Malin Filler – Senior Regulatory Affairs Manager
The stimulating role as Regulatory Affairs Manager at Cinclus Pharma fits Malin like a glove. She is currently working intensively to prepare all regulatory activities required for the start of the phase III program for the drug candidate linaprazan glurate, a task that is both challenging and exciting.
Malin has worked several years at the Swedish Medical Products Agency as an assessor in pharmacokinetics and regulatory issues and comes most recently from the consulting company SDS Life Science where, in addition to this, she has also been responsible for strategic regulatory issues in several drug development projects. She gets to use her entire spectrum of experience in her current role. What primarily attracted her to Cinclus Pharma was the collective competence of the team and the exciting development phase of the project.
"It is unique to work in such a diverse team. Many people in this small company have impressive pharmaceutical industry experience. We are growing rapidly, and right now, we are approaching the final steps before a potential launch. It's a very exciting journey.
As Regulatory Affairs Manager, Malin is involved in designing the study program for the upcoming phase III studies. Already in the planning phase, clear guidelines need to be followed, all to ensure that the right things happen at the right time and in the right order. As a Regulatory Affairs Manager, Malin's mission is to navigate the regulations to find ways forward, avoid pitfalls, and at the same time, keep track of ever-changing legislation.
"We are in a very intensive period, and much work lies ahead of us. We are currently working to initiate phase III studies in the US and Europe. It is both fascinating and challenging to create a study program that fits several markets. Therefore, I work extensively on scientific advice with regulatory authorities and compile and evaluate the scientific data that underpins a successful development program.
In November 2022, positive topline results from the completed phase II studies were presented. Currently, work is ongoing to compile the final results from phase II. Once finished, the results and plans for the phase III studies will be presented to the FDA and EMA.
"The next step in the process is to apply to start phase III. If everything goes according to plan, we can hopefully start the studies at the end of 2023. The aim is to create a basis for approving linaprazan glurate as a drug."
A powerful driving force for Malin is to be part of solving the unmet medical need existing in GERD.
"GERD is a widespread disease where current treatment does not provide sufficient effect for all patients, and we see that we have a drug candidate that has the potential to help these people. If we obtain an approved drug, we can increase the quality of life for many people, which drives me in my daily work. It is an interesting project, and I think we have a very good chance of success," Malin concludes.