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Leader in Project Management and/or Alliance Management
Catégorie :

Consulting

Date de dernière mise à jour :

27 février 2017

Lieu :

France

CV :

Laurence T. Rimsky, Ph. D.
Mobile: +32 497 49 57 82 -- Landline: +32 3 290 75 40
laurence.rimsky@me.com

An Accomplished Leader and Scientist with International Experience in the Pharmaceutical Industry Business and with Peered Recognized Scientific Knowledge. Expertise in Drugs and Diagnostic Device Development, European and US Regulations, Medical and Scientific Affairs, Medical and Scientific Writing, Data Analysis, Clinical Protocol Design. Astute Eye for Business Needs

Objective
Leadership position in project management, and/or medical affairs in an innovative pharma organization.
Summary
Senior Project Leader and Key Stakeholder of global clinical development teams in international and start-up pharmaceuticals companies
Medical Affairs Officer, elaboration and design of scientific and clinical programs, managed interfaces with external partners. Familiar with Phase I to IV clinical trials (adults and children). Highly recognized scientist (5 patents and over 50 publications in major journals).
Fluency in communication with European, Japanese and US regulatory agencies
Project Manager certified by the George Washington University School of Business
Bilingual French and English, basic understanding of Dutch
Key competences
Fully operational strategic team leader with proven communication and leadership skills
A genuine ability to think out of the box and an eye for details leading to accurate analysis of data
A drive to strive for a continued business development with strategic objectives in mind
Strong business acumen
Passionate, energetic, engaged, and thoughtful
Professional Experience
Ablynx, Ghent, Belgium 2015 – 2016
Senior Project Leader; Acting Medical Affairs Officer
Responsible for the program and the team (14 members) developing first nebulized inhalation technology for infants with life threatening bronchiolitis ALX -0171, one of Ablynx wholly owned lead compounds
¬ Wrote 2016 business plan defining the program goals and objectives (scientific, clinical, regulatory, manufacturing and commercial) and determined ALX-0171asset valuation
¬ By pro-actively managing relevant stakeholders ensuring swift decision-making, acted to have the optimal development strategy and plan, including risk management and communication plans, in line with company strategy and vision, endorsed by the governance bodies
¬ Supervised the execution of the approved development plan by identifying the project needs, aligning the organization, managing stakeholders, identifying and bringing issues impacting the strategy to resolution
¬ Manage the approved budget (external costs and internal resources -- up to 25M euros), pro-actively monitoring the project's critical path and resource forecasting
¬ Responsible for the supervision and coordination of medical affairs activities related to ALX-0171 (Identifying and recruiting KOLs, creating the first ALX-0171 advisory board, heading the publication planning committee
¬ Lead the life cycle management team to strategic decision on the next indication for ALX017. Supervised the governance of partners and consultants to successful collaborations.
¬ Initiated and successfully carried the regulatory submission of ALX0171 to Japan
Janssen Diagnostics, Johnson & Johnson, Beerse, Belgium 2013 – 2015
Medical and Scientific Affairs Management of the Respiratory Illnesses and HIV
¬ Strategic leader and company representative at FP7 and IMI European consortia (PREPARE; RAPP-ID)
¬ Company regulatory representative (EDMA)
¬ Project leader for respiratory illnesses responsible for dissemination and presentations of data
¬ Managed academic research collaborations; scientific and medical writing; mentoring
¬ Account management and budget
¬ Elaboration and execution of respiratory diseases and HIV communication plan

