Conversation with Silvia Sanguinetti, Sr. USA Regulatory Affairs Manager21 March 2022
At IBSA, all regulatory affairs related to North America (United States and Canada) are incorporated into the R&D Scientific Affairs department. Indeed, this connection between regulatory affairs and R&D embodies the approach and the main purpose of the US/Canada Regulatory Affairs team: to manage all the regulatory aspects for the American and Canadian market, with a constant drive towards scientific innovation. Silvia Sanguinetti, Sr. USA Regulatory Affairs Manager at IBSA Group, will tells us more.
CAN YOU EXPLAIN BETTER THIS MUTUAL RELATION BETWEEN REGULATORY ISSUES AND SCIENTIFIC INNOVATION?
The focus of my work is on the Food and Drug Administration (FDA), which is the US government body that deals with the control and regulation of food and pharmaceutical products, and medical devices. Before being marketed in the US, every new drug must undergo a thorough review process by the FDA.
But this body performs much more than a simple regulatory function: it’s an actual driving force of scientific innovation. As with all Regulatory Agencies worldwide, its priority is to provide patients with safe and effective drugs. At the same time, however, it strongly encourages the use of the most advanced technologies at all stages of drug development, including the new and complex clinical trial designs required for approval. IBSA has several projects currently underway for the United States, and the fact that my department is closely integrated into the R&D function facilitates our involvement from the very beginning of each project.
To anticipate the expectations of the FDA and Health Canada, we need to know very well the rules and guidelines (the FDA has published more than 2,000 texts!), and possibly also the strategies used by other companies to obtain approval. Another of our tasks is to provide our scientific feedback on new programs, ahead of the meetings with FDA technical reviewers, which we manage in collaboration with R&D. Every day, our “regulatory mentality” is therefore constantly oriented towards R&D.
HOW DOES ALL THIS AFFECT YOUR WORK?
When we prepare the new registrations, we build a comprehensive dossier of scientific data that allows the technical reviewers of the regulatory bodies to understand all aspects of our products: chemical and biological characteristics, proven absence of toxic effects, selection of the pharmaceutical formulation dosage, manufacture, quality control, choice of a suitable container... The dossier details all clinical studies conducted on patients in order to demonstrate the efficacy and safety of the drug, together with information on how the product is absorbed and metabolised. We also provide support in the preparation of the Package Leaflets, which will then be carefully reviewed, word by word, to verify the accuracy of the labelling, as well as medical information and transparency. This phase of our work is very stimulating, because we can “connect” all the information and provide the rationale that was used to create the pharmaceutical product.
Another important part of my job is managing the life cycle of the approved products, to ensure that registrations are always compliant with current practices, which in fact are constantly evolving to adapt to market growth (an example: the increase in production batch sizes), technological progress (from manual to automatic), quality improvement (more sensitive analytical methods), and the expansion of the manufacturing sites (for example, in the case of IBSA, all the dynamics related to the opening of the new Cosmos plant).
In addition, we support our North American subsidiary (IBSA Pharma Inc.) and our distributors, who report all input and feedback from the doctors and patients who use our products.
LOOKING AT THE DEPARTMENT’S CHALLENGES, WHAT ARE THE ACTIVITIES OR PROJECTS THAT WILL BE IMPLEMENTED OVER THE NEXT YEARS?
The challenge for the next few years is to get the approval in the US for several drugs currently in development. We will be able to achieve this by focusing primarily on innovation and quality.
For us, the main challenge in dealing with regulatory affairs with the United States is to be able to predict the FDA’s expectations – and thus avoid unnecessary negotiations – in order to save time and energy. For this reason, it’s important that we collaborate in the strategic decisions of the project leaders, and that we are always prepared to provide solid scientific support on any of our choices related to drug development. To facilitate this, we are used to “wearing the FDA’s hat” with our colleagues… and it works!
A further goal of the team is to improve our ability to communicate effectively with the authorities, so as to allow them to easily navigate the huge amount of scientific data that certify the quality, safety and effectiveness of our products.
HOW IMPORTANT IS TEAMWORK?
Teamwork and a good professional harmony are essential. I am grateful to my team for the dedication and focus they have shown – and are showing – in this very complex period linked to the pandemic. Among their various qualities, I particularly appreciate the critical and independent attitude they show in their work.
Also essential is the leadership by competent people. In this sense, I consider myself very fortunate: I would like to thank my boss and the clinical team for the effectual and fruitful professional interaction, and for the patience they show during our discussions. Each work group, each department and each function has its own objectives and its own focus. As I said, in our case we are often forced to “wear the FDA’s hat”, which involves the need to be very rigorous and demanding, and it’s great when this approach is received positively and with a constructive spirit!