Conversation with Barbara Cometti, Senior R&D Scientific Affairs Manager at IBSA Group01 February 2022
As the name suggests, IBSA’s R&D Scientific Affairs department deals with the research and development of drugs. Very complex and specific, the activities of this department start with the preclinical phase, going up to the clinical studies, through the trials on healthy volunteers and patients alike. IBSA’s R&D Scientific Affairs also provides scientific support to the other departments of the company: in addition to helping colleagues handle questions from patients and doctors, the creation of documents to support products is also often required, with particular reference to articles published on peer reviewed scientific journals.
Barbara Cometti, Senior R&D Scientific Affairs Manager of IBSA Group, is responsible for these activities for the Reproductive Medicine therapeutic area, with a particular focus on the development and maintenance of fertility hormones, and today she will talk to us about her work and experience in IBSA.
WHAT HAS BEEN THE EVOLUTION OVER TIME OF THE ACTIVITIES OF THE R&D SCIENTIFIC AFFAIRS DEPARTMENT?
I started working in IBSA 19 years ago. In those days, clinical trials were as rigorous and scrupulous as they are today, but the regulatory requirements they were based on were milder. Today, authorities have considerably raised the bar: they require increasingly more detailed studies, as well as a careful supervision of all phases. The work, therefore, has necessarily become more complex, and management now requires a comprehensive group of highly skilled people, to ensure that everything is done in the best possible way. Fortunately, technology has also evolved, and the new electronic and digital systems come to our aid. At the beginning of my journey at IBSA, I spent whole days entering data into a PC, copying it from cards filled in by hand by doctors; today these things are done directly and automatically, thanks to the eCRFs (electronic Case Report Forms). Similarly, the management of study documents has undergone a generational change: at the end of 2021, we switched to an electronic management system via eTMF (electronic Trial Master File), which will allow a reduction in the amount of paper and, at the same time, a better immediate quality control and a greater sustainability.
WHAT ARE, IN YOUR OPINION, THE MOST IMPORTANT QUALITIES TO EXCEL IN YOUR FIELD?
Scientific research is always evolving, and it is essential to keep up to date on new therapies and the new protocols implemented by the specialists. Our job is not only to have already known products approved, but also to evaluate new niches and new uses for our products. It is also necessary to keep constantly updated on the European, American and global guidelines, which change and are updated continuously, in order to ensure that our work and our studies are adequate and up to the demands of the regulatory authorities (drug agencies), which are increasingly more demanding and meticulous. Furthermore, working directly with clinical centres, and consequently with patients, the unexpected is just around the corner. It is therefore essential to always be informed about what is happening, and to be ready to solve all the problems that arise daily: good managerial skills and a flexible mind are indispensable.
LOOKING AT THE CHALLENGES OF THE DEPARTMENT, WHAT ARE THE ACTIVITIES OR PROJECTS THAT WILL BE DEVELOPED IN THE COMING MONTHS/YEARS?
With regard to fertility, we are currently carrying out some very important projects. An example among all is our progesterone in aqueous solution for subcutaneous injection, which is already registered in many countries in the indication “luteal phase support”. We are working to obtain its approval also in the United States, and we are testing other indications, even very far from fertility, always faithful to the IBSA philosophy: testing new therapies in indications and dosages not yet known, in the name of innovation, which is one of the pillars of our company.
IF YOU WERE TO GIVE YOURSELF SOME ADVICE 19 YEARS AGO, ON YOUR FIRST DAY AT IBSA, WHAT WOULD IT BE?
I would tell myself not to stop being curious, to continue looking for the best part of every project and the positive side in every situation, and to see every difficulty not as an unbeatable obstacle, but as a possibility of growth: only in this way can we improve and gain experience. Also, I would tell myself not to be afraid to interact and exchange views, especially with people with more experience, since only those who know more than you can teach you the tricks of the trade and help you make progress.