Caroline C. Sigman, PhD, President and CEO, founded CCS Associates in 1985. Dr. Sigman has extensive experience in drug development, cancer prevention and treatment, carcinogenesis, and biomarkers. She has served as principal investigator for more than 30 National Institutes of Health (NIH) projects, and has collaborated with government agencies, academia, and the pharmaceutical industry to design development strategies and clinical protocols for the evaluation of molecularly targeted drugs and biomarkers. She has contributed to infrastructure development, agent and biomarker selection, study activation, and management activities for multidrug clinical studies including Master Protocols (“Master INDs”). She has developed criteria for and evaluated cutting-edge translational research projects on biomarkers. Dr. Sigman has authored or coauthored more than 175 journal articles and book chapters and holds a PhD in chemistry/biochemistry.
Donya Bagheri, MA, DABT, Executive Director and Senior Director, Research and Development, oversees clinical monitoring and auditing staff at CCSA, and coordinates and manages data generated from client-sponsored studies. Ms. Bagheri has served as the project director for multiple large clinical trials including international phase 3 studies and Master Protocols, and as the principal investigator for NIH and commercial data coordinating centers. She has developed numerous specialized tools for efficient management of study data and training documentation, prepared and managed clinical monitoring and auditing plans, and managed studies involving collaboration among multiple clinical investigators with complex data analysis for both government and private sector clients. Ms. Bagheri is certified as a Diplomate of the American Board of Toxicology (DABT) and holds an MA in toxicology.
Linda A. Doody, PhD, DABT, Executive Director, directs CCSA’s regulatory affairs and safety reporting activities in support of commercial, government, and nonprofit drug development. Dr. Doody has developed strategies, coordinated with pharmaceutical partners, served as liaison with FDA, and reviewed and prepared more than 3300 submissions to over 100 Investigational New Drug applications (INDs) and Clinical Trial Agreements. Dr. Doody was responsible for the development and implementation of the Master IND. She serves as a clinical safety expert for NIH and commercial studies and has managed processing and assessing over 1700 serious adverse event reports. Dr. Doody is certified as a Diplomate of the American Board of Toxicology (DABT) and holds a PhD in pharmacology and toxicology.