Barbara is a highly experienced internist, endocrinologist, and pharmaceutical executive, having led numerous global safety programs for product approvals with FDA and EMA. She has 25 years of experience guiding teams in pharmacovigilance, clinical development, and Benefit Risk Management.

Approach

Barbara’s approach to analyzing and conveying data is to understand the strengths and limitations of the data in the context of patient need, disease state, and the competitive landscape. She proactively identifies and communicates issues and gaps to achieve transparency and credibility.

Background

Barbara’s experience spans the product lifecycle. She has led Phase 1 through 4 studies, led the safety program for global product approvals including with FDA and EMA, was the company representative for the HAART Oversight Committee, worked with the CIOMS XII working group, led the development of structured benefit-risk assessments for global product submissions, and oversaw development of global risk-minimization programs. Barbara also taught medical and pharmacy students about pharmacovigilance and risk management at Northwestern Memorial Hospital.

Barbara obtained her MD from McGill University in Montreal, Canada, and completed a specialty in general internal medicine with a sub-specialty in Endocrinology and Metabolism at the University of Toronto. She conducted basic science research at Beth Israel Deaconess Hospital in Boston and clinical work at Northwestern Memorial Hospital in Chicago while continuing basic science research in obesity. Barbara has authored numerous publications ranging from HIV and HCV development programs and endocrine complications of HIV therapy to innovative approaches to benefit-risk management, including a digital concept tool.

Special Interests

Barbara enjoys spending time with her husband and two Labradoodles. She loves walking and running nature trials, reading, playing piano, cooking, and travelling the world. Barbara is an author, writing children’s books based on her dogs.