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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays). Bioanalysis (2018) 10(24), 1973-2001

2018 White Paper on Recent Issues in Bioanalysis: Focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity) . Bioanalysis (2018) 10(23), 1897-1917

Charles M. Bark, Ameur M. Manceur, LaShaunda L. Malone, Mary Nsereko, Brenda Okware, Harriet K. Mayanja, Moses L. Joloba, Isabelle Rajotte, Marija Mentinova, Phyla Kayb, Seydina Lo, Patrick Tremblay, Catherine M. Stein, W. Henry Boom, Eustache Paramithiotis Identification of Host Proteins Predictive of Early Stage Mycobacterium tuberculosis Infection. EBIOMedicine, June 20, 2017, DOI:

Chad Bradford, Rob Severinsen, Trina Pugmire, Matison Rasmussen, Kathryn Stoddard, Yuta Uemura, Spencer Wheelwright, Marija Mentinova, Daniel Chelsky, Stephen W. Hunsucker, Paul Kearney, Durlin Hickok, Tracey C. Fleischer, Ilia Ichetovkin, J. Jay Boniface, Gregory C. Critchfield, John M. Peltier Analytical validation of protein biomarkers for risk of spontaneous preterm birth. Clinical Mass Spectrometry, 3 (2017), p. 25–38.

An Song, Anita Lee, Fabio Garofolo*, Surinder Kaur, Jeff Duggan, Christopher Evans, Joe Palandra, Lorella Di Donato, Keyang Xu, Ronald Bauer, Mark Bustard, Linzhi Chen, Laurent Cocea, Stephanie Croft, Fabrizio Galliccia, Sam Haidar, Nicola Hughes, Akiko Ishii-Watabe, Rafiqul Islam, Barry Jones, John Kadavil, Carsten Krantz, Gustavo Mendes Lima Santos, Timothy Olah, João Pedras-Vasconcelos, Ludovicus Staelens, Yoshiro Saito, Natasha Savoie, Kara Scheibner, Susan Spitz, Nilufer Tampal, Eric Thomas, Stephen Vinter, Jason Wakelin-Smith, Jan Welink, Jianing Zeng & Shaolian Zhou 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – Hybrid LBA/LCMS and input from regulatory agencies). Bioanalysis. 2016; 8(23), 2457–2474.

Croisé P, Houy S, Gand M, Lanoix J, Calco V, Tóth P, Brunaud L, Lomazzi S, Paramithiotis E, Chelsky D, Ory S, Gasman S. Cdc42 and Rac1 activity is reduced in human pheochromocytoma and correlates with FARP1 and ARHGEF1 expression. Endocrine-related cancer. 2016; 23(4):281-93. PMID:26911374

Achkar JM, Cortes L, Croteau P, Yanofsky C, Mentinova M, Rajotte I, Schirm M, Zhou Y, Junqueira-Kipnis AP, Kasprowicz VO, Larsen M, Allard R, Hunter J, Paramithiotis E. Host Protein Biomarkers Identify Active Tuberculosis in HIV Uninfected and Co-infected Individuals. EBioMedicine. 2015; 2(9):1160-8. PubMed [journal] PMID:26501113

Hare BJ, Haseltine E, Fleming M, Chelsky D, McIntosh L, Allard R, Botfield M. A signature for immune response correlates with HCV treatment outcome in Caucasian subjects. J Proteomics. (2015) 116:59-67.

Spellman DS, Wildsmith KR, Honigberg LA, Tuefferd M, Baker D, Raghavan N, Nairn AC, Croteau P, Schirm M, Allard R, Lamontagne J, Chelsky D, Hoffmann S, Potter WZ Development and evaluation of a multiplexed mass spectrometry based assay for measuring candidate peptide biomarkers in Alzheimer's Disease Neuroimaging Initiative (ADNI) CSF. Proteomics Clin Appl. (2015) doi: 10.1002/prca.201400178. [Epub ahead of print]

Li XJ, Hayward C, Fong PY, Dominguez M, Hunsucker SW, Lee LW, McLean M, Law S, Butler H, Schirm M, Gingras O, Lamontagne J, Allard R, Chelsky D, Price ND, Lam S, Massion PP, Pass H, Rom WN, Vachani A, Fang KC, Hood L, Kearney P. A blood-based proteomic classifier for the molecular characterization of pulmonary nodules. Sci Transl Med. (2013) 5: 207ra142.

Galagan JE, Minch K, Peterson M, Lyubetskaya A, Azizi E, Sweet L, Gomes A, Rustad T, Dolganov G, Glotova I, Abeel T, Mahwinney C, Kennedy AD, Allard R, Brabant W, Krueger A, Jaini S, Honda B, Yu WH, Hickey MJ, Zucker J, Garay C, Weiner B, Sisk P, Stolte C, Winkler JK, Van de Peer Y, Iazzetti P, Camacho D, Dreyfuss J, Liu Y, Dorhoi A, Mollenkopf HJ, Drogaris P, Lamontagne J, Zhou Y, Piquenot J, Park ST, Raman S, Kaufmann SH, Mohney RP, Chelsky D, Moody DB, Sherman DR, Schoolnik GK. The Mycobacterium tuberculosis regulatory network and hypoxia. Nature (2013) 499:178-83

Canuel M, Sun X, Asselin MC, Paramithiotis E, Prat A, Seidah NG. Proprotein convertase subtilisin/kexin type 9 (PCSK9) can mediate degradation of the low density lipoprotein receptor-related protein 1
PloS one. 2013; 8(5):e64145. PMID:23675525

Chaves-Olarte E, Guzmán-Verri C, Paramithiotis E, Moreno E. What have we learned from Brucella proteomics? In Brucella: Molecular Microbiology and Genomics 2nd ed, (2011) I. Lopez-Goni & D. O’Callaghan, eds. Caister Academic Press.

