title: Development of advanced therapies in Italy: Management models and sustainability in six Italian cell factories.
abstract: On November 10, 2014, the representatives of all six certified Good Manufacturing Practices (GMP) cell factories operating in the Lombardy Region of Italy convened a 1-day workshop in Milan titled "Management Models for the Development And Sustainability of Cell Factories: Public-Private Partnership?" The speakers and panelists addressed not only the many scientific, technological and cultural challenges faced by Lombardy Cell Factories, but also the potential impact of advanced therapy medicinal products (ATMPs) on public health and the role played by translational research in this process. Future perspectives for research and development (R&D) and manufacturing processes in the field of regenerative medicine were discussed as well. This report summarizes the most important issues raised by the workshop participants with particular emphasis on strengths and limitations of the R&D and manufacturing processes for innovative therapeutics in Lombardy and what can be improved in this context while maintaining GMP standards. The participants highlighted several strategies to translate patient-specific advanced therapeutics into scaled manufacturing products for clinical application. These included (i) the development of a synergistic interaction between public and private institutions, (ii) better integration with Italian regulatory agencies and (iii) the creation of a network among Lombardy cell factories and other Italian and European institutions.
authors.affiliation: Laboratory of Cell and Gene Therapy Stefano Verri, San Gerardo Hospital, Monza, Italy; Tettamanti Research Center, Pediatric Clinic Monza Brianza per il Bambino e la sua Mamma (MBBM) Foundation, Monza, Italy. Electronic address: g.gaipa@hsgerardo.org.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gaipa
authors.affiliation: Center of Cellular Therapy "G. Lanzani" AO HPG23, Bergamo, Italy.
authors.forename: Martino
authors.initials: M
authors.lastname: Introna
authors.affiliation: Center of Cellular Therapy "G. Lanzani" AO HPG23, Bergamo, Italy.
authors.forename: Josee
authors.initials: J
authors.lastname: Golay
authors.affiliation: NCNbio srl, Milan, Italy.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Nolli
authors.affiliation: Molmed spa, Milan, Italy.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Vallanti
authors.affiliation: Cell Therapy Production Unit, Besta Foundation, Milan, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Parati
authors.affiliation: Cell Factory Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
authors.forename: Rosaria
authors.initials: R
authors.lastname: Giordano
authors.affiliation: Areta International srl, Gerenzano, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Romagnoli
authors.affiliation: Lombardy Region, Milan, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Melazzini
authors.affiliation: Laboratory of Cell and Gene Therapy Stefano Verri, San Gerardo Hospital, Monza, Italy; Tettamanti Research Center, Pediatric Clinic Monza Brianza per il Bambino e la sua Mamma (MBBM) Foundation, Monza, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Biondi
authors.affiliation: Laboratory of Cell and Gene Therapy Stefano Verri, San Gerardo Hospital, Monza, Italy; Tettamanti Research Center, Pediatric Clinic Monza Brianza per il Bambino e la sua Mamma (MBBM) Foundation, Monza, Italy.
authors.forename: Ettore
authors.initials: E
authors.lastname: Biagi
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000458:organization & administration / Q000592:standards; D001709:Biotechnology / Q000458:organization & administration / Q000592:standards; D018929:Cell Culture Techniques / Q000379:methods / Q000592:standards; D060846:Cell Engineering / Q000379:methods / Q000592:standards; D006801:Humans; D007558:Italy; D007753:Laboratories / Q000458:organization & administration*; D017146:Models, Organizational; D015397:Program Evaluation / Q000592:standards; D058996:Quality Improvement; D035703:Therapies, Investigational / Q000379:methods / Q000592:standards
keywords: advanced therapies medicinal products; cell factories; clinical research; good manufacturing practice