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On the project: Regulatory Research on Companion Diagnostics (RegCDx)
Dr. Tatjana Hübner on personalised medicine, the cooperation within a federal authority and the resolution to always remain curious.
At the BfArM, research activities are closely intertwined with regulatory tasks. They create an important basis for a better understanding of mechanisms of action, minimisation of side effects, or the evaluation of therapeutic concepts. Such complex subjects and correlations are not always easy to understand – especially for laypersons. In order to give us a first glimpse of the intriguing scope of activities and research areas, our researchers will be answering five questions about their work at the BfArM.
We will be starting with Tatjana Hübner from the research group Pharmacogenomics who is involved in the project RegCDx (Regulatory Research on Companion Diagnostics). This project is focussed on pharmacogenomic and genetic diagnostic procedures for personalised pharmacotherapy.
1. Concisely, for those of us who are not specialists like you: What impact does your research have on our everyday life?
How a person reacts to a medicinal product depends on the individual composition of their genes which in turn has an influence on their metabolism. The scientific field that focuses on this is called pharmacogenomics. This is where our research comes in: with the help of pharmacogenomic and genetic diagnostic procedures we can already determine whether a patient could have a risk of experiencing certain side effects prior to beginning treatment. The methods for doing this – frequently high-throughput procedures – are very complex. It is the aim of our research project to advance the corresponding expertise within the BfArM and to evaluate which existing and new genetic test methods are suitable as companion diagnostics.
This is currently not that visible in everyday life because such procedures are not yet part of routine care. Nonetheless, pharmacogenetic tests are already being used in the treatment of cancer or HIV. While more and more medicinal products are being introduced to the market, for which such tests are recommended prior to prescription, there is, however, not yet an automatism regarding their use in routine care.
2. If nothing else – what should everybody retain from this interview with regard to your research subject?
Our genes have an influence on the effects that a medication has on us. This belongs to the field of personalised medicine, of which pharmacogenomics is only one branch. In the future, we will be seeing more individual adjustments due to the progression made in high-throughput procedures. From my point of view, this will especially improve the situation of elderly people who often take several medicines that all have the potential to interact with each other. In this context, our genes play a role with regard to many medicinal products.
3. Considering the wealth of areas and institutions for research: How did you come to this research field, or rather, when did you know "this is IT"?
I have always been interested in genetics. Whereas my development towards regulatory research was stepwise. I studied molecular biology. My doctoral thesis at the LIMES Institute in Bonn was dedicated to gene expression. I investigated the effect of substances on various signalling pathways. Even then, I had discovered that there are strong individual aspects – both with regard to metabolism regulation as well as target gene expression. Following my doctorate, I underwent further training in clinical research – already with the idea of turning towards regulatory research. Then, in 2017, the possibility of working on individualised approaches within the EMPAR project in the BfArM's Pharmacogenomics research group opened up and I applied for the job immediately.
4. Working in research at the BfArM: What is different from what you had expected?
To be quite honest, I hadn't imagined the cooperation between the various BfArM divisions to be as good – and especially as quick – as it is. When coordinating the EMPAR study, I had contact with several different divisions and all of them worked well together. The necessary support was always there. I had expected this to be more complicated in a governmental authority.
5. Your favourite researcher in history and why?
Alexander Fleming. He is a great example for always remaining curious. He did not dispose of the contaminated Petri dish – as many of us probably would have – but became fascinated with the mould it contained. As a biologist especially, I of course find that very likeable. This is how he discovered penicillin which is so important for us. It was his curiosity of that contamination which ultimately gained him the Nobel Prize.
Background of th RegCDx project
Over the past ten years, the development of pharmacogenomic and genetic diagnostic procedures for personalised pharmacotherapy has made enormous progress. At the same time more and more medicinal products are being licensed that require testing of genetic markers, because these markers have an influence on the individual safety and efficacy of the medicinal product in question. Accordingly, the rules and regulations for placing in vitro diagnostics (i.e., tests outside the body) on the market have been further developed. The European Regulation on in vitro diagnostic medical devices (IVDR) came into force on 25 May 2017 and replaced the existing Directive after a transition period of five years. The RegCDx project supported this transition in order to master the scientific and regulatory challenges associated with the assessment of companion diagnostics under the new IVDR.
The first part of the project was carried out by scientists from the Medical Devices Division. They dealt with the modalities of the continuous exchange of information between BfArM, Paul-Ehrlich-Institut (PEI) and those partners participating in the implementation of the IVDR regarding the safety and performance of in vitro diagnostics and established the corresponding prerequisites.
The second part of the project is being covered by the Research Division with Tatjana Hübner's team. This part of the project focuses on gaining methodological expertise on which accompanying tests are suitable for which application. In order to do so, the research group is conducting its own investigations into high-throughput sequencing in cases of adverse drug reactions. This project is expected to run until the end of March 2024.
After having studied biology, Tatjana Hübner completed her doctorate in molecular biomedicine at the Life and Medical Sciences (LIMES) Institute in Bonn. There, she worked as a research assistant on the regulatory effect of amino acids on metabolism and neurotransmitter production. Subsequently, she worked as a medical writer and in the project management of an agency specialised in health communication. In 2017, she started working at the BfArM (research group Pharmacogenomics) where she assumed the position of study coordinator in the EMPAR project. Her focus has been on the project Regulatory Research on Companion Diagnostics since 2020.
