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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 5: Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

Session Chair(s)

Barbara  Morollo, RN

Barbara Morollo, RN

  • Head, Pharmacovigilance
  • Corbus Pharmaceuticals, United States
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues, or cells. As such, ATMPs can be classified into three main types:
  • Gene therapy medicines that contain genes that have a therapeutic, prophylactic, or diagnostic effect
  • Somatic-cell therapy medicines that contain cells or tissues that have been manipulated to change their biological characteristics such that they can be used to cure, diagnose, or prevent diseases
  • Tissue-engineered medicines that contain cells or tissues that have been modified so they can be used to repair, regenerate, or replace human tissue This session will examine the evolving Pharmacovigilance and Risk Management landscape concerning ATMPS, and will examine the challenges of conducting meaningful product surveillance and developing patient-central risk minimization plans in the setting of advanced therapies. This session will also explore the concept of conducting benefit-risk assessments in the gene therapy setting and will also spend time discussing the potential impact of the EMA’s draft guidance on safety and efficacy follow-up and risk management of Advanced Therapeutics which was released in February 2018.
  • Learning Objective : Upon completion of this session, the participant should be able to:
    • Describe why the approach to pharmacovigilance, including signaling with ATMPs is different from other pharmaceutical products
    • Understand the complexities involved in determining the benefit-risk assessment of an ATMP
    • Be familiar with the new draft guidance on safety and efficacy follow-up and risk management of Advanced Therapeutics

    Speaker(s)

    Adamma  Mba-Jonas

    Pharmacovigilance for CAR-T Gene Therapies

    Adamma Mba-Jonas

    • Chief Medical Officer
    • FDA/CBER, United States
    Barbara  Morollo, RN

    Speaker (no slides)

    Barbara Morollo, RN

    • Head, Pharmacovigilance
    • Corbus Pharmaceuticals, United States
    Jan  Petracek

    Benefit-Risk Management of Recently Authorized ATMPs in the EU – Lessons Learned

    Jan Petracek

    • Director
    • Institute of Pharmacovigilance, Czech Republic
    David  Chonzi

    Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

    David Chonzi

    • Vice President, Head of PV and Epidemiology
    • Allogene Therapeutics, United States