A QSP Platform Model for COVID 19 Vaccine Development | Prof. Piet H. van der Graaf, Drs. Artur Belov, Osman Yogurtcu, and Rosalin Arends

From 2013-2016 Prof. Piet H. van der Graaf was the CSO/Director of Research of the Leiden Academic Centre for Drug Research (LACDR, The Netherlands). Before this, he held various research leadership positions at Pfizer (United Kingdom) between 1999-2013 in Discovery Biology (Head of Sexual Health Therapeutic Area), Pharmacokinetics and Drug Metabolism (leading Translational Quantitative Pharmacology) and Clinical Pharmacology/Pharmacometrics. He was involved in a large number of drug discovery and development programs in multiple therapeutic areas and responsible for the nomination of more than 15 clinical development candidates. He holds several patents in the field of target discovery. From 1990-1994 he received his doctorate training in quantitative receptor pharmacology with Nobel laureate Sir James Black at King's College London and thereafter worked as a postdoctoral fellow of the Royal Netherlands Academy of Sciences at Leiden University on the development of mechanism-based pharmacokinetic-pharmacodynamic (PKPD) approaches. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology (PSP) before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet is a Fellow of the British Pharmacological Society (BPS) and has (co-)authored more than 180 peer-reviewed papers in the area of quantitative and translational pharmacology. He was the recipient of the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP).

Dr. Artur Belov received his doctoral training in pharmacology and biophysics at the New York University School of Medicine in 2016, where he studied the assembly of various cytokine-receptor signaling complexes. He is currently a student at University of Texas-Austin pursuing graduate studies in applied statistics. After completing his Presidential Management Fellowship in 2018, he joined the US Food and Drug Administration as an operations research analyst in the Office of Biostatistics and Epidemiology. Artur is a member of the Center for Biologics Evaluation and Research (CBER) Model Informed Drug Development working group. Artur also assists in the administration of FDA-funded grants that support the use and development of novel approaches for assessing the post-marketing safety and efficacy of CBER-regulated products.

Osman Yogurtcu is a researcher-reviewer at the Office of Biostatistics and Epidemiology at the Center for Biologics Evaluation and Research at the US Food and Drug Administration where his focus is on Quantitative Benefit-Risk assessment of therapeutics, Model Informed Drug Development, and Real-world Data and Real-World Evidence review. He received his PhD in mechanical engineering from Johns Hopkins University, MSc degree in computational science and engineering and BSc in electronics engineering from Koc University.

Rosalin H. Arends, PhD, is the Head of Neuroscience and Vaccines and Immunotherapies in the department of Clinical & Quantitative Pharmacology at AstraZeneca, Gaithersburg, USA. Over the last 30 years, a major focus of her career has been progressing the field of model-based PK and PK/PD analyses of new therapeutics across disease areas. She started in this field by obtaining a Masters in Bio-Pharmaceutical Sciences from Leiden University, The Netherlands, followed by a PhD in Pharmaceutical Sciences at the University of Washington, Seattle, WA, USA after which she worked at Amgen, Abgenix, Pfizer, MedImmune and AstraZeneca. At Astrazeneca, Dr. Arends currently leads a group of scientists that supports Clinical Pharmacology, Pharmacometrics and Clinical Immunogenicity deliverables for early and late stage drug candidates for Microbial Sciences and Neuroscience projects.