Helene Gazzano-Santoro, PhD Genentech, Inc.

Hélène Gazzano-Santoro is Director of Analytical Development & Quality Control heading a bioassay group with primary responsibilities in the development and validation of all in vitro biological methods that are used in the QC control systems of Genentech clinical and commercial products. The group also supports product release/stability testing for the biological assays of all clinical products, potency testing for process development and method transfer.

Hélène has over 25 years of academic and industrial experience in the Life Sciences. Prior to joining Genentech in 1995, she worked as a Research Scientist at Xoma Corporation and at Stanford University School of Medicine. She completed her Ph.D. in Cellular and Molecular Pharmacology at the School of Medicine, in Nice University (France). Hélène has authored/co-authored 48 peer-reviewed scientific publications with Universities, FDA & Industry sponsors, 2 patents and has given over 35 presentations at national/international scientific conferences as keynote/invited speaker or session chair.

She is currently member of the program committee of the CASSS & FDA sponsored “Bioassays: Scientific Approaches & Regulatory Strategies” conference, member of the Planning Committee for the USP Bioassay Workshop. She is also serving as an USP expert volunteer member of the 2010-2015 Monographs - Biologics and Biotechnology 1 Expert Committee.