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 ​

10:30-11:30

Difficulty of access to the ATMP drugs

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10:30-10:50: TBC

INV01: A patient's point of view

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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

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11:10-11:30: Alessando Aiuti, SR-Tiget, Milan

INV03: Innovative regulatory solutions

• Regulatory and administrative barriers

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

11:30-12:00

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

12:00-12:30

Round table discussion

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

12:30-13:30

Lunch Break​​

13:30-13:50

The CAT and the regulatory development of an ATMP​

Barbara Bonamassa, AIFA, Rome

INV05: CAT and the regulatory development of an ATMP​

• State of the art

• Points of implementation

13:50-14:10

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

TBC

INV06: Collaboration through institutions, industry and healthcare facilities

14:10-14:30

Innovative therapies and ATMP's: point of view of AIFA

TBC

INV07: ​Therapeutic innovation, access to the Innovative Medicines Fund and monitoring registers

14:30-14:50

Innovative pricing & reimbursement models: managing uncertainty and facilitating access

Oriana Ciani, Bicocca University, Milan

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

14:50-15:10

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

TBC

INV09:

15:10-15:45

Round table discussion​ on strategies to improve accessibility

Moderator: Alessandro Aiuti, Alberto Auricchio​

• 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​