Download - CV Gilbert LEFEVRE
CV Dr Gilbert Lefèvre
Summary
Twenty-five years pharmaceutical development experience in early
and late stages with expertise in Translational Sciences, Clinical
Pharmacology, Pharmacokinetics, Pharmacodynamics and
Dose/Exposure-Response relationships. Completion of registration
dossier components for regulatory submissions, defense and
negotiation with Health Authorities worldwide (incl. FDA Ad.C.,
EMA/CHMP (incl. Oral Hearing), SM, PDCO, PMDA ..). Evaluation
of licensing opportunities. People management, including management
of international, multicultural, cross-functional teams. Collaborations
with Academia and public health institutions.
Personal Details
Full name Gilbert LEFÈVRE
Date of Birth 23-Mar-1962
Nationality French
Marital Status Married, two children
Address - Office Novartis Institutes for Biomedical Research (NIBR)
Novartis Campus, Basle, Switzerland
Tel. +41 79 722 52 77
Address - Home 24 rue Principale
F-68210 Gildwiller, France
Tel. +33 6 33 24 74 64
Education
1989 PhD in Life Sciences (Physiology of Development and Ontogeny) (Development of monoclonal and polyclonal antibodies and of anti-idiotypes) University of Paris (Jussieu), France
1987 Graduated in General Immunology
INSTITUT PASTEUR of Paris, France
1986 Diplôme d'Etudes Approfondies (DEA) in Physiology of Development
University of Paris (Jussieu), France
1985 Master in Biology
University of Paris (Orsay), France
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CV Dr Gilbert Lefèvre
Industrial Experience
2009 - present Senior Expert Scientist Clinical PKPD/DMPK
Global Line Function Projects Lead
Neurosciences, Musculoskeletal Disorders, Infectious Diseases,
Tropical Medicines, Oncology
Novartis NIBR, DMPK, Basel, Switzerland
2005 - 2009 Expert Scientist Clinical PKPD/DMPK
Neurosciences, Infectious Diseases, Tropical Medicines
Novartis NIBR, DMPK, Basel, Switzerland
1997 - 2005 Clinical Pharmacology Scientist
Exploratory Development (PRIDE: Proof of Research In DEvelopment)
Novartis Pharma AG, Basel, Switzerland
1996 - 1997 Head of Immunobioanalytics and Pre-Clinical Pharmacokinetics
Novartis Pharma SA, Rueil-Malmaison, France
1991 - 1996 Head of Immunobioanalytics and Pharmacokinetics
Ciba-Geigy, Rueil-Malmaison, France
1989 - 1990 Head of a Laboratory of Development, Calibration and Production of
antibodies and immuno-diagnostic systems for human health
Clonatec, Paris, France
Academic Positions
1988 - 1989 Clinical Virology Laboratory Associate Director
Hôpital du Val de Grâce, Paris, France
1986 - 1989 Biomedical Research Fellow
Hôpital des Enfants Malades (INSERM), Paris, France
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CV Dr Gilbert Lefèvre
Regulatory Experience (key project approvals)
2014/2015 Coartem®/Riamet
® High Strength Tablet (Artemether-
Lumefantrine)
Switzerland, WHO, Infectious Diseases, Malaria in adults
2010 Coartem®/Riamet
® Tablet (Artemether-Lumefantrine)
US FDA (Ad. Board), Infectious Diseases, Malaria in adults and
pediatrics
2008 Coartem®/Riamet
® Dispersible for Pediatrics (Artemether-
Lumefantrine). Switzerland, EU, WHO, and endemic countries WW,
Infectious Diseases, Malaria in pediatrics
2007 Exelon® Patch (Rivastigmine), Neurosciences, Alzheimer’s Disease,
Parkinson’s Disease Dementia
2005 Dapsone, Infectious Diseases, Leprosy
2002 Egaten, Infectious Diseases, Anthelmintic agent, Liver fluke
1999 Coartem®/Riamet
® Tablet (Artemether-Lumefantrine),
Switzerland, EU, WHO and endemic countries WW, Infectious
Diseases, Malaria
1997 Femara® (Letrozole), Oncology, Advanced Breast Cancer
1996 Revasc® (Desirudin), Cardiovascular, Deep Venous Thrombosis
Professional and Management Trainings (key external courses)
2002 Development Managers Program
CDR International (cdr-intl.com)
Florham Park, NJ, USA, and Freiburg, Germany
1998 The Clinical Expert Report
Management Forum Ltd (D.B. Jefferys/Ph. Collett), London, UK
1998 Advanced Methods in Pharmacokinetics/Pharmacodynamics
M. Rowland/L. Sheiner, Sils-Maria, Switzerland
1992 Leadership and Management
IMD, Lausanne, Switzerland
1992 Pharmacokinetic Issues in Drug Development and Research
M. Rowland/Th. Tozer, Tours, France
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CV Dr Gilbert Lefèvre
Awards – Nominations - Membership
2015 Novartis Fusion Team Award for Courageous Decision-Making
and Risk Taking.
