Speakers’ Presentations

DAY 1

SESSION 1: SURROGATE ENDPOINTS AND MRD

• Overview of requirements for surrogate endpoint adoption by CHMP/EMA
  • Beatriz Flores (Medicines and Healthcare Products Regulatory Agency – MHRA, UK)
• Overview of validated methods and thresholds used to assess MRD in MM
  • Andy Rawstron (Leeds Teaching Hospitals NHS Trust, UK)
  • Bruno Paiva (University of Navarra, Spain)

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)

DAY 2

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?