QSP Week | Session 4: Credibility Assessment of QSP Models for Regulatory Use WG

Federico Reali, PhD, is Group Leader of the Quantitative Systems Pharmacology (QSP) group at Fondazione The Microsoft Research – University of Trento Centre for Computational and Systems Biology (COSBI). His expertise is in systems biology and QSP modeling applied to drug development across multiple therapeutic areas, including neurodegenerative disorders and lysosomal storage diseases. He leads and coordinates multidisciplinary research teams and collaborates with pharmaceutical companies and non-profit organizations on translational QSP projects. He is also a Teaching Fellow at the University of Trento, where he teaches probability and statistics and supervises undergraduate and graduate students. Federico Reali serves as Vice President of the Scientific Committee of the Italian National Life Sciences Cluster ALISEI. His current interests focus on using quantitative models, digital twins, and data-driven approaches to support clinical decision-making, therapeutic stratification, and the translation of complex biological data into clinically meaningful insights.

Alexander is a Chemist with a PhD focusing on theoretical and computational methods for structural and optical property predictions. He then spent several years in academia (U. of Lyon) working on molecular dynamics simulation and free energy methods dedicated to protein structure and aggregation. Alex moved to systems pharmacology applying large-scale disease and quantitative systems pharmacology models integrated into clinical trial simulations, across a number of disease areas. Alex is now leading the QSP team within ESQlabs with the aim to promote widespread application of integrated PBPK and QSP modeling. He is also currently affiliated at the pharmacy Department of University of Namur, working towards better qualifying PBPK/QSP for regulatory decision making. 

Conner Sandefur, PhD, is a Senior Scientist in QSP Solutions at Simulations Plus, where he develops mechanistic, systems-based models to support client decision-making and model‑informed drug development. His work focuses on injury and repair dynamics and nonlinear disease processes, with an emphasis on transparent, mechanism‑first model design that strengthens credibility across QSP applications.