2014 Novartis Awards for Accountable and Effective Teamwork,
Effective Mentoring, Open and Inclusive Collaboration, Strategic
Thought, Tap Existing Organizational Knowledge.
2010 Prix Galien US Award http://www.eurekalert.org/pub_releases/2011-04/w-pgw040411.php
2010 International Health Professional of the Year 2010, and Top 100
Health Professionals 2010. IBC Cambridge, England.
Man of The Year in Medicine & Healthcare 2010, and Great Minds
of the 21st Century. The American Biographical Institute Board of
International Research, Raleigh, USA.
2005 + Member of the Editorial Boards of scientific journals: The Open
Drug Delivery Journal, BioMed Research International, The World
Journal of Translational Medicine.
Member of the peer review panels of international journals dedicated
to Clinical Pharmacology, Pharmacokinetics, Neurosciences,
Alzheimer’s Disease, Malaria, Infectious Diseases, Tropical
Medicines.
2005 WHO’S WHO IN THE WORLD. A Who’s Who in America Publication.
Marquis Who’s Who 21st Century Editions.
1986 Prizewinner of the Fondation Marcel Bleustein-Blanchet pour la
Vocation, Paris, France
Sponsored by Dr. Charles Mérieux (Pasteur-Mérieux Institute)
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CV Dr Gilbert Lefèvre
Publications and Congresses
1. Josso N, Vigier B, Picard JY, Lefèvre G, Tran D. Anti-Müllerian Hormone. The fifth International
Meeting of the International Society of Differentiation, Boulder, Collorado, USA, 3-7 August
1987.
2. Legeai L, Lefèvre G, Vigier B, Picard JY, Josso N. A monoclonal antibody against human
testicular Anti-Müllerian Hormone. Am J Reprod Immunol Microbiol 1988, 18: 39-42.
3. Lefèvre G, Tran D, Hœbeke J, Josso N. Anti-idiotype antibodies to a monoclonal antibody raised
against Anti-Müllerian Hormone exhibit anti-Müllerian biological activity. Mol Cell Endocrinol
1989, 62: 125-133.
4. Cardot JM, Lefèvre G, Godbillon J. Pharmacokinetics of rec-hirudin in healthy volunteers after
intravenous administration. J Pharm Biopharm 1994, 22: 147-156.
5. Zoldhelyi P, Janssens S, Lefèvre G, Van de Werf F. Were plasma hirudin levels in the GUSTO-2A
trial higher than expected from pharmacokinetics studies in volunteers with stable coronary
disease ? American College of Cardiology, 44th Annual Scientific Session, April 1995.
6. Zoldhelyi P, Janssens S, Lefèvre G, Collen D, Van de Werf F. Effects of heparin and hirudin
(CGP 39393) on thrombin generation during thrombolysis for acute myocardial infarction.
Circulation 1995, Vol 92 (Suppl I), No 8.
7. Zoldhelyi P, Janssens S, Lefèvre G, Collen D, Van de Werf F. Accelerated thrombin generation
during conjunctive treatment of myocardial infarction with t-PA and r-hirudin. XVth Congress of
the International Society on Thrombosis and Haemostasis. Jerusalem, Israel, June 11-16, 1995.
8. Zoldhelyi P, Janssens S, Lefèvre G, Van de Werf F. Plasma hirudin and aPTT levels in acute
patients of the GUSTO-2A trial compared with hirudin levels and aPTT in volunteers with stable
coronary disease. Eur Heart J 1995, 16 (Suppl): 177.
9. Kinoshita T, Kawasugi K, Yamanaka H, Sagawa T, Koyama Y, Hama H, Hamauzu T, Ogushi J,
Nishimura M, Kuyama Y, Matsuda J, Kamakura M, Miyake K, Nagase M, Yasuda K, Kazama M,
Yamanaka M, Lefèvre G. Clinical evaluation of recombinant hirudin, CGP 39 393. Phase I study:
single and multiple dose administration in healthy volunteers. J Clinical Therapeutic and
Medicines [Article in Japanese] 1995, 6: 1143-1175.
