What drives our alumni?
What drives our course participants and alumni? These entrepreneurial biomedical professionals from academia and industry all work to improve human health. What is their motivation to do what they do? What is their vision for the future of their field?
We’ll start the series off with Juul van den Reek, MD PhD, epidemiologist in training in the dermatology department of Radboud University Medical Center in the Netherlands. Juul’s work focusses on biologic treatment of plaque psoriasis. She recently completed the PJ Futurelab blended course Clinical Development and is finalizing her clinical trial proposal for submission in the “PJFL Best Clinical Trial Challenge” and a chance to win a €500.000 ZonMw grant. In this interview, she shares her thought on the urgent questions in the field and highlights the importance of pragmatic trials in drug development.
Although biologics are reimbursed by most health insurance companies in the Netherlands, biologics are relatively expensive. They are indicated for moderate to severe psoriasis and strict requirements exist for reimbursement e.g. failure with other treatments and intolerance for light therapy.Another urgent matter, which is of course difficult to solve, is personalized medicine. We are searching within other fields, such as genetics and immunology, to find predictors that will help us use the available agents as efficiently as possible. Right now, many treatments are by trial and error: we treat with agent A and if it doesn’t work, we try agent B. This is very inconvenient for the patient because we have to wait a few months before we can switch to another agent. In the meantime, the patient continues to suffer from active psoriasis. It is also very costly because we have to find the correct starting dose each time, we do all the lab and then after 3 months we have to conclude that it isn’t working. Biomarkers in the broadest sense. We are looking for biomarkers in the broadest sense which also includes clinical biomarkers. For example, we know that women generally don’t respond very well to certain agents. Being a woman can of course not directly be considered a biomarker but it can have a large impact on the results. In addition, we are looking at pharmacogenetic markers, e.g. if certain SNPs [single-nucleotide polymorphisms] or genes can predict effecacy, and immunological markers such as cytokines and if we can predict responses based on immune phenotyping.
Recently published studies in the Britisch Journal of Dermatology showed correlations between pharmacogenetic markers and response to biologic treatment. *Variations in CD48 SNP predicts response to etanercept use (van den Reek, Coenen, Arias et al, BJD 2017;176(5):1288-96)* *HLA-Cw6 is a promising predictor for ustekinumab response (van Vugt, van den Reek, Coenen en Jong, BJD 2018;178(17):86-94)*These are all prospective studies. In 2005, the RadboudUMC set up a prospective registry to collect real-world safety and efficacy data from patients who are taking biologics. The clinical data comes from 16 dermatological centers in the Netherlands, including UMC Utrecht, Maastricht and several peripheral center. In addition, we collect blood and DNA samples from these patients and the aim is to couple the registry data with the blood and DNA data.
Juul during the Clinical Development on-campus course in June 2018
These analyses were recently published in Acta Dermato-Venereologica: van den Reek, van Vugt, van Doorn et al, Acta Derm Venereol 2018;98(7):648-654.
This grant refers to a €500.000 grant from ZonMw. Juul is finalizing the clinical trial proposal that she started during the PJ Futurelab Clinical Development course and will submit her proposal in the “Best Clinical Trial Proposal" Challenge for a chance to win the competitive grant. *The winner of the "Best Clinical Trial Proposal" Challenge 2018 has since been announced. Read more*
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Clinical Development On-campus Extended
Question Based Clinical Development facilitates the design of a rational and efficient development pathway for new medical interventions. Learn the principles behind QBCD and how to apply it to real R&D projects.
Clinical Research in the Netherlands - Legislation & Procedures
Before starting a medical research study, it is reviewed and approved by an authorized reviewing committee. Learn the practical steps to navigate the review system of clinical research. This course is specific for the Netherlands.
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