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Items: 1 to 50 of 123

1.

Ser625 of msn2 transcription factor is indispensable for ethanol tolerance and alcoholic fermentation process.

Vamvakas SS, Kapolos J, Farmakis L, Koskorellou G, Genneos F.

Biotechnol Prog. 2019 May 14:e2837. doi: 10.1002/btpr.2837. [Epub ahead of print]

PMID:
31087774
2.

Multistakeholder Advice at the European Medicines Agency: Is It Still Needed?

Vamvakas S, Moseley J, Vetter T.

Clin Pharmacol Ther. 2019 Apr;105(4):819-821. doi: 10.1002/cpt.1335. Epub 2019 Feb 27. No abstract available.

PMID:
30811587
3.

Specific serine residues of Msn2/4 are responsible for regulation of alcohol fermentation rates and ethanol resistance.

Vamvakas SS, Kapolos J, Farmakis L, Genneos F, Damianaki ME, Chouli X, Vardakou A, Liosi S, Stavropoulou E, Leivaditi E, Fragki M, Labrakou E, Gashi EG, Demoli D.

Biotechnol Prog. 2019 Mar;35(2):e2759. doi: 10.1002/btpr.2759. Epub 2018 Dec 24.

PMID:
30507007
4.

The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

Tafuri G, Lucas I, Estevão S, Moseley J, d'Andon A, Bruehl H, Gajraj E, Garcia S, Hedberg N, Massari M, Molina A, Obach M, Osipenko L, Petavy F, Petschulies M, Pontes C, Russo P, Schiel A, Van de Casteele M, Zebedin-Brandl EM, Rasi G, Vamvakas S.

Br J Clin Pharmacol. 2018 May;84(5):1013-1019. doi: 10.1111/bcp.13524. Epub 2018 Mar 5.

5.

Swings and Roundabouts in CNS Drug Biomarkers.

Isaac MB, Vamvakas S.

J Prev Alzheimers Dis. 2017;4(3):134-135. doi: 10.14283/jpad.2017.18. No abstract available.

PMID:
29182702
6.

Marketing authorisation of orphan medicines in Europe from 2000 to 2013.

Hofer MP, Hedman H, Mavris M, Koenig F, Vetter T, Posch M, Vamvakas S, Regnstrom J, Aarum S.

Drug Discov Today. 2018 Feb;23(2):424-433. doi: 10.1016/j.drudis.2017.10.012. Epub 2017 Oct 23. Review.

7.

Diagnostic biomarkers for Alzheimer's disease: a regulatory view.

Isaac MT, Vamvakas S, Isaac MB.

Lancet Neurol. 2017 Aug;16(8):580-581. doi: 10.1016/S1474-4422(17)30223-5. Epub 2017 Jul 11. No abstract available.

PMID:
28721916
8.

Human nucleus pulposus intervertebral disc cells becoming senescent using different treatments exhibit a similar transcriptional profile of catabolic and inflammatory genes.

Vamvakas SS, Mavrogonatou E, Kletsas D.

Eur Spine J. 2017 Aug;26(8):2063-2071. doi: 10.1007/s00586-017-5198-0. Epub 2017 Jun 23.

PMID:
28646455
9.

Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.

Farkas AM, Mariz S, Stoyanova-Beninska V, Celis P, Vamvakas S, Larsson K, Sepodes B.

Front Med (Lausanne). 2017 May 16;4:53. doi: 10.3389/fmed.2017.00053. eCollection 2017.

10.

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

Powers JH 3rd, Patrick DL, Walton MK, Marquis P, Cano S, Hobart J, Isaac M, Vamvakas S, Slagle A, Molsen E, Burke LB.

Value Health. 2017 Jan;20(1):2-14. doi: 10.1016/j.jval.2016.11.005. Epub 2017 Jan 10.

11.

How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.

Tafuri G, Pagnini M, Moseley J, Massari M, Petavy F, Behring A, Catalan A, Gajraj E, Hedberg N, Obach M, Osipenko L, Russo P, Van De Casteele M, Zebedin EM, Rasi G, Vamvakas S.

Br J Clin Pharmacol. 2016 Oct;82(4):965-73. doi: 10.1111/bcp.13023. Epub 2016 Jul 1.

12.

Identification and validation of biomarkers for autism spectrum disorders.