10. Gygax D, Botta L, Ehrat M, Graf P, Lefèvre G, Oroszlan P, Pfister C. Immuno and other
approaches in pharmacokinetics. 11th Bioanalytical Forum, University of Surrey, Guildford, UK
and 4th International Congress of Therapeutic Drug Monitoring and Clinical Toxicology, Vienna,
Austria, 1995. In Methodological Surveys in Bioanalysis of Drugs, Vol 24. Biofluid assay for
peptide-related and other drugs; Ed. E. Reid, H. M. Hill; I. D. Wilson, 1996, pp 11-19.
11. Lefèvre G, Duval M, Botta L, Godbillon J. Direct microtitre plate radioimmunoassay of
savoxepine in unextracted plasma. J Immunoassay 1996, 17(1): 29-46.
12. Gygax D, Botta L, Ehrat M, Graf P, Lefèvre G, Oroszlan P, Pfister C. Immunoassays in
monitoring biotechnological drugs. Ther Drug Monit 1996, 18 (4): 405-409.
13. Godbillon J, Cardot JM, Lecaillon JB, Lefèvre G, Sioufi A. Bioequivalence assessment: a
pharmaceutical industry perspective. Eur J Drug Metab Pharmacokinet 1996, 21(2): 153-158.
14. Müller P, Botta L, Lefèvre G, Ezzet F. Pharmacokinetics of a new oestradiol matrix patch in
healthy postmenopausal volunteers and symptomatic women. World Congress of Gynecology,
November 1996, Sydney, Australia.
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CV Dr Gilbert Lefèvre
15. Lefèvre G, Duval M, Gauron S, Piraino A, Morgan J, Palmisano M, Brookman L, Rolan P,
Godbillon J, Close P. The effects of renal impairment on the pharmacokinetics and
pharmacodynamics of desirudin (™REVASC). Sixth European Congress of Biopharmaceutics and
Pharmacokinetics, Athens, Greece, April 22-24th, 1996. Eur J Drug Metab Pharmacokinet 1996,
(Suppl) No 263: 89.
16. Amin DM, Mant TGK, Walker SM, Kerry R, Lloyd P, Lefèvre G, Close P. Effect of a 15-minute
infusion of DDAVP on the pharmacokinetics and pharmacodynamics of ™REVASC during a
four-hour intravenous infusion in healthy male volunteers. Thromb Haemostas 1997, 77: 127-132.
17. Colussi D, Parisot C, Brunner L, Rossolino M, Lefèvre G. Protein binding in plasma of valsartan, a
new angiotensin II receptor antagonist. J Clin Pharmacol 1997, 37(3): 214-221.
18. Lefèvre G, Duval M, Gauron S, Brookman L, Rolan P, Morris T, Piraino A, Morgan J, Palmisano
M, Close P. The effects of renal impairment on the pharmacokinetics and pharmacodynamics of
desirudin. Clin Pharmacol Ther 1997, 62: 50-59.
19. Colussi D, Parisot C, Lefèvre G. Plasma protein binding of letrozole, a new nonsteroidal aromatase
enzyme inhibitor. J Clin Pharmacol 1998, 38: 727-735.
20. Thomsen M, Lefèvre G, Ezzet F, Bindschedler M. Co-artemether: pharmacokinetic profile of a
combined anti-malaria compound treatment. 2nd
European Congress on Tropical Medicine,
Liverpool, UK, 14-18th September 1998, Abstr. No. P31.
21. Colussi D, Parisot C, Lefèvre G. Binding of iralukast to serum proteins and erythrocytes:
measurements using ultrafiltration and an erythrocyte partitioning method. Eur J Pharm Sci 1998,
7: 167-173.
22. Parisot C, Colussi D, Lefèvre G. Co-artemether: protein binding of artemether and lumefantrine.
7th European Congress of Biopharmaceutics and Pharmacokinetics (ECBP) and 5
th Congress of the
European Federation of Pharmaceutical Sciences (EUFEPS), Jerusalem, Israel, 25-30 April 1999.
Eur J Pharm Sci 1999, 8(2): xxvii, Abstr. No. 110.
23. Colussi D, Parisot C, Legay F, Lefèvre G. Binding of artemether and lumefantrine to plasma
proteins and erythrocytes. Eur J Pharm Sci 1999, 9: 9-16.
24. Lefèvre G, Thomsen M. Clinical pharmacokinetics of artemether and lumefantrine (Riamet). Clin
Drug Invest 1999, 18(6): 467-480.
25. Lefèvre G, Gauron S. Automated quantitative determination of the new renin inhibitor CGP 60536
by high-performance liquid chromatography. J Chromatogr 2000, 738(1): 129-136.
26. Lefèvre G, Bindschedler M, Ezzet F, Schaeffer N, Meyer I, Thomsen M. Pharmacokinetic
interaction trial between co-artemether and mefloquine. Eur J Pharm Sci 2000, 10(2): 141-151.