Janssen Infectious Diseases, Johnson & Johnson, Beerse, Belgium 2010 - 2015
Janssen Diagnostics, Johnson & Johnson, Beerse, Belgium
Senior Principal Scientist, Clinical Virology
¬ Lead virologist of post-approval clinical development and research for EDURANT
¬ Cross functional representative of Janssen ID at Janssen Diagnostics
¬ Scientific officer – Mentoring
Janssen Infectious Diseases, Johnson & Johnson, Beerse, Belgium 2004 - 2010
Tibotec BVBA, Johnson & Johnson, Mechelen, Belgium
Director, Clinical Virology
¬ Lead virologist of preclinical and clinical development of EDURANT and company representative for all virology aspects of ELVIPLERA/COMPLERA development by Gilead Inc.
¬ Cross-functional project leader of the clinical virology teams in charge of the deliveries for the EMEA and FDA submissions including: document preparation, medical writing, and data analyses for the anti-HIV drugs PREZISTA (darunavir - TMC114), INTELENCE (etravirine - TMC125) and EDURANT (rilpivirine - TMC278)
¬ Head of the clinical virology team, data management processes, and quality assurance (FTE = 5)
¬ Cross-functional research project team leader -- genotypic and phenotypic high throughput assays development
Gilead Sciences Inc., Durham, NC, USA 2003 - 2004
Triangle Pharmaceuticals Inc., Durham, NC, USA
Principal Scientist, Research and Development
Lead preclinical research and development of new therapeutic vaccine for HBV (Dynavax)
Lead preclinical development of EMTRIVA, an anti HIV drug, including FDA submission
HIV research group head and scientific officer
Virology expert and company representative (i.e. Scientific Advisory Board Meetings, Investigator Meetings)
Triangle Pharmaceuticals Inc., Durham, NC, USA 1999 -2003
Senior Research Scientist, Clinical Virology and Diagnostics
HIV and HBV lab manager (FTE = 9) - e.g.: Development and validation of high throughput assays
Organized, conducted, and participated in various scientific research projects
Duke University Medical Center, Durham, NC, USA 1991 -1999
Post-Doctoral Fellow/Research Associate
Description of the mechanism of action of the regulatory proteins HIV-1 rex and HTLV-1 rev
HIV-1 vaccine development
Discovery of FUZEON resistance profile

Education
Baccalaureat, Sciences – Lycée de Meudon, France, 1975
Bachelor Degree, Biochemistry - Université Pierre & Marie Curie, Paris, France, 1978
Master Degree, Biology and Biochemistry - Université Pierre & Marie Curie, Paris, France, 1980
Ph. D., Biology and Biochemistry - Université Pierre & Marie Curie, Paris, France, 1984
Post-Doctoral Training – Hôpital Saint Louis – Hôpital Gustave Roussy, Paris France 1984-1987
Post-Doctoral Training – Duke University, Howard Hughes Medical Institute, Durham NC, USA 1987-1989

Laurence T. Rimsky, Ph. D.
Mobile: +32 497 49 57 82 -- Landline: +32 3 290 75 40
laurence.rimsky@me.com

Annexes

Continuing Education
¬ Managing People for Maximum Performance & Strategies for Enhancing Executive Influence - JFK School of Government - Harvard University, (2000)
¬ Project Management Associate - George Washington University (2007)
¬ High Level Presentation Skills & Process Excellence Primer Certification - Belgium (2012)
¬ Energy 4 Performance - Belgium (2013)
¬ Clinical Trial Monitor Accreditation - Barnett International Cambridge Healthtech Institute (2014)
¬ Pepal Health System Strengthening Project - Janssen with NGO Pepal/Baylor Uganda (2014)

Professional Affiliations
¬ International Society of Antiviral Research (ISAR)
¬ American Association of Microbiology (ASM)
¬ American Association of Immunology (AAI))
¬ International Union of Immunological Societies (IUIS)
¬ European Society of Clinical Microbiology and Infectious Diseases (ESCMID)
¬ European Scientific Working group on Influenza (ESWI)

Patents
¬ Mutant rex genes encoding trans-dominant repressors of HIV/HTLV replication (1990)
¬ Methods, plasmid vectors and primers for assessing HIV viral fitness. / Procédés, vecteurs de type plasmides et amorces servant à évaluer la valeur adaptative virale du VIH. Tibotec Pharmaceuticals June 2007: CA 2631881 WO 2007/065926 (1 worldwide citation) EP1960554
¬ Methods and means for assessing HIV gag/protease inhibitor therapy. Method and means for determining the replication rate of a viral population. / Procédé et moyen de détermination du taux de réplication d'une population virale. Tibotec Pharmaceuticals April 2007: CA 2625976 WO 2007/042568
¬ Methods and means for assessing HIV gag/protease inhibitor therapy. / Procédés et moyens destinés a évaluer une thérapie fondée sur les inhibiteurs de la protéine gag et de la protéase du VIH. Tibotec Pharmaceuticals October 2007: CA 2646586, EP1946111, WO 2007/118849; Tibotec Pharmaceuticals January 2009: EP2010680
¬ Methods, plasmid vectors and primers for assessing HIV viral fitness. Tibotec Pharmaceuticals February 2009: CN 200680051987

