Ron Schultheis, MS, MBA, has 18 years of project management experience encompassing multiple facets of the clinical commercialization process from early stage regulatory planning, business and market plan development an the execution of a full range of clinical operations capabilities. Mr. Schultheis has led numerous teams that successfully developed a wide array of clinical products and applications. While at UroCor, Inc., a successful start-up company subsequently purchased by Laboratory Corporation of America, Mr. Schultheis led product development teams to launch several diagnostic products for the management of bladder cancer, prostate cancer, and kidney disease. Mr. Schultheis also interfaced with the regulatory and manufacturing arms of a major therapeutic manufacturer for the launch of a biotherapeutic for the treatment of bladder cancer. In addition, while at UroCor he led the development team for a radiation therapy product for the treatment of prostate cancer. Mr. Schultheis has proven experience in development of product specifications, technology, and market evaluation. He was the leader of teams responsible for evaluating new product opportunities in the clinical pathology market while at UroCor, Inc and in the infectious disease market while at Meridian BioSciences. Mr. Schultheis started his career in clinical trials management with Kendle International and has consulted for several major pharmaceutical companies on Phase II-IV development. Most recently, Mr. Schultheis has served as Sr. Director, Clinical Operations for a medical device development firm conducting PMA enabling research for its medical device clients; and providing regulatory and development strategy planning for early stage diagnostic and biotherapeutic companies. Mr. Schultheis holds a Masters degree in the field of immunology and infectious disease. His product management and development experience includes oncology and infectious disease diagnostics, molecular diagnostics, cardiology, diabetes, and biotherapeutic and medical device applications for the treatment of urologic cancer. David Ralph, MBA, Ph.D., has more than two decades of project management and commercial development expertise in diagnostic product development, cancer biology, cancer genetics, infectious diseases and microbial ecology. He has overseen the successful development of numerous molecular assays for mutation detection, large scale genotyping of humans and identification of pathogens. Dr. Ralph has also been either the Principal Investigator or an integral member of teams that have commercialized ELISA, IHC and immunocytochemical assays for the clinical management of a wide array of cancers. In addition, Dr. Ralph has extensive experience writing invention disclosures and patent applications and evaluating intellectual property. He has served on NIH-NCI SBIR grant review committees evaluating the commercial feasibility of early-stage technologies. In addition, he has a successful track record of developing business and product development strategies for the attainment of extramural funding from private equity investors. Dr. Ralph received his Ph.D. in 1986 from The Ohio State University interdisciplinary program in molecular, cellular and developmental biology. Dr. Ralph completed postdoctoral training fellowships at the Columbia University medical school and at the Memorial Sloan-Kettering Cancer Center. He then worked at the California Institute for Biological Research (CIBR), a not for profit affiliate of Strategene Incorporated, where he help develop differential display PCR as a tool to examine differential gene expression. Also while at CIBR, Dr. Ralph pioneered early applications of PCR for the identification and discrimination of various pathogens. In 1994, Dr. Ralph joined UroCor as head of their gene discovery group and left Urocor in 2000 as their Director of Diagnostic Product Development. While at UroCor, Dr. Ralph acted as the lead scientist responsible for evaluation and/or clinical validation of new diagnostic products and in licensing opportunities. Since 2000, Dr. Ralph has acted as the Chief Scientific Officer for a biotechnology start up and has directed commercialization of molecular based products employing bioinformatics to aid clinicians in the management of patients with breast cancer and other complex diseases. Anne Davies, MS, Director of Clinical Operations, at IGBS has over twenty years experience in clinical operations. Most recently, she was the Assistant Director of Clinical Operations for Kendle International, Inc., the third largest pharmaceutical and medical device contract research organization on the globe. Ms. Davies routinely managed integrated study teams that included the departments of clinical statistics, medical writing, data management, clinical regulatory and clinical monitoring. Ms. Davies was responsible for daily interaction and management of study timelines, recruitment, and financial metrics for clients such as Pfizer, Inc., Merck, Aventis, Fournier Pharma, and the NCI.