The Experts

Prior to joining qPharmetra in September 2018, Alexander worked as a Senior Scientist at AbbVie, where he was the clinical pharmacology and pharmacometrics lead of multiple Phase I/II studies supporting development of biologics and small molecules in immunology. During his two and a half years at AbbVie, Alexander was responsible to inform and optimize study design through population modeling and simulation and provided strategic input across multidisciplinary teams to ensure successful integration of clinical pharmacology aspects into the overall project development. Besides his established expertise in population modeling and model-based drug development, he also authored clinical study reports, Phase I/II protocols, PK/PD reports and supported clinical pharmacology sections of regulatory documents. Alexander obtained his PhD in pharmaceutical sciences from the University of Florida, where he worked in the therapeutic area of infectious diseases and is a pharmacist by training.

Alix joined the qPharmetra team in April 2023 as an associate consultant. Alix studied Pharmacy at Université Paris Descartes where she did several internships related to the pharmacometrics field applied to therapeutic drug monitoring (Hôpital Beaujon and Inserm UMR1137) and drug development (Sanofi).

After graduating, she started her PhD at Freie Universität Berlin in the group of Professor Charlotte Kloft. Alix’ research focused on optimizing infliximab treatment in inflammatory bowel diseases patients. She used mixed hidden Markov and popPK modelling to investigate the development of immunogenicity in Crohn’s disease patients receiving infliximab therapy and the impact of disease severity on infliximab clearance in acute severe ulcerative colitis patients.

Ben joined qPharmetra in March 2018 with 25 years of experience in the pharmaceutical industry supporting projects throughout the drug development process from clinical candidate selection through approval and post-marketing studies. He has worked in both large and small pharmaceutical companies as well as in biotech to design and implement the clinical pharmacology strategy to support the successful global registration of medications. Ben has extensive experience in the development of medications to treat cancer but also has experience in other therapeutic areas including diseases of the lung, central nervous system disorders, infectious diseases, dermatology, and gastrointestinal disorders. Ben brings extensive experience in interactions with the FDA, including Oncologic Drug Advisory Committee meetings, Health Canada, and European regulatory agencies.

Before joining qPharmetra in 2014, Eva was a Pharmacometrician with AstraZeneca. During her eight years at AstraZeneca, Eva was responsible for planning and executing modeling and simulation activities for development of drugs in several different therapeutic areas, throughout all stages of clinical development. She has experience with regulatory submissions, has excellent technical skills and is characterized by delivering products with high quality and dedication.

Eva holds a M.Sc in Chemical Engineering from Uppsala University with focus on pharmaceutical science, including a master thesis dealing with PK/PD modeling of metformin.

Prior to joining qPharmetra in August 2018, Farrah completed her post-doctoral studies at the Mathematical Biosciences Institute focusing on biochemical models for human physiology and disease. Her research used a variety of mathematical methods from applied dynamical systems, numerical analysis, and biostatistics to understand critical issues in depression, arsenic detoxification, gender differences in one-carbon metabolism and personalized medicine. Farrah attended the University of Tennessee at Chattanooga for her masters, concentrating in Applied Statistics, then completed her PhD in Applied Mathematics from Colorado State University. Her work focused on structures of viral capsids and understanding nucleic acid-protein interactions in HIV-1. Farrah is especially interested in quantitative methods to characterize biological systems, disease processes, and mechanisms of PKPD.

Fredrik joined qPharmetra in July 2016, and he brings 10 years’ experience in pharmacometric consulting to the team. He has worked in a number of clinical areas, including cardiovascular, neuroscientific, oncology, virology, renal disease. He completed his PhD in toxicokinetics at the National Institute for Working Life in Stockholm, Sweden, applying Bayesian estimation techniques to PBPK models for risk assessment purposes. He followed his dissertation with three years of Post-Doctoral research at the Uppsala University Pharmacometrics Group, with a focus on modeling of ordered categorical data.

Before joining qPharmetra in 2014, Jan worked for more than 25 years as a Senior Scientist in the pharmaceutical industry. In that role he contributed to numerous Phase 1-3 projects in the Women’s Health (contraception, infertility, and HRT) and CNS (depression and anesthesiology) areas. His activities focus on executing dataset preparation, non-compartmental PK analysis, and quality control. He wrote several SOPs and manuals regarding PK analyses, data-management, archiving and IT procedures and developed SAS macros, WinNonLin workstreams and R scripts for easy and standardized PK analyses. Jan holds a Bachelor of Engineering in Analytical Chemistry.

