Ensigna Biosystems was founded in March 2014 with a unique blend of expertise, enabling the development of targeted therapies and the implementation of personalized medicine. We are a Contract Research Organization dedicated to providing outstanding service to the biopharmaceutical industry. In addition, we seek active collaborations with academic and industrial partners to develop new and innovative molecular diagnostics.
The company occupies 7,300 sq ft of lab and office space at Gate510 in San Leandro, California and is fully equipped for histopathology, molecular biology and tissue culture.
Management Team
Michel Faure
Founder, President, and CEO
Dr. Faure received his Ph.D. in Molecular Biology from Université Paris-Sud, Orsay (France) and did a postdoc at Columbia University. He then took a position at the CNRS in France and afterwards returned to the US for a second postdoc at UCSF. There Dr. Faure worked in Professor Henry Bourne’s lab, where he made several key contributions to the understanding of the cross-talk between GPCRs and the MAPK pathway. He then joined SUGEN, a pioneer in the field of kinase inhibitors, where he led several early drug discovery projects in oncology. He later joined Chiron/Novartis in Emeryville where his responsibilities included defining and implementing biomarker and patient stratification strategies for oncology drug discovery projects. He also managed several outside collaborations, including the procurement and validation of tool antibodies. Dr. Faure brings more than twenty years of biopharmaceutical research experience in oncology drug discovery. He founded Ensigna Biosystems, Inc. in March 2014 because he understands how the most advanced molecular pathology techniques are essential to the development of targeted therapies and the implementation of personalized medicine.
Yu-Chien Chou
Co-founder and Vice President
Dr. Chou has over 15 years of hands-on research experience in preclinical pharmacology, translational oncology and biomarker strategies for therapeutic drug discovery. Prior to joining Ensigna Biosystems, she led teams at Exelixis responsible for in vivo characterization of developmental compounds for numerous oncology and metabolic disease programs. She also worked as an oncology scientist in Experimental Pathology/Translational Sciences at Novartis. She has held positions at the Lawrence Berkeley National Laboratory and UC Berkeley, making significant contributions to the understanding of mammary carcinogenesis. Her sphere of expertise includes PK/PD/efficacy, tissue-based biomarker analysis supporting lead optimization, translational research and IND filings, immunohistochemistry and antibody validation. Dr. Chou received her Ph.D. (Endocrinology and Cancer Biology) from UC Berkeley and a B.S. degree (Biology) from Yokohama City University, Japan. In her role as Vice President, Dr. Chou is managing our histopathology facility and building our histology team, using automated immunohistochemistry technologies to aid in antibody validation and biomarker strategy.
Isto Leinonen
Project Manager
Mr. Leinonen has an M.Sc. degree in Molecular Biotechnology and Diagnostics from the University of Turku, Finland and more than 10 years of research and development experience in the biotechnology industry. Prior to joining Ensigna Biosystems he worked as a Scientist and Project Manager at Leica Biosystems Amsterdam, the Netherlands. He led multiple FISH projects from early feasibility to launch, resulting in product registrations both in Europe and in the US. At Ensigna Biosystems, Isto is responsible for project management.
Robert Ertsey
Sr. Manager, Lab Operations
Mr. Ertsey has extensive hands-on experience in translational biomedical research in the areas of oncology and pulmonary disease. His expertise spans the range of the drug discovery process, including in vitro and in vivo preclinical research, method development and clinical trial specimen analysis. He has made key research contributions to drug and diagnostic candidates that are currently in Phase I-III clinical trials or have advanced to standard-of-care after FDA approval. Prior to joining Ensigna Biosystems he held research and lab management positions at Stanford University in the Cancer Research Institute and Wall Center for Cardiopulmonary Disease. He also worked in basic and translational research at UCSF in the Cardiovascular Research Institute. Mr. Ertsey received his B.A. in Biochemistry from UC Berkeley and M.Sc. in Genetics from UC Santa Barbara.
Consultants
Ensigna Biosystems uses a network of experienced consultant pathologists to perform discovery and toxicologic pathology.
Jita De
Pathologist
Dr. Jitakshi De has been a pathology consultant for Ensigna Biosystems since 2017. She is also the founder of KromePath, a consulting company, as well as a Fellow of the American Society of Clinical Pathology, the College of American Pathologists, and a member of pathology, hematology, and cytometry professional societies.
She received her M.D. from Duke University, completed pathology residency at the UTHSC of Houston and her fellowship in Hematopathology at The University of Michigan. Her research interests include target-specific peptide discovery from a combinatorial peptide library, prognostic factors and phenotypic-genotypic correlations in acute and chronic leukemia, and immunocytochemical analysis of purified hematopoietic stem cells. She also has applied novel algorithms for statistical pattern recognition to identify and characterize leukemic stem/progenitor cells through high dimensional cytometry analysis of cell signaling pathways.
She has more than 8 years of experience in pathology practice in hospital and commercial laboratory settings. She brings a deep mechanistic understanding of assay development and validation of novel biomarkers in oncology and in autoimmune, infectious, and metabolic disorders.
BIO|OPTIONS
Preferred Tissue Provider
BIO|OPTIONS provides human tissues and biological materials to researchers and scientists for molecular and genomicc research. We have been working with them for the past several years and have been extremely satisfied with the quality and the pricing of their tissues.
BIO|OPTIONS is physician owned and operated. They understand the needs of research scientists and how to procure the best biospecimens to ensure experimental success. They possess extensive experience in sample collection ensuring that proper protocols are followed, correct consents obtained and samples comprehensively annotated.