27. Lefèvre G, Duval M, Poncin A. Direct micro-radioimmunoassay of the new renin inhibitor
CGP60536. J Immunoassay 2000, 21(1): 65-84.
28. Bindschedler M, Lefèvre G, Ezzet F, Schaeffer N, Meyer I, Thomsen M. Cardiac effects of co-
artemether (artemether/lumefantrine) and mefloquine given alone or in combination to healthy
volunteers. Eur J Clin Pharmacol 2000, 56: 375-381.
29. Lefèvre G, Looareesuwan S, Treeprasertsuk S, Krodsood S, Silachamroon U, Gathmann I, Mull R,
Bakshi R. A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for
multidrug resistant Plasmodium falciparum malaria in Thailand. Am J Trop Med Hyg 2001,
64(5,6): 247-256.
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CV Dr Gilbert Lefèvre
30. Bindschedler M, Lefèvre G, Degen P, Sioufi A. Comparison of the cardiac effects of the
antimalarials co-artemether and halofantrine in healthy participants. Am J Trop Med Hyg 2002,
66(3): 295-300.
31. Lefèvre G. No evidence of cardiotoxicity of co-artemether in comparison to halofantrine (oral
communication). The Royal College of Physicians of London, 11 S
t Andrew Place, Regent Park,
London, UK. 25-April-2002.
32. Lefèvre G, Carpenter P, Souppart C, Schmidli H, Martin JM, Lane A, Ward C, Amakye D.
Interaction trial between artemether-lumefantrine (Riamet®) and quinine in healthy subjects. J Clin
Pharmacol 2002, 42(10): 1147-1158.
33. Lefèvre G, Carpenter P, Souppart C, Schmidli H, McClean M, Stypinski D. Pharmacokinetics and
electrocardiographic pharmacodynamics of artemether-lumefantrine (Riamet®) with concomitant
administration of ketoconazole in healthy subjects. Br J Clin Pharmacol 2002, 54: 485-492.
34. Lefèvre G. Antipaludiques et Cardiotoxicité – Profil de tolérance de Coartem® et interactions
médicamenteuses (communication orale). Universités Africaines Coeur-Paludisme, 16-17th
Novembre 2002, Paris, France.
35. Lefèvre G. Pharmacokinetic and cardiosafety data on an artemisinin combination (oral
communication). 8th Conference of the International Society of Travel Medicine (CISTM8), 9
th
May 2003, New York, USA.
36. Lefèvre G et al. 8th Conference of the International Society of Travel Medicine (CISTM8), 7-11
th
May 2003, New York, USA.
Presentation of 6 posters on Coartem®/Riamet
®:
36. Pharmacokinetics of artemether-lumefantrine (Coartem®/Riamet®), including the effect of food (Lefèvre et al.) 37. A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for multidrug-resistant Plasmodium falciparum
malaria in Thailand (Lefèvre et al.)
38. Interaction trial between artemether-lumefantrine (Riamet®) and quinine in healthy subjects (Lefèvre et al.) 39. Pharmacokinetic interaction trial and study on cardiac effects between co-artemether and Mefloquine (Lefèvre et al.)
40. Pharmacokinetics and electrocardiographic pharmacodynamics of artemether-lumefantrine (Riamet®) with concomitant administration of ketoconazole in healthy subjects (Lefèvre et al.)
41. Comparison of the cardiac effects of the antimalarials co-artemether and halofantrine in healthy participants (Bindschedler et al.)
42. Lefèvre G, Makanga M, Falade C, Ibarra de Palacios P, Denouël J, Schmidli H. Pharmacokinetics
of the 6-dose regimen of co-artemether in African infants and children with acute, uncomplicated
falciparum malaria. 52nd
Annual Meeting of the American Society of Tropical Medicine and
Hygiene (ASTMH), 3-7 December 2003, Philadelphia, PA, USA.
43. Makanga M, Fallade C, Premji Z, Ibarra de Palacios P, Stockmeyer M, Lefèvre G. Efficacy, safety
and pharmacokinetics of a co-artemether (artemether 20 mg, lumefantrine 120 mg) 6-dose regimen
in african infants and children with acute, uncomplicated Plasmodium falciparum malaria (oral
communication). Africa European Conference on Travel Medicine (AECTM), 8-11th February
2004, Cape Town, South Africa.
44. Lefèvre G. Clinical pharmacokinetics and cardiosafety (QTc) profile of Coartem®. Advisory
Board Meeting. 10-11 March 2005, Dakar, Senegal.
