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.

Rob is a partner at Consilium, a consultancy partnership between Rob Hemmings and Tomas Salmonson, both long-standing contributors to the EU regulatory network. Consilium supports companies in the design of clinical development programmes, the design, analysis and interpretation of clinical trials, regulatory strategy and regulatory interactions. Previously Rob worked at AstraZeneca and then for 19 years at the MHRA, during which time he served as CHMP member at EMA for 11 years and chaired the Scientific Advice Working Party at EMA. Rob has co-authored multiple regulatory guidance documents and continues to work on any and all aspects of evidence generation and regulatory policy in respect of medicine’s development.

Dr. Wolfgang Kothny is a physician who did his clinical training in the department of cardiology at the University Munich before joining the industry in 1999. Wolfgang joined Novartis in 2007 and currently is holds the Position of Global Head Clinical Sciences. Before that, he was Therapeutic Area Head for diabetes/metabolism.