1. Current Status, Position

Prof Dr Isabelle Huys is currently Professor of Regulatory Sciences at the University of Leuven. She is teaching and researching in the domain of regulatory frameworks on medicinal product development, market approval and market access, as well as intellectual property rights.  

2. Education

Prof Dr Isabelle Huys is a pharmacist by training (KU Leuven, Belgium), with a PhD in pharmaceutical sciences (toxicology) from KU Leuven, Belgium and a further specialisation (LL.M.) in intellectual property rights (IPR) and regulatory sciences (Max-Planck-Institute for IPR, Munich, Germany).

3. Research Area

Prof Dr Isabelle Huys' research focuses on access to medicines and therapies. The research program studies diverse legal and regulatory aspects along the continuum of a medicinal product life cycle, from medicinal product discovery, development, approval, reimbursement and market adoption. The research program focuses on all types of medicinal products (small molecules, biologicals, advanced therapy medicinal products (ATMPs)) and diagnostics. Topics include biobanking and access to (human) biological samples and data, the use of real-world data/evidence (RWE) in medicinal product development and market access, repurposing of medicines for other (e.g. cancer) indications, patient preferences in medicinal product development and evaluation, precision medicine and companion diagnostics, off-patent strategies of biological products and market access of biosimilar and drug shortages. 

4. Conflict of interest: none