Loth E, Spooren W, Ham LM, Isaac MB, Auriche-Benichou C, Banaschewski T, Baron-Cohen S, Broich K, Bölte S, Bourgeron T, Charman T, Collier D, de Andres-Trelles F, Durston S, Ecker C, Elferink A, Haberkamp M, Hemmings R, Johnson MH, Jones EJ, Khwaja OS, Lenton S, Mason L, Mantua V, Meyer-Lindenberg A, Lombardo MV, O'Dwyer L, Okamoto K, Pandina GJ, Pani L, Persico AM, Simonoff E, Tauscher-Wisniewski S, Llinares-Garcia J, Vamvakas S, Williams S, Buitelaar JK, Murphy DG.

Nat Rev Drug Discov. 2016 Jan;15(1):70-3. doi: 10.1038/nrd.2015.7. No abstract available.

PMID:
26718285
13.

Early market access of cancer drugs in the EU.

Martinalbo J, Bowen D, Camarero J, Chapelin M, Démolis P, Foggi P, Jonsson B, Llinares J, Moreau A, O'Connor D, Oliveira J, Vamvakas S, Pignatti F.

Ann Oncol. 2016 Jan;27(1):96-105. doi: 10.1093/annonc/mdv506. Epub 2015 Oct 20. Review.

PMID:
26487583
14.

Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

Walton MK, Powers JH 3rd, Hobart J, Patrick D, Marquis P, Vamvakas S, Isaac M, Molsen E, Cano S, Burke LB; International Society for Pharmacoeconomics and Outcomes Research Task Force for Clinical Outcomes Assessment.

Value Health. 2015 Sep;18(6):741-52. doi: 10.1016/j.jval.2015.08.006. Epub 2015 Aug 24.

15.

Regulatory watch: Impact of scientific advice from the European Medicines Agency.

Hofer MP, Jakobsson C, Zafiropoulos N, Vamvakas S, Vetter T, Regnstrom J, Hemmings RJ.

Nat Rev Drug Discov. 2015 May;14(5):302-3. doi: 10.1038/nrd4621. Epub 2015 Apr 17. No abstract available.

PMID:
25881970
16.

The European Medicines Agency's strategies to meet the challenges of Alzheimer disease.

Haas M, Mantua V, Haberkamp M, Pani L, Isaac M, Butlen-Ducuing F, Vamvakas S, Broich K.

Nat Rev Drug Discov. 2015 Apr;14(4):221-2. doi: 10.1038/nrd4585.

PMID:
25829266
17.

From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.

Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G.

Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4.

PMID:
25669457
18.

The future is now: model-based clinical trial design for Alzheimer's disease.

Romero K, Ito K, Rogers JA, Polhamus D, Qiu R, Stephenson D, Mohs R, Lalonde R, Sinha V, Wang Y, Brown D, Isaac M, Vamvakas S, Hemmings R, Pani L, Bain LJ, Corrigan B; Alzheimer's Disease Neuroimaging Initiative; Coalition Against Major Diseases.

Clin Pharmacol Ther. 2015 Mar;97(3):210-4. doi: 10.1002/cpt.16. Epub 2014 Dec 27.

19.

Mannan-conjugated myelin peptides prime non-pathogenic Th1 and Th17 cells and ameliorate experimental autoimmune encephalomyelitis.

Tseveleki V, Tselios T, Kanistras I, Koutsoni O, Karamita M, Vamvakas SS, Apostolopoulos V, Dotsika E, Matsoukas J, Lassmann H, Probert L.

Exp Neurol. 2015 May;267:254-67. doi: 10.1016/j.expneurol.2014.10.019. Epub 2014 Oct 30.

PMID:
25447934
20.

The European Medicines Agency experience with biomarker qualification.

Manolis E, Koch A, Deforce D, Vamvakas S.

Methods Mol Biol. 2015;1243:255-72. doi: 10.1007/978-1-4939-1872-0_15. Review.

PMID:
25384751
21.

Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.

Hill DLG, Schwarz AJ, Isaac M, Pani L, Vamvakas S, Hemmings R, Carrillo MC, Yu P, Sun J, Beckett L, Boccardi M, Brewer J, Brumfield M, Cantillon M, Cole PE, Fox N, Frisoni GB, Jack C, Kelleher T, Luo F, Novak G, Maguire P, Meibach R, Patterson P, Bain L, Sampaio C, Raunig D, Soares H, Suhy J, Wang H, Wolz R, Stephenson D.