Language and Personal Data
Bilingual French/English, basic understanding of Dutch (in progress)
Microsoft Office, Visio, Microsoft Project
French and US citizen, resident of Belgium: Kortrijksesteenweg 1010-0204, Ghent 9000 (East Flanders).
Open to relocation in English and French speaking settings.
Genuinely interested in the improvement of medical care management in remote setting

Remarques :

Selected major Publications
¬ Rimsky L, Wakasugi H, Ferrara P, Robin P, Capdevielle J, Tursz T, Fradelizi D and Bertoglio J. Purification to homogeneity and NH2-terminal amino acid sequence of a novel interleukin 1 species derived from human B cell line. Journal of Immunology 1986. 136: 3304-3310.
¬ Wakasugi, H, Rimsky L, Mahe Y, Mahmoud Kamel A, Fradelizi D, Tursz T and Bertoglio J. An EBV-containing B cell line produces a novel type of interleukin 1 and uses it as a growth factor. Proceedings National Academy of Sciences USA. 1987. 84: 804-808.
¬ Bertoglio J, Rimsky L, Kleinerman ES and Lachman L. B cell derived interleukin 1 is cytotoxic for melanoma cells and promotes the proliferation of an astrocytoma cell line. Lymphokine Research. 1987. 6: 83-91.
¬ Harel-Bellan A., Quillet A, Marchiol C, Gerard JP, Wakasugi H, Bensimon C, Rimsky L and Fradelizi D. Lack of reconstitution of nude mice alloreactivity by purified IL2 and induction of non H2 specific effector cells by crude supernatants. Cellular Immunology. 1987. 105, 251-261.
¬ Rimsky L, Hauber J, Dukovick M, Malim MH, Langlois A, Cullen BR and Greene WC. The rex protein of HTLV-1 can biologically replace the rev protein of HIV-1. Nature. 1988, 335; 738-740.
¬ Wollman E, Dauriol L, Rimsky L, Shaw A, Jaquot JP, Wingfield P, Graber P, Dessarps F, Robin P, Galibert F, Bertoglio J and Fradelizi D. Cloning and expression of a cDNA for Human Thioredoxin. Journal of Biological Chemistry. 1988, 263; 15506-15512.
¬ Böhlein E, Siekevitz EM, Ballard DW, Lowenthal JW, Rimsky L, Bogerd LH, Hoffman J, Wano Y, Franza BR and Greene WC. Stimulation of the human Immunodeficiency virus Type -1 enhancer by the human T cell Leukemia virus type 1 tax gene product involve the action of inducible cellular proteins. Journal of Virology. 1989, 1578-1586.
¬ Bertoglio J, Wollman E, Shaw A, Rimsky l and Fradelizi D. Identification of Interleukin 1 by 3B6 human EBV-B cell line. Lymphokine Research. 1989. 8; 19-24.
¬ Rimsky L, Duc Dodon M, Dixon EP and Greene WC. Trans-dominant inactivation of HTLV-1 and HIV-1 gene expression by mutation of the HTLV-1 Rex transactivator. Nature, 1989, 341, 453-456.
¬ Hanly SM, Rimsky LT, Malim MH, Kim JH, Hauber J, Duc Dodon M, Le S, Maizel JV, Cullen BR and Greene WC. Comparative analysis of the HTLV-I Rex and HIV-I Rev Trans-regulatory proteins and their RNA response elements. Genes & Development. 1989, 3; 1534-1544.
¬ Harel-Bellan A, Krief P, Rimsky LT, Farrar LW and Mishal Z. Flow cytometry resonance-energy-transfer suggests an association between low affinity interleukin 2 binding site and HLA Class I molecules. Biochemical Journal 1990. 268:35-40.
¬ Kim JH, Kaufmanns PA, Hanly SM, Rimsky LT and Greene WC. Rex trans regulation of Human T Cell Leukemia Virus type II Gene Expression. Journal of Virology. 1991. 65; 405-414.
¬ Wild C, Grenwell T, Rimsky-Clarke L, Matthews M. The inhibitory activity of an HIV-1 peptide correlates with its ability to interact with a leucine zipper structure. AIDS Research and Human Retroviruses. 1995. 11: 323-325.
¬ Girard, M, Meignier B, Barre-Sinoussi F, Kieny M, Matthews T, Muchmore E, Nara PL, Rimsky L, Weinhold K, and Fultz P. Vaccine-induced protection in chimpanzees against infection by heterologous human immunodeficiency virus type 1. Journal of Virology. 1995, 69; 6239-2248
¬ Rimsky LT, Sughars DC and Matthews TJ. Determinants of HIV-1 resistance to gp41 derived inhibitory peptides. Journal of Virology. 1998, 72: 986-993.
¬ Painter GR, Rimsky LT, Furman PA, Schinazi RF and Quinn JA. Preclinical and clinical development of anti-HIV, anti-HBV oxathiolane nucleoside analog emtricitabine. 2002. Frontiers in viral Hepatitis Ed. By RF Schinazi, C. Rice and JP Somadossi. Elsevier Science. 2002, 521-555
¬ Selmi B, Deval J, Courcambeck J, Feng J, Rimsky L, Boretto J, Sarfati S, Guerreiro C, Mulard L and Canard B. How and when incorporation rate and binding affinity of nucleoside analogues are major determinants of drug-resistance by HIV-RT: Common features of drug resistance at the molecular level mediated by L74V, K65R, Q151M complex and M184V RT. Frontiers in Drug Development for Antiretroviral Therapies. 2002.
¬ Jacquard C, Nassal M, Pichoud C, Ren S, Schultz U, Guerret S, Chevallier M, Werle B,  Peyrol S, Jamard, Rimsky LT, Trepo C, Zoulim F. Effect of a combination of clevudine and emtricitabine with adenovirus-mediated delivery of gamma interferon in the woodchuck model of hepatitis B virus infection. Antimicrobial Agents and Chemotherapy. 2004. 48: 2683–2692.
¬ Feng JY, Myrick FT, Margot NA, Mulamba GB, Rimsky L, Borroto-Esoda K, Selmi B, Canard B.. Virologic and enzymatic studies revealing the mechanism of K65R- and Q151M-associated HIV-1 drug resistance towards emtricitabine and lamivudine. Nucleosides Nucleotides Nucleic Acids. 2006. 25: 89-107.

