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Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!

Session 11: Immuno-oncology – The benefits and the Safety Challenges

Session Chair(s)

Stephen  Knowles, MD, MRCP

Stephen Knowles, MD, MRCP

  • Chief Medical Officer
  • Halozyme Therapeutics, United States
William  Gregory, PhD

William Gregory, PhD

  • Senior Director, Safety and Risk Management
  • Pfizer Inc, United States
The introduction of immuno-oncology (IO) agents (e.g., checkpoint inhibitors) into the clinic has led to huge improvements in the treatment of solid tumors. With these benefits come significant concerns related to immune-mediated organ toxicity which can be severe or fatal and requiring prompt recognition and treatment. An overview of the underlying biology of checkpoint inhibitors will be presented, along with how this translates into safety concerns and how these risks are monitored, assessed, and managed from an industry perspective. This will be followed by a discussion of the challenges facing regulatory agencies in assessing the benefit-risk balance of these agents, how this is evolving as the experience with these agents has increased in the post-approval setting, broader prescriber base and different tumor types, and how this translates into ensuring a positive benefit-risk through continued safety surveillance and risk mitigation measures.
Learning Objective : Upon completion of this session, the participant should be able to:
  • Describe the mechanism of action of IO agents and how this can lead to adverse events
  • Describe the approach taken to monitoring the safety of IO agents
  • Understand the benefit risk assessment needed for these agents


Oswaldo L Bracco, MD

Assessment and Management of Immune-Mediated Events Occurring with Immune Checkpoint Inhibitors

Oswaldo L Bracco, MD

  • Associate Vice President Oncology Early Phase and External Collaborations
  • Merck & Co, United States
Margaret   Thompson

Challenges of Safety Labeling for Anti-PD1/PD-L1/CTLA-4 Agents

Margaret Thompson

  • Medical Officer,Melanoma and Sarcoma Team
  • Division of Oncology Products 2 (DOP2), FDA, United States
Ashley  Ward, MD

Risk-Benefit Considerations for Immuno-Oncology Products

Ashley Ward, MD

  • Senior Director, Clinical Development
  • Foundation Medicine, United States