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.

Education

  • 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

Selected Publications

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