recent Publications
¬ Molina JM, Cordes C, Ive P, Vibhagool A, Rimsky L, Vanveggel S, Williams P, Boven K. Efficacy and safety of TMC278 in treatment-naïve, HIV-infected patients: Week-96 data from TMC278-C204. 9th International Congress on Drug Therapy in HIV Infection. 2008. Abstract P002.
¬ Vingerhoets J, Azijn H, Tambuyzer L, Dierynck I, De Meyer S, Rimsky L, Peeters M, De Smedt G, de Bethune MP, Picchio G . Activity of etravirine on different HIV-1 subtypes: Week 48 data of the pooled DUET trials and in vitro susceptibility in treatment-naïve patients. 9th International Congress on Drug Therapy in HIV Infection. 2008. Abstract 189.
¬ Rimsky, LT, Tambuyzer L, Vingerhoets J, Azijn H, Staes M, Picchio G, Kraus G, and de Bethune MP. Compilation of mutations associated with resistance to NNRTIs deduced from clinical samples, in-vitro analyses, and bibliographical studies, 16th International HIV Drug Resistance Workshop. 2007. Abstract 63.
¬ Tambuyzer L, Azijn H; Rimsky LT; Vingerhoets J; Lecocq P; Kraus G; Picchio G; de Bethune MP. Compilation and prevalence of mutations associated with resistance to non-nucleoside reverse transcriptase inhibitors. Antiviral Therapy. 2009. 14: 103-109.
¬ Rimsky L, Azijn H, Tirry I, Vingerhoets J, Mersch R, Kraus G, de Bethune MP, Picchio G. In-vitro resistance profile of TMC278, a next-generation NNRTI; Evidence of a higher genetic barrier and a more robust resistance profile than first-generation NNRTIs. 18th International HIV Drug Resistance Workshop. 2009. Abstract 120.
¬ Azijn H, Tirry I, Vingerhoets J, de Bethune MP, Kraus G, Boven K, Jochmans D, Van Craenenbroeck E, Picchio G, Rimsky L. TMC278, a next-generation nonnucleoside reverse transcriptase inhibitor (NNRTI), active against wild-type and NNRTI-resistant HIV-1. Antimicrobial Agents Chemotherapy. 2010. 54: 718-727.
¬ Pozniak A, Morales-Ramirez J, Katabira E, Steyn D, Lupo S, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky L, Vanveggel S, Boven K. TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a Phase IIb randomized trial. AIDS. 2010. 24: 55-65.
¬ Rimsky L, Eron J, Clotet B, Vingerhoets J, Azijn H, Vanveggel S, Hoogstoel A, Stevens M, Boven K, Picchio G. Characterization of the resistance profile of TMC278: 48-week analysis of the Phase 3 studies ECHO and THRIVE. 50th International Conference on Antimicrobial Agents and Infectious Diseases. 2010. Abstract H-181.
¬ Napolitano L, Paquet A, Petropoulos C, Whitcomb J, Rimsky L, Vingerhoets J, Picchio G, Haddad M. Impact of genotypic mutations on phenotypic susceptibility to rilpivirine. 51th ICAAC International Conference on Antimicrobial Agents and Infectious Diseases. 2011.
¬ Aimee Wilkin, Anton Pozniak, Javier Morales-Ramirez, Dewald Steyn, Maria Santoscoy, Grinsztejn B, Kiat Ruxrungtham, Rimsky L, Vanveggel S, Boven K. TMC278 shows favorable tolerability and non-inferior efficacy compared to efavirenz over 192 weeks in HIV-1-infected treatment-naïve patients. 19th Annual Canadian Conference on HIV/AIDS Research. 2010. Abstract 7214.
¬ Vingerhoets J; Azijn A; Tambuyzer L; Dierynck I; De Meyer S; Rimsky L; Nijs S; De Smedt G, de Béthune MP, Picchio G. Short communication: activity of etravirine on different HIV type 1 subtypes: in vitro susceptibility in treatment-naive patients and week 48 pooled DUET study data. AIDS Research and Human Retroviruses. 2010. 26: 621-624.
