Each drug must satisfy three critical aspects: quality, efficacy and safety. The R&D Scientific Affairs department is responsible for the latter two: efficacy and safety. At IBSA, Claudia Scarsi Perler holds the role of Sr. R&D Scientific Affairs Manager, dealing with the endocrinology (thyroid) therapeutic area. Today she will talk about her experience at IBSA, and how efficacy and safety fit into her daily work.
Conversation with Claudia Scarsi Perler, Sr. R&D Scientific Affairs Manager at IBSA Group
CAN YOU DESCRIBE YOUR JOB MORE IN DETAIL?
My department – R&D Scientific Affairs – deals with the research and development of IBSA drugs (and medical devices). Once a new formulation has been developed – and sometimes even earlier – we take up the baton from the R&D Pharmaceutical department in order to start all the studies necessary to prove that the drug is safe and effective in treating a given indication.
As Senior R&D Scientific Affairs Manager, I am in charge of defining the preclinical and clinical product development plan, and coordinating the related activities, from the design of the individual studies to their implementation, up to the presentation of the results to the Regulatory Authorities and their publication.
I am in charge of the endocrinology therapeutic area and, in addition to R&D Pharmaceutical, I work closely with the Regulatory Affairs and Marketing divisions: many studies, in fact, are targeted to the registration of the product, but just as many are born from marketing needs. Outside, we have contacts with Regulatory Authorities and Ethics Committees, as well as with the doctors, hospitals and research organisations that carry out the trials on our behalf.
WHAT DO YOU CONSIDER THE MAIN CHALLENGE OF YOUR JOB?
The most difficult and critical part of the Scientific Affairs Manager’s job is to translate the strategic goal – once it has been clarified – into a research objective that is relevant and, at the same time, achievable. This implies the ability to build a feasible clinical study, which is (ideally) methodologically flawless and attainable within the established time and budget limits. This is a task that can be very challenging at times. In addition, it is also very delicate, since the results will be seen only after 2-3 or more years – after the investment is complete – and therefore we don’t have the possibility to make any in-progress adjustment.
The study set-up phase then follows, in which it is necessary to plan all the required activities and coordinate the parties involved, define in detail flows, processes and responsibilities and plan for the risks and actions to mitigate them, so that all the gears of the mechanism work together, and without jamming, in the realisation of the more strictly clinical part of the study. Finally, once the study has been activated, we just have to solve the unforeseen and potential critical issues that arise every day...
HOW HAVE YOUR DEPARTMENT’S ACTIVITIES BEEN EVOLVING OVER TIME?
The evolution of the activities in the R&D Scientific Affairs department has been huge; just think that when I started, in 2004, we were just over 10 people and today we are about 30. This is mainly due to three factors.
On the one hand, there has been a real explosion in the regulation of clinical research. Until 1995, not even the basic “Good Clinical Practice” rules were implemented, while today every single aspect of research is regulated by each country in a very specific way, and new rules are issued and updated regularly. We therefore need to be constantly “on the ball”, and much of our work is aimed at ensuring compliance.
At the same time there has been an increase in the complexity of clinical research, with more information, factors and methodologies to be taken into consideration when designing a study (just consider the exponential increase in the number of scientific publications in recent years).
Last, digitisation: if in 2004 data and documents were mainly collected on paper, today all the parties involved (companies, investigators, patients) have IT tools that allow – and require – an immediate processing, anywhere and at any time. All this resulted in the need for an increasingly greater specialisation, but unfortunately also in an increase in costs and times. Clinical research today requires a great deal of commitment, and we must be careful and selective in our choices.
IBSA’S PILLARS ARE PERSON, INNOVATION, QUALITY AND RESPONSIBILITY. WHICH OF THESE DO YOU FEEL CLOSEST TO YOUR DAILY ACTIVITIES? IN WHAT TERMS?
Quality is essential to clinical research, since each study is carefully scrutinised by the authorities and the scientific community.
I very much appreciate IBSA’s attention to the Person, which is part of its DNA. In my 17 years (a milestone I recently reached!) working at IBSA it has in fact remained a constant; I have been able to see this personally, also recently, and for this I am very grateful. In our department we try to transfer this attention to the People towards the outside, trying to get to know who works for us and to establish contact. In fact, I find that the human contact aspect is extremely motivating in our work.
Lastly, Responsibility is a basic pillar for R&D Scientific Affairs, both because each study is subject to the judgment of the Regulatory Authorities and the scientific community, and because we have contact – albeit indirect – with patients. Of them we only know a randomly assigned number and a series of anonymous data, collected as part of the clinical trial, but there is a strong awareness that behind these numbers there is a Person, with a history of disease and all that this entails. A sense of responsibility towards them is therefore inevitable.