Isabelle Huys is a pharmacist and doctor in pharmaceutical sciences with further specialization in IPR and regulatory sciences. She is a professor at the Faculty of Pharmaceutical Sciences and member of the Center for IT & Intellectual Property IT law of KU Leuven. She worked for several years as Advisor for European Projects, IP Officer and later as Regional Development officer at the KU Leuven Research & Development department and she performed post-doctoral research at the Law Faculty of KU Leuven in the domain of patents and genetic inventions.
Enormous amounts of samples with associated data of patients are being collected within the scope of clinical research projects every day. To improve our understanding of underlying mechanisms of diseases and to develop transformative therapeutics, it is crucial that samples with associated data collected within clinical trials can be accessed and re-analyzed. This is especially true for personalized medicine strategies, where obtaining information about molecular biomarkers with corresponding clinical outcomes from both failed and successful drugs would offer the opportunity to gain understanding of an individual’s response to treatment. To safeguard personal information and respect people’s privacy, the collection, use and sharing of personal data and samples is subject to legal protection. Several legal questions remain, such as how can researchers access the existing data and sample collections today, and on which legal basis can existing data and samples collections be reused. This presentation will discuss major legal challenges in the context of data sharing and personalized medicine.