Flora MUSUAMBA TSHINANU

Modeling and Simulation of exposure and response to treatment

Use of Modeling and Simulation to address questions related to regulatory science

Prof. Flora Musuamba Tshinanu PharmD, PhD

UNamur, Faculty of medicine, Department of pharmacy, Research Unit in Clinical Pharmacology and Toxicology (URPC) 

Vice Chair person at EMA Modelling and Simulation Working Party

Pharmacovigilance/Pharmacometrics expert at FAMPH

Research portal UNamur  |  ORCID  |  LinkedIn

Expertise and research interests

Regulatory science, Pharmacometrics, PK/PD modelling and simulations

Group members

PhD students: Marco Dionisi, Happy Phanio Djokoto, Grace Shalom Govere, Lisa Hanquet and Camille Massaux

Research projects

  • ONGOING Improving the regulatory assessment of in silico approaches used in the development of drugs for pediatric or orphan diseases: the case of painkillers. Ongoing PhD thesis by Marco Dionisi. Funding: ERAMET project.
  • ONGOING Improving the regulatory assessment of in silico approaches used in the development of drugs for pediatric or orphan diseases: The case of rare hematological disorders. Ongoing PhD thesis by Grace Shalom Govere. Funding: FSR UNAMUR – Federal Agency for Medicines and Health Products (FAMPH)
  • ONGOING Complementary use of modeling and simulation and quantitative meta-analysis approaches to optimize drug development and evaluation: The case of oral contraceptives. Ongoing PhD thesis by Camille Massaux. Funding: UNamur
  • ONGOING Complementary use of modeling and simulation and quantitative meta-analysis approaches to optimize drug development and evaluation: The case of CAR-T cells. Ongoing PhD thesis by Lisa Hanquet. Funding: ERAMET project.
  • ONGOING ERAMET project : Ecosystem for RApid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines.
  • ONGOING Optimization of in silico data evaluation (pharmacokinetic and pharmacodynamic models) used in drug development. Ongoing PhD thesis by Happy Phanio Djokoto. Under co-supervision by Prof. Flora Musuamba Tshinanu, UNamur and Prof. Jean-Michel Dogné, UNamur.
  • Pharmacokinetic modeling and control design for drug dosing. PhD thesis defended by Pauline Thémans on 07/07/2021. Under co-supervision by Prof. Joseph Winkin, UNamur, Department of mathematics (promoter) and Prof. Flora Musuamba, UNamur, Department of pharmacy (co-promoter).

Selected publications

ALL PUBLICATIONS IN PUBMED

Musuamba FT, Cheung SYA, Colin P, Davies EH, Barret JS, Pappalardo F, Chappell M, Dogne JM, Ceci A, Della Pasqua O, Rusten IS. Moving Toward a Question-Centric Approach for Regulatory Decision Making in the Context of Drug Assessment. Clin Pharmacol Ther. 2023 Jul;114(1):41-50.

Skottheim Rusten I, Musuamba FT. Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework. CPT Pharmacometrics Syst Pharmacol. 2021 Nov;10(11):1281-1296.

Musuamba FT, Skottheim Rusten I, Lesage R, Russo G, Bursi R, Emili L, Wangorsch G, Manolis E, Karlsson KE, Kulesza A, Courcelles E, Boissel JP, Rousseau CF, Voisin EM, Alessandrello R, Curado N, Dall'ara E, Rodriguez B, Pappalardo F, Geris L. Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility. CPT Pharmacometrics Syst Pharmacol. 2021 Aug;10(8):804-825.

Viceconti M, Pappalardo F, Rodriguez B, Horner M, Bischoff J, Musuamba Tshinanu F. In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products. Methods. 2021 Jan;185:120-127.

Thémans P, Dauby N, Schrooyen L, Lebout F, Delforge M, Nasreddine R, Libois A, Payen MC, Konopnicki D, Wuillaume F, Lescrainier C, Verlinden V, Dogné JM, Hamdani J, Musuamba FT. Model informed dosing of hydroxycholoroquine in COVID-19 patients: Learnings from the recent experience, remaining uncertainties and gaps. Br J Clin Pharmacol. 2021 Feb;87(2):674-682.

Thémans P, Belkhir L, Dauby N, Yombi JC, De Greef J, Delongie KA, Vandeputte M, Nasreddine R, Wittebole X, Wuillaume F, Lescrainier C, Verlinden V, Kiridis S, Dogné JM, Hamdani J, Wallemacq P, Musuamba FT. Population Pharmacokinetics of Hydroxychloroquine in COVID-19 Patients: Implications for Dose Optimization. Eur J Drug Metab Pharmacokinet. 2020 Dec;45(6):703-713.

Musuamba FT, Bursi R, Manolis E, Karlsson K, Kulesza A, Courcelles E, Boissel JP, Lesage R, Crozatier C, Voisin EM, Rousseau CF, Marchal T, Alessandrello R, Geris L. Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges. CPT Pharmacometrics Syst Pharmacol. 2020 Apr;9(4):195-197.

Nanga TM, Doan TTP, Marquet P, Musuamba FT. Toward a robust tool for pharmacokinetic-based personalization of treatment with tacrolimus in solid organ transplantation: A model-based meta-analysis approach. Br J Clin Pharmacol. 2019 Dec;85(12):2793-2823.

Thémans P, Marquet P, Winkin JJ, Musuamba FT. Towards a Generic Tool for Prediction of Meropenem Systemic and Infection-Site Exposure: A Physiologically Based Pharmacokinetic Model for Adult Patients with Pneumonia. Drugs R D. 2019 Jun;19(2):177-189.

Musuamba FT, Manolis E, Holford N, Cheung S, Friberg LE, Ogungbenro K, Posch M, Yates J, Berry S, Thomas N, Corriol-Rohou S, Bornkamp B, Bretz F, Hooker AC, Van der Graaf PH, Standing JF, Hay J, Cole S, Gigante V, Karlsson K, Dumortier T, Benda N, Serone F, Das S, Brochot A, Ehmann F, Hemmings R, Rusten IS. Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014). CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):418-429.

Musuamba FT, Teutonico D, Maas HJ, Facius A, Yang S, Danhof M, Della Pasqua O. Prediction of disease progression, treatment response and dropout in chronic obstructive pulmonary disease (COPD). Pharm Res. 2015 Feb;32(2):617-27.

Contact

flora.musuamba@unamur.be