Mouna Akacha is the Group Head of the Statistical Methodology group of Novartis Pharma AG, based in Basel, Switzerland. She and her team provide internal advice for clinical projects in all development phases and therapeutic areas. She is engaged in developing and implementing innovative statistical methods for clinical projects covering estimand discussions and approaches for missing data, longitudinal data, and recurrent event data. Before joining Novartis, Akacha studied mathematics at the University of Oldenburg in Germany. She holds a PhD in statistics from the University of Warwick in the United Kingdom.

Dr. James Hung is currently Director, Division of Biometrics I, CDER, US FDA. The division provides services for the medical divisions: Neurology, Psychiatry, Anesthesiology, Addiction Medicine, and Pain Medicine, Medical Imaging and Radiation Medicine.