45. Lefèvre G, Sędek S, Huang A, Saltzman M, Rosenberg M, Kiese B, Fordham P. Pharmacokinetics
of a transdermal patch formulation of rivastigmine in healthy volunteers: relative effects of body
site application. J Clin Pharmacol 2007, 47: 471-478.
46. Cummings J, Lefèvre G, Small G, Appel-Dingemanse S. Pharmacokinetic rationale for the
rivastigmine patch. Neurology 2007, 69: S10-S13.
47. Abdulla S, Sagara I, Borrmann S, Nahum A, Bassat Q, Hamel M, Ogutu B, Björkman A,
Andriano K, Cousin M, Lefèvre G, Ubben D. Efficacy and safety of a new dispersible tablet
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CV Dr Gilbert Lefèvre
formulation of artemether-lumefantrine in pediatric patients with acute uncomplicated Plasmodium
falciparum malaria – Randomized, investigator-blinded, multicenter comparison with the crushed
tablet. 56nd
Annual Meeting of the American Society of Tropical Medicine and Hygiene
(ASTMH), 4-8th November 2007, Philadelphia, PA, USA.
48. Mercier F, Lefèvre G, Huang A, Schmidli H, Amzal B, Appel-Dingemanse S. Rivastigmine
exposure provided by a transdermal patch versus capsules. Curr Med Res Opin 2007, 23: 3199-
3204.
49. Mercier F, Lefèvre G, Huang A, Schmidli H, Amzal B, Appel-Dingemanse S. Rivastigmine
exposure provided by a transdermal patch versus capsules (poster). 10th International Hong Kong /
Springfield Pan-Asian Symposium on Advances in Alzheimer Therapy, 28 February-1 March
2008, Hong Kong.
50. Lefèvre G, Sędek G, Jhee S, Leibowitz MT, Huang A, Enz A, Maton S, Ereshefsky L, Lopez P,
Ho YY, Sagan C, Appel-Dingemanse S. Pharmacokinetics and bioavailability of the novel daily
rivastigmine transdermal patch compared with twice-daily capsules in patients with mild-to-
moderate Alzheimer’s disease. Clin Pharmacol Ther 2008, 83: 106-114.
51. Lefèvre G, Pommier F, Sędek G, Allison M, Huang A, Kiese B, Ho YY, Appel-Dingemanse S.
Pharmacokinetics and bioavailability of the novel rivastigmine transdermal patch versus
rivastigmine oral solution in healthy elderly subjects. J Clin Pharmacol 2008, 48: 246-252.
52. Hatz C, Soto J, Nothdurft HD, Zoller T, Weitzel T, Loutan L, Bricaire F, Gay F, Burchard GD,
Andriano K, Lefèvre G, Ibarra de Palacios P, Genton B. Treatment of acute uncomplicated
falciparum malaria with artemether-lumefantrine in non-immune populations: a safety, efficacy
and pharmacokinetic study. Am J Trop Med Hyg 2008, 78(2): 241-247.
53. Shua-Haim J, Smith S, Picard F, Sedek S, Athalye S, Pommier F, Lefèvre G. Steady-state
pharmacokinetics of rivastigmine in patients with mild to moderate Alzheimer’s disease not
affected by co-administration of memantine. Clin Drug Invest 2008, 28(6): 361-374.
54. Borrmann S, Sallas W, Marrast AC, Lefèvre G, Kern S. Impact of African diet components on
exposure to lumefantrine in infants and children receiving artemether-lumefantrine (Coartem) for
uncomplicated malaria. ICTM 2008, XVIIth International Congress for Tropical Medicine and
Malaria, Sept 29-Oct 3, 2008, Jeju Island, Korea.
55. Borrmann S, Djimé A, Abdulla S, Lefèvre G, Andriano K. Pharmacokinetic-pharmacodynamic
features of artemether-lumefantrine administered as dispersible tablet compared to the crushed
commercial tablet in African children with P. falciparum malaria. ICTM 2008, XVIIth
International Congress for Tropical Medicine and Malaria, Sept 29-Oct 3, 2008, Jeju Island,
Korea.
56. Lefèvre G, Abdulla S, Lyimo J, Agyemang A, Reynolds C, Pascoe S, Fitoussi S, Yeh CM, Nuortti
M, Rivière GJ, Séchaud R. Early development of the new artemether-lumefantrine dispersible
tablet: Palatability and pharmacokinetics in healthy subjects. ASTMH 2008, 57th Annual Meeting
of the American Society of Tropical Medicine and Hygiene, 7/11-Dec-2008, New Orleans, LA,
USA.