Hunter J, Chelsky D. “Protein Biomarker Discovery Using Mass Spectrometry–Based Proteomics” in Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy, J. Wiley & Sons, Inc., M.R. Bleavins, C. Carini, M. Jurima-Romet, R. Rahbari, Eds., (2010) 101-120

Lamontagne J, Béland M, Forest A, Côté-Martin A, Nassif N, Tomaki F, Moriyón I, Moreno E, Paramithiotis E. Proteomics-based confirmation of protein expression and correction of annotation errors in the Brucella abortus genome. BMC Genomics. (2010) 11:300.

Migneault and J.M. Hunter, Industrialized MS-based Proteomics in the Search for Circulating Biomarkers Bioanalysis (2010) 1: 1149-63.

Lamontagne J, Forest A, Marazzo E, Denis F, Butler H, Michaud JF, Boucher L, Pedro I, Villeneuve A, Sitnikov D, Trudel K, Nassif N, Boudjelti D, Tomaki F, Chaves-Olarte E, Guzmán-Verri C, Brunet S, Côté-Martin A, Hunter J, Moreno E, Paramithiotis E. Intracellular adaptation of Brucella abortus. J. Proteome Res. (2009) 8:1594.

Hunter J, Paramithiotis E. Protein biomarker quantification by mass spectrometry. Expert Opin Med Diagn. (2009) 3:11-20.

Jutras I, Houde M, Currier N, Boulais J, Duclos S, LaBoissière S, Bonneil E, Kearney P, Thibault P, Paramithiotis E, Hugo P, Desjardins M. Modulation of the phagosome proteome by interferon-gamma. Mol. Cell. Proteomics (2008) 7:697-715

Lamontagne J, Butler H, Chaves-Olarte E, Hunter J, Schirm M, Paquet C, Tian M, Kearney P, Hamaidi L, Chelsky D, Moriyón I, Moreno E, Paramithiotis E. Extensive cell envelope modulation is associated with virulence in Brucella abortus. J. Prot. Res. (2007) 6:1519-1529

Follettie MT, Pinard M, Keith JC Jr, Wang L, Chelsky D, Hayward C, Kearney P, Thibault P, Paramithiotis E, Dorner AJ, Harris HA. Organ Messenger Ribonucleic Acid and Plasma Proteome Changes in the Adjuvant-Induced Arthritis Model: Responses to Disease Induction and Therapy with the Estrogen Receptor-beta Selective Agonist ERB-041 Endocrinology (2006) 147: 714-723


Oldaker T, Whitby L, Saber M, Holden J, Wallace PK and Litwin V. ICCS/ESCCA Consensus Guidelines to detect GPI-deficient cells in Paroxysmal Nocturnal Hemoglobinuria (PNH) and related Disorders Part 4 – Assay Validation and Quality Assurance. Cytometry Part B2018; 94B: 67–81.

Stéphane Pillet, Éric Aubin, Sonia Trépanier, Jean-François Poulin, Bader Yassine-Diab, Jan ter Meulen, Brian J. Ward and Nathalie Landry. Humoral and cell-mediated immune responses to H5N1 plant-made virus-like particle vaccine are differentially impacted by alum and GLA-SE adjuvants in a Phase 2 clinical trial NPJ Vaccines. (2018) 3.

Landry N, Pillet S, Favre D, Poulin JF, Trépanier S, Yassine-Diab B, Ward BJ. Influenza virus-like particle vaccines made in Nicotiana benthamiana elicit durable, poly-functional and cross-reactive T cell responses to influenza HA antigens. Clin Immunol. (2014) 154(2):164-77.

El-Far M, Pellerin C, Pilote L, Fortin JF, Lessard IA, Peretz Y, Wardrop E, Salois P, Bethell RC, Cordingley MG, Kukolj G. CD160 isoforms and regulation of CD4 and CD8 T-cell responses. J TranslMed. (2014), 12:217.

Kulpa DA, Lawani M, Cooper A, Peretz Y, Ahlers J, Sékaly RP. PD-1 coinhibitory signals: the link between pathogenesis and protection. Semin Immunol. (2013) 25(3):219-27.

Peretz Y, He Z, Shi Y, Yassine-Diab B, Goulet JP, Bordi R, Filali-Mouhim A, Loubert JB, El-Far M, Dupuy FP, Boulassel MR, Tremblay C, Routy JP, Bernard N, Balderas R, Haddad EK, Sékaly RP. CD160 and PD-1 co-expression on HIV-specific CD8 T cells defines a subset with advanced dysfunction. PLoS Pathog. (2012) 8(8) :e1002840.