Global Benefit-Risk Leader, Eli Lilly
Becky Noel is the Global Lead of the Benefit-Risk Assessment group at Eli Lilly and Company, where she and her team are responsible for providing benefit-risk assessment support across the Lilly portfolio. Since 2005, Becky has been extensively involved in developing and promoting systematic methods for benefit-risk assessment, both internally at Lilly and externally via the PhRMA Benefit-Risk Action Team (BRAT), the PhRMA Benefit-Risk Global Convergence issues team, the Center for Innovation in Regulatory Science (CIRS) Benefit-Risk Task Force, and the Innovative Medicines Initiative work stream devoted to benefit-risk assessment and the IMI project focused on the use of patient preferences. Along with other Lilly colleagues, Becky also recently edited and contributed to the book, Benefit-Risk Assessment in Pharmaceutical Research and Development. Becky was a instrumental participant in the International Council on Harmonization (ICH) M4E(R2) effort, significantly contributing to the updated presentation of benefit-risk information in the clinical overview.
Pharmaceutical industry and regulators use decision analysis within their organizations to support complex benefit risk decision-making. Systematic use of quantitative benefit risk assessment is possible in future interactions between these stakeholders. Regulators are exploring ways in which quantitative decision analysis approaches, methods and tools can be used to inform benefit risk assessment and decision making […]