Programme

9:00-10:00

Registration and welcome coffee

10:00-10:30

Welcome

Chairs: ​Luigi Naldini, Franco Locatelli, Concetta Quintarelli, Alberto Auricchio

Welcome address & objectives of the workshop ​

10:30-10:50

The CAT and the regulatory development of an ATMP​

Barbara Bonamassa, AIFA, Rome

INV01: CAT and the regulatory development of an ATMP​

• State of the art

• Points of implementation

10:50-11:30

Difficulty of access to the ATMP drugs​​​

10:50-11:10: Stefano Benvenuti, Fondazione Telethon, Milan

INV02: New development and distribution models​

• Drugs approved in Italy to date

• Drugs not available in Italy whilst approved in EU

• Drugs not available in EU whilst approved in US

• Cost and economic sustainability: Academic and non profit models

​​

11:10-11:30: Alessandro Aiuti, SR-Tiget, IRCCS Ospedale San Raffaele, Milan

INV03: Innovative regulatory solutions

• Regulatory and administrative barriers

• Technology platforms, pilot initiatives for academic developers and "regulatory sandbox​es"

​

11:30 - 11:50: Annalisa Scopinaro, Unimao, Roma (virtual)

INV04: Patient Perspective

11:50-12:20

Experience in the field

Franco Locatelli, Bambino Gesù Children's Hospital, Rome

INV04: Point of care in Italy

• Evolution of manufacturing to reduce barriers

• Successes and shortcomings in the application of CART therapies

• The Italian network on ATMPs, PNRR and PNC projects

12:20-12:40

Round table discussion

Moderator: Concetta Quintarelli, Bambino Gesù Children's Hospital, Rome

12:40-12:50

General Assembly of the SITGEC​​

12:40-13:30

Lunch Break​​

13:30-14:00

The role of AIFA to support innovation and access to ATMP therapies

Paolo Foggi, AIFA, Rome

INV06: Collaboration through institutions, industry and healthcare facilities

14:00-14:20

HTA Regulation

Pia Rivetti di Val Cervo, Aifa, Rome

INV07:  Impact of joint scientific consultation and joint clinical evaluation on the future development of ATMPs

14:20-14:40

Innovative pricing & reimbursement models: managing uncertainty and facilitating access

Oriana Ciani, Bocconi University, Milan

INV08: Innovative price & reimbursement models: managing uncertainty and facilitating access

14:40-15:10

Role of the Ministry of Health: economic and organisational challenges in the evolution towards personalised medicine 

Americo Cicchetti, Ministero della Salute

INV09:

15:10-15:45

Round table discussion​ on strategies to improve accessibility

Moderator: Alessandro Aiuti, Alberto Auricchio​

Panel: All speakers & 

Michela Gabaldo, VP ATMP Global Regulatory Affairs, Evotec

Graziella Pellegrini, Università di Modena e Reggio Emilia

• Collaboration between institutions, industry and healthcare facilities

• Proposals for regulatory simplification

• Innovative financing models

15:45-16:00

Closing words

Chairs: ​Luigi Naldini, Franco Locatelli, Concetta Quintarelli​