Head of Benefit-Risk Evaluation
Sanofi, France
Stephanie Tcherny-Lessenot, MD, MSc, MPH, Head of BR evaluation at Sanofi
Stéphanie, public health physician, has over 20 years of experience working in pharma companies on Pharmacoepidemiology and benefit-risk evaluation to support market access, pricing, benefit-risk and safety evaluation. After her appointments at Eli Lilly, she joined Global Pharmacovigilance & Epidemiology department at Sanofi in 2010 as a Global Pharmacoepidemiologist, and then moved to new roles of Pharmacoepidemiology Lead and Head of Benefit-Risk evaluation. Among other activities, she supported registration of Multiple Sclerosis and rare diseases drugs and post-marketing referrals for CNS drugs. Stephanie is one of the leading experts in the qualitative and quantitative benefit-risk field and has conducted many benefit-risk analyses for development and marketed drugs for over 13 years. Stephanie has also been active in different public-private partnerships, not only in the field of BR evaluation, but also in Real World Data, Epidemiology and Signal Detection: big data initiatives to develop the methods for web-based signal detection and several IMI (European Innovative Medicine Initiative) projects, including PROTECT for improvement of pharmacoepidemiology methods, WEB-RADR for signal detection methods using social media, PREFER on patients preferences and ConcePTION for safety of drugs in pregnant women. As part of her involvement of CIOMS working group XII on Benefit-Risk balance for medicinal products she is leading the parts related to role of patient in structured benefit-risk and methodological considerations for collection of patient insights. She is now leading patient-centric benefit-risk approaches and contributes to implementation of patient preference studies to support drug development.