ROUNDTABLE Lack of Harmonization in CGT: Can we Achieve Global Convergence?
Wednesday, May 31, 2023 10:45 AM - 11:45 AM
Room 251
Regulation & Reimbursement
Roundtable
Should convergence on CGT names, regulation and manufacturing be an objective for the field?
Moderator
Massimo Dominici, MD, Professor of Medical Oncology, Director of Oncology and Cell Therapy Laboratory, University of Modena and Reggio Emilia, Italy
Co-Moderator
Ilona Reischl, PhD, Chair, EMA Committee for Advanced Therapies, Austria
Panelists
Raffaella Balocco Mattavelli, PharmD, Head, INN Programme and Classification of Medical Products, World Health Organization, Italy/Switzerland
Marisa Delbò, PharmD, Chair of the Coordinating Committee of the Expert Circle on Human Blood, Tissues & Cells and Advanced Therapies Medicinal Products, PIC/S, Italy
Celia Witten, MD, PhD, Deputy Director, Center for Biologics Evaluation and Research, FDA, USA
Session Description
The recent developments in cell and gene therapies (CGT) are positively impacting global health. At the same time, they are opening challenges on how the field can be harmonized from a nomenclature, regulatory and GMP manufacturing points of view. This roundtable will be focused on these aspects involving key stakeholders such as WHO, regulatory agencies and GMP inspectors. Panelists will share their experience and vision on the topic providing a perspective on the harmonization of CGT at different levels, starting from existing efforts for an improved impact and a global patient benefit.
Moderator
Massimo Dominici, MD, Professor of Medical Oncology, Director of Oncology and Cell Therapy Laboratory, University of Modena and Reggio Emilia, Italy
Co-Moderator
Ilona Reischl, PhD, Chair, EMA Committee for Advanced Therapies, Austria
Panelists
Raffaella Balocco Mattavelli, PharmD, Head, INN Programme and Classification of Medical Products, World Health Organization, Italy/Switzerland
Marisa Delbò, PharmD, Chair of the Coordinating Committee of the Expert Circle on Human Blood, Tissues & Cells and Advanced Therapies Medicinal Products, PIC/S, Italy
Celia Witten, MD, PhD, Deputy Director, Center for Biologics Evaluation and Research, FDA, USA
Session Description
The recent developments in cell and gene therapies (CGT) are positively impacting global health. At the same time, they are opening challenges on how the field can be harmonized from a nomenclature, regulatory and GMP manufacturing points of view. This roundtable will be focused on these aspects involving key stakeholders such as WHO, regulatory agencies and GMP inspectors. Panelists will share their experience and vision on the topic providing a perspective on the harmonization of CGT at different levels, starting from existing efforts for an improved impact and a global patient benefit.
Massimo Dominici MD
Professor of Medical Oncology, Director of Oncology and Cell Therapy Laboratory
University of Modena & Reggio Emilia
Moderator
Professor of Medical Oncology, Director of Oncology and Cell Therapy Laboratory
University of Modena & Reggio Emilia
Moderator
Raffaella Balocco Mattavelli PharmD
Head, INN Programme and Classifcation of medical products
World Health Organization
Panelist
Head, INN Programme and Classifcation of medical products
World Health Organization
Panelist
Marisa Delbò PharmD
Chair of the Coordinating Committee of the Expert Circle on Human Blood, Tissues & Cells and Advanced Therapies Medicinal Products
PIC/S
Panelist
Chair of the Coordinating Committee of the Expert Circle on Human Blood, Tissues & Cells and Advanced Therapies Medicinal Products
PIC/S
Panelist