Session-5-Advanced-Therapies

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Session 5: Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

Session Chair(s)

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assessments in the gene therapy setting and will also spend time discussing the potential impact of the EMA’s draft guidance on safety and efficacy follow-up and risk management of Advanced Therapeutics which was released in February 2018.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Be familiar with the new draft guidance on safety and efficacy follow-up and risk management of Advanced Therapeutics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)

Pharmacovigilance for CAR-T Gene Therapies

Adamma Mba-Jonas

FDA, United States

Chief Medical Officer, CBER

Speaker (no slides)

Barbara Morollo, RN

Corbus Pharmaceuticals, United States

Head, Pharmacovigilance

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

Jan Petracek, MD, MSc

Ivigee, Czech Republic

CEO

Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

David Chonzi

Allogene Therapeutics, United States

Vice President, Head of PV and Epidemiology

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Pharmacovigilance and Risk Management Strategies Conference

Session 5: Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

Session Chair(s)

Barbara Morollo, RN

Speaker(s)

Pharmacovigilance for CAR-T Gene Therapies

Speaker (no slides)

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

Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics

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