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Dalia KHACHMAN
29 years old
Paris, France
[email protected]
PHARMACOKINETIC ASSESSOR (AFSSaPS) – BIOEQUIVALENCE STUDY
MODELER IN POPULATION PHARMACOKINETICS – PHARMACOMETRICS
Pharm.D., preparing a Ph.D. Degree in Clinical Pharmacokinetics
PROFESSIONAL EXPERIENCE

From 03/2011
Pharmacokinetic assessor at the Agence Française de Sécurité Sanitaire des Produits
de Santé (AFSSaPS) – Pharmacokinetic unit (Saint-Denis, France)
• In charge of the assessment (with respect to the EMA guidelines) of the pharmacokinetic part of the Marketing Authorisation applications for National and European procedures (decentralised, centralised and mutual recognition procedures with FRANCE as Reference or Concerned Member State): generic applications (bioequivalence studies, biowaiver, non-compartmental and statistical analysis) and population pharmacokinetic analyses. • Participating to pre-submission meeting with applicant for Marketing Authorisation. • Support of Pharmacy students during their internship at the Pharmacokinetic unit. 11/2007-01/2011 Biostatistics Department of the National Veterinary School of Toulouse, INRA,
UMR 1331, Toxalim (E7 team) (Toulouse, France)
• Population pharmacokinetic modelling of ciprofloxacin in critically ill patients: modelling both inter-individual and inter-occasion variability. ciprofloxacin regimen in intensive care patients based on pharmacodynamic target attainment through the use of pharmacokinetic-pharmacodynamic (PK/PD) analysis and Monte Carlo simulation. • Critical analysis of graphical tools for global model evaluation such as Visual Predictive Checks (VPC) and others tools developed around VPC (confidence interval-VPC, Numerical Predictive Checks, Prediction Corrected-VPC). • Critical analysis of standardised residuals (WRES, CWRES, PWRES) and Normalised • Development of a new graphical tool for global evaluation of nonlinear mixed-effects models in population pharmacokinetics: the VIsual Predictive Extended Residuals (VIPER). • Support of two Master students in modelling and simulation. Laboratory of Clinical Pharmacokinetics and Toxicology (Toulouse, France)
• Practice of High Performance Liquid Chromatography (HPLC) with UV detection. • Dosage of ciprofloxacin and linezolid plasma samples of critically ill patients by • Validation of HPLC analytical assays of benzodiazepines, clomipramine and hydroxychloroquin in human breast milk in order to assess the degree of exposure of the breastfed infants. • Teaching for University Degree of Toxicology students: “Oral antidiabetic drugs • Teaching for Laboratory of clinical pharmacokinetic and toxicology team: “GLP-1 and Type-2 Diabetes mellitus: from pathophysiology to therapeutic applications” (1 hour). 09/2006-06/2007 Laboratory of myocardium remodelling and preconditioning, UPRES 3860 (Angers,
• Development of Langendorff model of isolated perfused rat hearts in the laboratory. • Ex vivo studies of the effects of Erythropoietin (EPO) on the heart hemodynamics and ventricular arrhythmias during reperfusion after a global myocardial ischemia on isolated perfused rat hearts. 10/2005-05/2006 Clinical Pharmacy Internship: Al Sahel General Hospital (7 months) and “Dar El Ajaza
El Islamiya Hospital” Psychiatric department (1 month), Lebanon. Drug Information Centre, Lebanon: 1 month training.
Hospital Pharmacy, Al Sahel General Hospital, Lebanon: 1 month training.
07/2003-09/2003 Medical Analysis Laboratory, Sainte-Thérèse Hospital, Lebanon: 2 months training.
07/2002-08/2005 Community Pharmacy: 7 months at Safa pharmacy and 1 month at Houmani pharmacy,

