Room: KERNHEM 1-2

Time: 09:00 to 11:00
Chair: Sjaak Bot (Janssen)

Organizing FIGON partner: Regulatory Science Network Netherlands (RSNN)

A wave of innovative oncology treatments is progressing from bench to clinic. This includes treatment strategies such as chimeric T cell receptors (CAR-T) and other approaches that are categorized as Advanced Therapy Medicinal Products by the EMA. These products have the potential to transform the future of oncological treatment, but require innovative approaches concerning the risk-benefit assessment and subsequent market access. In this session we will discuss questions such as: Is the current regulatory landscape ready to facilitate registration of these innovative therapies to patients at the earliest appropriate time? Can we learn from the hurdles and barriers in the current ATMP regulation to prepare ourselves for new cancer therapies such as CAR-T?

09:00 - 09:10 Introduction

Invited lectures:

09:10 - 09:35

Regulatory considerations for ATMP based cancer therapies

Dr. Marcel Hoefnagel – Medicines Evaluation Board (CBG-MEB)

09:35 - 10:00

Planning for successful and efficient ATMP development

Dr. Harm Hermsen – Xendo

10:00 - 10:25

Access to innovative cancer therapies: the patient view

Dr. Pauline Evers – nfk

Selected abstracts:

10:25 - 10:40

Challenges in Commercial Advanced Therapy Development in Europe

Renske ten Ham - Utrecht University

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10:40 - 11:00 Panel discussion

Indicated speaker time includes 5 minutes for discussion