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Virtual

Feb 22, 2021 7:00 AM - Feb 24, 2021 8:00 PM

(Eastern Standard Time)

Latin America Regulatory Conference

Session 5: Regulatory Pathways for IO drugs and How to Select the Right Endpoint(s)

Session Chair(s)

Carlos  Pinoargote

Carlos Pinoargote

Chief Operating Officer

BRCR Global, United States

Leonardo  Semprun, PharmD

Leonardo Semprun, PharmD

Global Regulatory Policy Lead-LatAm

MSD, Panama

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

Surrogate Endpoints that FDA Accepts to Support an Accelerated Approval of IO Drugs

Amy McKee, MD

Parexel International, United States

Chief Medical Officer and Global Head, Oncology Center of Excellence

Sacha  Wissink, PhD

Understand Surrogate Endpoints that EMA Accepts to Support an Accelerated Approval of IO Drugs

Sacha Wissink, PhD

MSD Netherlands, Netherlands

Executive Director, Regulatory Affairs Europe

Lawrence  Liberti, PhD, RAC

Observation of Endpoint Properties and their Relationship to the Regulatory Success in the Approval of Oncology Drugs

Lawrence Liberti, PhD, RAC

The Kim Center/ USC DRQS, United States

Director, D.K. Kim International Center for Regulatory Science

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