"As do many at Genentech, I have friends and family members whose lives have benefited from our products. This personal connection, plus understanding the clear impact of our work to improve healthcare, provides me a constant motivation to keep pushing forward."
I joined Genentech in 1987 and led the newly-formed mass spectrometry group in the Research organization. That year we acquired a four-sector mass spectrometer, at the time the most advanced instrument available and one of only a handful in the world. The instrument provided new abilities to study proteins and their post-translational modifications, and Genentech quickly became recognized in the mass spectrometry community. Our lab developed methods for peptide sequencing, phosphopeptide analysis, disulfide mapping, and other applications. Among our projects, we developed a method called Peptide Mass Fingerprinting, in which peptide masses from a protein digestion are searched against a protein sequence database in order to identify the protein. This methodology became the foundation for the burgeoning field of proteomics, and was recognized by the 2002 Distinguished Contribution in Mass Spectrometry Award from the American Society for Mass Spectrometry (shared with my collaborators W.Henzel and C.Watanabe). In 2002 I joined a start-up company to develop mass spectrometry-based diagnostic tests for early detection of cancer.
In 2006 I returned to Genentech to lead the Analytical Operations department in the Process Development organization (now Pharma Technical Development) where I initiated the use of highly automated methods. In 2007 I became a Director of Protein Analytical Chemistry. The department is responsible for physico-chemical method development, analytical characterization, critical quality attribute assessment, and analytical and control strategies for the clinical biologics pipeline. In 2017 I was appointed as Chair of the Analytical Review Committee, with oversight of specifications for all biologics in clinical development and at the time of commercial launch.
My research has led to 78 publications and book chapters, over 100 presentations at national and international conferences, and 6 issued US patents. I was Associate Editor of Molecular & Cellular Proteomics from 2008-2014.
My current role is Chair of the Analytical Review Committee in the Technical Development organization, with oversight of specifications for biologics in clinical development and at the time of commercial launch. Specifications are the analytical procedures and their acceptable ranges that ensure a safe and effective product. They are based on an understanding of each molecule’s attributes and their potential impact on activity, pharmacokinetics, immunogenicity, and safety – Critical Quality Attributes. My research interests include learning more about the biological impact of these attributes, for example, through in vitro and in vivo experiments to decipher how they change after administration to patients. I am also involved in continuing development of strategies for sequence variant analysis, comparability assessment, and control system justification.
In addition, my role provides many opportunities to guide and mentor scientists and team leaders.