Hi, I have been working in the Model-Informed Drug Development field for more than 20 years. I have done projects for small start-ups, small, mid and large Pharmaceutical companies as well as Global Health key players like the Gates Foundation. My core services are focused on pharmacometrics analyses to support your drug development programs. I have contributed to 100+ projects, serving 40+ different clients ranging from pre-clinical, translational qsp and regulatory Population PK/PD filings using the totality of data including large phase III registration trials as well as real world data. Under my belt, I have contributed to 10+ regulatory approvals for FDA, EMA, PMDA, China and Health Canada across various therapeutic areas namely in rare diseases and pediatrics. Feel free to send me an email to start our discussion on how to start collaborating.
My current and previous roles involved leading, mentoring and building pharmacometrics teams across the globe first with Pharsight in Montreal Canada and later with Certara in Cairo (Egypt) and Cape Town (South Africa). I have a passion for teaching and for building tools that empower non-coders to communicate efficiently. Some of my R packages include (coveffectsplot
, ggquickeda
and tidyvpc
).
Full Professional Researcher | Savic Lab
UCSF, San Francisco | 2025 - Present
Senior Director Pharmacometrics | Strategic Services Certara
Cairo/Cape Town | 2019 - 2024
Director Pharmacometrics | Strategic Services
Certara, Montreal | 2014 - 2019
Associate Director Pharmacometrics | Consulting Services
Pharsight, Montreal | 2009 - 2014
Senior Associate Scientist | Reporting and Analysis Services
Pharsight, Montreal | 2007 - 2009
University of Montreal, Montreal | Quebec, Canada
PhD Pharmaceutical Sciences (Pharmacometrics) | 2006 - 2012
University of Montreal, Montreal | Quebec, Canada
MSc Pharmaceutical Sciences (Pharmacometrics) | 2004 - 2006
University of Saint Joseph | Beirut Lebanon
MSc Biostatistics and Epidemiology | 2002 - 2004
Lebanese University | Beirut, Lebanon
Pharm D | 1997 - 2003
Pharmacokinetic and pharmacodynamic modelling of continuous erythropoiesis receptor activator in children: A comprehensive analysis and real-world data validation. Samer Mouksassi, Franz Schaefer, Bradley A. Warady, Claus P. Schmitt, Sylvie Meyer Reigner, Milena Studer, Pascal Chanu, Nicolas Frey. Br J Clin Pharmacol. 2025;1–12. doi:10.1002/bcp.70165
Pharmacometric Analysis to Describe Pharmacokinetics and Exposure-Efficacy Response of Ivermectin in Adolescents Infected with Trichuris trichiura. Ajayi DT, Orherhe OM, Pillai GC, Mouksassi S, Steffens B, Bräm D, Sprecher V, Hofmann D, Buettcher M, Coulibaly JT, Ali SM, Keiser J, Pfister M. P. J Clin Pharmacol. 2024 Nov 6. doi: 10.1002/jcph.6158.
Postmarketing Assessment of Antibody-Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach. Asiimwe IG, Chtiba N, Mouksassi S, Pillai GC, Peter RM, Yuen E, Pilla Reddy V. CPT Pharmacometrics Syst Pharmacol. 2025 Mar 4. doi: 10.1002/psp4.70013.
Advancing pharmacometrics in Africa-Transition from capacity development toward job creation. Pillai GC, Mouksassi S, Asiimwe IG, Rayner CR, Kern S, Sinxadi P, Denti P, Decloedt E, Waitt C, Ogutu BR, de Greef R. CPT Pharmacometrics Syst Pharmacol. 2025 Mar;14(3):407-419.
Quantifying natural amyloid plaque accumulation in the continuum of Alzheimer’s disease using ADNI. Elhefnawy ME, Patson N, Mouksassi S, Pillai G, Shcherbinin S, Chigutsa E, Gueorguieva I. J Pharmacokinet Pharmacodyn. 2025 Jan 25;52(1):15.
EEDBI Consortium.Anthropometry relationship with duodenal histologic features of children with environmental enteric dysfunction: a multicenter cross-sectional study. Jamil Z, VanBuskirk K, Mweetwa M, Mouksassi S, Smith G, Ahmed T, Chandwe K, Denno DM, Fahim SM, Kelly P, Mahfuz M, Mallawaarachchi I, Marie C, Moore SR, Petri WA Jr, Ali SA. Am J Clin Nutr. 2024 Sep;120 Suppl 1:S65-S72.
Multiplexed immunohistochemical evaluation of small bowel inflammatory and epithelial parameters in environmental enteric dysfunction. VanBuskirk K, Mweetwa M, Kolterman T, Raghavan S, Ahmed T, Ali SA, Begum SKN, Besa E, Denno DM, Jamil Z,/> Kelly P, Mahfuz M, Moore SR, Mouksassi S, Petri WA Jr, Tarr PI, Sullivan PB, Moskaluk CA; EEDBI Consortium. . Am J Clin Nutr. 2024 Sep;120 Suppl 1:S31-S40.
Histopathology underlying environmental enteric dysfunction in a cohort study of undernourished children in Bangladesh, Pakistan, and Zambia compared with United States children. Kelly P, VanBuskirk K, Coomes D, Mouksassi S, Smith G, Jamil Z, Hossain MS, Syed S, Marie C, Tarr PI, Sullivan PB, Petri WA Jr, Denno DM, Ahmed T, Mahfuz M, Ali SA, Moore SR, Ndao IM, Tearney GJ, Ömer H Yilmaz, Raghavan SS, Moskaluk CA, Liu TC; EEDBI Consortium. Am J Clin Nutr. 2024 Sep;120 Suppl 1:S15-S30.
Understanding Drug Exposure and Trichuris trichiura Cure rates: A Pharmacometric Approach for Albendazole‑Ivermectin Co‑medication in Tanzania and Côte d’Ivoire. Pillay‑Fuentes Lorente V, Nwogu‑Attah J, Steffens B, Bräm D, Sprecher V, Hofmann D, Buettcher M, Pillai G, Mouksassi S, Coulibaly J, Pfister M, Keiser J Drugs R D. 2024 Jun;24(2):331-340./>
Machine-Learning Assisted Screening of Correlated Covariates: Application to Clinical Data of Desipramine./> Asiimwe IG, S’fiso Ndzamba B, Mouksassi S, Pillai GC, Lombard A, Lang J. AAPS J. 2024 May 30;26(4):63.
Totality of evidence of the effectiveness of repurposed therapies for COVID-19: Can we use real-world studies alongside randomized controlled trials? Mandema J, Montgomery H, Dron L, Fu S, Russek-Cohen E, Bromley C, Mouksassi S, Lalonde A, Springford A, Tsai L, Ambery P, McNair D, Qizilbash N, Pocock S, Zariffa N. Clin Transl Sci. 2023 Oct;16(10):1842-1855.
When not, analyzing data, building exciting data displays and innovating with new trial designs, I enjoy spending time in nature, working out and reading.