¬ Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven K; TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a Phase IIb randomized trial. AIDS. 2010. 24: 55-65.
¬ Calvin Cohen, Molina JM, Cahn P, Clotet B, Fourie J, Grinsztejn B, Hao W, Johnson M, Saag M, Supparatpinyo K, Crauwels H, Rimsky L, Vanveggel S, Peter Williams. Pooled Week 48 efficacy and safety results from ECHO and THRIVE, two double-blinded, randomised, Phase III trials comparing TMC278 versus efavirenz in treatment-naïve, HIV-1-infected patients. 18th International AIDS Conference. 2010. Abstract THLBB206
¬ Cohen C, Molina JM, Cahn P, Clotet B, Fourie J, Grinsztejn B, Hao W,Johnson, M Saag M, Supparatpinyo K, Crauwels H, Rimsky L, Vanveggel S, Williams P, Boven K. Pooled Week 48 efficacy and safety results from ECHO and THRIVE, two double-blind, randomized, phase III trials comparing TMC278 versus efavirenz in treatment-naive, HIV-1-infected patients. Frontiers in Drug Development for Antiretroviral Therapies. 2010. Abstract 45.
¬ Calvin Cohen, Molina JM, Cahn P, Bonaventura Clotet, Jan Fourie , Grinsztejn B, W Hao, Margaret Johnson, Khuanchai Supparatpinyo, Crauwels H, Rimsky L, Vanveggel S, Peter Williams , Boven K. Pooled Week 48 safety and efficacy results from ECHO and THRIVE Phase III trials comparing TMC278 vs. EFV in treatment-naïve, HIV-1-infected patients. 10th International Congress on Drug Therapy in HIV Infection. 2010. Abstract O432.
¬ Calvin Cohen, Molina JM, Cahn P, Bonaventura Clotet, Khuanchai Supparatpinyo, Crauwels H, Rimsky L, Vanveggel S, Peter Williams, Deborah Schaible, Boven K. Pooled week 48 efficacy and safety results from ECHO and THRIVE, two double-blind randomized, Phase III trials comparing TMC278 versus efavirenz in treatment-naive, HIV-1-infected patients. American Conference for the Treatment of HIV. 2011. TP01-3.
¬ Vingerhoets J, Rimsky L, Van Eygen , et al. Screening and baseline mutations in the rilpivirine phase III trials ECHO and THRIVE: prevalence and impact on virologic response. International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies. 2011. Abstract 41.
¬ Rimsky L, Vingerhoets J, van Eygen V, et al. Genotypic and phenotypic characterization of HIV-1 isolates obtained from patients failing TMC278 in the phase III studies ECHO and THRIVE: 48-week analysis. International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies. 2011. Abstract 9
¬ Kulkarni R, Babaoglu K, Lansdon EB, Rimsky L, Van Eygen V, Picchio G, Svarovskaia E, Miller MD, White KL. Cross-talk between the HIV reverse transcriptase NRTI and NNRTI binding pockets: interactions between E138K and M184I and drug resistance. International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies. 2011. Abstract 13.
¬ Haddad M, Napolitano LA, Paquet AC, Evans MC, Petropoulos CJ, Whitcomb J, Rimsky L. Vingerhoets, J, Picchio, G, Coakley E. Impact of HIV-1 reverse transcriptase E138 mutations on rilpivirine drug susceptibility. International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies. 2011. Poster #10.
¬ Stellbrink HJ, Cohen C, Molina JM, et al. Pooled Week 96 efficacy and safety results from the double-blind, randomised, Phase III trials comparing rilpivirine (RPV; TMC278) versus efavirenz (EFV) in treatment-naïve, HIV-1-infected adults. 12th European AIDS Conference. 2011. PE7. 3/5.
¬ Rimsky L, Vingerhoets J, Van Eygen V, Eron J, Clotet B, Hoogstoels A, Boven K, Picchio G. Characterization of the resistance profile of TMC278: 48-week analysis of the Phase 3 studies ECHO and THRIVE. 50th International Conference on Antimicrobial Agents and Infectious Diseases. 2010. Abstract H-1810
