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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, United States
Leonardo  Semprun, RPh

Leonardo Semprun, RPh

  • Director, Global Regulatory Policy - Latin America
  • 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

  • Vice President, Regulatory & Access
  • Parexel International, United States
Sacha  Wissink, PhD

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

Sacha Wissink, PhD

  • Executive Director, Regulatory Affairs Europe
  • MSD, Netherlands
Lawrence  Liberti, PhD, RPh, RAC

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

Lawrence Liberti, PhD, RPh, RAC

  • Adjunct Research Professor
  • Temple University School of Pharmacy, Reg. Affairs and QA Grad Program, United States

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