Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly. Since joining Lilly, Becky has been extensively involved in leading the development of systematic approaches to benefit-risk assessment, both internally at Lilly and externally via the PhRMA Benefit-Risk Action Team (BRAT), the Innovative Medicines Initiative PROTECT project, the International Conference on Harmonization, and via multiple other forums.

Bennett Levitan, MD-PhD is Executive Director, Global R&D Epidemiology at J&J. He introduced state of the art patient-focused benefit-risk (B-R) assessment to Janssen and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the PhRMA BRAT Framework, the MDIC Patient-Centered B-R Framework, the IMI PREFER public-private partnership and ISPOR's Quantitative B-R Task Force. He serves on committees that inform policy including the ICH Working Group on Patient Preference Studies, MDIC's Science of Patient Input Project and PhRMA's Patient-Focused Drug Development Work Group. He received a B.Sc. (Elec Eng) from Columbia Univ and an M.D.-Ph.D. (Bioengineering) from the Univ of PA.

Dr Shahrul Mt-Isa is a senior statistician at the School of Public Health, Imperial College London. He has a width of experience and interest in benefit-risk assessment, decision analysis, evidence synthesis and data visualisation, as applied in pharmaco/-epidemiology & clinical trials. He works on PROTECT Benefit-Risk project for the past 5 years. He co-led the BR assessment methodology, visual representation reviews, BR training and website development (http://www.protectbenefitrisk.eu/).