Abstract:
This webinar covers both the regulatory and industry perspectives on TDM/MIPD for biological and biosimilar drugs in Europe. It will begin by outlining the regulatory approval process, emphasizing the clinical pharmacology studies and dose optimization required for regulatory compliance, illustrated with case examples involving, e.g., infliximab. The discussion will then shift to the pharmaceutical industry’s role, focusing on the optimization of analytical assays for clinical studies and their possible application in therapeutic drug monitoring (TDM). Additionally, it will highlight on the use of TDM for originators and biosimilars and potential commercial advantages of it.
Paulo Paixãois an Assistant Professor in Pharmacokinetics and Biopharmaceutics at the Pharmacy Faculty of Lisbon University since 2012. He is also a Clinical Pharmacology assessor at INFARMED (Portuguese Regulatory Agency) since 2003 and a member of the former Pharmacokinetics Working Party (PKWP) from EMA and a current member of the Methodological Working Party MWP, also from EMA. In his regulatory work, he has been involved in the assessment of bioequivalence and general clinical pharmacokinetics in Centralized, Decentralized, Mutual recognition and National Procedures. Regarding research, his main topics of interest has been related to pharmacokinetics and Therapeutic Drug Monitoring. In particular, he has been involved on creating and optimizing drug development tools, namely, on the use of QSAR and data integration procedures with PBPK models in particular for modelling and simulation on oral drug absorption. Latter research interests are related to the better understanding of the physiology of the GI tract and its consequences in clinical variability for oral drug products.
Gregor Schaffar, Ph.D., heading the Clinical Bioanalytics Laboratories at Sandoz, which focus on the development and validation of state-of-the-art pharmacokinetic, PD/biomarker as well as immunogenicity assays in support of the in-house biosimilar development programs at all stages. Dr. Schaffar received his Ph.D. in Biochemistry from the University of Munich, Germany, and held various positions in research and development in industry before joining Sandoz. In the past years, he has been involved in several successfully approved biosimilar programs globally.