57. Borrmann S, Sallas W, Marrast AC, Lefèvre G, Kern S. Exposure to lumefantrine in infants
receiving artemether-lumefantrine (Coartem) for uncomplicated malaria: impact of African diet
components. ASTMH 2008, 57th Annual Meeting of the American Society of Tropical Medicine
and Hygiene, 7-11-Dec-2008, New Orleans, LA, USA.
58. Djimdé A, Borrmann S, Abdulla S, Lefèvre G, Andriano K. Pharmacokinetic and
pharmacodynamic characteristics of a new dispersible tablet formulation of artemether-
lumefantrine compared to the crushed commercial tablet in African children with P. falciparum
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CV Dr Gilbert Lefèvre
malaria. ASTMH 2008, 57th Annual Meeting of the American Society of Tropical Medicine and
Hygiene, 7/11-Dec-2008, New Orleans, LA, USA.
59. Abdulla S, Sagara I, Borrmann S, D’Alessandro U, Gonzales R, Hamel M, Ogutu B, Martensson
A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Björkman A, Beck HP,
Andriano K, Cousin M, Lefèvre G, Ubben D, Premji Z. Efficacy and safety of artemether-
lumefantrine dispersible tablet in African infants and children with uncomplicated malaria: a
randomized, investigator-blinded, multicentre comparison with the crushed commercial tablet.
Lancet 2008, 372: 1819-1827.
60. Lefèvre G, Büche M, Sędek G, Maton S, Enz A, Lorch U, Sagan C, Appel-Dingemanse S. Similar
rivastigmine pharmacokinetics and pharmacodynamics in Japanese and White healthy participants
following the application of novel rivastigmine patch. J Clin Pharmacol 2009, 49: 430-443.
61. Kurz A, Farlow M, Lefèvre G. Pharmacokinetics of a novel transdermal rivastigmine patch for the
treatment of Alzheimer’s disease: a review. Int J Clin Pract 2009, 63(5): 799-805.
62. Djimdé A and Lefèvre G. Understanding the pharmacokinetics of Coartem®. Malar J 2009, 8
(Suppl 1): S4.
63. Juma E, Sallas WM, Lyimo J, Marrast AC, Lefèvre G, Djimdé A. Exposure to lumefantrine in
infants and children receiving artemether-lumefantrine for uncomplicated malaria: impact of
African diet components. PMA and KPA Conferences 2009.
64. Djimdé A, Sallas WM, Lyimo J, Marrast AC, Lefèvre G, Borrmann S. Exposure to lumefantrine in
infants and children receiving artemether-lumefantrine for uncomplicated malaria: impact of
African diet components. 5th Multilateral Initiative on Malaria (MIM) Pan-African Malaria
Conference, 2-6th Nov 2009, Nairobi, Kenya.
65. Abdulla S, Lefèvre G, Lyimo J, Agyemang A, Reynolds C, Pascoe S, Fitoussi S, Yeh CM, Nuortti
M, Rivière GJ, Séchaud R. Early development of the new artemether-lumefantrine dispersible
tablet: palatability and pharmacokinetics. 5th Multilateral Initiative on Malaria (MIM) Pan-African
Malaria Conference, 2-6th Nov 2009, Nairobi, Kenya.
66. Borrmann S, Sallas WM, Machevo S, Gonzáles R, Björkman A, Mårtensson A, Hamel M, Juma E,
Ogutu B, Djimdé A, D’Alessandro U, Marrast AC, Lefèvre G, Kern SE. The effect of food
consumption on lumefantrine bioavailability in African children receiving artemether-lumefantrine
crushed or dispersible tablets (Coartem®) for acute uncomplicated Plasmodium falciparum
malaria. Trop Med Int Health 2010, 15(4): 434-441.
67. Borrmann S, Sallas WM, Machevo S, Gonzáles R, Björkman A, Mårtensson A, Hamel M, Juma E,
Ogutu B, Djimdé A, D’Alessandro U, Marrast AC, Lefèvre G, Kern SE. The effect of food
consumption on lumefantrine bioavailability in African children receiving artemether-lumefantrine
crushed or dispersible tablets (Coartem®) for acute uncomplicated Plasmodium falciparum
malaria. Trop Med Int Health 2010, 15(4): 434-341.
68. Abdulla S, Amuri B, Kabanywanyi AM, Ubben D, Reynolds C, Pascoe S, Fitoussi S, Yeh CM,
Nuortti M, Séchaud R, Kaiser G, Lefèvre G. Early clinical development of artemether-
lumefantrine dispersible tablet: palatability of three flavours and bioavailability in healthy subjects.
Malar J 2010, 9: 253-261.
69. Lefèvre G, Klingelhöfer L, Mollenhauer B, Kassubek J, Ebersbach G, Tenenbaum N.
Pharmacokinetics of rivastigmine patch (Exelon) in patients with Parkinson’s disease dementia.
