SURROGATE ENDPOINT: WHAT IS BEYOND MM?
- Andy Rawstron (Leeds Teaching Hospitals NHS Trust, UK) – What hurdle for concordance with endpoints does MRD negativity need to achieve to shift practice in other indications?