Excellence is in the attention to detail: IBSA's R&D secret07 October 2020
Conversation with Giuseppe Roberto Mautone, Head of R&D Scientific Affairs
Excellence does not simply appear from one day to the next. It usually comes at the end of a journey, whether that journey is long or short, with more or fewer steps, always full of pitfalls. To reach the goal, you have to go all the way, discover, invest, innovate and perfect. IBSA’s excellence is just that: a milestone on a route that began in the early 1980s. For a company whose mission is to produce ‘drugs in the best form’, however, excellence is a moving target. It moves a few steps each day and the only way to keep up with it is to never stop.
Today we’re speaking to Giuseppe Roberto Mautone, Head of R&D Scientific Affairs, an IBSA veteran who has been with the company since 1987, when “the historical offices in the town of Massagno (Lugano, Switzerland) were simply well-appointed rooms” and IBSA had two flagship products. Today, one of those is an international market leader sold across two continents.
There have been many milestones along the IBSA journey, but it’s worth remembering the time “we bought a new chemical substance: diclofenac epolamine. To define the degree of safety of this molecule, a complete development process (toxicology, pharmacology and clinical studies) was required. A spirit of sacrifice combined with the prospect of making it through steered IBSA right and, thanks to a partnership with a Japanese company, we created a plaster and an innovative pharmaceutical form, allowing us to register the product first in Europe and then in other markets. IBSA was, despite strong resistance from the American authorities (FDA), the first company to bring a topical form of diclofenac to the United States. The scepticism for product registration on American territory was overcome thanks to quality clinical studies conducted in the USA.”
At the end of the 1990s, work began in another therapeutic area: “it was then that the development of gonadotropins in fertility began, first time registered in Switzerland in 1996. Over the next few years, after having opened the collection and production sites for the partially purified product in China, it was introduced to a number of European and non-European markets. Today IBSA is a world leader in the field of fertility.”
Doctor Mautone, beyond the anecdotal, what is really at the foundation of IBSA research?
The expression ‘Drugs in the best form’ sums up nicely IBSA's vocation, which is to create a product that guarantees the best compliance i.e. the absorption of the active ingredient with as few side effects as possible. At IBSA, various pharmaceutical forms align with this statement, from soft capsules to subcutaneous solutions of certain drugs, which, in addition to maximum effect, guarantee self-management of treatment. At the moment, we’re also conducting a study into migraines that could represent an incredible innovation for millions of patients.
Creating easy-to-use products allows clinicians to explore indications and applications that are not those for which the product is registered. For example, an American university is testing our progesterone in the treatment of COVID-19 (read the news here), while other researchers are working on a medical device for the treatment of bronchitis, which could also be used in COVID-19 therapy.
Looking at IBSA's challenges, what is your focus?
I would say the focus is on attention to detail; the details reveal the care and dedication with which we work to achieve our objectives. It’s in the details that a product can become unique and inimitable, defining the perfection of the product itself during research. We work to develop and produce innovative products with the utmost commitment and we believe that research reflects our desire to never stop, to evolve, to change and to open up new, unthinkable paths. It is in this spirit that we work with our Marketing, Business Operations, Medical Affairs departments each day to create modern products at various levels, capable of responding to, but above all anticipating, the needs of both doctors and patients.
Continuous research is as much a stimulus as working side by side with the authorities and university clinical centres: meeting their challenges with an eye to the investments that the company can actually afford, on products that might give concrete, marketable results.