Our regulatory and industry experiences make us unique in solving your regulatory, endpoint, statistical and trial design challenges. Because we understand the challenges facing both industry and regulators, we help you anticipate regulatory hurdles and guide you to successful regulatory submissions.
For over 24 years, I worked as a biostatistician at the Center for Drugs and Evaluation Research at the US Food and Drug Administration (FDA) in roles that included Master Reviewer, Team Leader and Statistical Reviewer.
The first seven years were a career highlight. I supported the Division of Anti-viral drug products at the height of the AIDS and HIV epidemic when only 1 approved treatment (AZT) was on the market. Working together with industry, we pioneered new study designs and first in class treatments for HIV/AIDS and opportunistic infections with the aim to get new medicines to patients as quickly as possible. One of my projects was the prototype for the accelerated approval regulation. As FDA approved new products, placebo-controlled studies were no longer an option and new approaches were required. Thus began the onset of equivalence studies, now known as non-inferiority studies, for which I initiated the first working group.
While many may say working at the FDA qualifies them to be your consultant, here is what differentiates me.
CDER appointed me the prestigious role of Master Reviewer in recognition of my regulatory and statistical expertise, skills and contributions across numerous therapeutic areas and policy initiatives. Only a few reviewers achieved this status that required a rigorous application and review process.
From FDA, I went to industry where I held numerous roles at AstraZeneca. I used my statistical regulatory experience and addressed challenging regulatory questions, prepared teams for regulatory interactions, and reviewed and commented on regulatory submissions. I used my statistical expertise and knowledge of regulatory expectations to lead the development of a Missing Data Best Practices guideline and to write the Patient-reported Outcomes Guidance on the design and interpretation of studies that use PROs. I served as the global project statistician for AZ’s Alzheimer’s product.
In my last role I was Director, Information Sciences for Oncology and Immuno-oncology. My group provided scientific information to all late-stage development oncology and immuno-oncology project to enable quick and well-informed decisions.
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