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Valerie Quarmby Staff Scientist and Director, BioAnalytical Sciences at Genentech, A member of the Roche Group, USA


Valerie Quarmby, Ph.D. is an industry thought leader with 25 years of
experience in biotherapeutic development.
In her role as Staff Scientist in the Department of BioAnalytical Sciences at
Genentech, Valerie provides strategic and technical guidance to the Core
Biophysical Characterization & Reagent Facility (CBCRF), and the
Department of BioAnalytical Sciences (BAS). Valerie works at the
intersection between biotherapeutic product and process development,
providing guidance and scientific direction to governance committees and
project teams working on Genentech programs from Early Development
through post-­‐approval. Valerie also participates in due diligence reviews of
business development opportunities and has extensive experience with
Health Authority interactions.
Valerie has overseen and participated in development strategies for first
product approvals and/or line extensions for: Nutropin, Xolair, Raptiva,
Rituxan, Avastin, Lucentis, Herceptin, Perjeta, Kadcyla, Ocrevus and
Tecentriq. Valerie has created bioanalytical platforms and strategies for
therapeutic proteins currently in the gRED drug development pipeline, and
she has also participated in more than 40 IND/CTD regulatory filings.
Valerie is past Chair of the AAPS Therapeutic Protein Immunogenicity Focus
Group and was a member of the 2010-­‐2015 USP Immunogenicity Testing
Expert Panel. Valerie has published more than 60 publications in peer-­‐
reviewed journals and has co-­‐authored several AAPS sponsored industry
guidance documents.
In 2014, in recognition of her many contributions to the pharmaceutical
industry, Dr. Quarmby was selected to be an AAPS Fellow.

Agenda Sessions