The 10th International Conference on Alzheimer’s & Parkinson’s diseases. Barcelona, Spain,
March 9-13, 2011.
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CV Dr Gilbert Lefèvre
70. Lefèvre G, Marrast AC, Grüninger H. Novartis malaria initiative: best practice example of
pharmaceutical industry’s engagement in the fight against malaria. Ann NY Acad Sci 2011, 1222:
19-29.
71. Eckermann G, Lefèvre G. Cytochrome P-450 enzymes and their influence on the efficacy and
safety of cholinesterase inhibitor treatment for Alzheimer’s disease. Abstract accepted for the 164th
Annual Meeting of The American Psychiatric Association (APA), May 14-18, 2011, Honolulu,
Hawaii.
72. Djimdé A, Tekete M, Abdulla S, Lyimo J, Bassat Q, Mandomando I, Lefèvre G, Borrmann S.
Pharmacokinetic and pharmacodynamic characteristics of a new pediatric formulation (dispersible
tablet) of artemether-lumefantrine in African children with uncomplicated malaria. Antimicrob
Agents Chemother 2011, 55(9): 3994-3999.
73. Meremikwu M, Alao MJ, Gbadoé AD, Tshefu A, Lefèvre G, Walter V, Cousin M, Hamed K,
Ogutu B. Evaluation of the efficacy, safety and PK of artemether-lumefantrine dispersible tablet in
the treatment of acute uncomplicated Plasmodium falciparum malaria in infants weighing <5 kg.
7th European Congress on Tropical Medicine & International Health, Oct 3-6, 2011, Barcelona,
Spain.
74. Bassat Q, Menéndez C, Machevo S, Nahum A, Lyimo J, Maiga H, Märtensson A, Bashraheil M,
Ouma P, Walter V, Nwaiwu O, Kipkeu C, Lefèvre G, Ogutu B. Artemether-lumefantrine
(Coartem) body weight ranges are associated with similar efficacy and safety in African infants
and children with uncomplicated falciparum malaria. Malar J 2011, 10(1): 369.
75. Carrasquilla G, Barón C, Monsell EM, Cousin M, Walter V, Lefèvre G, Sander O, and Fisher LM.
Randomized, prospective, three-arm study to confirm the auditory safety and efficacy of
artemether-lumefantrine in Colombian patients with uncomplicated Plasmodium falciparum
malaria. Am J Trop Med Hyg 2012, 86(1): 75-83.
76. Hamed K, Meremiku M, Alao MJ, Gbadoé, Tshefu A, Lefèvre G, Walter V, Cousin M, Ogutu B.
Evaluation of the efficacity, safety and pharmacokinetics of artemether-lumefantrine dispersible
tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infants weighing
<5 kg. Abstract at the VIII International Congress for Tropical Medicine and Malaria (ICTMM)
and XLVIII Congress of the Brazilian Society for Tropical Medicine. Rio de Janeiro, Brazil, 2012.
77. Jain JP, Lakshminarayana SB, Lefèvre G, Sivasubramanian R, Blasco F, Sunkara G. Differences
in the pharmacokinetics of currently approved antimalarial drugs in uncomplicated malaria
patients compared to healthy subjects. Malar J 2012, 11 S1 P118.
78. Lefèvre G, Bhad P, Jain JP, Stein D, Kalluri S, Hardike D, Kaiser G. The novel 80/480 mg tablet
formulation of artemether-lumefantrine (Coartem®) is bioequivalent to a dose of four individual
standard tablets in healthy volunteers. Abstract/poster at 61st Annual Meeting of the American
Society of tropical Medicine and Hygiene (ASTMH), Atlanta, Georgia, USA, 2012.
79. Diagana T, Leong J, Lefèvre G. Discovery and early development of novel antimalarial drugs for
the treatment of P. falciparum and P. viva malaria. In: Keystone meeting Drug Discovery for
Protozoan Parasites (J1), 15-20 January 2012, Santa Fe, USA.
80. Lefèvre G, Bhad P, Jain JP, Kalluri S, Cheng Y, Stein DS. Evaluation of two novel tablet
formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-
label, two-period study. Malar J 2013, 12: 312-322.
81. Lamorde M, Byakika-Kibwika P, Mayito J, Nabukeera L, Ryan M, Hanpithakpong W, Lefèvre G,
Back D, Khoo S, Merry C. Lower artemether, dihydroartemisinin and lumefantrine concentrations
during rifampicin-based tuberculosis treatment. AIDS 2013, 27(6): 961-965.
