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Translational drug research: from developing experimental models to (first in human) clinical trials
Belgium (BeMSA) - KU Leuven, Leuven
Center Clinical Pharmacology, Herestraat 49, 3000 Leuven, Belgium
Prof. dr. Jan de Hoon
Dorien Bamps, PhD student; Heleen Marynissen, PhD student
Type of Research Project
- Clinical Project without Laboratory work
What is the background of the project?
The Center for Clinical Pharmacology is an academic research organization, focusing on early clinical drug development including phase I clinical trials, with over 25 years of experience in drug research. The trials are partly academic, partly industry sponsored. The student will be able to observe clinical trials first-hand, ranging from the related regulations to how a study protocol is put into practice. Furthermore, the student will be able to learn more about the academic research. Our own focus is on a superfamily of ion channels, the transient receptor potential (TRP) channels, which have been put forward as appealing targets for new analgesic drugs. However, clinical development of TRP-based drugs has not been very successful so far, often hampered by incomplete knowledge concerning their human role as well as the lack of translational models.
What is the aim of the project?
Our aim is to develop translational models, known as target engagement biomarkers, focusing on Transient receptor potential cation channel (TRP) subfamily V member 1 (TRPV1), subfamily 1 member 1 (TRPA1) and subfamily M member 3 (TRPM3). In the past, the capsaicin model was developed as a target engagement biomarker for TRPV1 and more recently, the cinnamaldehyde model was introduced to evaluate TRPA1 activity in humans. In the future, we aim to further characterize the TRPV1 and TRPA1 models as well as to develop a new biomarker assay for TRPM3.
What techniques and methods are used?
The research concerns in vivo clinical research with healthy subjects and patients. Depending on the study, different techniques will be used. For the academic part, laser Doppler imaging is an important technique to measure the dermal blood flow.
What is the role of the student?
- The student will mainly observe
- The student will observe the practical experiments but will be highly involved in the analysis of the results
- The tasks will be done under supervision
What are the tasks expected to be accomplished by the student?
Concerning the commercial studies, the role of the student will be solely observant. Depending on the phase the academic research is in, the student can be more involved, for example in pharmaceutical preparations or in performing laser Doppler imaging. At the end of the exchange, the student will submit a scientific report focusing on a study of his/her choice or on the academic research he/she was involved in. For this purpose the student is expected to go more deeply in to that subject.
Will there be any theoretical teaching provided (preliminary readings, lectures, courses, seminars etc)
The student is welcome to join trainings organized at the unit, for example a course on Good Clinical Practice (GCP) or a study specific training. However, no specific theoretical teaching will be organized for the student.
What is expected from the student at the end of the research exchange? What will be the general outcome of the student?
- The student will prepare a scientific report
What skills are required of the student? Is there any special knowledge or a certain level of studies needed?
The student should be interested in clinical research, eager to know, but at the same time discrete/professional in contacts with study participants. Subjects passed: Master students with a basic knowledge concerning clinical pharmacology
Are there any legal limitations in the student’s involvement
Type of students accepted
This project accepts: - Medical students - Students in biomedical fields
- Frank et al.; Clinical Biomarkers in Drug Discovery and Development; Nature; 2003.
- Buntinx L. et al. Development of anti-migraine therapeutics using the capsaicin-induced dermal blood flow model. British Journal of Clinical Pharmacology; 2015.
- Buntinx et al.; Development of an in vivo target-engagement biomarker for TRPA1 antagonists in humans; Br J Clin Pharmacoly; 2017.
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