#30: Machine Learning in Pharmacovigilance
Shaun Comfort, MD, MBA
- Principal Medical Director
- Genentech, A Member of the Roche Group, United States
Dr. Comfort is Principal Medical Director for Roche in the Inflammatory, Infectious Disease, and Ophthalmology Safety Science group and leads innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 16 years combined industry/regulatory experience including roles as former Medical Reviewer at the US FDA, VP of Clinical Research at Anesiva, and CMO for Adaptix Clinical Solutions. Most recently, he has been involved in evaluating and developing AI solutions for Pharmacovigilance resulting in two 2018 papers with his team in Drug Safety. He has a broad range of interests including operations research, monte-carlo applications in real options/project valuation, statistics and computational physics.
Bruce Donzanti, PhD
- Bruce A. Donzanti, LLC Pharmaceutical Consulting Services, United States
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.
Robert Ball, MD, MPH, MSc
- Deputy Director, Office of Surveillance and Epidemiology, CDER
- FDA, United States
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.
- Group Manager, Vigilance Intelligence and Research Group
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and middle income countries. Mick is the current Chair of the MedDRA Management Committee and is a board member of the Uppsala Monitoring Centre.