Tarrytown, New York, United States
Graduated from Hiram College, The University of Akron and The Ohio State University with studies in virology, immunology, pathology, microbiology, parasitology, organic chemistry, biochemistry and ornithology. Extensive professional research experience in infectious diseases including HIV, Rubella, Toxoplasma, CMV, and hepatitis. Lead scientist for the development of the first fully automated Hepatitis C Virus Immunoassay (Bayer/Siemens). Multiple teaching and professor positions in the sciences as well as peer reviewed scientific publications and patents.
Direct and coordinate the transfer of the nine Centaur Infectious Disease methods on to the new Centaur CP platform. The methods are HAVM, HAVT, HBcM, HBcT, Anti-HBsAG, HBsAG, HBsAg Confirmatory, HCV and HIV. Responsibilities include planning, resource management and scheduling migration activities with a group of eight to ten scientists. Participate in the preparation and negotiation of proposals for the internal studies and the external clinical trials for the European (PEI) and the US (FDA) regulatory bodies. For the European studies a proposal was prepared and negotiated with the EU regulatory body. In the US a Pre-IDE was prepared and negotiated with the FDA to meet the FDA migration strategy. Participate in the preparation of the IVVD technical files for submission to the European regulatory body. Additional responsibilities included the preparation of all of the Technical Reviews and each of the Instructions for Use (package inserts).
Lead the development of the ADVIA Centaur HCV assay from feasibility to product launch. Activities included assay formulation and optimization, scale up production and transfer to manufacturing. Prepare Technical Reviews 1, 2, and 3 and participate in clinical trial data analysis and regulatory approval processes for Europe, US, Canada, Australia and Japan. Additional responsibilities included HCV presentations (e.g. World Wide Marketing) and all of the ADVIA Centaur Infectious Disease Assays (HAV, HBV, HCV and HIV) to potential customers.
Direct product transfer from development to pilot scale through manufacturing. Preparation of research reports and design reviews, including the European Launch data submissions. Participate in the clinical trial protocol development and the PLA submission. Review and report on technology, licensing/patent, and business strategies in the area of human retroviruses. Collaborate with Chiron and Cambridge Biotech for the development and assessment of diagnostic technologies (e.g. bDNA, RIBA) and raw materials (recombinants and peptides). In collaboration with Cambridge Biotech, implement improvements for the HTLV I (rp21e Enhanced) EIA. Design and direct process changes for raw materials, product manufacture and quality control systems. Preparation of progress reports, clinical trial protocol development and the IND submission.