Roundtable: The Risk of Introducing a New Product into a GMP Facility: Aligning on Critical Parameters
Wednesday, May 31, 2023 09:15 AM - 10:15 AM
Room 242B
Bioprocessing & Biomanufacturing
Roundtable
Moderator
Massimo Dominici, MD, Professor of Medical Oncology, Director of Oncology and Cell Therapy Laboratory, University Hospital of Modena & Reggio Emilia, Italy
Panelists
Gloria Carmona Sanchez, MSc, Scientific Coordinator, Andalusian Network for the design and translation of Advanced Therapies – Fundación Progreso y Salud M.P., Spain
Michela Gabaldo, PharmD, Vice President, ATMP Global Regulatory Affairs, ATMP Global Regulatory Affairs, EVOTEC, Italy
Anna Pasetto, PhD, Director of the Center for Advanced Cell Therapy (ACT), Centre for Advanced Cell Therapy (ACT-centre), Norway
Session Description
Being ready for cGMP manufacturing in the early clinical development of novel cell and gene therapies may be a challenge for either academia or industry. During this roundtable we will share panelists' experiences with critical parameters that need to be considered when a new product is going to be introduced into a GMP facility. We will share academic and corporate experience dissecting the concept of pre-GMP manufacturing to then discuss specific considerations emerging when a new product needs a cGMP environment and the related tasks, such as reagent selection, key products (viral vectors, selective growth factors) and specific procedures. The panelists will speak to their own experiences regarding the collaboration with academia, SME or big pharma sharing how they deal with new products.
Learning Objectives
Massimo Dominici, MD, Professor of Medical Oncology, Director of Oncology and Cell Therapy Laboratory, University Hospital of Modena & Reggio Emilia, Italy
Panelists
Gloria Carmona Sanchez, MSc, Scientific Coordinator, Andalusian Network for the design and translation of Advanced Therapies – Fundación Progreso y Salud M.P., Spain
Michela Gabaldo, PharmD, Vice President, ATMP Global Regulatory Affairs, ATMP Global Regulatory Affairs, EVOTEC, Italy
Anna Pasetto, PhD, Director of the Center for Advanced Cell Therapy (ACT), Centre for Advanced Cell Therapy (ACT-centre), Norway
Session Description
Being ready for cGMP manufacturing in the early clinical development of novel cell and gene therapies may be a challenge for either academia or industry. During this roundtable we will share panelists' experiences with critical parameters that need to be considered when a new product is going to be introduced into a GMP facility. We will share academic and corporate experience dissecting the concept of pre-GMP manufacturing to then discuss specific considerations emerging when a new product needs a cGMP environment and the related tasks, such as reagent selection, key products (viral vectors, selective growth factors) and specific procedures. The panelists will speak to their own experiences regarding the collaboration with academia, SME or big pharma sharing how they deal with new products.
Learning Objectives
- To learn about critical parameters to be considered upon introducing a new product into a GMP environment for clinical uses between academia and industry.
- To identify the different issues that are emerging from early phases of clinical trials to marketing authorization also accounting hospital exemption.
- To establish product-dependent general and specific procedures to get them into clinic.
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
Gloria Carmona MSc
Scientific Coordinator
Andalusian Network for the design and translation of Advanced Therapies – Fundación Progreso y Salud M.P.
Panelist
Scientific Coordinator
Andalusian Network for the design and translation of Advanced Therapies – Fundación Progreso y Salud M.P.
Panelist
Anna Pasetto PhD
Director of the Center for Advanced Cell Therapy (ACT)
Centre for Advanced Cell Therapy (ACT-centre)
Panelist
Director of the Center for Advanced Cell Therapy (ACT)
Centre for Advanced Cell Therapy (ACT-centre)
Panelist