Our regulatory and industry experience helps us solve regulatory, endpoint, statistical and trial design problems. Because we understand the concerns of both sponsors and regulators, we can help you anticipate regulatory hurdles and build successful submissions.
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For more than 24 years Lisa worked as a biostatistician at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration, as Master Reviewer, Team Leader and Statistical Reviewer. Early in her career she supported the Division of Anti-viral Drug Products during the HIV/AIDS epidemic, where her work included a prototype for the accelerated approval regulation and the launch of the first working group on non-inferiority studies.
Appointed by CDER in recognition of her regulatory and statistical expertise – a status reached by only a few reviewers.
After FDA, Lisa held several roles at AstraZeneca, answering regulatory questions and preparing teams for regulatory interactions, leading a missing data best practices guideline, writing the company’s guidance on studies that use patient-reported outcomes, and serving as global project statistician for its Alzheimer’s product.
Global project statistician for AstraZeneca’s Alzheimer’s product.