Clinical Development: Online Certificate (Biotechnology): Faculty
Michelle Gray, M.H.S., has more than 18 years of research experience with devices, small molecules, and biologics. She has worked on US and international studies in all phases of trials for private and public organizations, and taught clinical trials classes at the university level. Michelle's focus has been on clinical operations and program management and has been part of several IND and NDA submissions. She is currently working with a small Bay Area biotech company. Michelle received her master's at John Hopkins University School of Public Health.
Michael Herrler, M.B.A., Ph.D., has more than 12 years of experience in product development and program management in the medical device and in-vitro diagnostics industries. He worked for Fortune 500 companies such as BD Biosciences, Amgen, Genentech, and Roche Diagnostics. He also had technical leadership and management roles at several start-up companies in the San Francisco Bay Area. Currently, he is managing Life Technologies' first companion diagnostics program in partnership with GlaxoSmithKline.
Michael has a Ph.D. in Biochemistry from University of Marburg, Germany, and an M.B.A. with focus on Technology & Innovation Management from University of Maastricht, The Netherlands. He is certified as Project Management Professional (PMP) and New Product Development Professional (NPDP).
Peter Shabe, M.S., is President of Advance Research Associates, Inc., a contract research organization (CRO) providing data management and biostatistical services to medical device, biotech and pharmaceutical industries. Prior to starting ARA, he worked as a biostatistician for several pharmaceutical and CRO companies and taught statistics courses at several universities.
Bethany Van Veen has been involved in drug safety and pharmacovigilance (PV) within the pharmaceutical industry for more than 15 years including 13 years in PV management and leadership in both large and small companies. She recently began a consulting business providing strategic PV advice to Bay Area pharmaceutical companies. Prior to this, Bethany was the Sr. Director of Safety Operations with the Drug Safety Risk Management team at InterMune, Inc. where she was responsible for drug safety case management, vendor and global affiliate management, quality management, and drug safety informatics.
Susan Wade has extensive experience in Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) including more than twenty-five years of industrial training in the areas of Quality Assurance, Quality Control, and product development for manufacturers of pharmaceuticals and medical devices. Susan has global experience with auditing, validation, analytical and bioanalytical assay development, as well as development of policies and systems for ISO, QSR, cGMP, and GLP compliance. Susan has worked as an independent consultant to industry since 2000. Susan has a B.A. degree in Biochemistry from California State University, Hayward.