Clinical Immunology team member, leading early development teams and driving success of programs as they transition through the pipeline into clinical development.

Developing and implementing strategy for the assessment of anti-drug immunogenicity in clinical stage and post-marketed biologic drug products. Interface with Clinical Development and Regulatory groups to contribute immunogenicity sections of clinical protocols, clinical study reports (CSR), IND documents and marketing authorization applications. Evaluate risks associated with hypersensitivity reactions elicited in patients with lysosomal storage diseases prior to treatment. Devise strategies to assess the correlation of anti-drug humoral and cellular immune responses with drug safety, activity and efficacy.

Integral and senior team member of a translational biology group: executed a translational role between Research and Clinical Development in support of viral vaccine development. Role involved developing predictive or correlative biomarker strategy, validating immunological assays and working closely with clinical development and clinical operation teams to design clinical study protocols. Developed and executed a systematic and thorough immune-profiling strategy that identified correlative biomarkers of RSV disease in the vaccine target population Led a team of associate scientists in assay optimization and qualification, enabling development of GLP fit-for-use immunoassays to make critical program decisions Initiated and successfully managed productive, long-term, scientific collaborations with key opinion leaders in academia, technical consultants and CRO companies Led a team of 15 scientists in 3 immune monitoring trials to evaluate cellular immune responses to FluMist® vaccination in human adult volunteers Designed and executed IND-enabling animal model studies to assess humoral and cellular immune responses to respiratory viral vaccines (ferret and mouse models) Presented significant research and clinical findings at high impact immunology conferences and authored peer-reviewed scientific publications Organized, hosted and conducted a highly successful symposium on cell-mediated immunology bioassays that received acclaim through the company’s Director’s Award Initiated and successfully managed productive, long-term, scientific collaborations with key opinion leaders in academia, technical consultants and CRO companies Trained and mentored several research associates, junior scientists and summer interns, enabling them to perform at their highest potential

Integral member of a pre-clinical drug development team coordinating several aspects of biomarker discovery and immunology. Supported the anti-CD40 antibody therapeutics program for treatment of B cell malignancies Identified and characterized B cell biomarkers for clinical assay development Successfully interfaced and collaborated with clinical development teams to help stratify target patient populations in support of personalized medicine Presented significant pre-clinical research findings at a major international medical conference and for publication in a peer-reviewed journal, in an invention disclosure and patent filing

Cellular & molecular immunology of lymphocytes, B cell activation & signaling, costimulatory modulation of antigen processing cells, fluorescence microscopy & imaging. Developed a transgenic mouse model system to investigate the role of co-receptor molecules in B cell activation and functions Investigated fatty acylation of integral membrane proteins in lipid rafts as a fundamental mechanism underlying B cell activation and prolonged signaling Initiated collaborations with scientists within and outside of NIH to support and expand research efforts on the role of lipid rafts in immune receptor signaling