Palazzo Branciforte, Palermo
On 26 and 27 November took place in Palermo, Palazzo Branciforte, the workshop “Development of Advanced Therapy Medicinal Products”, organized by the Foundation Ri.MED with the support of the European Advanced Translational Research Infrastructure (EATRIS) under the project PON “R & C” 2007-2013 – Laboratorio Pubblico Privato Neurodiabete.
It was an excellent training opportunity for the Foundation: part of the Ri.MED researchers conducts preclinical research, translational research, and cell therapy production programs at the Regenerative Medicine and Biomedical Technologies Unit located in the premises of IRCCS ISMETT in Palermo.
“The team of Ri.MED researchers has developed over the years a specific know-how in the field of cell therapy and biomedical engineering,” says Alessandro Padova, General Director of the Foundation “This has allowed us to have today a really innovative portfolio of research projects. Our goal is to advance projects in preclinical stages to get to clinical candidates for Advanced Therapies and it is essential to network internationally with pharmaceutical and biotechnology companies and with key opinion leaders present here today, who for various reasons contribute to the development process of ATMP “.
The event was attended by some of the most important protagonists of European scene: academics industrial, regulatory bodies and hospitals: different points of view centered on the common goal of improving human health.
The workshop provided knowledge and tools to understand the European regulatory landscape, the use of biomarkers in the development of ATMP and to identify key aspects to bring a product to market. The course was structured as a interactive discussion platform: each participant was provided a “clicker” with pushbutton response, to interact directly and in real time.
26 November
8.30 Registration
09:00 Welcome Pier Giulio Conaldi
09:05 Introduction to the course and classification of ATMPs Giovanni Migliaccio
09:25 Challenges in the development of tissue engineered products Graziella Pellegrini
10:55 Coffee break
11:15 Challenges in the development of cell therapies Luc Sensebe
12.45 Introduction to gene therapy medicinal products Maria Cristina Galli
13:30 Lunch
14:30 Challenges in Clinical Trials for ATMPs Christian Jorgensen
16:00 Biomarker discovery, validation, and commercialisation Andreas Scherer
17:30 Get together
27 November
09:00 Introduction to the second day Alessandro Padova
09:15 How to ensure market orientation when you have a new idea? Ciro Tetta
10:00 From Academia to industry: the experience with Holoclar Andrea Chiesi
10.45 Coffee break
11.15 Economic valorisation of translational research Giovanni Migliaccio
12:00 Panel discussion: Translational Medicine, current landscape and a vision of the future
13:00 End of workshop
Speakers:
Andrea Chiesi, PhD
Direttore R&D Portfolio Management Chiesi Farmaceutici S.p.A.
Pier Giulio Conaldi, MD, PhD
Director of Regenerative Medicine and Biomedical Technologies Ri.MED Unit c/o IRCCS ISMETT, Palermo, Italy
Maria Cristina Galli , PhD
Senior Researcher at the Istituto Superiore di Sanità (ISS), Italy
Co-Chair of the ATMP Product Platform within EATRIS
Christian Jorgensen, MD, PhD
Director of IRMB Institut de Recherche de Médecine Régénératrice et de Biothérapies Head of Research Unit Inserm U 1183,ECellFrance coordinator; Head of clinical unit for osteoarticular diseases and Department for Biotherapy at University Hospital CHU Lapeyronie University Hospital, Montpellier France.
Giovanni Migliaccio, PhD
Scientific Director of EATRIS
Alessandro Padova, PhD
Director General, Ri.MED Foundation
Graziella Pellegrini, PhD
Head of Cell Therapy Program, Center for Regenerative Medicine
Department of Life Sciences ,University of Modena e Reggio Emilia
Andreas Scherer, PhD
Project Director – Biomarkers and Molecular Diagnostics, Institute for Molecular Medicine Finland (FIMM) Nordic EMBL Partnership for Molecular Medicine
Biomedicum Helsinki
Luc Sensebé, MD, PhD
EFS Medical & Scientific director in charge of Adult Stem Cells
Deputy Director of STROMALab UMR5273 – INSERM U1031
Chair of MSC Committee of ISCT Toulose
Ciro Tetta, MD
Director Extracorporeal Therapies Research Department, Division of Medicine, Fresenius Medical Care, Bad Homburg, Germany