EDUCATION

11/2007 till present: Ph.D. student in Clinical Pharmacokinetics.
Subject Dosage adjustment of ciprofloxacin in critically ill patients by population approach. Advisors Prof. P.L. Toutain, Prof. G. Houin, Prof. D. Concordet, Dr C.M. Laffont. Scholarship Lebanese National Council for Scientific Research (Beirut) for two years. Laboratory Biostatistics Department of the National Veterinary School of Toulouse. UMR 1331, Toxalim (E7 team), F-31027 Toulouse, France. Doctoral school Biologie-Santé-Biotechnologies, Paul Sabatier University, Toulouse, France. Workshop on “PK & PK/PD modelling” (Toulouse, France) organised by the European College of Veterinary Pharmacology and Toxicology (ECVPT). Monolix workshop at PAGE satellite meeting (Athens, Greece). Workshop on “EURS is Yours” organised by Exteda (Saint-Denis, France). Workshop on “Understanding the experimental pharmacokinetics and toxicokinetics” organised by AFSSaPS (Saint-Denis, France). Post-graduate degree in Exotic and travel pathology, with honours.
Faculty of Medicine, Paul Sabatier University, Toulouse, France. Workshop on “PK/PD & Population kinetics” (Toulouse, France) organised by the Post-graduate degree in Pharmacokinetics, with honours, Major of promotion.
Faculty of Pharmacy, Paul Sabatier University, Toulouse, France. • Leadership and management (Toulouse, France). • Medicine development stages – post marketing surveillance (Toulouse, France). • Biostatistics – level I (Toulouse, France). • Biostatistics – level II (Toulouse, France). Master of Sciences in Human pathophysiology and experimental models, with
honours. Faculty of Medicine, University of Angers, Angers, France.
Doctor of Pharmacy (Pharm.D.), with honours. Faculty of Pharmacy, Lebanese
University, Hadath, Lebanon. Scientific equivalence with the French Pharm.D. degree delivered by the French Ministry of Higher Education on March 2011. Master Certificate in Molecular basis of host-infectious agents’ relationship, with
honours. Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon. Diploma of Higher Education in Chemistry.
Faculty of Sciences I, Lebanese University, Hadath, Lebanon.
French Baccalaureate Diploma, scientific section, Academy of Nice (France).
School Cours Lamartine, Abidjan, Ivory Coast.

LANGUAGES

French: fluent, native language (92.50/100 at DELF B2 diploma in 2006). English: professional use (805 at TOEIC test in 2008). Arabic: mother tongue. Spanish: basic (3-year course).
COMPUTER SKILLS

Regulatory skills: EURS is Yours. Modelling skills: NONMEM, Monolix. General: Oracle Crystal Ball, R, EndNote, Microsoft Office (word, excel, PowerPoint). Basic knowledge in: Microsoft Visual C++, WinNonlin, LaTeX. INTERESTS

