title: Translational research on advanced therapies.
abstract: Fostering translational research of advanced therapies has become a major priority of both scientific community and national governments. Advanced therapy medicinal products (ATMP) are a new medicinal product category comprising gene therapy and cell-based medicinal products as well as tissue engineered medicinal products. ATMP development opens novel avenues for therapeutic approaches in numerous diseases, including cancer and neurodegenerative and cardiovascular diseases. However, there are important bottlenecks for their development due to the complexity of the regulatory framework, the high costs and the needs for good manufacturing practice (GMP) facilities and new end-points for clinical experimentation. Thus, a strategic cooperation between different stakeholders (academia, industry and experts in regulatory issues) is strongly needed. Recently, a great importance has been given to research infrastructures dedicated to foster translational medicine of advanced therapies. Some ongoing European initiatives in this field are presented and their potential impact is discussed.
authors: Dipartimento di Biologia Cellulare e Neuroscienze, Istituto Superiore di Sanità, Rome, Italy. filippo.belardelli@iss.it
authors: Filippo
authors: F
authors: Belardelli
authors: Paola
authors: P
authors: Rizza
authors: Franca
authors: F
authors: Moretti
authors: Cintia
authors: C
authors: Carella
authors: Maria Cristina
authors: MC
authors: Galli
authors: Giovanni
authors: G
authors: Migliaccio
mesh_terms: D064987:Cell- and Tissue-Based Therapy; D004358:Drug Therapy; D015316:Genetic Therapy; D006801:Humans; D023822:Tissue Engineering; D057170:Translational Research, Biomedical / Q000458:organization & administration / Q000639:trends*