Overall Safety Assessment – Standard Safety Tables and Figures

Dr James Buchanan, Covilance 

Dr James Buchanan is an independent drug safety consultant. He graduated from the University of California, San Francisco with a PharmD degree in clinical pharmacy. He worked in the area of clinical toxicology at the Bay Area Regional Poison Control Center at San Francisco General Hospital before entering the pharmaceutical industry. Dr Buchanan began his industry career at Genentech, where he worked for nine years in the areas of medical information and drug safety in the clinical development department. He subsequently moved to Gilead Sciences to establish a drug safety department. After leaving Gilead Sciences, he started the drug safety department at Tularik, where he acted as Chief Safety Officer until the company was acquired five years later by Amgen. Following the merger with Amgen, he moved to Nuvelo to establish a drug safety department and act as Chief Safety Officer, where he also had responsibility for clinical operations, biostatistics and data management. Dr Buchanan next served with BioSoteria for five years as the head of the medical and safety consulting group, which was subsequently acquired by Dohmen Life Science Services.

Dr Buchanan is currently president of Covilance, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group and is a co-lead on the Interactive Safety Graphics taskforce that is developing novel, open-source interactive graphical tools to identify and evaluate safety issues during drug development. 

Mary Nilsson, Eli Lilly

Mary Nilsson is Executive Director-Statistics, Safety Analytics at Eli Lilly. Mary received her master’s degree in statistics from Iowa State University in 1989 and has been employed at Eli Lilly since then. She is currently a researcher in the Safety Analytics group. Mary consults with molecule teams on safety analysis planning for Phase II to III studies and integrated submission documents. Her primary interests include analyses of adverse event data, analyses of laboratory data, statistical analysis plans, and collection and analysis of suicide-related events. Additionally, she co-leads the PHUSE Safety Analytics Working Group, creating cross-functional education and cross-industry recommendations for standard safety analyses and displays.

Mary received a MS degree in statistics from Iowa State University in 1989. She has been employed at Eli Lilly since 1989 and is currently a research advisor in the Safety Analytics group within the Statistical Sciences function.

Dr Veronica Pei, FDA

Dr Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service, currently serving as an Associate Director for Biomedical Informatics (ADBMI) in the Office of New Drugs (OND) at the FDA. In this role, Dr Pei is involved in development, implementation and support of bioinformatics initiatives as well as data standards within the OND. She is the current FDA topic lead for the ICH M11 expert working group on the Structure and Content of Clinical Protocols. She also serves as lead for the FDA Standard Safety Tables and Figures Integrated Guide. Prior to joining the FDA, she was a practising emergency physician, with interests in medical education and global emergency medical system development. After completing her BSc in Biological Sciences at the University of Toronto and her MD at McMaster University, Dr Pei received a master of education in health professional education from the University of Toronto. She subsequently completed residency training in emergency medicine at the Hospital of the University of Pennsylvania and fellowship training in international emergency medicine and received a master of public health in international health policy and programs at The George Washington University.