Speakers
Rebecca Noel, DrPH, MPH
Executive Director, Benefit-Risk Assessment, Eli Lilly, United States
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.
Telba Irony, PhD, MS, MSc
Senior Scientific Director, Quantitative Sciences, Janssen R&D, United States
Telba is Senior Scientific Director in Quantitative Sciences at Janssen R&D. She comes from FDA where she pioneered the use of Bayesian statistics and wrote several guidance documents. She received the FDA Excellence in Analytical Science Achievement Award for spearheading innovative regulatory science studies culminating in the release of novel guidance documents, supporting complex policy decision making and changing the submission review paradigm. Recently at the Center for Biologics, her portfolio expanded to include the Science of Patient Input, Complex Innovative Designs, and trials for rare diseases. She received a PhD from Berkeley, is fellow of the American Statistical Association and member of International Statistical Institute.
Robyn R. Lim, PhD
Senior Science Advisor, Health Products and Food Branch, Health Canada, Canada
Dr Lim’s focus is modernizing Canada’s federal drug regulatory system, developing the benefit-harm-uncertainty evidence standard for Canada’s amended Food and Drugs Act. Her interests are scientifically and socially-responsible patient-focussed and life-cycle approaches for therapeutic product development and decision-making. She assessed CNS drugs (TPD, HPFB, 1996-2006) and developed TPD’s Good Review Guiding Principles, receiving awards for regulatory assessment excellence and creativity/innovation. She holds a Ph.D. in Molecular Neurophysiology (Physiological Laboratory, Cambridge University, Trinity College, Cambridge, U.K), B.Sc.H. and M.Sc. in Biochemistry (Queen's University, Kingston, Ontario).
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