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Session 5: Regulatory Pathways for IO drugs and How to Select the Right Endpoint(s)
Session Chair(s)
Carlos Pinoargote
Chief Operating Officer, BRCR Global, United States
Leonardo Semprun, PharmD
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
From a medical and clinical point of view, it is important to point out that, when a disease is found in different stages, clinical studies to determine the safety and efficacy of the treatment are designed accordingly and regarding the disease to be treated /stage in which it is found. The intend of this session will be to discuss primary endpoints criteria of the clinical studies of IO drugs. In this session, we could bring with SME´s some of the most used valuation criteria. Guidance documents from the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) include endpoints that demonstrate clinical benefit and therefore can be used as primary endpoints in clinical trials seeking regulatory approval.
Learning Objective : - Understand surrogate endpoints that FDA/EMA accepts to support an accelerated approval of IO drugs
- Understand factors associated with regulatory success in the approval of Immune oncology (IO) drugs based on primary end points
Speaker(s)
Amy McKee, MD
Chief Medical Officer and Global Head, Oncology Center of Excellence, Parexel International, United States
Surrogate Endpoints that FDA Accepts to Support an Accelerated Approval of IO Drugs
Sacha Wissink, PhD
Executive Director, Regulatory Affairs Europe, MSD Netherlands, Netherlands
Understand Surrogate Endpoints that EMA Accepts to Support an Accelerated Approval of IO Drugs
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Observation of Endpoint Properties and their Relationship to the Regulatory Success in the Approval of Oncology Drugs