Experience

GENERAL FLUIDICS CORPORATION

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Vice President of Assay Development

  • Jul 2021 - Present

  Leading clinical chemistry, hematology and immunoassay development for point-of-care systems. Leading clinical chemistry, hematology and immunoassay development for point-of-care systems.



OpGen, Inc.

• Biotechnology Research
• 1 - 100 Employee

• Senior Vice President, Research & Development

  • 2012 - Jul 2021

  Transformed OpGen into precision medicine company to combat antibiotic-resistant infections • Designed and launched Acuitas® AMR Gene Panel IVD for detection of 28 antimicrobial resistance markers in several Enterobacterales, Pseudomonas aeruginosa and Enterococcus faecalis • Led clinical trials, algorithm development, data analysis and FDA submission for 510(k) clearance • Scientific leadership of Acuitas Lighthouse® bioinformatics solutions for genotypic prediction of antibiotic… Show more Transformed OpGen into precision medicine company to combat antibiotic-resistant infections • Designed and launched Acuitas® AMR Gene Panel IVD for detection of 28 antimicrobial resistance markers in several Enterobacterales, Pseudomonas aeruginosa and Enterococcus faecalis • Led clinical trials, algorithm development, data analysis and FDA submission for 510(k) clearance • Scientific leadership of Acuitas Lighthouse® bioinformatics solutions for genotypic prediction of antibiotic resistance, infection control and outbreak analysis including $22MM partnership with the New York State Department of Health and Merck’s ILÚM Health Solutions to detect, track and control antimicrobial-resistant infections across New York State • Established state-of-art CLIA laboratory for genomic and FDA-validated genome sequencing analysis of antibiotic resistance and prediction of phenotypic susceptibility of clinical bacterial infections • Established molecular IVD manufacturing capabilities Show less Transformed OpGen into precision medicine company to combat antibiotic-resistant infections • Designed and launched Acuitas® AMR Gene Panel IVD for detection of 28 antimicrobial resistance markers in several Enterobacterales, Pseudomonas aeruginosa and Enterococcus faecalis • Led clinical trials, algorithm development, data analysis and FDA submission for 510(k) clearance • Scientific leadership of Acuitas Lighthouse® bioinformatics solutions for genotypic prediction of antibiotic… Show more Transformed OpGen into precision medicine company to combat antibiotic-resistant infections • Designed and launched Acuitas® AMR Gene Panel IVD for detection of 28 antimicrobial resistance markers in several Enterobacterales, Pseudomonas aeruginosa and Enterococcus faecalis • Led clinical trials, algorithm development, data analysis and FDA submission for 510(k) clearance • Scientific leadership of Acuitas Lighthouse® bioinformatics solutions for genotypic prediction of antibiotic resistance, infection control and outbreak analysis including $22MM partnership with the New York State Department of Health and Merck’s ILÚM Health Solutions to detect, track and control antimicrobial-resistant infections across New York State • Established state-of-art CLIA laboratory for genomic and FDA-validated genome sequencing analysis of antibiotic resistance and prediction of phenotypic susceptibility of clinical bacterial infections • Established molecular IVD manufacturing capabilities Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Translational Medicine, Inflammation and Autoimmunity

  • 2011 - 2012

  Led R&D, program management and external alliances for biomarkers and companion diagnostics for inflammation and autoimmune biologics (rheumatoid arthritis, lupus, inflammatory bowel disease and psoriasis) • Target validation, pharmacodynamic and experimental medicine studies • Patient stratification for pre-clinical and Phase I/II studies Led R&D, program management and external alliances for biomarkers and companion diagnostics for inflammation and autoimmune biologics (rheumatoid arthritis, lupus, inflammatory bowel disease and psoriasis) • Target validation, pharmacodynamic and experimental medicine studies • Patient stratification for pre-clinical and Phase I/II studies



Duke University

• United States
• Higher Education
• 700 & Above Employee

• Director and General Manager

  • 2009 - 2011

  Launched a unique academic/commercial venture in biomarker development co-owned by LabCorp and Duke University’s Translational Medicine Institute. Led strategy, operations, program management and executive alliances for clinical diagnostic programs in leukemia, breast cancer, glioblastoma, osteoarthritis and immunology. Launched a unique academic/commercial venture in biomarker development co-owned by LabCorp and Duke University’s Translational Medicine Institute. Led strategy, operations, program management and executive alliances for clinical diagnostic programs in leukemia, breast cancer, glioblastoma, osteoarthritis and immunology.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Site Director, Biomarkers

  • 2001 - 2009

  Led R&D, program management and external partnerships for biomarker and companion diagnostics in pharmaceutical development • Design, development, analytical validation, technology transfer, clinical trials, regulatory clearance and launch • Oncology, fibrosis, obesity, diabetes, atherosclerosis, COPD, Alzheimer’s and infectious diseases Led R&D, program management and external partnerships for biomarker and companion diagnostics in pharmaceutical development • Design, development, analytical validation, technology transfer, clinical trials, regulatory clearance and launch • Oncology, fibrosis, obesity, diabetes, atherosclerosis, COPD, Alzheimer’s and infectious diseases



BD

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Director, Molecular Diagnostics, Oncology and Pharmacogenomics

  • 1988 - 2001

  Initiated and led BD’s molecular diagnostic and biomarker discovery programs for oncology and infectious diseases • BD management board for biomarker discovery and pharmacogenomic partnerships • Invented Strand Displacement Amplification (SDA) and the molecular IVD platform ProbeTecET • Elected to BD's Hall of Fame for Technology and Innovation Initiated and led BD’s molecular diagnostic and biomarker discovery programs for oncology and infectious diseases • BD management board for biomarker discovery and pharmacogenomic partnerships • Invented Strand Displacement Amplification (SDA) and the molecular IVD platform ProbeTecET • Elected to BD's Hall of Fame for Technology and Innovation