Swimming, cinema, travelling, baby-sitting. LIST OF PUBLICATIONS

1. Khachman D, Conil JM, Georges B, Saivin S, Houin G, Toutain P-L, Laffont CM. Optimizing
ciprofloxacin dosing in intensive care unit patients through the use of population pharmacokinetic-pharmacodynamic analysis and Monte Carlo simulations. Journal of Antimicrobial Chemotherapy. 2011;66(8):1798-1809. [original article] 2. Mailly N, Khachman D, Escat F, Larroque J-M, Gandia P. Circumcision with degloving. Feuillets de
Radiologie. 2010;50(6):332-335. [case study; in French] 3. Tamareille S*, Ghaboura N*, Treguer F, Khachman D, Croué A, Henrion D, Furber A, Prunier F.
Myocardial reperfusion injury management: Erythropoietin compared with postconditioning. American Journal of Physiology - Heart and Circulatory Physiology. 2009;297(6):H2035-H2043. [original article] *denotes co-first authorship 4. Khachman D, Gandia P, Sallerin F, Mailly N. Immediate and delayed hypersensitivity reactions to
iodinated radiographic contrast agents: an update. Thérapie. 2009;64(5):331-339. [review article; in French] 5. Khachman D, Gandia P, Gaillard M-A, Seraissol P, Mendousse P, Assouline C, Houin G.
Clomipramine in breast milk: a case study. Journal de Pharmacie Clinique. 2009;28(1):33-38. [original article; in French] 6. Khachman D, Gandia P, Sena F, Tortissier C, Seraissol P, Assouline C, Berrebi A, Houin G. Transfer
of benzodiazepines into breast milk: clinical and analytical aspects. Annales de Toxicologie Analytique. 2008;20(4):165-179. [original article; in French] 7. Conil JM, Georges B, De Lussy A, Khachman D, Seguin T, Ruiz S, Cougot P, Fourcade O, Houin G,
Saivin S. Ciprofloxacin use in critically ill patients: pharmacokinetic and pharmacodynamic approaches. International Journal of Antimicrobial Agents. 2008;32:505-510. [original article] Publications in progress…
8. Khachman D, Laffont CM, Concordet D. Shortcomings of Visual Predictive Checks-like tools for the
evaluation of nonlinear mixed-effects models. [research article] 9. Laffont CM*, Khachman D*, Concordet D. A new graphical tool for nonlinear mixed-effects model
global evaluation: the VIsual Predictive Extended Residuals. [research paper] *denotes co-first authorship ORAL COMMUNICATIONS
1. Khachman D, Laffont CM and Concordet D. A new graphical tool for global model evaluation in
population pharmacokinetic and/or pharmacodynamic: the Visual Predictive Extended Residuals. 6th P2T (Physiology, Pharmacology & Therapeutics), Grenoble: March 2011. 2. Khachman D, Conil JM, Georges B, Saivin S, Houin G, Toutain P-L and Laffont CM. Optimising
ciprofloxacin dosing in intensive care patients based on pharmacodynamic target attainment through the use of population pharmacokinetic-pharmacodynamic analysis and Monte Carlo simulation. 6th P2T, Grenoble: March 2011. 3. Khachman D, Laffont CM, Concordet D. You have problems to interpret VPC? Try VIPER!
19th PAGE (Population Approach Group in Europe), Berlin: June 2010. 4. Gandia P, Khachman D. Pharmacokinetic of drugs in breast milk: interest in the use of ultra sensible
techniques (GC-MS, HPLC-MS) in clinical trial – case studies. Drugs, toxic products and breastfeeding: what are the data in 2008? Eudipharm Seminar, Paris: March 2009. 5. Ghaboura N, Tamareille S, Khachman D, Treguer F, Furber A, Prunier F. Erythropoietin protects the
heart against ischemic-reperfusion injury: comparison with ischemic postconditioning-induced cardioprotection. XIXes Journées Européennes de la Société Française de Cardiologie, Paris: January 2009. POSTERS & MODERATED POSTERS

