Malek Okour, BDS, PhD

Curriculum Vitae · updated November 2026

MALEK OKOUR, BDS, PhD

Clinical Pharmacology & Pharmacometrics Leader

Portfolio Strategy | Model-Informed Drug Development (MIDD) | Global Regulatory Submissions

Washington, DC Metro(832) 630-7130malek.f.okour@gmail.comlinkedin.com/in/malek-okour-73020520malekokour.com

Executive Profile

Clinical pharmacology and pharmacometrics leader with 13+ years across research and industry, including GSK and Servier, spanning first-in-human studies through global registration. Leads strategy for four oncology assets and multidisciplinary matrix teams, combining model-informed drug development (MIDD), global regulatory submissions, CRO governance and independent scientific innovation.

Selected High-Impact Achievements

  • Global approvals & regulatory impact. Supported clinical pharmacology for 5+ marketing approvals and 10+ submissions across FDA, EMA, PMDA, MHRA, TGA, Swissmedic, ANVISA and China (Tibsovo, Onivyde, Trelegy); delivered model-informed analyses supporting clinical study waivers, ethnic bridging and regional regulatory approvals for Onivyde; led Trelegy agency queries, MHRA inspection readiness and Dectova EMA Day-120 responses.
  • Leadership, oversight & recognition. Four-asset oncology strategy; cross-functional matrix leadership; CRO and vendor oversight; scientist mentoring. GSK Worldwide Top 10% IPT Award; 3 Gold/4 Silver/5 Bronze awards; ASCPT/ACCP committees.
  • Early-to-late development. FIH starting dose/escalation for an oncology ADC and GSK3008356; GSK3191607 microdose study; BCL2 inhibitor dose optimization, fixed-dose-combination bioequivalence, Phase 3 and NDA/MAA lifecycle development.
  • Special populations. Volibris pediatric extrapolation endorsed by EMA rapporteur/co-rapporteur (GSK Gold); Dectova neonatal dosing to 28 weeks postmenstrual age; Japanese ethnobridging for Onivyde and sotrovimab; renal/hepatic impairment.
  • Clinical pharmacology, ethnic bridging & submissions. FIH/SAD/MAD study design, dose optimization, DDI, food effect, concentration-QTc and bioanalytical strategy; authored CTD 2.7.1/2.7.2, Investigator's Brochures, PIPs, briefing packages and health-authority responses.
  • Pharmacometrics, modeling & simulation. Population PK/PD (PopPK), exposure-response, PBPK, TMDD, multi-analyte ADC and translational modeling for dose/regulatory decisions; NONMEM, Monolix, nlmixr2, Phoenix, R/Shiny, Python, Simcyp, GastroPlus.
  • Therapeutic & modality breadth. Oncology, respiratory/COPD, pulmonary arterial hypertension, HIV and other infectious and metabolic diseases; small molecules, monoclonal antibodies, ADCs, liposomal products and pegylated enzymes, among others.
  • Patent & innovation. Granted HBV patent co-inventor (AU2023213173B2); DosePredict creator (J Clin Pharmacol, 2020; MMV workshops).

Professional Experience

Director, Clinical Pharmacology

Mar 2022 – Present

Servier Pharmaceuticals

Boston, MA (Remote)
  • Functional clinical pharmacology lead for four oncology assets (Tibsovo, Onivyde, Oncaspar and Asparlas), coordinating a cross-functional scientific matrix team and pharmacometrics partners.
  • Own clinical pharmacology and MIDD strategy across late-stage programs, global submissions, labeling and life-cycle activities, informing dose, exposure-response and special-population decisions.
  • Lead clinical pharmacology contributions to Tibsovo submissions across cholangiocarcinoma and chondrosarcoma, partnering with Clinical Development, Translational Medicine, Biostatistics and Regulatory.
  • Author NDA/MAA clinical pharmacology content, CTD Module 2.7.2 and agency responses; translate model-based analyses into documented development and regulatory decisions.
  • Oversee Certara and ICON modeling deliverables; mentor scientists, lead 3+ modeling/AI workshops and contribute quantitative assessments to business-development diligence.
  • Provided study oversight and coauthored a 2026 translational PK/PD publication on calaspargase pegol in hepatocellular carcinoma, linking preclinical tumor-growth inhibition with human PK to explore dosing.

Manager, Clinical Pharmacology Modeling & Simulation

Oct 2015 – Feb 2022

GlaxoSmithKline (GSK)

Collegeville, PA
  • Supported clinical pharmacology and pharmacometrics across 8+ programs in respiratory, pulmonary arterial hypertension, infectious and metabolic disease, from candidate selection through registration.
  • Supported 10+ global submissions using population PK/PD, exposure-response and PBPK; contributed to Trelegy, Anoro and Dectova regulatory responses, EMA Day-120 queries and MHRA inspection readiness.
  • Developed evidence for adult-to-pediatric ambrisentan/Volibris extrapolation and neonatal intravenous zanamivir/Dectova dosing simulations.
  • Analyzed IV/IM sotrovimab PK in Japanese and Caucasian volunteers (Clin Pharmacokinet, 2024); advanced FIH PK/safety and microdose programs for GSK3008356 and GSK3191607.
  • Built reproducible pharmacometrics and R/Shiny workflows adopted across the group; co-invented an HBV combination-therapy patent.

