QSP Week | Session 4: Credibility Assessment of QSP Models for Regulatory se WG
Includes a Live Web Event on 04/24/2026 at 9:00 AM (EDT)
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Chair(s): Blerta Shtylla
Federico Reali: Working Group Updates
Alexander Kulesza: The Landscape of QSP Modelling and Virtual Populations in the AI Era: From Current to Best Practice
Conner I. Sandefur: AI-Ready QSP: How Emerging Standards can Support Transparency, Credibility, and Future Regulatory Use
Alexander Kulesza, Conner I. Sandefur, Federico Reali: Panel Discussion: AI, Reporting, and Trust in QSP Modelling
Blerta Shtylla, PhD
Research Fellow Pharmacometrics & Systems Pharmacology
Pfizer Research and Development

Federico Reali
Alexander Kulesza, PhD
Principal Scientist
Systems Pharmacology Lead
Dr. Alexander Kulesza is currently Principal Scientist and Lead of Systems Pharmacology at ESQlabs GmbH, Saterland, Germany operating out of Lyon, France. He is also affiliated with the University of Namur, Belgium. After completing his theoretical and computational chemistry Diplom at the Humboldt-University Berlin, he obtained his PhD from the Free University Berlin studying inorganic - biomolecular hybrid systems by ab-initio quantum chemistry methods and molecular dynamics. He then moved to Lyon, France focusing on integrating advanced molecular dynamics techniques like replica-exchange and Free-Energy methods to integrate gas-phase structural biology experiments data for elucidating structurally disordered proteins. Alexander then moved out of fundamental reasearch into drug development joining Novadiscovery (now Nova In silico) as Scientist, then team leader then executive manager and since then working on quantitative systems pharmacology modeling combined with physiologically based pharmacokinetics in inflammatory, immune, infectious, metabolic disorders and (immuno)oncology with a focus on model credibility assessment for potential regulatory applications.
