Faculty of Pharmacy launches major regulatory science initiative

With the ongoing recruitment of three doctoral students, Uppsala University is stepping up its investment in regulatory science. The goal is to establish the foundation for a research school that will contribute to the Swedish life science sector's access to regulatory expertise: to understand and improve the regulatory frameworks surrounding a drug throughout its entire lifecycle.

“In dialogue with the Swedish Medical Products Agency, industry and other stakeholders, we see an increasing need for expertise in regulatory science and its practical application. We have already begun working within our networks with forums and open seminars, and that we now enter research-level activities is met with great enthusiasm from the industry,” says Mathias Hallberg, Dean of the Faculty of Pharmacy.

The doctoral positions are divided between the faculty's three departments. To optimize the societal impact of the initiative, external co-supervisors are attached to the projects, and the ambition is to welcome the new doctoral students to Uppsala’s Biomedical Center already this spring. One of the teams that is now preparing for a place in the forefront is Professor Mikael Hedeland's research group in Analytical Pharmaceutical Chemistry.

“This initiative allows us to develop new methods for quality control of therapeutic oligonucleotides – a type of synthetically produced drugs built from DNA and RNA sequences. This is a relatively young scientific field where both industry and regulatory authorities need tools to harness the potential and ensure the safety of drug candidates.”

At the research group in pharmaceutical technology, a doctoral student will study the safety and risks associated with splitting drugs administered in tablet form. With a focus on drugs where small dose differences can have major impacts, the project will analyse tablet design and divisibility, as well as how the body absorbs the drug. The goal is to contribute to safer dose adjustment, especially for children, the elderly and other sensitive patient groups.

“Being involved in innovation projects and supporting the writing of regulatory documents, I know from experience how challenging it is to navigate regulatory landscapes. The launch of a faculty-wide initiative in this field is, in my view, an crucial factor in the long-term consolidation of Sweden's position as a leading life science nation, and we are very much looking forward to plying an active role in the important work ahead,” says Albert Mihranyan, Professor of Pharmaceutical Technology.

In a third project, a doctoral student, placed in Professor Andrew Hooker’s research group, will examine how pharmacometric models and statistical methods can provide improved support for decision-making in regulatory matters. Along the way, new tools will also be created with the goal of contributing to increased efficiency and stability in the development of future drugs.

“We see how the entire pharmaceutical sector, from smaller, niche companies and consulting firms to authorities, is in need of regulatory knowledge and expertise. Our Faculty of Pharmacy has the resources to contribute here, and it feels fantastic that we are now starting this joint journey with the potential to strengthen the Swedish life sciences,” says Anja Sandström, Deputy Dean for first and second cycle education.

text: Magnus Alsne, photo: Mikael Wallerstedt a o