ONCOLOGY & SCIENTIFIC/EXECUTIVE LEADERSHIP & RESEARCH
- 35+ years in diagnostics and pharma scientific clinical research and executive leadership in Oncology, Immunology, and Infectious Diseases; integration of Dx biomarkers into pharma clinical trials; and translational cancer research.
Chief Scientific Officer, C-Suite Executive/Diagnostic and Pharma Management, Biomarkers/Companion Dx, Liquid Biopsy Tests, Clinical Trials, Regulatory/FDA Submissions, Assay Development, Molecular Biology, Virology, Business Development, and Commercialization Strategies.
Therapeutic Areas of Expertise: Biomarkers, Biotechnology, Oncology, and Tumor Immunology, including analysis of tissue and circulating immune cells, such as T cells, B cells, macrophages, etc.; analysis of the tumor micro-environment with IHC, RNA scope, and RNA seq technologies; analysis of circulating immune cells by flow cytometry and technologies, such as offered by Nanostring, etc. Development and validation of PK and ADA assays for therapeutic products.
PhD in Medical Microbiology from Thomas Jefferson Medical School, and Harvard Fellow at MGG for four years. Authored 300+ peer-reviewed abstracts and full-length publications. Discovered and patented the circulating extracellular domain for HER-2, and led Bayer Dx /Oncogene Science team to develop the HER-2 blood test into an automated IVD cleared test.
Consultant, Various Start-up Therapeutics Companies
Planned, designed, and managed preclinical studies with small, start-up biotechs utilizing DNA seq, RNA seq, traditional and multiplex IHC, FISH, qPCR, flow cytometry, cell-free DNA, and circulating microRNA. Designed, oversaw, and managed studies usually outsourced to CROs. As acting CSO, responsible for biomarker development and selection of a companion diagnostic to select patients, and evaluation of IVD companies to develop a companion diagnostic. Led efforts to develop immuno-oncology studies to determine if immune cells (T cells, macrophages, and technologies to identify these cells ) contribute to the response of patients treated with various drugs. These studies used FFPE sections with technologies such as DNA seq, IHC, RNA scope, and RNA seq. Partnered with CMO to apply knowledge from preclinical studies to identify patients for clinical trials. Efforts resulted in posters presentations at immuno-oncology meetings, such as STIC.
President, Oncogene Science, a division of Bayer/Siemens Healthcare Diagnostics
Managed all aspects of the merged Oncogene Science Business, Scientific, and Manufacturing Operations into Bayer, and then into Siemens Healthcare Dx, including the discovery of proprietary monoclonal antibodies, development of oncology ELISA tests, and GMP/ISO manufacturing. Focused on linking soluble biomarkers with targeted oncology therapies as potential companion diagnostic for HER-2 targeted therapies. Tests were intended for patient selection, predicting therapy outcome, or monitoring therapeutic efficacy. The serum HER-2 test is a real-time biomarker test to monitor response or lack of response of HER-2 positive breast cancer tumors to HER-2 specific therapies.
Chief Scientific Officer, Wilex, Inc. (formerly Oncogene Science)
Responsible for all internal and external activities, including scientific networking, business development, sales and marketing/customer service, international distribution, regulatory, FDA submissions, and overall Quality Management System. Established the scientific and business strategic direction. Provided scientific and business leadership to develop companion diagnostics, including biomarkers for HER-2, CAIX, and uPA. Integrated the serum HER-2 test into pharma clinical trials as a companion Dx for HER-2 targeted therapies. Led the Oncogene Science team that developed a CAIX IHC IVD and a CE MARK CAIX ELISA test as potential Dx for the CAIX-targeted drug, Rencarex, a MAb-based drug that targets the CAIX surface antigen, which is highly expressed in renal cell carcinoma.
Chief Scientific Officer and CEO, On-Q-ity
Oversaw two separate technologies in this cancer diagnostics company: an immunohistochemistry (IHC) program that developed a panel of DNA repair enzyme biomarkers to predict response to drug therapies, and a program focused on the capture and characterization of circulating tumor cells (CTC) from blood samples. Developed a unique and proprietary CTC platform based on physical size and affinity capture, used in head/neck and prostate cancer.