Despite the challenges launched by the current pandemic, the consolidate series of the Foresight Training Courses (FTCs) that Fondazione Gianni Benzi organises annually has not stopped. This year the XIII FTC “Challenges for researchers and regulators facing the pandemic crisis" was held virtually and in a shorter version on 23 October 2020. It was focused on the European new pharmaceutical strategy that aims to improve and accelerate patients’ access to high-quality, safe and affordable medicines and to support further innovation in the European pharmaceutical sector.
The first session of the course deeply addressed the new strategy, presented by Fabio D’Atri, representative from the Health and Food Safety Directorate General of the European Commission (EC), and how this strategy has been perceived by different stakeholders, involved in the announced revolution of the EU Pharmaceutical System through the public consultation launched by the EC in June 2020. The crucial role of the public consultation process in the promotion of this new strategy was highlighted by Viviana Giannuzzi and Enrico Bosone, members of the Fondazione Benzi Scientific Committee, introducing also our point of view.
The company perspective, presented by Ansgar Hebborn from La Roche AG was discussed, as well as François Houyez from the European Organisation for Rare Diseases (EURORDIS) gave the patients’ voice on medicines access, particularly patients affected from rare diseases.
During the course it was discussed how the unexpected pandemic framework is encouraging and forcing the European Regulatory System and the drug development process to change to be more efficient and closer to the patients’ needs.
Marco Cavaleri, chair of the COVID-19 Task force at the European Medicines Agency (EMA), gave an insight on the EMA regulatory framework for timely approval of new and innovative drugs and vaccines in the current circumstances. Moreover, the impact of COVID-19 on the clinical trials conduction and the new approaches that can be taken for future trials were deeply analysed by Martine Dehlinger-Kremer, president at the European CRO Federation - EUCROF & PRA Health Sciences.
Andrea Gambotto from University of Pittsburgh and Martin Ryser, representative of the Janssen’s COVID 19 vaccine program, presented the key aspects on the development of new vaccines against COVID-19, highlighting both the company and the academia perspectives.
The EU pharmaceutical debate includes the proposal to revise two main EU Pharmaceutical System pillars: The Orphan Medicines Regulation and the Paediatric Regulation. During the last session of the course interesting considerations on the orphan medicinal products were provided by Viviana Giannuzzi and Violeta Stoyanova-Beninska from the Committee for Orphan Medicinal Products at EMA, while Pirkko Lepola, chair of the European Network of Paediatric Research at the European Medicines Agency (EnprEMA) and Donato Bonifazi project coordinator of the European Paediatric Translational Research Infrastructure, offered an insight on the paediatric medicine development.
The role of the artificial intelligence to promote innovation in the pharmaceutical sector, was also analysed during the speech of Francesca Mazzi, researcher at Queen Mary University of London and Fedele Bonifazi, Head of the Information Technology & Research laboratory at Fondazione Benzi.
Finally an insight on the ethical concerns and risks in health emergency, including patients protection and fundamental rights was fully discussed by Annagrazia Altavilla, expert in health Law and Bioethics at Espace Ethique PACA-Corse/AP-HM and Marek Migdal, from the Children’s Memorial Health Institute in Warsaw.
These contributions resulted in an interesting discussion that will pave the way for possible improvements for patients, companies and researchers.
To learn more in detail about the topics discussed during the course visit our website here, where you can freely consult some of the teaching material shared during the webinar and watch the recordings of some speeches.