Malek OkourB.D.S., Ph.D.
Clinical Pharmacology & Pharmacometrics Leader
Director, Clinical Pharmacology, Modeling and Simulation — Servier
Dr. Okour combines a hands-on modeling foundation with the ability to build the software behind the science — from multi-agent AI frameworks to Neural-ODE engines — and has contributed clinical pharmacology and pharmacometrics support across programs associated with 5+ global regulatory approvals.
Positioning Statement
Malek Okour is a Clinical Pharmacology & Pharmacometrics Leader with 12+ years across GSK, Servier, and Merck, currently serving as Director of Clinical Pharmacology, Modeling and Simulation at Servier. He combines a hands-on modeling foundation with the ability to build the software behind the science, leading quantitative drug development end to end — population PK/PD, exposure–response, PBPK, and systems pharmacology — from first-in-human dose selection through global submission. He has contributed clinical pharmacology and pharmacometrics support across programs associated with 5+ global regulatory approvals (FDA, EMA, PMDA, TGA, Swissmedic, ANVISA).
Author or co-author of 20+ peer-reviewed articles. Co-inventor of Australian-granted patent AU2023213173B2, with related international applications.
He also designs and ships production AI/ML and automation tools: an open reference architecture for multi-agent pharmaceutical AI (Pharazi.ai), an AI-first pharmacometrics platform (Pharmax.ai), a public collection of 119 clinical pharmacology tools (PharmKit.dev), and an open-source Neural-ODE PK engine (DeepPK).
Career Highlights
Outcomes that matter — quantified impact across drug development, regulatory science, and innovation.
End-to-End Clinical Pharmacology
Contributed clinical pharmacology and pharmacometrics support across programs associated with 5+ global regulatory approvals — spanning oncology, respiratory, infectious disease, and rare diseases.
Global Regulatory Experience
Contributed to regulatory submissions across FDA, EMA, PMDA, TGA, Swissmedic, ANVISA, MHRA, and China NMPA.
Top 10% Worldwide at GSK
Innovation, Performance & Trust Award — top 10% of all GSK employees globally. Plus multiple Gold, Silver, and Bronze awards for regulatory impact (2016–2020).
AI/ML Platform Builder
Creator of PharmKit, a public collection of 119 clinical pharmacology tools. Also built Pharazi.ai (multi-agent AI reference architecture), Pharmax.ai (AI-first pharmacometrics platform), and DeepPK (Neural-ODE PK engine).
20+ Peer-Reviewed Articles
Author or co-author of 20+ peer-reviewed articles across CPT:PSP, J Clin Pharmacol, Clin Pharmacokinet, Br J Clin Pharmacol, and more.
Granted Patent
Co-inventor of Australian-granted patent AU2023213173B2 for Hepatitis B combination therapy, with related international applications.
View →Career Timeline
Servier Pharmaceuticals
Director, Clinical Pharmacology, Modeling and Simulation
Boston, MA (Remote) · Mar 2022 – Present
GlaxoSmithKline (GSK)
Manager, Clinical Pharmacology Modeling & Simulation
Collegeville, PA · Oct 2015 – Feb 2022
Merck & Co.
Pharmacometrics Intern
Rahway, NJ · Jun 2014 – Sep 2014
University of Minnesota
Graduate Researcher & Teaching Assistant
Minneapolis, MN · Aug 2012 – Dec 2015
Various Institutions, Jordan
Clinical Dentistry & Medical Education
Jordan · 2009 – 2010
Innovation Lab
Open-source tools and AI platforms pushing the frontier of pharmacometrics.
Pharazi.ai
Open Reference Architecture for Multi-Agent Pharmaceutical AI
Open reference architecture with ClinPharm, Pharmacometrics, Regulatory, and Audit-Chain agents — designed against ICH M15, 21 CFR Part 11, EU Annex 11, CDISC SDTM, and ICH E6(R3).
Pharmax.ai
AI-First Pharmacometrics Platform
AI-first pharmacometrics platform for model building, diagnostics, simulation, and reporting — bridging computational pharmacology with modern AI/ML workflows.
PharmKit.dev
Public Collection of 119 Clinical Pharmacology Tools
Creator of PharmKit, a public collection of 119 clinical pharmacology tools across 13 domains and 4 agencies — PK/PD calculators, DMPK, biologics PK (ADC multi-analyte PK visualizer, TMDD simulator), and regulatory intelligence.