Alzheimers Dement. 2014 Jul;10(4):421-429.e3. doi: 10.1016/j.jalz.2013.07.003.

PMID:
24985687
22.

Altered expression of oligodendrocyte and neuronal marker genes predicts the clinical onset of autoimmune encephalomyelitis and indicates the effectiveness of multiple sclerosis-directed therapeutics.

Evangelidou M, Karamita M, Vamvakas SS, Szymkowski DE, Probert L.

J Immunol. 2014 May 1;192(9):4122-33. doi: 10.4049/jimmunol.1300633. Epub 2014 Mar 28.

23.

Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude.

Ehmann F, Papaluca Amati M, Salmonson T, Posch M, Vamvakas S, Hemmings R, Eichler HG, Schneider CK.

Clin Pharmacol Ther. 2013 May;93(5):425-32. doi: 10.1038/clpt.2013.14. Epub 2013 Jan 24.

PMID:
23549149
24.

Factors influencing non-approval of new drugs in Europe.

Putzeist M, Mantel-Teeuwisse AK, Aronsson B, Rowland M, Gispen-de Wied CC, Vamvakas S, Hoes AW, Leufkens HG, Eichler HG.

Nat Rev Drug Discov. 2012 Dec;11(12):903-4. doi: 10.1038/nrd3894. No abstract available.

PMID:
23197028
25.

Sarcopenia: biomarkers and imaging (International Conference on Sarcopenia research).

Abellan van Kan G, Cderbaum JM, Cesari M, Dahinden P, Fariello RG, Fielding RA, Goodpaster BH, Hettwer S, Isaac M, Laurent D, Morley JE, Pahor M, Rooks D, Roubenoff R, Rutkove SB, Shaheen A, Vamvakas S, Vrijbloed JW, Vellas B.

J Nutr Health Aging. 2011 Dec;15(10):834-46. No abstract available.

PMID:
22159770
26.
27.

The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation.

Pignatti F, Gravanis I, Herold R, Vamvakas S, Jonsson B, Marty M.

Clin Cancer Res. 2011 Aug 15;17(16):5220-5. doi: 10.1158/1078-0432.CCR-11-0623.

28.

New pathway for qualification of novel methodologies in the European Medicines Agency.

Manolis E, Vamvakas S, Isaac M.

Proteomics Clin Appl. 2011 Jun;5(5-6):248-55. doi: 10.1002/prca.201000130. Epub 2011 Apr 28. Review.

PMID:
21538915
29.

Role of modeling and simulation in pediatric investigation plans.

Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, Saint Raymond A.

Paediatr Anaesth. 2011 Mar;21(3):214-21. doi: 10.1111/j.1460-9592.2011.03523.x. Epub 2011 Jan 18. Review.

PMID:
21244569
30.

A role for neuronal NF-κB in suppressing neuroinflammation and promoting neuroprotection in the CNS.

Emmanouil M, Taoufik E, Tseveleki V, Vamvakas SS, Probert L.

Adv Exp Med Biol. 2011;691:575-81. doi: 10.1007/978-1-4419-6612-4_60. No abstract available.

PMID:
21153363
31.

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.

Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu YZ, Thompson KL, Goering PL, Vidal JM, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Lima BS, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W.

Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10.

PMID:
20458315
32.

Towards consensus practices to qualify safety biomarkers for use in early drug development.

Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y.

Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10.

PMID:
20458314
33.

Comparative gene expression analysis in mouse models for multiple sclerosis, Alzheimer's disease and stroke for identifying commonly regulated and disease-specific gene changes.

Tseveleki V, Rubio R, Vamvakas SS, White J, Taoufik E, Petit E, Quackenbush J, Probert L.

Genomics. 2010 Aug;96(2):82-91. doi: 10.1016/j.ygeno.2010.04.004. Epub 2010 May 7.

34.

TNFRI is a positive T-cell costimulatory molecule important for the timing of cytokine responses.

Evangelidou M, Tseveleki V, Vamvakas SS, Probert L.

Immunol Cell Biol. 2010 Jul;88(5):586-95. doi: 10.1038/icb.2010.12. Epub 2010 Mar 9.

