Promoting pharmaceutical innovation, particularly in the field of neurodegenerative diseases, and making it accessible to patients more quickly. Seizing and regulating the potential of artificial intelligence, with its unprecedented amount of information and data. These were the topics at the centre of the meeting between the President of the Italian Medicines Agency, Robert Nisticò, and the President of the German Federal Institute for Drugs and Medical Devices (BfArM), Karl Broich, held yesterday in Bonn. Nisticò, accompanied by the head of AIFA's Independent Research Office, Armando Magrelli, visited the Federal Independent Medicines Authority, AIFA's German analogue, and the DZNE (German Center for Neurodegenerative Diseases), Europe's largest research centre on neurodegenerative diseases, of which the Italian Pierluigi Nicotera is scientific director. The visit marked the start of an international dialogue designed to continue.

“I hope for an increasingly decisive role for AIFA in the European context, – Nisticò emphasises – one of the objectives of my mandate is to strengthen relations with the agencies of other countries, the European Medicines Agency (EMA) and other international bodies. The German Medicines Agency is a strategic partner as it has experience in early access to innovation, promoting research and development policies. Furthermore, it is implementing modern programmes for the optimal use of AI in regulatory decision-making processes".

During the meeting, the importance of strengthening cooperation at EU level was discussed: for the presidents of the two regulatory agencies, harmonisation and collaboration are indeed essential in order to provide patients with faster access to innovative therapies and, at the same time, to counteract medicine shortages. EU-funded projects such as IncreaseNET and CHESSMEN, of which AIFA is the lead partner, can contribute to this.

Nisticò and Broich discussed how the conditions for research and development of precision therapies can be improved, with the aim of promoting innovation in the health sector and ensuring the sustainability of the system. In particular, research in the field of neurodegenerative diseases is experiencing a moment of great ferment, which has led to the discovery of various biomarkers, with an increasingly important role in better understanding and early detection of these disorders, and to new therapeutic approaches.

At the centre of the meeting between the two presidents, finally, there was the topic of shortages and the actions taken to improve the safety of medicine supply, such as the role that AI can also play in this area.

“‘It was a pleasure to welcome Professor Robert Nisticò and Dr Armando Magrelli to Bfarm, – commented Broich – this opportunity for stimulating discussion opens up new perspectives and encourages us to promote joint solutions”.