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- Joe Arndt
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- Doug Larigan
- Kejie Li
- Edward Lin
- John Lydeard
- Jeffrey Martin
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- Sha Mi
- Alvydas Mikulskis
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- Sarav Narayanan
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- Antonio Valencia
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- Ru Wei
- Andreas Weihofen
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- Brian Wipke
- Guangqing Xiao
- Zhili Xin
My group supports the drug development programs in multiple sclerosis and Alzheimer’s disease indications that have transitioned or are in the process of transitioning from research into clinical development. We are actively involved in supporting the evaluation of pharmacokinetic parameters of candidate drugs and performing characterization of immunogenicity responses to administered drugs. In addition, our key focus is on evaluation of appropriate biomarkers that would enable better understanding of the mechanisms of action of a drug and characterization of relevant pathways, or provide useful pharmacodynamics, safety, efficacy, patient stratification and other endpoints that would aid clinical development of candidate drugs and provide support of drug products in postmarketing phase. In that respect, we are interested in research leading to fundamental understanding of the underlying biology of the above-mentioned diseases and are continuously evaluating the state-of-the-art assay technologies and data analysis tools to support these efforts.
Our special interest is also in taking a deeper dive into development of the cutting-edge tools and practices for characterization of anti-drug antibody (ADA) responses to drug treatment. ADAs often vary significantly in their physical-chemical properties (e.g., affinity, avidity, stability, etc.), antibody types (e.g., IgGs, IgMs, etc.), concentrations, ability to simply bind or neutralize drug activity, be transient or persistent, etc., and may impact pharmacokinetics, pharmacodynamics, bioavailability, efficacy and safety of a drug product. Measurement and characterization of such diverse ADA responses pose unique challenges and provide exciting opportunities for development of appropriate solutions.
I joined the development translational sciences team at Biogen in 2008 after developing variety of assay technologies and assays for genomics and proteomics applications at PerkinElmer. I have more than 15 years of assay development experience, hold a Green Belt certification in Six Sigma and implementation of Design of Experiment (DOE) and have a long-standing interest in assay development sciences and assay technologies.
- Postdoctoral Fellow, Harvard Medical School, Boston, MA, 1996
- Postdoctoral Fellow, International Institute of Cellular and Molecular Pathology, Brussels, Belgium, 1994
- Ph.D., Moscow Institute of Physics and Technology, Moscow, Russia, 1992
- M.S., Moscow Institute of Physics and Technology, Moscow, Russia, 1988
- 2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.
Bioanalysis. 2013 Dec;5(23):2903-18. doi: 10.4155/bio.13.238. Epub 2013 Oct 10.
Stevenson L, Garofolo F, DeSilva B, Dumont I, Martinez S, Rocci M, Amaravadi L, Brudny-Kloeppel M, Musuku A, Booth B, Dicaire C, Wright L, Mayrand-Provencher L, Losauro M, Gouty D, Arnold M, Bansal S, Dudal S, Dufield D, Duggan J, Evans C, Fluhler E, Fraser S, Gorovits B, Haidar S, Hayes R, Ho S, Houghton R, Islam R, Jenkins R, Katori N, Kaur S, Kelley M, Knutsson M, Lee J, Liu H, Lowes S, Ma M, Mikulskis A, Myler H, Nicholson B, Olah T, Ormsby E, Patel S, Pucci V, Ray C, Schultz G, Shih J, Shoup R, Simon C, Song A, Neto JT, Theobald V, Thway T, Wakelin-Smith J, Wang J, Wang L, Welink J, Whale E, Woolf E, Xu R.
- Novel data analysis methods to overcome cut point challenges and enable comprehensive assessment of antidrug binding activity in confirmatory assays.
J Immunol Methods. 2013 Jun 28;392(1-2):38-48. doi: 10.1016/j.jim.2013.03.008. Epub 2013 Mar 28.
Mikulskis A, Yeung D, Chen W, Mehta D, Amaravadi L.
- Solution ELISA as a platform of choice for development of robust, drug tolerant immunogenicity assays in support of drug development.
J Immunol Methods. 2011 Feb 28;365(1-2):38-49. doi: 10.1016/j.jim.2010.11.011. Epub 2010 Dec 1.
Mikulskis A, Yeung D, Subramanyam M, Amaravadi L.
- Proteomic patterns for classification of ovarian cancer and CTCL serum samples utilizing peak pairs indicative of post-translational modifications.
Proteomics. 2007 Nov;7(22):4045-52.
Liu C, Shea N, Rucker S, Harvey L, Russo P, Saul R, Lopez MF, Mikulskis A, Kuzdzal S, Golenko E, Fishman D, Vonderheid E, Booher S, Cowen EW, Hwang ST, Whiteley GR.
- A robust biomarker discovery pipeline for high-performance mass spectrometry data.
J Bioinform Comput Biol. 2007 Oct;5(5):1023-45.