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CV Dr Gilbert Lefèvre
82. White N, Nosten F, Pukrittayakamee S, Jittmala P, Pyae Phyo A, Rueangweerayut R, Diagana T,
Li R, Magnusson B, Lefèvre G, Jain JP, Leong J. Rapid clearance of parasitemia by the novel
spiroindolone KAE609 in a phase 2 open-label study of adults with acute, uncomplicated
Plasmodium falciparum or vivax malaria mono-infection. 62nd
Annual Meeting of the American
Society of Tropical Medicine and Hygiene (ASTMH), Washington DC, USA, 2013.
83. White N, Pukrittayakamee S, Pyae Phyo A, Rueangweerayut R, Nosten F, Jittmala P, Jain JP,
Lefèvre G, Li R, Magnusson B, Diagana T, Leong FJ. Spiroindolone KAE609 for falciparum and
vivax malaria. NEJM 2014, 371(5): 403-410.
84. Leong FJ, Li R, Jain JP, Lefèvre G, Magnusson B, Diagana T, Pertel P. A first-in-human
randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of
novel antimalarial spiroindolone KAE609 (Cipargamin) to assess its safety, tolerability and
pharmacokinetics in healthy adult volunteers. Antimicrob Agents Chemother 2014, 58(10): 1-6.
85. Leong FJ, Li R, Jain JP, Lefèvre G, Magnusson B, Diagana T, Pertel P. A first-in-human
randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of
novel antimalarial spiroindolone KAE609 (cipargamin), to assess the safety, tolerability and
pharmacokinetics in healthy adult volunteers. Challenges in Malaria Research Conference 2014
(Sept), University of Oxford, UK.
86. Stein DS, Jain JP, Lickliter J, Kangas M, Machineni S, Griffin P, Lefèvre G. A phase 1 study
evaluation of the pharmacokinetic/pharmacodynamic interaction of the antimalarial agents
KAE609 (cipargamin) and piperaquine. Challenges in Malaria Research Conference 2014 (Sept),
University of Oxford, UK.
87. Stein DS, Jain JP, Lickliter J, Kangas M, Machineni S, Griffin P, Lefèvre G. A phase 1 evaluation
of the pharmacokinetic/pharmacodynamic interaction of the antimalarial agents KAE609 and
Piperaquine (PPQ). 63rd
Annual Meeting of the American Society of Tropical Medicine and
Hygiene (ASTMH) 2014 (Nov), New Orleans, USA.
88. Tiono AB, Tinto H, Alao MJ, Meremikwu M, Tshefu A, Ogutu B, Ouedraogo A, Lingani M,
Cousin M, Lefèvre G, Jain JP, Duparc S, Hamed K. Increased systemic exposures of artemether
and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria
treated with artemether-lumefantrine (Coartem®). Malar J 2015, 14: 157-167.
89. Stein D, Jain JP, Kangas M, Lefèvre G, Machineni S, Griffin P, and Lickliter J. Open-Label,
single-dose, parallel-group study in healthy volunteers to determine the drug-drug interaction
potential between KAE609 (cipargamin) and piperaquine. Antimicrob Agents Chemother 2015,
59(6): 3493-500.
90. Lefèvre G, Callegari F, Xiong Y, Nox S. Absence of effect of renal impairment on rivastigmine
pharmacokinetics in patients with Alzheimer ’s Disease. 1st Congress of the European Academy of
Neurology. Berlin, Germany, June 20-23 2015.
91. Lefèvre G, Callegari F, Xiong Y. Absence of effect of renal impairment on rivastigmine
pharmacokinetics in patients with Alzheimer’s Disease. The 2015 Alzheimer’s Disease Congress,
London, UK, June 23-25 2015.
92. Jain JP, Ganesan S, Lefèvre G, Sunkara G. Estimation of amount of artemether and lumefantrine
excreted through breast milk. 9th European Congress on Tropical Medicine and International
Health (ECTMIH 2015), Basle, Switzerland, 6-13 September 2015, and 64th Annual Meeting of
the American Society of Tropical Medicine and Hygiene (ASTMH), Philadelphia, PA, USA, 25-
29 October 2015.
93. WWARN Lumefantrine PK/PD Study Group. Artemether-lumefantrine treatment of
uncomplicated Plasmodium falciparum malaria: a systematic review and meta-analysis of day 7
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CV Dr Gilbert Lefèvre
lumefantrine concentrations and therapeutic response using individual patient data. BMC Medicine
1015, 13:227-246.
94. Lefèvre G, Callegari F, Gsteiger S, Xiong Y. No effect of renal impairment on rivastigmine
pharmacokinetics in patients with Alzheimer’s Disease. Final version under submission process.