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PhD on PK/PD modeling of therapeutic monoclonal antibodies for therapeutic drug monitoring - Belgium
KU Leuven (company)
Posted on : 02 June 2017
- Anti-tumornecrosis factor-alfa (anti-TNF) drugs are being used for the treatment of patients with chronic inflammatory diseases such as psoriasis, rheumatoid arthritis, and inflammatory bowel diseases. These biological drugs are able to induce and maintain remission, but inter- and intra-individual variability in the pharmacokinetic (PK) processes lead to a variable therapeutic response.
- The development of an immune response against these drugs (i.e. the development of anti-drug antibodies (ADA)), is one of the many factors that can influence the PK of the biologicals and may give rise to loss of response.
- The Laboratory for Therapeutic and Diagnostic Antibodies has developed assays to measure serum concentrations of anti-TNF drugs (infliximab, adalimumab,golimumab and etanercept), anti-integrin drugs (vedolizumab) and anti-interleukin drugs (ustekinumab, secukinumab), and to quantify the immune response against these drugs (ADA).
- These assays are used for therapeutic drug monitoring (TDM) and they are the basis to support clinical decision-making.
This project includes:
- The systematic collection of data in databases: treatment regimen modalities, serum concentrations, immune response and other covariates and therapeutic response, in collaboration with different divisions.
- The development of population pharmacokinetic/pharmacodynamics (popPK/PD) models based on the data in the databases.
- The identification and quantification of covariates that influence the PK and PD of these biological.
- The development and validation of simulation models for the prediction of the PK profile of individual patients.
- The development and validation of dosing algorithms based on simulation models, in order to support clinical decision-making
- Reporting the obtained results as scientific publications and presentations at national and international conferences.
- A Master’s degree in Pharmaceutical Sciences, Medical or Biomedical Sciences or Bio-informatics or equivalent (with at least distinction).
- You have a strong commitment and engagement to carry out this project for 4 years.
- You are dynamic, flexible and you have an open attitude towards problems and challenges.
- You can take decisions and work independently.
- You are prepared to stay abroad in order to learn specific skills.
- You are highly interested in topics as pharmacokinetics, pharmacodynamics, statistics and mathematical modelling.
- Participation in courses/training on these topics is a plus.
- You have excellent social and communicative skills in order to work in an interdisciplinary team (collaborations with clinicians, pharmacists, lab technicians, nurses and statisticians).
- You are fluent in English (speaking and writing) and you can read and understand Dutch.
- You have good didactic skills and you can coach and motivate students.
- Experience with NONMEM/Monolix/Pmetrics, R, Spotfire and Symcyp is a plus.
- A PhD position in an international multidisciplinary team.
- You will be supported by dedicated pharmacometrics experts and will have the opportunity to follow courses.
- We offer a full-time PhD position for 1 year, extendable to 4 years after yearly positive evaluation.
- The candidate is encouraged, and will be internally supported, to apply for independent personal funding.