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

[email protected]

Address - Home 24 rue Principale

F-68210 Gildwiller, France

Tel. +33 6 33 24 74 64

[email protected]

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

2


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

3


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


® 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


® 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

4


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)

http://www.eurekalert.org/pub_releases/2011-04/w-pgw040411.php

5


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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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.

7


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

8


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

9


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.

10


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.

http://www.google.fr/url?sa=t&source=web&cd=1&ved=0CBwQFjAA&url=http%3A%2F%2Fwww.ectmihbarcelona2011.org%2F&ei=tQxmTtvLNor0sgbS09CVCg&usg=AFQjCNHY42UQIXqDJev1MVwqqNcmox3Yog

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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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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.

cv gilbert lefevre

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