Catherine Sigler, DVM, MPH, PhD
Senior Epidemiologist, Epidemiology and Risk Management Group
catherine.sigler@unitedbiosource.com
Catherine Sigler, DVM, MPH, PhD, provides technical expertise in pharmaceutical safety issues related to epidemiologic or large streamlined clinical trial approaches and risk minimization action plans (RiskMAPs). Following work as a veterinary clinician, she began her training in epidemiology during the 1980s as a fellow in the US Public Health Service’s Epidemiology Training program and then joined the Parke-Davis Research Division of the Warner-Lambert Company.
During her 15-year tenure with Parke-Davis as an epidemiologist, she was responsible for a wide variety of risk management activities, including providing risk management support for the Rezulin (troglitazone) product safety questions that stemmed from spontaneous reports of liver failure following use of the product. These activities included natural history of disease studies, postmarketing data summarization for the advisory committee meetings and design of an HMO research network automated database study of the relation of anti-diabetic agents with liver disease. Because Parke-Davis also marketed and developed antiepileptic drug products, Dr. Sigler was asked to serve as the company’s representative on the Antiepileptic Drug Pregnancy Registry.
In 2000, following the Pfizer merger, she worked in the New York-based Pfizer Safety Evaluation and Epidemiology group, leading the team for Neurontin (gabapentin) pharmacovigilance activities. Dr. Sigler later managed the Pfizer Ann Arbor group in Risk Evaluation and Documentation, responsible for such regulatory components as Common Technical Documents and advisory committee briefing documents.
She has broad therapeutic area experience and direct expertise in risk management strategies, including signal evaluation and the design, conduct and analysis of case-control, cohort, registries and large streamlined clinical trials. As a senior epidemiologist with United BioSource Corporation, Dr. Sigler has been primary author of—and leads teams in the creation of—RiskMAPs and Risk Evaluation Minimization Plans (REMS).