Earlier Experience

  • Pharmacometrics Intern — Merck & Co.2014
  • Graduate Researcher & Teaching Assistant — University of Minnesota2012–2015
  • Neuroscience Research Fellow — University of Houston2010–2012
  • General Dentist (General Practitioner) — Dental Clinics2008–2010

Scientific Software & Tools

  • DeepPK (GitHub). Created a mechanistic/neural-ODE PK engine for model comparison and diagnostics.
  • DosePredict (GitHub | Publication). Developed R/Shiny dose-prediction software (J Clin Pharmacol, 2020).
  • PharmKit (pharmkit.dev). Created public AI-assisted clinical pharmacology, DMPK and regulatory tools.

Scientific Leadership & Service

  • Industry collaboration. Served on the IQ Consortium working group on dose optimization for novel oncology modalities (FIH–RP2D).
  • Professional service. Served on ASCPT Webinar and Early Career committees and the ACCP Education Committee.
  • Peer review. Reviewer for journals including The Journal of Clinical Pharmacology, Clinical Pharmacology in Drug Development and British Journal of Clinical Pharmacology, among others.
  • CRO and vendor oversight. Oversee Certara and ICON pharmacometrics deliverables supporting development and regulatory decisions.

Teaching, Mentoring & Scientific Exchange

  • Teaching and mentoring. Supported PharmD and graduate clinical pharmacology/PK teaching; mentored scientists and interns through analysis review, workshops and structured feedback.
  • Scientific community. Organized the DMPK-CPMS SALT Seminar Series beginning in 2016; session moderator, First Phase-0/Microdosing Stakeholder Meeting, Washington, DC (2019).
  • Presentations and workshops. MMV PK/PD meetings (London, UK; Bangkok, Thailand); microdose presentation, State University of Maringá (Brazil, online).

Education

  • PhD, Experimental & Clinical Pharmacology — University of Minnesota, College of Pharmacy2015
  • Bachelor of Dental Surgery (BDS) — Jordan University of Science and Technology2009

Publications

Works in preparation · Working titles

  1. 1.Child-Pugh Classification and Its Pharmacokinetic Limitations — A Model-Based Clinical Pharmacology Framework for Dosing in Hepatic Impairment. Original research. Potential journal: Clinical Pharmacology & Therapeutics.
  2. 2.Designing AI Agent Systems for Drug Development: Scientific Workflows, Governance and Traceable Analysis. Review (structured research). Potential journal: Drug Discovery Today.
  3. 3.Clinical Pharmacology and Pharmacometrics — A Practical Guide to Drug Development, Modeling and Dose Selection. Book. Potential publisher: Springer Nature. Draft in development.

