"I enjoy reducing seemingly complex issues to simple clear concepts that enable strategic clarity and efficient decision-making, and I love to tell stories about how we developed new analytical tools and understanding to enable the licensing of important new therapies."
After earning a Bachelor’s degree in Biochemistry from UC-Berkeley, I worked in the protein chemistry labs at the Gladstone Institutes in SF and then at Cetus (a biotech company) in Emeryville. In 1984, I joined Genentech’s nascent Analytical Chemistry group in process development, initially in molecular characterization roles for development products. I was promoted to Scientist in 1992, and then Senior Scientist in 1997, largely based on original studies that identified unexpected and often novel protein modifications and variants, which also led to the good-natured “Dr. Doom” honorific awarded to me by project team colleagues.
I was the global Xolair Genentech/Novartis CMC team leader from Phase II through the initial licensing stage, and led a Development Sciences team that brought in an external product. I was the head of PTD analytical development and QC functions from 2004 to 2014, during which we developed our successful ongoing strategies for comparability assessments, clinical specifications, critical quality attribute identification, and Quality by Design commercial control strategies. I was also the ad interim head of Roche’s global PTD-Quality function (2014 to 2015).
During my early career, I identified a number of unexpected protein variants and post-translational modifications, including norleucine misincorporation, deamidation and isomerization sites, mAb heavy chain hinge cleavage and C-terminal lysine processing, O-fucosyl modifications of EGF domains, and sequence variants due to mutations in the transfected genes. I later focused on mAb structural characterization to identify sources of variation that could affect bioactivity or pharmacokinetics. These characterization studies supported our regulatory strategies by giving the Health Authorities confidence in our analytical capabilities.
I have been in analytical development leadership positions for the past decade, developing strategies for molecular characterization and product specifications, for assessing product comparability after process and manufacturing site changes, and for assigning Critical Quality Attributes to guide specification (control strategy) decisions. I am now focusing on reviews of license applications and technical development strategies, and I’m teaching our newer scientists how to use analytical information for product development and licensing.