A conversation with Stefano Rovati, Sr. R&D Scientific Affairs Manager24 April 2023
IBSA’s current President and CEO, Arturo Licenziati, took over the leadership of the company in 1985. Almost four decades later, among the first people to join the company – and still collaborating with it today – is Stefano Rovati, Sr. R&D Scientific Affairs Manager, in IBSA since September 1986. In this interview he talks about his past, present and future in our company.
CAN YOU TELL US MORE ABOUT YOUR ROLE AND THE EVOLUTION OF THE R&D SCIENTIFIC AFFAIRS DEPARTMENT?
I was hired at IBSA immediately after graduating, and in 1995 I joined the R&D team, which at the time consisted of four people in all. Since then, the evolution of the R&D Scientific Affairs department has been incredible.
At the beginning we somehow “scraped along”, in order to meet all the needs related to the development of a new drug with our limited resources: we would collaborate with all the different clinical research centres in Switzerland and abroad, collecting experimental data, analysing them directly in-house and, ultimately, writing the study reports for the new product’s registration dossier. Today, my department is made up of a few dozen highly specialised collaborators, often divided by therapeutic area, who work in a coordinated way.
In particular, we Project Managers draw up development plans and coordinate preclinical and clinical studies, which are increasingly conducted with the support of external research organisations. We also work in synergy with the Regulatory Affairs department for the interactions with national and supranational Regulatory Agencies, both in the pre-submission phases and during the evaluation process of the registration dossiers.
IBSA IS AN INCREASINGLY INTERNATIONAL COMPANY; HOW DOES THIS PROPENSITY TO INTERNATIONALISATION IMPACT ON YOUR DEPARTMENT’S WORK?
Historically, research is actually an area with an international reach, and the activities related to the development of drugs in IBSA are no exception. With the adoption by the main Regulatory Agencies – such as FDA and EMA – of the recent international guidelines for the harmonisation of the technical requirements for drug registration (the famous ICH guidelines of the International Council for Harmonisation), the international significance of our work is even more noticeable. Many clinical trials – especially the pivotal ones, which support the efficacy and safety of a new drug – are increasingly designed and carried out as multicentre and multinational studies, conducted simultaneously – for example – in Europe and America.
LOOKING AT THE CHALLENGES OF YOUR DEPARTMENT, WHAT ARE THE ACTIVITIES OR PROJECTS THAT WILL BE DEVELOPED OVER THE NEXT MONTHS/YEARS?
The explosion of research costs and the significant increase in the time-to-market for new products are leading to the development of increasingly innovative techniques and approaches, aimed at making drug development more efficient. On the one hand, this trend intends to reduce the risks associated with areas characterised by a lack of knowledge – such as, for example, the use of software to simulate the behaviour of a new molecule in perhaps still unexplored pathological situations, or in particularly vulnerable patient categories, such as those of pediatric age – and on the other to better integrate the successive phases of development of a drug according to the so-called “adaptive-design” approach, which allows to save precious time compared to the classic approach with distinct development phases. The applications of “modelling & simulation”, which fall under the so-called “in silico trials”, allow to obtain preliminary information useful for optimising the design of in vivo studies in humans, for example by minimising certain risks for patients undergoing treatment within the clinical study. Today, in some cases data from “in silico” studies even replace in vivo trials, making them obsolete.
And again, the exploitation of the enormous potential of “real world” data, i.e. all the clinical data generated during clinical practice which, once they are made accessible in structured databases, will be very useful for research both on the natural evolution of certain still little known conditions and on the effective efficacy – and above all safety – of the new drugs during their normal use. This is a new area of research, one in which our department will have to grow a lot in the near future, in order to face the challenges of the increasingly competitive world of pharmaceutical research and development.