Donald Very, Ph.D.

With over thirty years of diagnostic and pharmaceutical assay development and performance qualification experience in such diverse clinical areas as oncology, infectious disease, and metabolic disease, Dr. Very has extensive experience in all phases of diagnostic assay research and device development, performance validation, clinical trial design and implementation, and regulatory approval.

Dr. Very is currently serving as the Interim Director of the M.S. Degree Program in Biotechnology for Duquesne University. Additionally, he is President, CEO, and Founder of Naviter Bioanalytics, LLC, a global science and technology development firm specializing in technological due diligence, bioanalytical method development, performance qualification, and regulatory approval of diagnostics and medical devices. Previously, Dr. Very served as Vice President, Scientific Strategy, Technology and Research at Helomics Corporation where he was responsible for the identification, evaluation, and implementation of new technologies, assay platforms, and tests to augment the company's clinical laboratory, comprehensive tumor profiling platform, and contract research offerings. Prior to Helomics, he was Vice President of Research and Assay Development for Ancera, Inc., where he successfully led efforts to develop quantitative cell, nucleic acid, and protein assays for the company's proprietary, magnetic fluid-based, diagnostic platform; and Vice President of Immunology and Assay Development for the Institute for Bioanalytics, LLC (IBA), where he was responsible for the overall scientific, operational, and research activities of the Institute. At IBA, he successfully built a profitable contract research business. Under his leadership, IBA completed over 200 cell, nucleic acid or antibody-based assay development and performance qualification projects in support of the research programs of clients in the pharmaceutical, diagnostic, and biotechnology industries. Dr. Very also served as a Senior Research Scientist for the Diagnostics Division of Bayer Corporation, where he was responsible for the design and execution of clinical trials, performance validation studies for the AFP, CA 125 II, and CA 15-3 tumor marker assays for the Bayer Immuno 1^TM Immunoanalyzer, and the preparation and submission of 510(k) applications to the FDA for these assays. These activities culminated in the FDA's approval of all these assays for use in the U.S. Dr. Very began his career as a researcher and supervisor of the BL-2 and BL-3 laboratories affiliated with the U.S. Army Medical Research Unit in the Republic of Korea. Managing a staff of six scientists, his team conducted clinical and diagnostic research on hantaviral and rickettsial diseases endogenous to the Korean peninsula.

Dr. Very is a frequently invited speaker at national and international scientific symposia discussing topics ranging from advances in personalized medicine in oncology, the clinical utility of serum biomarkers in the diagnosis and management of disease, the development and performance qualification of multiplexed immunoassays, and the future of the in vitro diagnostic industry. He received his Bachelor of Science degree in Biology from the University of Notre Dame, a Master of Science degree in Biology from the University of Texas at San Antonio, and a Doctorate in Microbiology/Immunology from Boston University.

• Ph.D., Microbiology/Immunology, Boston University
• M.S., Biology, University of Texas at San Antonio
• B.S, Biology, University of Notre Dame