Repurposing to cover unmet needs: the current scenario in Europe and the proposed changes to the Pharmaceutical Legislation
Drug repurposing or repositioning is defined as the process of finding new uses outside the scope of the original medical indication for existing drugs. It might relate to new patients populations, dosage forms or routes of administration.
Currently, repurposing represents an emerging and dynamic drug development strategy as it is expected that the development of a repurposed drug would be quicker with reduced costs and development risks. Approved drugs have been used and studied in case of urgent needs to make new therapies available to patients, like COVID-19 pandemic. In settings with special needs, like paediatric and rare diseases, characterised by well-known challenges, repurposing has been also considered as an opportunity to cover unmet medical needs.
Moreover, the recent proposal to revise the pharmaceutical legislation, released by the European Commission, includes impactful changes specifically dealing with repurposing. Debates on this and possible outcomes are ongoing both at European and national level.
In this perspective, this year, Fondazione Gianni Benzi, in collaboration with Università degli Studi di Bari Aldo Moro, organises the XVI Foresight Training Course, that is dedicated to repurposing aimed to cover unmet medical needs. The Course will be held on 18 December in Bari, Italy at Università degli Studi di Bari and online.
The following keynote topics around repurposing will be discussed:
- Current and proposed regulatory provisions and decision-making to be undertaken in the EU for Research & Development (R&D) and marketing authorisation;
- Industry and academic approaches and collaboration to repurposing as a R&D opportunity;
- Commercial perspectives and strategies to repositioning drugs;
- The meaning of repurposing in the paediatric context;
- Need for specific formulations to comply with the specific patient needs;
- Tools potentially supporting R&D of repurposed drugs, maximising the pharmacological approach and the evidence to endorse their use, like in silico approaches and real world data;
- Possible impact of changes proposed by the European Commission to the pharmaceutical legislation under Articles 48 and 75 of the proposed Regulation.
Renowned experts in the field, including representatives from the European Institutions, academia, companies and patients will provide their contribution to the discussion, aimed to gather the point of view of all the stakeholders involved in the medicine research & development process.
The course is free of charge for students, researchers, representatives from patients’ associations and not for profit organisations. A registration fee is foreseen for participants from companies and for-profit organisations only.
Deadline for registration on 4th December! Please consider that now it is possible to join online only. The maximum number of people joining in presence has been reached. You will receive the link to join once the registration has been completed.
Course Scientific Committee
Nunzio Denora | Università degli Studi di Bari Aldo Moro
Francesco Leonetti | Università degli Studi di Bari Aldo Moro
Viviana Giannuzzi | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Fedele Bonifazi | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus