Dr. Janet L. Lathey did her Ph.D in Microbiology with emphasis on Viral Immunology from the University of Tennessee, Knoxville, USA. She is a senior level virologist, immunologist and translational scientist; expert in vaccine development and measuring product effectiveness, specializing in bioassay development, validation, and assay standardization. She helped in developing vaccines for infectious diseases and cancer and secure marketing approval for influenza vaccines. She is a Consultant, expert in bioassay development, validation and standardization, Bioassay Institute of Maryland. She serves as Director of Immunology and Assay Validation at Emergent BioSolutions in Gaithersburg, MD. Her work areas were Toxin Neutralization assays, ELISA and ELISpot for potency and clinical trials of Anthrax vaccine. She is a Project representative and Manager at Sanofi Pasteur involved with standardizing serological and cell culture assays for influenza vaccine clinical trials, efficacy studies and product licensure. She is a Director of Virology and Immunology at SeraCare produced an ELISpot kit and an HPV cellular assay control for market and set up proficiency testing using ELISpot for HIV and Cancer programs. She is the Clinical immunology group leader at ZYCOS, developed bioassay for clinical testing of a therapeutic vaccine for HPV. Prior to biotech, she is the Co-director of the Retrovirology Laboratory at the University of California, San Diego, leader in the development and standardization of immunological and virological biomarker assays used in anti-retroviral clinical trials for treatment of HIV.
Assay development and implementation in clinical trials; Vaccine and anti-viral product development and clinical trial testing; Potency Testing for product release and stability testing; Assay development and validation; Product development, assay kits and controls; Quality Assurance for consensus assay and reagent banks; Laboratory supervision and maintenance: Bioassays, ELISA, ELISpot, cell and virus culture; Standardization biomarker assay for HIV, Influenza, Cancer and Anthrax.