¬ Cohen CJ, Andrade-Villanueva J, Clotet B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naïve adults affected with HIV-1 (THRIVE): a phase 3 randomised, non-inferiority trial. Lancet. 2011. 378: 229-237.
¬ Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky L, Vanveggel S, Boven K. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naïve adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011. 378: 238-246.
¬ Cohen C, Andrade-Villanueva J, Clotet B, Fourie J, Johnson M, Ruxrungtham K, Wu H, Zorrilla, Crauwels H, Rimsky L, Vanveggel S, Boven K. Pooled Week 96 efficacy, C resistance and safety results from the double-blind, randomised, phase III trials comparing rilpivirine (RPV, TMC278) versus efavirenz (EFV) in treatment-naïve, HIV-1-infected adults. 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, 17–20 July 2011. Abstract TULBPE032
¬ Wilkin A, Pozniak AL, Morales-Ramirez J, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven K, on behalf of the TMC278-C204. Study group. Long-term efficacy, safety, and tolerability of rilpivirine (RPV, TMC278) in HIV type 1-infected antiretroviral-naive patients: Week 192 results from a phase IIb randomized trial. AIDS Research and Human Retroviruses. 2011. 28: 437-446.
¬ Haddad M, Napolitano LA, Paquet AC, Evans MC, Petropoulos CJ, Whitcomb J, Rimsky L. Vingerhoets, J, Picchio, G, Coakley E. Impact of HIV 1 reverse transcriptase E138 mutations on rilpivirine drug susceptibility; 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, 17–20 July 2011. Antiviral Therapy; 16 Suppl 1: A18.
¬ Rimsky L, Vingerhoets J, Van Eygen V, Eron J, Clotet B, Vanveggel S, Boven K, Picchio G. Genotypic and phenotypic characterization of HIV 1 isolates obtained from patients on rilpivirine therapy experiencing virologic failure in the phase 3 ECHO and THRIVE studies: 48-week analysis. J Acquir Immune Defic Syndr. 2012. 59: 39-46
¬ Kulkarni R, Babaoglu K, Lansdon EB, Rimsky L, Van Eygen V, Picchio G, Svarovskaia E, Miller MD, White KL. The HIV-1 reverse transcriptase M184I mutation enhances the E138K-associated resistance to rilpivirine and decreases viral fitness. J Acquir Immune Defic Syndr. 2012. 59: 47-54.
¬ Wilkin A, Pozniak AL, Morales-Ramirez J, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven On Behalf of The TMC278-C204 Study Group. Long-Term Efficacy, Safety, and Tolerability of Rilpivirine (RPV, TMC278) in HIV Type 1-Infected Antiretroviral-Naive Patients: Week 192 Results from a Phase IIb Randomized Trial. AIDS Res Hum Retroviruses. 2012. 28: 437-446.
¬ Cohen C, Molina J, Cahn P, Clotet B, Fourie J, Grinsztejn B, Wu H, Johnson M, Saag M, Supparatpinyo K, Crauwels H, Lefebvre E, Rimsky L, Vanveggel S, Williams P, Boven K; on behalf of the ECHO and Thrive study groups. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naïve, HIV-1-infected patients: pooled results from the phase 3 double-blind, randomized ECHO and THRIVE trials. Journal of Acquired Immune Deficiency Syndrome. 2012. 60: 33-42.
¬ Rimsky L, Van Eygen V, Vingerhoets J, Hoogstoel A, Stevens M, Boven K, and Picchio G. Week 96 resistance analysis of the rilpivirine (RPV, TMC278) phase 3 trials in treatment-naïve HIV-infected adults. 19th Conference on Retrovirus and Opportunistic Infections. 2012. Poster 708.
