22 Jun HER2 testing: correlating analytic sensitivity to patient test results
Collaborator(s): NordiQC
Status: Open
Regulatory Advisor
Dr. Radcliffe (Radcliffe Consulting, Inc.) has more than 20 years of experience assisting medical device and diagnostics companies with technical assessment, marketing, and clinical/regulatory issues. Gail was awarded her PhD in Molecular Biology from Brown University and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. Afterward, she worked at GENE-TRAK and then Cytyc, until 1998, when she founded Radcliffe Consulting, Inc. Dr. Radcliffe consults with medical device companies, for market research, regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development, and clinical trial support. Her experience includes a wide range of products in digital pathology, laser dissection devices, companion diagnostics, and multiplex molecular, POC and CLIA Waived in vitro diagnostic devices.
President
Dr. Bogen is a Board-Certified Clinical Pathologist, having graduated from the University of Chicago Pritzker School of Medicine (M.D.) and the Weizman Institute of Science (Ph.D.), with a post-graduate residency and research fellowship at the Brigham and Women’s Hospital. He is Adjunct Professor of Pathology and Laboratory Medicine at Tufts University School of Medicine and Medical Director, Clinical Chemistry Laboratory (part-time) at Tufts Medical Center. Dr. Bogen is an inventor on 22 patents, all of which relate to various medical diagnostic technologies. In addition, he served for a decade on several NIH grant review committees, mainly for the Innovative Molecular Analysis of Cancer Technologies program sponsored by the National Cancer Institute. Dr. Bogen was previously the founder of CytoLogix Corporation, which developed the Artisan® instrument system for automated complex histopathology stains (now sold and supported by Agilent Corporation).
Vice President and Co-Founder, Manufacturing
Ms. Vani is a co-founder of BCS. She has over 20 years of laboratory experience in biochemistry, molecular biology, and histology. Vani has operational responsibilities for BCS’s cGMP manufacturing processes and document control system in compliance with policies and SOPs. After receiving a Masters degree in Chemistry, she initially worked in Drosophila genetics, gaining experience in the field of molecular biology at Columbia University, New York NY. She later joined the R&D at CytoLogix Corp., Cambridge MA. She is a co-author on numerous peer-reviewed journal articles.
Vice President, Commercial Operations
Scott brings 20 years of experience in the immunohistochemistry and molecular diagnostic branches of the Pathology Laboratory. Scott began his career with other members of the Boston Cell Standards team at Cytologix, and then went on to work at Dako and as an original member of the Vision Biosystems North American team, later acquired by Leica (Danaher). Scott has worked for several VC-backed start-up companies in the molecular diagnostics space, and most recently was Global Vice President of Sales, Service, and Field Support at Biocare Medical. Scott received a BS in Chemistry and a BA in English/Journalism from the University of Delaware.
Vice President, Research & Development
Dr. Sompuram is Co-Founder, Co-Inventor, and Vice President of R&D at BCS. He is also an Adjunct Assistant Professor of Pathology and Laboratory Medicine at Boston University School of Medicine. He received his PhD and trained as a Post-Doctoral Fellow at Boston University School of Medicine (Pathology/Immunology). Previously, he was Research Manager at Cytologix Corp. in Cambridge, MA. He co-developed the proprietary microscope slide coating technology and leads the cancer biomarker epitope mapping program. Dr. Sompuram is an inventor with five patents and has co-authored numerous publications and textbooks. He has over three decades of expertise in molecular biology, antibody engineering, and phage-display technologies (both antibody and peptide phage display). During his Post-Doctoral training, he was involved in developing cancer therapeutic polyclonal phage antibodies, which were eventually commercialized. Dr. Sompuram led the Boston Cell Standards team’s efforts in developing and applying these technologies in the area of cancer detection and diagnosis and serves as the company’s Clinical Study Monitor and Coordinator.
Scientific / Managerial Consultant
Dr. Zeheb brings to BCS a 25-year track record of successfully developing and launching medical diagnostic products. He received his PhD in biochemistry from the Albert Einstein College of Medicine of Yeshiva University. At Oncogene Science, Inc., he initiated and developed a new product line of quantitative immunoassays resulting in the commercialization of the company’s first ELISA kits. As Director of R&D for Ventana Medical Systems, he led the team that developed the first instrument for automating in situ hybridization assays. He was the founding Vice President of Research at CytoLogix Corporation, where he directed the development of the Artisan® staining platform and associated staining kits for both immunohistochemical and special stains applications. Dr. Zeheb was Senior Vice President of Research and Development at Dako Corporation (US) and the Director of Molecular and Immunohistochemical Laboratories in the Department of Anatomic Pathology of the Lahey Clinic. He has authored numerous publications and patents and been the recipient of NIH and private research grants.
Scientific / Managerial Consultant
Dr. Tachovsky has held executive positions in both private and publicly-traded companies. Most recently, Tom served as Technology Licensing Officer at the Massachusetts Institute of Technology. His portfolio included medical devices and research tools. During his tenure at M.I.T., he was responsible for over 1000 invention disclosures from M.I.T. inventors including filing and prosecution of intellectual property, negotiating IP terms with sponsors and authoring over 100 license agreements. Tom received a Ph.D. in microbiology from the University of Rochester Medical School, an M.S. in management from Leslie University and B.S. in biology from Gonzaga University.