Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World Evidence, including managing the Sentinel System.

Dr. Comfort is a Principle Scientific Enablement Director for Roche in Science Enablement and Processes, leading innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 20 years combined biopharma industry/regulatory experience. Dr. Comfort’s current work focuses on developing machine-learning models to evaluate Drug-Adverse Event causality and predict Project/Phase Probability of Success. Recently he published his first book focused on using mathematical estimation in healthcare: How Much Is that Cure in the Window? Simple Math Solutions for Complicated Problems in Biology, Medicine, and Healthcare.

Sunita Dhar is an Executive Medical Group Director in Clinical Safety and the Franchise head for the I2O portfolio at Genentech. Sunita joined the industry after 12 years of clinical practice and has over seventeen years of experience in drug development, safety science, and pharmacovigilance across multiple therapeutic areas. Prior to joining Roche/Genentech in 2011, she led the drug safety department at a mid-size biopharmaceutical company in the Bay Area. Sunita is passionate about making a positive impact on the growth and development of colleagues, bringing transformative therapies to patients, and improving patient access beyond regulatory approval through new innovative tools, technology, and smart data analytics.

Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while in academia. He continued his research in industry before moving over to clinical development and eventually Medical Affairs. Bruce has held various positions in industry, including Head of Drug Safety at Genentech and now Senior Group Director of Pharmacovigilance Innovation Policy in Global Regulatory Affairs. In this role, Bruce focuses on current challenges in pharmacovigilance, such as predictive drug safety and quality of safety data sources.

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.