DeepPK
Open-Source Neural-ODE PK Engine
Neural-ODE PK engine spanning small-molecule and multi-analyte ADC PK (conjugated ADC, total antibody, free payload; DAR dynamics, TMDD) with automated AIC/BIC/RMSE model comparison and FDA-aligned credibility reporting.
DosePredict
Peer-Reviewed Dose-Prediction Tool
Generalized PK-based Shiny dose-prediction application (J Clin Pharmacol, 2020) adopted in MMV PK/PD modelling workshops.
HBV Combination Therapy Patent
Australian-Granted Patent (AU2023213173B2)
Co-inventor of Australian-granted patent AU2023213173B2 for Hepatitis B combination therapy, with related international applications.
Selected Publications
A curated selection of DOI-verified, peer-reviewed publications spanning pharmacokinetics, pharmacometrics, regulatory science, and AI-augmented drug development.
Hoeben E; Madelain V; Acharya C; Barbier Saint Hilaire P; Tyagi E; Okour M; Fouliard S "PKPD-Based Translational Modeling of Calaspargase Pegol Preclinical Activity in Hepatocellular Carcinoma" European Journal of Drug Metabolism and Pharmacokinetics (2026)
Nader A; Alexander E; Brintziki D; Haggag AZ; Harrison SA; Hawes IA; Hezareh M; Lippa AM; Okamasa A; Okour M; Okuda N; Sager JE; Segal S; Shida Y; Skingsley A; Williams R; Yoon EY; Austin D "Pharmacokinetics, Safety, and Tolerability of Anti-SARS-CoV-2 Monoclonal Antibody, Sotrovimab, Delivered Intravenously or Intramuscularly in Japanese and Caucasian Healthy Volunteers" Clinical Pharmacokinetics (2024)
Okour M; Thapar MM; Farrell C; Lukas MA; Beghetti M; Beerahee M "Pediatric Population Pharmacokinetic Modeling and Exposure-Response Analysis of Ambrisentan in Pulmonary Arterial Hypertension and Comparison With Adult Data" The Journal of Clinical Pharmacology (2023)
Pearson RA; Wicha SG; Okour M "Drug Combination Modeling: Methods and Applications in Drug Development" The Journal of Clinical Pharmacology (2023)
Okour M "DosePredict: A Shiny Application for Generalized Pharmacokinetics-Based Dose Predictions" The Journal of Clinical Pharmacology (2020)
Okour M; Al-Kofahi M; Austin D "Hydroxychloroquine and azithromycin as potential treatments for COVID-19; clinical status impacts the outcome" Journal of Pharmacokinetics and Pharmacodynamics (2020)
Okour M; Jacobson PA; Israni A; Brundage RC "Comparative Evaluation of Median Versus Youden Index Dichotomization Methods: Exposure-Response Analysis of Mycophenolic Acid and Acyl-Glucuronide Metabolite" European Journal of Drug Metabolism and Pharmacokinetics (2019)
Okour M; Jacobson PA; Ahmed MA; Israni AK; Brundage RC "Mycophenolic Acid and Its Metabolites in Kidney Transplant Recipients: A Semimechanistic Enterohepatic Circulation Model to Improve Estimating Exposure" The Journal of Clinical Pharmacology (2018)
Showing only DOI-verified publications — full list available upon request.
Technical Expertise
AI/ML & Automation
Pharmacometrics & Quantitative Tools
Programming & Data Science
Full-Stack Development
Regulatory & Strategy
Research Domains
Academic Background
University of Minnesota
PhD, Experimental & Clinical Pharmacology
2012 – 2015 · Minneapolis, MN
Emphasis: Clinical Pharmacology & Pharmacometrics · Advisor: Richard C. Brundage, PharmD, PhD
University of Houston
PhD Program, Pharmacology (Transferred)
2010 – 2012 · Houston, TX
Emphasis: Neuropharmacology · Advisor: Jason Eriksen, PhD
Jordan University of Science & Technology
Bachelor of Dental Surgery (B.D.S.)
2004 – 2009 · Irbid, Jordan
Recognition
GSK Worldwide Top 10%
Innovation, Performance & Trust Award (2019)
Awarded to the top 10% of all GSK employees worldwide for demonstrating the most impactful performance against objectives and role modeling of GSK values.
Professional Service
Professional Societies
Academic Service
Let's Connect
Interested in collaboration, speaking engagements, or research partnerships in clinical pharmacology, pharmacometrics, and AI-driven drug development?