Jantine joined the qPharmetra team in April 2023, after working as modelling and simulation scientist (pharmacometrician) at Idorsia Pharmaceuticals. During her three years at Idorsia, Jantine was responsible for modelling and simulation activities supporting drug development in several therapeutic areas (e.g., auto-immune, genetic, and cardiovascular diseases) at different stages of clinical development. She is also a member of the organization committee of the annual Basel Modeling & Simulation seminar.

Jantine completed her post-doctoral studies at the Swiss Tropical and Public Health Institute and the University’s Children Hospital in Basel. Her research included population PK and exposure-response analyses for anthelmintic drugs to improve dosing in children with helminth infections. Jantine holds a PhD in Pharmacology from Leiden University. Her work focused on the use of pharmacometrics to characterize first-pass and systemic metabolism of cytochrome P450 3A substrates in neonates, infants, and children. Additionally, she was actively involved in teaching activities in pharmacology for Bio-Pharmaceutical Sciences students at Leiden University.

K-G joined qPharmetra in January 2018 and has 35+years experience in the areas of pre-clinical DMPK and Clinical Pharmacology from Astra/AstraZeneca. K-G has mainly worked in the CNS area and he has special interest in design and interpretation of Clinical Pharmacology studies and development programs in the field. K-G has a PhD and holds a MSc in Pharmaceutical Science, both at Uppsala University, and is a Pharmacist by training.

Klas joined qPharmetra after finishing his PhD at Uppsala University in 2012. The main focus of his thesis was population PK/PD modeling in the disease area of schizophrenia, specifically mechanistic modeling of side effects during treatment with D2-receptor antagonists and translational aspects of predicting side effects. In addition, during his PhD he performed methodological research within the population modeling area and tutored on simulation and covariate modeling courses. In the 5+ years he has worked at qPharmetra his largest focus has been on modeling in oncology with experience in applying modeling in the full range of drug life-cycle, from pre-clinical to post-marketing. He also has experience in other therapeutic areas such as dermatology and nephrology. He holds an MSc in Pharmaceutical Bioscience from Uppsala University and is a Pharmacist by training.

Koen joined qPharmetra in July 2018. He obtained a M.Sc. in Biology from the Catholic University of Leuven (Belgium) in 2001 and his PhD, entitled “Chronic exposure of mice to cadmium: toxic effects on the renal proximal tubule”, from Hasselt University in 2008. In between his studies, Koen worked for approximately 2 years as a data analyst in the department of Global Clinical Pharmacokinetics and Clinical Pharmacodynamics of Johnson & Johnson Pharmaceutical Reasearch and Develoment, Beerse, Belgium. In this role he contributed to Phase I through III development programs for PK and PK/PD work in various therapeutic areas. After his PhD Koen assumed several roles where he was responsible for PK and PK/PD related work of in vitro, ADME and toxicokinetic studies, co-responsible for strategic planning of in vitro and (pre)clinical in vivo research including design/optimization of target product profiles and decision trees, mapping out of (pre)clinical drug development programs (infectious disease, gastro intestinal tract and virology), CRO selection and writing grant applications. Furthermore, Koen headed the pharmacokinetic and toxicokinetic department and later on as a consultant he was involved in executing modeling and simulation activities to support the implementation of the clinical pharmacology strategy.

Lars became a member of of qPharmetra in 2011. He completed his PhD in pharmacokinetics in 2006 at Uppsala University with Professors Mats Karlsson and Niclas Jonsson, and has been a consulting Pharmacometrician since 2007. He is the co-author of Perl-speaks-NONMEM (PsN), an enhanced toolkit for conducting population PK/PD modeling in NONMEM. Lars holds an MS in Molecular Biotechnology from Uppsala University and spent 1½ year as a Systems Developer before starting his PhD.

Lee is a co-founder of qPharmetra and is currently CFO. Lee has applied Pharmacometrics to solve drug development problems for 14 years. He has either taken part or led many analysis, and has a special focus on Rheumatoid Arthritis and Oncology. Lee’s interests are primarily on analyses that inform strategic, internal decision making, such as calculating the value of information from Proof of Concept trials, predicting clinical efficacy given early results to guide decisions on Phase III, and informing post marketing decisions. These reflect his advanced training, years of experience, and affinity for Decision Analysis.

Before joining qPharmetra in 2014, Marita worked for more than eight years as an Associate Principle Scientist in the Quantitative Pharmacology and Pharmacometrics department at Merck.  During her years at Merck, Marita was responsible for planning and execution of PK/PD and Modeling & Simulation activities. Within multidisciplinary development teams, Marita provided strategic input for the clinical pharmacology development strategy for new drugs from early development up to life-cycle management for a wide range of therapeutic areas. Marita has authored many clinical study protocols, clinical study reports, M&S reports and clinical pharmacology sections of regulatory documents in support of regulatory submissions. Marita is known for her excellent technical skills, dedication and a timely delivery of high-quality results. Marita holds an MSc in Biomedical Engineering from the Technical University of Eindhoven with a focus on Biomedical Imaging and Modeling.