PMID:
20212506
35.

Neuronal I kappa B kinase beta protects mice from autoimmune encephalomyelitis by mediating neuroprotective and immunosuppressive effects in the central nervous system.

Emmanouil M, Taoufik E, Tseveleki V, Vamvakas SS, Tselios T, Karin M, Lassmann H, Probert L.

J Immunol. 2009 Dec 15;183(12):7877-89. doi: 10.4049/jimmunol.0900834.

36.

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Regnstrom J, Koenig F, Aronsson B, Reimer T, Svendsen K, Tsigkos S, Flamion B, Eichler HG, Vamvakas S.

Eur J Clin Pharmacol. 2010 Jan;66(1):39-48. doi: 10.1007/s00228-009-0756-y. Epub 2009 Nov 20.

PMID:
19936724
37.

Folding in solution of the C-catalytic protein fragment of angiotensin-converting enzyme.

Vamvakas SS, Leondiadis L, Pairas G, Manessi-Zoupa E, Spyroulias GA, Cordopatis P.

J Pept Sci. 2009 Aug;15(8):504-10. doi: 10.1002/psc.1151. Erratum in: J Pept Sci. 2009 Dec;15(12):867.

PMID:
19551715
38.

Are women appropriately represented and assessed in clinical trials submitted for marketing authorization? A review of the database of the European Medicines Agency.

Müllner M, Vamvakas S, Rietschel M, van Zwieten-Boot BJ.

Int J Clin Pharmacol Ther. 2007 Sep;45(9):477-84. Review.

PMID:
17907590
39.

Expression, purification, and physicochemical characterization of the N-terminal active site of human angiotensin-I converting enzyme.

Vamvakas SS, Leondiadis L, Pairas G, Manessi-Zoupa E, Spyroulias GA, Cordopatis P.

J Pept Sci. 2007 Jan;13(1):31-6.

PMID:
16972307
40.

Analysis of renal cell transformation following exposure to trichloroethene in vivo and its metabolite S-(dichlorovinyl)-L-cysteine in vitro.

Mally A, Walker CL, Everitt JI, Dekant W, Vamvakas S.

Toxicology. 2006 Jul 5;224(1-2):108-18. Epub 2006 Apr 28.

PMID:
16730402
42.

The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome.

Pignatti F, Aronsson B, Gate N, Vamvakas S, Wade G, Moulon I, Le Courtois P.

Eur J Clin Pharmacol. 2002 Dec;58(9):573-80. Epub 2002 Nov 13.

PMID:
12525957
43.

Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology.

Pignatti F, Aronsson B, Vamvakas S, Wade G, Papadouli I, Papaluca M, Moulon I, Le Courtois P.

Crit Rev Oncol Hematol. 2002 May;42(2):123-35. Review.

PMID:
12007970
44.

Renal cell cancer correlated with occupational exposure to trichloroethene.

Vamvakas S, Brüning T, Bolt HM, Henschler D, Ulm K.

J Cancer Res Clin Oncol. 2000 Mar;126(3):178-80. No abstract available.

PMID:
10741913
45.

The toxicology expert: what is required?

Bass R, Vamvakas S.

Toxicol Lett. 2000 Mar 15;112-113:383-9.

PMID:
10720756
46.

Incidence and spectrum of dialysis-associated cancer in three continents.

Heidland A, Bahner U, Vamvakas S.

Am J Kidney Dis. 2000 Feb;35(2):347-51; discussion 352-3. No abstract available.

PMID:
10676739
47.

Increased genomic damage in lymphocytes of patients before and after long-term maintenance hemodialysis therapy.

Stopper H, Meysen T, Böckenförde A, Bahner U, Heidland A, Vamvakas S.

Am J Kidney Dis. 1999 Sep;34(3):433-7.

PMID:
10469852
48.
49.
50.

Changes in the classification of carcinogenic chemicals in the work area. (Section III of the German List of MAK and BAT values).

Neumann HG, Thielmann HW, Filser JG, Gelbke HP, Greim H, Kappus H, Norpoth KH, Reuter U, Vamvakas S, Wardenbach P, Wichmann HE.

J Cancer Res Clin Oncol. 1998;124(12):661-9.

PMID:
9879826

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