The Countervail Corporation
Countervail Corporation was formed in June 2007 to commercialize galantamine as an antidote to pesticide poisoning and volatile nerve gas.
Product development studies over the years have consistently demonstrated the effectiveness and safety of Countervail’s drug technology. As a compliment, the company recently added and is developing a novel diagnostic test technology for the detection of exposure to these toxins.
As a result of its success in the biotechnology industry, Countervail has garnered the support of federal funding, through grants and contracts, which it applies to the continued development of its drug and diagnostic technologies projects.
Countervail’s technologies are protected by issued and pending patents worldwide.
Prior to joining the Countervail team, Dr. Clement worked for more than a decade at Battelle Memorial Institute, a contract research organization, developing a myriad of biodefense/CBRNE/medical countermeasures in a cGXP/ICH environment. At Battelle, she served 11 years as a study director overseeing numerous studies compliant with Good Laboratory Practice (GLP) requirements that provided data for FDA filings. These research projects focused on designing novel assays, validation studies, analyzing multi-factorial data, interpreting complex statistical reports, and preparing reports and manuscripts. Her education in cell and molecular biology, coupled with more than 19 collective years of ligand binding assay development and validation, is strongly supportive of the diagnostic test development effort. Her career includes 14 years of experience working in the government contract research arena which has provided her with insight into project management, specifically how to deliver timely, on-budget deliverables that fit within the scope of the project.
She has been recognized as a Subject Matter Expert on anthrax and Ebola virus ligand binding assays (ELISA, ECL and cell based toxin neutralization assays), served on a validation committee at Battelle’s Biomedical Research Center, and was the principal investigator that led efforts to produce and qualify a critical reagent repository to support assay work requiring rare reagents for biothreat assays. Also, as study director in a GLP lab, Dr. Clement became adept at developing novel protocols (including IACUC and IRB approved protocols), supervising technical staff, evaluating research data, preparing technical reports, interacting with QA, monitoring safety and training, and liaising project timelines and budgets with management and sponsors.
Dr. Schiff is founder and CEO of Schiff & Company, a 26-year-old regulatory affairs, compliance and clinical research organization. Prior to founding Schiff & Company, Dr. Schiff served with a number of companies, including the Warner Lambert Company as group vice president of Diagnostics Research and Development; Hoffmann-La Roche, Inc. as director of the Department of Diagnostic Research and Product Development; the J. T. Baker Chemical Company (Richardson-Vicks) as director of Research & Development for the Diagnostics Division; the Hyland Division Travenol Laboratories (Baxter) as manager of Serology Research; and as an assistant professor in the Department of Anatomy at Tufts University’s Schools of Medicine and Dental Medicine.
Dr. Schiff has authored more than 50 publications and holds several patents on medical products. He received his bachelor’s degree from the City College of New York, a master’s degree from Iowa State University, and his doctorate from the University of California at Davis. He was a member of the Graduate Business faculty at Fairleigh Dickinson University and also lectures on International Business and Compliance with FDA rules and regulations. He serves on the boards of several companies, is a member of the Editorial Board of the Regulatory Affairs Professional Society and is listed in Marquis’ “Who’s Who in America,” “Who’s Who in the World,” “Who’s Who in the East,” “Who’s Who in Science & Engineering” and “American Men of Science.” Dr. Schiff is board certified in regulatory affairs and is a Certified Quality Auditor.