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.
Howard R. Higley, PhD, DABT, Senior Director, Scientific Affairs, serves as project manager for several NIH-based projects, examining imaging endpoint strategies to accelerate regulatory approval of new cancer drugs. In addition, Dr. Higley coordinates projects developing evidentiary standards and demonstrations of utility for technologies assessing minimal residual disease in acute lymphoblastic leukemia and multiple myeloma. He has been the study director/principal investigator on more than 125 pilot and Good Laboratory Practice in vivo research studies, served as a regulatory and clinical research scientist on more than 30 NIH clinical studies, and led a team that generated 14 systematic reviews and literature assessments on the pediatric use of drugs, including a report to Congress in support of the Best Pharmaceuticals for Children Act. Dr. Higley is certified as a Diplomate, American Board of Toxicology (DABT), and holds a PhD in anatomy.
Daniel Milgram, Chief, Technology and Bioinformatics; Senior Director, IT/Data Management, is a systems analyst with an extensive background in clinical information systems and database design for government and industry. Mr. Milgram has overseen data management for multiple NIH and private client-sponsored clinical studies and has designed, developed, maintained, and validated CCSA’s regulatory and safety reporting and tracking systems, as well as CCSA’s clinical data management systems and integrated applications. He was the master architect for an NIH-sponsored web-based regulatory document management system, as well as a multilingual clinical and scientific informatics system used in six countries. Mr. Milgram holds a BA in economics and international area studies.
Meena Navidi, PhD, Senior Director, Preclinical Research and Development Projects, leads the teams providing scientific support for preclinical drug discovery and development programs. She has authored numerous worksheets, narrative summaries, Clinical Development Plans, Investigational New Drug applications (INDs), annual reports, and Clinical Trial Agreements. Dr. Navidi is an experienced research scientist with expertise in biochemistry, neurochemistry, animal physiology, nutrition, and in vitro receptor studies. She holds a PhD in nutritional sciences.
Beverly D. Smolich, PhD, Senior Director, Clinical Research and Regulatory Affairs, is a drug development scientist with expertise in preclinical through clinical research, translational medicine, biomarker development, and regulatory affairs. Dr. Smolich manages scientific and regulatory review and reporting for NIH- and private-client sponsored programs, and directs and is the point of contact for FDA for regulatory submissions, including Investigational New Drug applications (INDs), Clinical Trial Agreements, and Investigator’s Brochures. Dr. Smolich has developed clinical trial materials for physicians and patients, and she has worked extensively with private biotechnology and pharmaceutical clients on regulatory and clinical development projects. Dr. Smolich holds a PhD in biology.