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Clinical Pharmacology
ClinPharm Companion
Study design, DDI, special populations and labeling, from first dose to final label.
CLINICAL PHARMACOLOGY · PHARMACOMETRICS · AI/ML
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.
12+
Years Drug Development
20+
Publications
119
PharmKit Tools
About
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).
Model-Informed Drug DevelopmentPopulation PK/PDExposure-ResponseMulti-Agent AI SystemsGlobal Regulatory StrategyAntibody-Drug ConjugatesNeural-ODE PK
Impact
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 →Experience
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
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).
PythonLangGraphGxPCDISC
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.
AI/MLPharmacometrics
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.
Next.jsPythonFastAPI
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.
PythonPyTorchNeural-ODE
DosePredict
Peer-Reviewed Dose-Prediction Tool
Generalized PK-based Shiny dose-prediction application (J Clin Pharmacol, 2020) adopted in MMV PK/PD modelling workshops.
RShiny
HBV Combination Therapy Patent
Australian-Granted Patent (AU2023213173B2)
Co-inventor of Australian-granted patent AU2023213173B2 for Hepatitis B combination therapy, with related international applications.
Drug DevelopmentHBV
AI Agents
Ask the books
Companions grounded in my two books, built for learning and drug-development work.
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Pharmacometrics
Pharmacometrics Companion
PopPK, exposure-response and model diagnostics explained with worked visuals.
Publications
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)
Pearson RA; Wicha SG; Okour M "Drug Combination Modeling: Methods and Applications in Drug Development" The Journal of Clinical Pharmacology (2023)
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)
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.
Skills
Technical Expertise
AI/ML & Automation
Multi-Agent AI (LangGraph)Neural-ODE PKXGBoostSHAPscikit-learnRAGPrompt EngineeringAuditable AI Pipelines (21 CFR Part 11 / Annex 11)Automated R/Shiny Reporting
Pharmacometrics & Quantitative Tools
NONMEMMonolixnlmixr2WinNonlin/PhoenixmrgsolvePsNPiranaPDx-POPGastroPlusSimcyp
Programming & Data Science
R (Shiny, tidyverse, ggplot2, vpc, xpose4, PKNCA)Python (PyTorch / Neural-ODE)LangGraphSQLGit/GitHubDockerGraphPad
Full-Stack Development
Next.jsFastAPIPythonSupabaseSQLGitDockerLinux/BashReact
Regulatory & Strategy
INDNDABLAMAABriefing DocumentsICH GuidelinesDue DiligenceFDAEMAPMDATGASwissmedicANVISAMHRAChina NMPA
Research Domains
Population PK/PDExposure-ResponsePBPKQSP / Systems PharmacologyDDI PredictionTMDDADC Multi-Analyte PKFIH / Dose-EscalationNCAModel-Informed Drug Development
Education
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
Awards
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.
Engagement
Professional Service
Professional Societies
ASCPT — American Society for Clinical Pharmacology and Therapeutics
ISoP — International Society of Pharmacometrics
ACCP — American College of Clinical Pharmacology
Academic Service
Peer reviewer for 15+ scientific journals
Abstract reviewer: ACCP, ASCPT, ACoP
Session moderator: Phase-0/Microdosing Meeting (2019)
Committee member: ASCPT Webinar, Early Career; ACCP Education
Contact
Let's Connect
Interested in collaboration, speaking engagements, or research partnerships in clinical pharmacology, pharmacometrics, and AI-driven drug development?