¬ Orkin C, Cohen C, Molina JM, Cassetti I, Chetchotisakd P, Lazzarin A, Rhame F, Stellbrink HJ, Taisheng L, Crauwels H, Rimsky L, Vanveggel S, Williams P and Boven K. Pooled Week 96 efficacy and safety results from the double-blind, randomised, Phase III trials comparing rilpivirine (RPV; TMC278) versus efavirenz (EFV) in treatment-naïve, HIV-1-infected adults. 18th Annual Conference of the British HIV Association. 2012.
¬ White K, Van Eygen V, Vingerhoets J, Boven K, Picchio G, Quercia R, Chuck S and Rimsky L. Week 96 resistance analysis of the ECHO and THRIVE truvada subset in treatment-naïve HIV-infected adults with ≤100,000 c/mL baseline viral load. 18th Annual Conference of the British HIV Association. 2012.
¬ Rimsky L, Van Eygen V, Vingerhoets J, Leijskens E, Picchio G. Reverse transcriptase connection-domain mutations were not associated with virologic failure or phenotypic resistance in rilpivirine-treated patients from the ECHO and THRIVE Phase III trials (Week 96 analysis). International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies. 2012. Poster #28.
¬ Rimsky L, Van Eygen V, Vingerhoets J, Thys K, Aerssens J, Stevens M, Picchio G. Similar prevalence of baseline HIV-1 minority variants among responders and virologic failures, as well as increased detection of HIV-1 minority variants at treatment-failure, in rilpivirine patients from the ECHO and THRIVE Phase III studies. XIX International IADS Conference. 2012. Abstract TUAB0302.
¬ White K, Quercia R, Van Eygen V, Boven K, Picchio G, Chuck S and Rimsky L. Week 96 Resistance analysis of the pooled ECHO and THRIVE truvada subset in treatment-naïve HIV-infected adults with ≤100,000c/mL baseline viral load. European HIV-1 Drug Resistance Workshop. 2012.
¬ Vingerhoets J, Rimsky LT, Van Ginderen M, Van Eygen V and De Meyer S. In-vitro selection experiments with rilpivirine and/or emtricitabine using clinical isolates, with E138K and/or M184I, obtained from patients with virologic failure. International Workshop on HIV & Hepatitis Virus Drug Resistance and Curative Strategies. 2013. Poster 93.
¬ Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoet J. 96-week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antiviral therapy. 2013. [Epub ahead of print]. DOI:10.3851/IMP2636
¬ Vingerhoets J, Rimsky L, Van Eygen V, Nijs S, Vanveggel S, Boven K, Picchio G. Pre-existing mutations in the rilpivirine Phase III trials ECHO and THRIVE: prevalence and impact on virological response. Antiviral Therapy. 2013. 18(2):253-6.
¬ Cohen CJ, Molina JM, Cassetti I, Chetchotisakd P, Lazzarin A, Orkin C, Rhame F, Stellbrink HJ, Li T, Crauwels H, Rimsky L, Vanveggel S, Williams P, Boven K; ECHO, THRIVE study groups. Week 96 efficacy and safety of rilpivirine in treatment-naive, HIV-1 patients in two Phase III randomized trials. AIDS. 2013. 27: 939-50.
¬ Molina JM, Clumeck N, Orkin C, Rimsky LT, Vanveggel S and Stevens M on behalf of the ECHO and THRIVE Study Groups Week 96 analysis of rilpivirine or efavirenz in HIV-1 patients with baseline viral load ≤100,000 copies/mL in the pooled ECHO and THRIVE Phase 3, randomized, double-blind trials. HIV Med. 2014 15: 57-62.
¬ Picchio GR, Rimsky LT, Van Eygen V, Haddad M, Napolitano LA, Vingerhoets J. Prevalence in the USA of rilpivirine resistance-associated mutations in clinical samples and effects on phenotypic susceptibility to rilpivirine and etravirine. Antivir Ther. 2014; 19: 819-23.
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