Expert Details

Expert in Molecular Oncology, Cervical Cancer, Breast Cancer, Immunohistochemistry, Diagnostics, and Pathology

Expert ID: 723655 Illinois, USA

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Expert trained as a classical molecular biologist using viral model systems to examine regulation of gene expression and DNA replication in bacterial and animal viruses. His post-doctoral work focused upon regulation and malignant transformation caused by human papovaviruses and adenoviruses. This research led to identification and characterization the p53 cellular oncogene, which plays a central role in many human cancers. Subsequently, as an independent investigator, Expert’s laboratory made the key observation that led to the recognition of the role of the p53 protein as the “guardian of the cellular genome” in normal, non-cancerous cells.

His major interest throughout his career has been in molecular oncology, specifically in the area of molecular diagnostics, where he has applied traditional and innovative techniques to the task of identifying and characterizing specific tumors and other cellular abnormalities. The approaches he has developed to achieve these goals include solid phase immunoassays, in situ hybridization, immunohistochemistry, immunofluorescence, PCR, and isothermal DNA amplification techniques.

A major focus of Expert’s attention has been means to identify women who are at risk for the development of invasive cervical cancers. In large part this has focused on approaches that add specificity to existing methods such as the Pap smear test for cellular abnormalities or tests for the human papillomavirus (HPV) genetic material. The assays he has developed have targeted the changes in gene expression that are hallmarks of cervical cells that have made the transition to precancerous growth, and are on their way to becoming tumors.

Expert has experience in both basic cancer research and its application in clinical practice. A major part of his career has been devoted to applying basic insights into oncogenesis and neoplastic progression to the understanding of cells and tissues submitted as patient samples to clinical diagnostics laboratories. He has lead efforts to apply and automate methods for the analysis of biopsies by using molecular and immunological probes to add information beyond that obtained from standard histopathology.

Most recently Expert has concentrated upon applying insights from genomics and proteomics to cell- and tissue-based screening and diagnostics assays. He has worked to develop algorithms that support the use of new forms of cancer chemotherapy, notably targeted therapies, for specific tumors. He has particular expertise and interest in the interface between diagnostics and treatment, often called theranostics or personalized medicine, as it applies to breast cancer, where the emergence of new treatments are having a great impact upon patient management. Similarly, through the application of integrated analysis of multiple parameters, systems biology, he developed a unique approach to cervical cancer screening that may supplant the Pap test as the standard of care in the United States, while serving as a point-of-care (POC) test in developing and otherwise under served markets.

Array

Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois - Rockford, Illinois - Aurora, Illinois - Naperville, Illinois - Joliet, Illinois - Elgin, Illinois - South Bend, Indiana - Gary, Indiana - Milwaukee, Wisconsin - Madison, Wisconsin

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Education

Year Degree Subject Institution
Year: 1977 Degree: PhD Subject: Molecular Biology Institution: University of California at Berkeley
Year: 1971 Degree: BA Subject: Biology Institution: University of California at Santa Barbara

Work History

Years Employer Title Department Responsibilities
Years: 2005 to 2006 Employer: Diamics, Inc. Title: Senior VP, R&D; Chief Scientific Officer Department: Responsibilities: • Founding scientist who led intramural and extramural research and development efforts of the company’s novel approach to cervical cancer screening, the C-MAP system.
• Developed strategic partnerships leveraging company’s intellectual properties, licenses, and developed products.
• Coordinated clinical trials of the C-MAP system and its components.
Years: 2003 to 2005 Employer: Molecular Diagnostics, Inc (Currently CytoCore) Title: VP, Molecular Technology Department: Responsibilities: • Chief scientist responsible for bringing the company’s slide based test platform for cervical cancer screening to clinical trial and PMA preparation.
• Responsible for scientific and strategic direction of project, and positioning for future development of the platform beyond cervical cytology and the domestic market.
Years: 2002 to 2003 Employer: Quantitative Diagnostics Laboratory (currently Targeted Molecular Diagnostics) Title: Director, R&D Department: Responsibilities: • Responsible for the development and implementation of cell and tissue based assays for use by pharmaceutical and biotechnology organizations involved in pre-clinical and Phase I through Phase III studies in new drug development.
• Responsible for the implementation of Quality Assurance Program for QDL’s pharmaceutical and reference laboratory work, and the transitioning of protocols to Ventana Medical Systems (parent company of QDL) for use in routine automated diagnostic and prognostic assays.
• Developed diagnostic algorithms for the categorization of breast cancer samples for patient treatment.
Years: 2001 to 2002 Employer: Self Title: Freelance medical writer and consultant Department: Responsibilities:
Years: 1998 to 2000 Employer: Molecular Staging Inc. Title: Director, Molecular Pathology Department: Responsibilities: • Established, equipped, and staffed laboratory.
• Initiated program to use of proprietary DNA amplification technology (RCAT), based upon rolling circle replication, for the sensitive and specific detection of nucleic acid and protein targets in cells and tissues.
• Directed research and development effort that reduced to practice the use of RCAT for flow cytometry on dispersed cells, and immunocytochemistry and in situ hybridization as applied to routinely fixed tissue specimens.
Years: 1991 to 1997 Employer: Quest Diagnostics, Inc. Title: Technical Director & Senior Research Scientict Department: Molecular Tissue Pathology/ Anatomic Pathology Responsibilities: • Managed the day-to-day operation of the production laboratory and directed the development of new diagnostic assays using immunohistochemistry and in situ hybridization.
• Directed research focusing upon cancer antigens with emphasis upon the molecular biology of breast, cervical, and prostate cancers.
• Developed PCR-based methods for detection of human papillomaviruses and clinically relevant gene rearrangements.
Years: 1986 to 1990 Employer: Enzo Biochem Title: Director of Technology Development Department: Responsibilities: Managed the development from feasibility through assay formatting, of tests for human immunodeficiency virus, human papillomaviruses, and other pathogens. These assays involved a variety of approaches including traditional dot blot and in situ hybridization analyses as well as nonradioactive oligonucleotide sandwich assays for pathogens and PCR-amplified genomic and viral nucleic acids. Responsible for the development of rapid nucleic acid-based diagnostic tests (in situ and soluble) for viral pathogens under federal contracts (DOD and NIH) and as clinical assays for commercial distribution.
Years: 1980 to 1986 Employer: Rutgers University Title: Assitant Professor Department: Biological Sciences/ Waksman Institute Responsibilities: Conducted grant-funded research directed toward understanding the molecular basis of neoplastic processes employing tumor viruses as model systems. Made initial observation of role of p53 oncoprotein in normal cellular growth. Lectured at the graduate and undergraduate levels, and supervised the research of B.A., M.A., and Ph.D. students.

Additional Experience

Training / Seminars
He has organized several symposiums concerned with the nature and treatment of cancer.
Vendor Selection
A chief scientist for a variety of established and start-up biomedical ventures he has been responsible for sourcing supplies and reagents, negotiating licensing agreements, and material transfer agreements
Other Relevant Experience
He has served as a medical writer preparing white papers and lay abstracts for the Leukemia Lymphoma Society.
He has extensive experience in the preparation of investors presentations for funding of several start-up ventures

Fields of Expertise

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