Max joined qPharmetra in October 2019 as an associate consultant. His contributions include population PK and PKPD analyses supporting dose selection decisions, and optimizing pediatric study designs, to labeling in target populations.

Prior to joining qPharmetra, Max worked as a Project Pharmacometrician (2017-2019) at Boehringer Ingelheim (Biberach an der Riß, Germany), where he was a core member of multiple early clinical development teams (late pre-clinical – PhI/II) in the therapeutic area Oncology, providing strategic and hands-on pharmacometric modeling and simulation support. Responsibilities included first-in-human dose predictions, informing dose-escalation strategies, tumor progression modeling and interactions with the FDA and its German counterpart, PEI, regarding PK/PD modeling and simulation sections of regulatory submission documents.

Max completed his PhD in Biopharmaceutical Sciences in 2015, Thesis title:  “Stress-induced immunomodulation of the innate immune system in cardiovascular disease” investigating the interplay between the innate immune system and acute cardiovascular complications of atherosclerosis in various pre-clinical disease models. After his PhD he worked as a post-doc (2016-2017) in the pharmacology group at the Leiden Academic Centre for Drug Research (LACDR) in collaboration with a biotechnology company, applying pharmacometric (PK and Item Response Theory disease progression) models to support the drug development of their lead compound aimed at slowing down disease progression in patients with Amyotrophic Lateral Sclerosis.

Michelle joined qPharmetra in 2021 with 14 years of experience as a Pharmacometrics Consultant. She has quantitative drug development experience in oncology, hematology, cardiovascular disease, vaccines, and infectious diseases. Michelle’s enthusiasm for consulting is fueled by the opportunity to collaborate with clients across all phases of drug development, from population PK and PK/PD analyses in support of regulatory submissions to model-based meta-analyses informing go/no-go decisions.
Michelle takes a pragmatic approach to modeling and is appreciated by clients for her commitment to their success. 

Nicolás joined qPharmetra in 2022 as an associate consultant. Nicolás holds a bachelor’s in Biomedical Sciences from the University of Barcelona and a master’s in Clinical Research from Imperial College London. After graduating, Nicolas worked at AstraZeneca in Gothenburg (Sweden) in various stages of drug development. In 2018, Nicolás returned to Spain to start his PhD at the University of Navarra. His thesis focused on the use pharmacometrics to facilitate decision-making in the fields of pain research and perioperative management.

Prior to joining qPharmetra in May 2018, Oskar completed his PhD in pharmacometrics at Uppsala University. The main focus of his thesis was mechanism-based modeling of glucose homeostasis both in humans and in animals. In addition, during his PhD he tutored in pharmacokinetics and PK/PD modeling courses. He has also worked as a pharmacometric consultant for 1.5 years applying his research from Uppsala University in several diabetes drug development projects. He holds an MSc in Pharmaceutical Bioscience from Uppsala University.

Before starting as a Consultant at qPharmetra in February 2022, Robin worked as a Senior Scientist (2018 – current) in the laboratory of Professor Charlotte Kloft at Freie Universitaet Berlin, where he still continues in a part-time position. He has mentored 15 PhD students to date in research topics applying pharmacometric approaches in anti-infective therapy, oncology, gastro-intestinal diseases, immunology, endocrinology and pediatrics. He is a Bio-science Engineer (BSc/MSc, 2014) by training and obtained his PhD in Pharmaceutical sciences in 2018 on the topic of bottom-up (IVIVE-PBPK), top-down (population PK/PD) and middle-out (retrograde PBPK) modelling and simulation in pediatric drug research at Ghent University, Belgium.

Apart from his academic work, Robin has experience as a freelance consultant in pharmacometrics (2020 – 2022). In this position, he has worked on translation of antiviral biologics from the pre-clinical to the clinical space, bioequivalence of complex formulation (inhalers, transdermal delivery systems), study design and PK/PD modelling of opioids.

Tim has consulted for the pharmaceutical industry since 2004 as a software developer, data manager, and modeler.  He has worked in oncology, cardiology, neurology, immunology, virology, endocrinology, and infectious diseases, including PopPK and exposure-response work supporting drug approval by the FDA and EMA.  He is expert at installation and configuration of NONMEM as well as transformation of its inputs and outputs.  He has published more than a dozen R packages on CRAN and presents regularly at ACoP on pharmacometric methodology.  His research interests include workflow optimization, systematic use of analysis metadata, and efficient visualization of results.  Tim holds a doctorate in Ecology from Michigan State University, and held positions with Metrum Research Group and Certara before joining qPharmetra in 2019.