Agenda Details

ROUNDTABLE (GRP) Twice the Challenge? Gene Edited iPSC derived T-Cell and NK/NK-like Products for Cancer Therapy

Wednesday, May 31, 2023 08:00 AM - 09:00 AM

Room 243

GRP

Roundtable

Are T cell and NK-like lines multiplying the regulatory and safety challenges in this new dawn of human therapy?

Moderator
Dominic Wall, BSc (Hons), PhD, FFSC (RCPA), Executive Director of Business Ventures & CEO,
Peter MacCallum Cancer Centre & Cell Therapies Pty Ltd, Australia

Panelists
Stephen Sullivan, PhD, MBA, Chief Operating Officer, iPSirius, France
Paula Salmikangas, PhD, Director of Biopharmaceuticals and ATMP, NDA Group AB, Finland
Shinichi Noda, Deputy Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA) ), Japan

Learning Objectives

To what extent can the quality attributes of an iPSC derived product be supplemented or superseded by the targeted product attributes developed with down-stream modification for the edited products?
How comparable and extensive does the limit of detection and sensitivity of the safety testing for editing fidelity and off-target modifications need to be to enter the clinic and how should these relate to the final product as opposed to the derived lines?
Is there agreed consensus on the clinical quality attributes of iPSC derived lines, and does this extend to further modifications that have enhanced the effector or immune function of these products?

Speakers/Moderators

Dominic Wall BSc (Hons) PhD FFSc (RCPA) GAICD
Executive Director of Business Ventures & CEO
Peter MacCallum Cancer Centre & Cell Therapies Pty Ltd
Moderator

Shinichi Noda
Deputy Review Director, Office of Cellular and Tissue-based Products
Pharmaceuticals and Medical Devices Agency (PMDA)
Panelist

Paula Salmikangas PhD
Director of Biopharmaceuticals and ATMP
NDA Group AB
Panelist

Stephen Sullivan PhD MBA MSc
Chief Operating Officer
iPSirius
Panelist

Session Details