1. Khachman D, Conil JM, Georges B, Saivin S, Houin G, Toutain P-L and Laffont CM. Optimising
ciprofloxacin dosing in intensive care patients based on pharmacodynamic target attainment. 20th PAGE, Athens: June 2011. 2. Seraissol P, Vieu S, Bats M-L, Gandia P, Khachman D, Lavit M, Houin G. Detection and
quantification of salbutamol through the use of a HILIC HPLC method well suited for anti-doping monitoring. 9th SEP, Toulouse: March 2011. 3. Khachman D, Conil JM, Georges B, Saivin S, Houin G, Toutain P-L and Laffont CM. Population
pharmacokinetics of ciprofloxacin in intensive care patients. 6th P2T, Grenoble: March 2011. 4. Tafzi N, Nazaroff K, Seraissol P, Khachman D, Gandia P, Lavit M, Houin G. A new high-
performance liquid chromatography method with HILIC column for quantification of polar drug: application to metformin. 6th P2T, Grenoble: March 2011. 5. Seraissol P, Vieu S, Bats M-L, Gandia P, Khachman D, Lavit M, Houin G. Detection and
quantification of salbutamol through the use of a HILIC HPLC method well suited for anti-doping monitoring. 6th P2T, Grenoble: March 2011. 6. Seraissol P, Vieu S, Bats M-L, Gandia P, Khachman D, Lavit M, Houin G. Measurement of
salbutamol in plasma and urines by liquid chromatography HPLC with HILIC column and detection by ion trap mass spectrometry: an appropriate method for anti-doping monitoring. SFTA-STC-TIAFT-SoHT-IATDMCT, Chamonix Mont-Blanc: March 2011. 7. Seraissol P, Khachman D, Gandia P, Lavit M, Houin G. Development of a new simple analytical
method for measurement of metformin par liquid chromatography with HILIC column suited for emergency. SFTA-STC-TIAFT-SoHT-IATDMCT, Chamonix Mont-Blanc: March 2011. 8. Khachman D, Conil JM, Georges B, Saivin S, Houin G, Toutain P-L and Laffont CM. PK/PD Monte
Carlo simulations to assess antibiotic efficacy and selection of bacterial resistance. Journées de Toxicologie Alimentaire (INRA), Castanet-Tolosan: December 2010. 9. Khachman D, Conil JM, Georges B, Saivin S, Houin G, Laffont CM. Population pharmacokinetic
analysis of ciprofloxacin in intensive care unit adult patients. 19th PAGE, Berlin: June 2010. 10. Seraissol P, Colombies N, Gandia P, Khachman D, Lavit M, Houin G. A novel HPLC method for
simultaneous quantification of three antiretroviral drugs: Raltegravir, Etravirine and Efavirenz. 5th P2T, Bordeaux: March 2010. 11. Khachman D, Gandia P, Gaillard M-A, Seraissol P, Mendousse P, Assouline C, Houin G.
Clomipramine in breast milk: a case study. 54th JIB, Paris: November 2009. 12. Khachman D, Gandia P, Sallerin F, Mailly N. Hypersensitivity to iodinated contrast agents. Bracco
imaging Laboratories. Journées Françaises de Radiologie, Paris: October 2009. 13. Tamareille S, Ghaboura N, Treguer F, Khachman D, Henrion D, Furber A, Prunier F. Activation of
the ERK1/2 signalling pathway mediates erythropoietin-induced cardioprotection: a comparison with ischaemic postconditioning. Heart Failure 2009, Nice: May-June 2009. 14. Ghaboura N, Tamareille S, Treguer F, Khachman D, Henrion D, Furber A, Prunier F. Critical role of
ERK1/2 in erythropoietin-mediated cardioprotection compared with ischemic postconditioning. 26th GRRC, Nancy: April 2009. 15. Khachman D, Gandia P, Sallerin F, Mailly N. Management of hypersensitivity reactions to iodinated
radiographic contrast agents. 4th P2T, Marseille: April 2009. 16. Khachman D, Gandia P, Sena F, Tortissier C, Seraissol P, Assouline C, Berrebi A, Houin G.
Benzodiazepines in breast milk: clinical and analytical aspects. 4th P2T, Marseille: April 2009. 17. Ghaboura N, Tamareille S, Khachman D, Furber A, Prunier F. Erythropoietin (EPO) is as effective as
mechanic post-conditioning to protect the heart against reperfusion injury. Printemps de la Cardiologie, Montpellier: May 2008.
REFERENCES

Prof. Georges Houin, Laboratory of Clinical Pharmacokinetics and Toxicology, Toulouse, France, tel: 0033 (0) 5 67690383, [email protected]. Prof. Pierre-Louis Toutain, National Veterinary School of Toulouse, UMR 1331, Toxalim, Toulouse, France, tel: 0033 (0) 5 61193814, [email protected]. Dr Céline Laffont-Rousset, Biostatistics Department of the National Veterinary School of Toulouse, UMR 1331, Toxalim (E7 team), Toulouse, France, tel: 0033 (0) 5 61193891, [email protected]. Dr Ridha Belaiba, Director of the Pharmacokinetic unit – AFSSaPS, Saint-Denis, France, tel: 0033 (0) 1 55873479, [email protected].

Source: http://www.biostat.envt.fr/spip/IMG/pdf/CV_Dalia_Khachman_EN.pdf