Fisher WG, Rosenblatt KP, Fishman DA, Whiteley GR, Mikulskis A, Kuzdzal SA, Lopez MF, Tan NC, German DC, Garner HR.
- Phosphopeptide analysis by directly coupling two-dimensional planar electrochromatography/thin-layer chromatography with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry.
J Chromatogr A. 2007 Jun 29;1155(1):112-23. Epub 2007 Apr 20.
Panchagnula V, Mikulskis A, Song L, Wang Y, Wang M, Knubovets T, Scrivener E, Golenko E, Krull IS, Schulz M, Heinz-Emil-Hauck, Patton WF.
- A novel, high-throughput workflow for discovery and identification of serum carrier protein-bound peptide biomarker candidates in ovarian cancer samples.
Clin Chem. 2007 Jun;53(6):1067-74. Epub 2007 Apr 26.
Lopez MF, Mikulskis A, Kuzdzal S, Golenko E, Petricoin EF 3rd, Liotta LA, Patton WF, Whiteley GR, Rosenblatt K, Gurnani P, Nandi A, Neill S, Cullen S, O'Gorman M, Sarracino D, Lynch C, Johnson A, Mckenzie W, Fishman D.
- Performance validation of an improved Xenon-arc lamp-based CCD camera system for multispectral imaging in proteomics.
Proteomics. 2005 Nov;5(17):4354-66.
Scrivener E, Boghigian BA, Golenko E, Bogdanova A, Jackson P, Mikulskis A, Denoyer E, Courtney P, Lopez MF, Patton WF.
- Biomarker discovery and analysis platform: application to Alzheimer's disease.
Biotechniques. 2005 Oct;39(4):606-7.
Kuzdzal S, Lopez M, Mikulskis A, Golenko E, DiCesare J, Denoyer E, Patton W, Ediger R, Sapp L, Ziegert T, Ackloo S, Wall MR, Mannion DP, della Cioppa G, Wolfe G, Bennett D, Melov S.
- High-resolution serum proteomic profiling of Alzheimer disease samples reveals disease-specific, carrier-protein-bound mass signatures.
Clin Chem. 2005 Oct;51(10):1946-54. Epub 2005 Aug 4.
Lopez MF, Mikulskis A, Kuzdzal S, Bennett DA, Kelly J, Golenko E, DiCesare J, Denoyer E, Patton WF, Ediger R, Sapp L, Ziegert T, Lynch C, Kramer S, Whiteley GR, Wall MR, Mannion DP, Della Cioppa G, Rakitan JS, Wolfe GM.
- Housekeeping genes in cancer: normalization of array data.
Biotechniques. 2005 May;38(5):739-45.
Khimani AH, Mhashilkar AM, Mikulskis A, O'Malley M, Liao J, Golenko EE, Mayer P, Chada S, Killian JB, Lott ST.
- Microscale fractionation facilitates detection of differentially expressed proteins in Alzheimer's disease brain samples.
Electrophoresis. 2004 Aug;25(15):2557-63.
Lopez MF, Mikulskis A, Golenko E, Melov S, Bennett D, Cherkasskiy A, Kuzdzal S, Kramer S, Sissors D.
- Proteomic analysis of mitochondrial proteins.
Int Rev Neurobiol. 2004;61:31-48.
Lopez MF, Melov S, Johnson F, Nagulko N, Golenko E, Kuzdzal S, Ackloo S, Mikulskis A.
- High-content proteomics: fluorescence multiplexing using an integrated, high-sensitivity, multiwavelength charge-coupled device imaging system.
Proteomics. 2003 Jul;3(7):1109-16.
Lopez MF, Mikulskis A, Golenko E, Herick K, Spibey CA, Taylor I, Bobrow M, Jackson P.
- Regulation of expression of the ethanol dehydrogenase gene (adhE) in Escherichia coli by catabolite repressor activator protein Cra.
J Bacteriol. 1997 Nov;179(22):7129-34.
Mikulskis A, Aristarkhov A, Lin EC.
- Translation of the adhE transcript to produce ethanol dehydrogenase requires RNase III cleavage in Escherichia coli.
J Bacteriol. 1996 Jul;178(14):4327-32.
Aristarkhov A, Mikulskis A, Belasco JG, Lin EC.
- The fliA gene encoding sigma 28 in Yersinia enterocolitica.
J Bacteriol. 1995 May;177(9):2299-304.
Iriarte M, Stainier I, Mikulskis AV, Cornelis GR.
- Regulation of the Yersinia enterocolitica enterotoxin Yst gene. Influence of growth phase, temperature, osmolarity, pH and bacterial host factors.
Mol Microbiol. 1994 Dec;14(5):905-15.
Mikulskis AV, Delor I, Thi VH, Cornelis GR.
- A new class of proteins regulating gene expression in enterobacteria.
Mol Microbiol. 1994 Jan;11(1):77-86.
Mikulskis AV, Cornelis GR.