Herantis Pharma Plc is a clinical-stage biotechnology company that develops disease-modifying therapies for neurodegenerative diseases. The company currently focuses mainly on Parkinson’s disease.
At the moment, Parkinson’s disease can only be treated symptomatically, as the current treatments do not impact the progression of the disease. Herantis’ lead drug candidate, HER-096, is designed to slow down or even stop the progression of the disease. HER-096 is a small synthetic peptide, developed based on the active site of a protein called the cerebral dopamine neurotrophic factor (CDNF).
“Developing drug candidates is Herantis’ core competence. We are a small company of about 10 employees, which means that we must outsource many of our activities. We design the drug candidates, but the required animal studies, clinical trials and manufacture of the drug products are outsourced,” says Katarina Jääskeläinen, Head of Clinical Operations at Herantis Pharma Plc.
Katarina started in 2005 at Herantis’ previous subsidiary and has more than 10 years of experience in clinical trials. At Herantis, Katarina is responsible for the clinical trial operations: she is involved in the selection of partners and trial sites as well as in preparing the trials and drafting clinical trial applications to the authorities. In addition, she follows the progress and conclusion of the trials.
Medfiles helps in clinical trials and pharmacovigilance activities
Herantis has worked with Medfiles from 2009, outsourcing tasks in which it lacks resources and competence. The cooperation has always revolved around carrying out clinical trials.
“Medfiles takes care of the monitoring of our clinical trials and often manages the project as a whole as well. During the past years, they have also helped us a lot in communicating with the authorities and drafting and submitting trial applications. We have also outsourced our clinical trials’ pharmacovigilance activities to Medfiles.”
This year Herantis has started using an electronic trial master file (eTMF) in which all essential trial documents are saved. The eTMF database was purchased as a service through Medfiles.
At the moment, Medfiles is involved in two clinical trials, managing the monitoring and pharmacovigilance activities for Herantis. Their lead drug candidate, HER-096, which is developed for Parkinson’s disease, has advanced to the clinical stage in 2023 and has been administered to humans for the first time in the Phase 1a clinical trial . The second study is a Phase 2 trial with a gene therapy product which is no longer under development, but the safety monitoring of the study still continues in Sweden.
Among other things, Medfiles handles the safety management of trials , processes serious adverse events and reports serious unexpected adverse effects into the Eudravigilance system in collaboration with Herantis. Furthermore, Medfiles follows any changes in the benefit-risk ratio and writes the annual safety reports related to the drug product together with Herantis.
Medfiles has also provided consultation to Herantis on other things, such as general GCP issues and questions related to the interpretation of regulatory requirements.
Quick and reliable expert help
Katarina is very happy with the cooperation that has already lasted for 15 years.
“As we outsource so many of our activities, it is important that we can trust our partner. The cooperation with Medfiles has worked so well! We’ve been able to trust them to provide a professional service and keep the timelines. With Medfiles, we can be sure that our trials are in good hands.”
According to Katarina, the cooperation is always easy and effortless, but all matters are nonetheless handled with absolute care. Medfiles also knows how to receive feedback and develop their service accordingly.
“During the years, I have worked with many of the Medfiles experts and got to know some of them quite well. They are easy to approach, and I feel that I can always ask for advice, whether it’s about an ongoing study or something more general about clinical trials. The Medfiles experts always respond quickly, and outstanding issues are resolved within the required schedule.”
Up to now, Herantis has carried out clinical trials in Finland, Sweden and USA. Trials in other countries have also been planned, which is why the fact that Medfiles’ extensive partner network enables easy cooperation around the world is very much appreciated by Katarina.
