ATMP

Advanced Therapy Medicinal Product

A_IATRIS logo

Advanced Therapy Medicinal Products (ATMPs) are a new category of medicines for gene therapy, cell therapy and tissue engineering.

ATMP represent significant tools for efficacious treatments in patients suffering for diseases with limited or absent therapeutic options.

Italy is a leading Country in this innovative medicinal product field as three ATMP out of the four available at present on the European market have been completely developed by Italian researchers and are produced in Italy.

 

MAIN INFRASTRUCTURES AND METHODOLOGIES AVAILABLE

ATMP development requires complex studies on molecular cellular design of the product as well as on its preclinical pharmacology and toxicology. ATMP are manufactured in high technology dedicated facilities and the final products administered to patients in highly specialized clinical centers able to manage the peculiarities of ATMP clinical trials. The whole development should comply with stringent regulatory requirements.

The platform provides specialized GMP facilities, facilities for preclinical studies, access to patients and clinical expertise. The platform also offers expert advice on regulatory and scientific aspects, quality assurance and intellectual propriety.

The covered areas are rare diseases, cutaneous and ocular epithelia diseases, oncology including pediatric oncology and orthopedics. The ATMP platform interacts with other product platforms.

Production:

5 GMP compliant pharmaceutical factories authorized by AIFA

Development:

Preclinical models of diseases

Platforms for gene editing, for  tissue engineering with 3d models

Clinical area:

Access to cohorts of patients

Clinical trials compliant with GCP

Immunological monitoring of patients treated with ATMP

 

TASK FORCE

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Chair: Dr. Maria Cristina Galli (ISS)
Co-Chair: Prof. Franco Locatelli