Published

  1. 1.Hoeben E, …, Okour M, et al. PKPD-Based Translational Modeling of Calaspargase Pegol Preclinical Activity in Hepatocellular Carcinoma. Eur J Drug Metab Pharmacokinet. 2026;51(5):549-566.
  2. 2.Nader A, …, Okour M, et al. Pharmacokinetics, Safety, and Tolerability of Anti-SARS-CoV-2 Monoclonal Antibody, Sotrovimab, Delivered Intravenously or Intramuscularly in Japanese and Caucasian Healthy Volunteers. Clin Pharmacokinet. 2024;63(1):57-68.
  3. 3.Riglet F, …, Okour M, et al. Successful Establishment of Optimal Biological Dose (OBD) through PK/PD Modeling of BCL2/BIM Complex Disruption in Clinical Trials using a BCL-2 Inhibitor. PAGE 32. Abstract 11163; poster III-095. 2024. [Poster]
  4. 4.Okour M et al. Pediatric Population Pharmacokinetic Modeling and Exposure-Response Analysis of Ambrisentan in Pulmonary Arterial Hypertension and Comparison With Adult Data. J Clin Pharmacol. 2023;63(5):593-603.
  5. 5.Pearson RA, …, Okour M. Drug Combination Modeling: Methods and Applications in Drug Development. J Clin Pharmacol. 2023;63(2):151-165.
  6. 6.Okour M et al. Population pharmacokinetic and exposure-response analysis for ambrisentan for the treatment of pulmonary arterial hypertension in paediatric subjects aged 8 to less than 18 years. PAGE 31. Abstract 10285; poster I-87. 2023. [Poster]
  7. 7.Geris JM, …, Okour MF, et al. Rapid antibody responses to Epstein-Barr virus correlate with reduced severity of primary infection. J Clin Virol. 2022;155:105267.
  8. 8.Okamasa A, Okour M, et al. Safety and Pharmacokinetics of the Anti-SARS-CoV-2 Monoclonal Antibody, Sotrovimab, Administered by Intravenous Injection in Japanese and Caucasian Healthy Volunteers. Kansenshogaku Zasshi. 2022;96(2):39-45.
  9. 9.Okour M. DosePredict: A Shiny Application for Generalized Pharmacokinetics-Based Dose Predictions. J Clin Pharmacol. 2020;60(11):1502-1508.
  10. 10.Austin D, Okour M. Evaluation of Potential Therapeutic Options for COVID-19. J Clin Pharmacol. 2020;60(8):976-977. [Letter]
  11. 11.Okour M et al. Hydroxychloroquine and azithromycin as potential treatments for COVID-19; clinical status impacts the outcome. J Pharmacokinet Pharmacodyn. 2020;47(3):187-188.
  12. 12.Mehta R, …, Okour M, et al. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020;59(1):67-79.
  13. 13.Zuo P, …, Okour M, et al. Population Pharmacokinetic/Pharmacodynamic Analysis of Intravenous Zanamivir in Healthy Adults and Hospitalized Adult and Pediatric Subjects With Influenza. Clin Transl Sci. 2020;13(1):157-168.
  14. 14.Ivy D, …, Okour M, et al. A Randomized Study of Safety and Efficacy of Two Doses of Ambrisentan to Treat Pulmonary Arterial Hypertension in Pediatric Patients Aged 8 Years up to 18 Years. J Pediatr X. 2020;5:100055.
  15. 15.Okour M et al. First-in-Human Pharmacokinetics and Safety Study of GSK3008356, a Selective DGAT1 Inhibitor, in Healthy Volunteers. Clin Pharmacol Drug Dev. 2019;8(8):1088-1099.
  16. 16.Okour M et al. A population analysis of the DGAT1 inhibitor GSK3008356 and its effect on endogenous and meal-induced triglyceride turnover in healthy subjects. Fundam Clin Pharmacol. 2019;33(5):567-580.
  17. 17.Okour M et al. Comparative Evaluation of Median Versus Youden Index Dichotomization Methods: Exposure-Response Analysis of Mycophenolic Acid and Acyl-Glucuronide Metabolite. Eur J Drug Metab Pharmacokinet. 2019;44(5):629-638.
  18. 18.Ahmed MA, Okour M, et al. Orphan drug development: the increasing role of clinical pharmacology. J Pharmacokinet Pharmacodyn. 2019;46(5):395-409.
  19. 19.Okour M, Brundage R. A Gallbladder-Based Enterohepatic Circulation Model for Pharmacokinetic Studies. Eur J Drug Metab Pharmacokinet. 2019;44(4):493-504.
  20. 20.Okour M et al. A Phase I Study to Show the Relative Bioavailability and Bioequivalence of Fixed-Dose Combinations of Ambrisentan and Tadalafil in Healthy Subjects. Clin Ther. 2019;41(6):1110-1127.
  21. 21.Okour M et al. Mycophenolic Acid and Its Metabolites in Kidney Transplant Recipients: A Semimechanistic Enterohepatic Circulation Model to Improve Estimating Exposure. J Clin Pharmacol. 2018;58(5):628-639.
  22. 22.Okour M et al. A human microdose study of the antimalarial drug GSK3191607 in healthy volunteers. Br J Clin Pharmacol. 2018;84(3):482-489.
  23. 23.Okour M et al. A Model of Endogenous and Meal-Induced Triglycerides (TG)-Population PKPD of GSK3008356 in Healthy Subjects. J Pharmacokinet Pharmacodyn. 45:S72-S73. 2018. [Conference abstract]
  24. 24.Okour M, Brundage R. Modeling Enterohepatic Circulation. Current Pharmacology Reports. 2017;3(5):301-313.
  25. 25.Okour M, Brundage R. A pharmacokinetic model for drugs undergoing enterohepatic circulation: A sensitivity analysis. J Pharmacokinet Pharmacodyn. 43:S29. 2016. [Conference abstract]
  26. 26.Okour M, Brundage R. Comparative Evaluation of Bias and Precision in Compartmental Models of Enterohepatic Circulation. J Pharmacokinet Pharmacodyn. 42:S54. 2015. [Conference abstract]
  27. 27.Okour M et al. Simultaneous Population Pharmacokinetic Analysis of Unbound Mycophenolic Acid (MPA), total MPA, and its MPAG and Acyl-MPAG Metabolites. J Pharmacokinet Pharmacodyn. 41:S56. 2014. [Conference abstract]

The PDF is generated from this page, so both always match.