Bob Wolfert Email & Phone Number

Memphis, Tennessee

The Hartwell Foundation is a philanthropic organization that seeks to inspire innovation and achievement by offering individual researchers an opportunity to fulfill their scientific goals. Through a unique funding process, we provide financial support to stimulate discovery in early-stage biomedical research that has not qualified for funding from traditional sources and that has the potential to benefit children of the United States. Our approach is to be selective, thorough, and accountable. We want the research to make a difference in the lives of children and their families.

Raleigh-Durham, North Carolina Area

Consulting services in the areas of Diagnostics Research and Development, Clinical trials, FDA submissions, Key Opinion Leader development.

Chantilly, Va

Scientific and management lead for all research and development activities, including Software Engineering, Hardware/Electrical Engineering, and Assay Development teams. Responsible for the management of all scientific and technical efforts for the purpose of the regulatory clearance of a novel platform for the automation and multiplexing of clinical immunoassays. Brought system and clinical panel through clinical trials and into FDA evaluation. Strategic and scientific lead for academic and partner technology collaboration and KOL development.

Washington D.C. Metro Area

Scientific and management lead for new product development in the Life Science Research consumables product line. Division accountabilities include reagent and platform development and validation, the development and characterization of critical biological reagents, and management of assay and contract services technical function.

Research Triangle Park, Nc

Responsible for the scientific direction of the diagnostic product development, using a mass spec-based approach for small molecule metabolomic biomarker discovery. Programs include research and development efforts in prostate and bladder cancer, diabetes, and kidney, liver and cardiovascular diseases. Management lead for all basic and clinical research, medical affairs and key opinion leader development.

South San Francisco, Ca

Executive Vice President/Chief Scientific OfficerFunctioned as the scientific and management lead for all efforts in cancer and cardiovascular disease research and product development, including protein and molecular-based programs. Responsible for all basic and clinical research, medical affairs and key opinion leader development. Served as a member of the Executive staff, reporting to the CEO. Responsible for budgeting, strategic planning, employee development, scientific interface to the Board of Directors and the investor community.Coordinated and directed the study design, execution and manuscript submission of more than 50 peer-reviewed published papers on Lp-PLA2 and the PLAC Test product, resulting in a significant arsenal of scientific and clinical data to be applied by the Regulatory, Sales and Marketing teams, and culminating in the following highlights:• Consensus panel statement on Lp-PLA2, published in 2008, which established our treatment algorithm for Lp-PLA2. • Lp-PLA2 Studies Collaboration meta-analysis paper, published in The Lancet, 2010, which reported the data and aggregate results on nearly 80,000 patients. • Inclusion in the 2010-11 AHA/ACC Cardiovascular treatment guidelines and the 2010-11 ASA/AHA Stroke treatment guidelines. • Developed strong and productive personal and professional relationships with national and international key opinion leader advisors, including collaborators from top medical and academic institutions, worldwide. • Successfully negotiated diaDexus and Lp-PLA2 into two major outcomes studies to address requirements of private medical insurance payers. Personally responsible for the management, coordination and execution of these studies, including data generation, and analysis.• Served as primary scientific and clinical interface to all major customers (including CLIA laboratories, physicians, patients and academic investigators).

ATAIRGIN TECHOLOGIES, INCORPORATED, Irvine, California Vice President, Research and DevelopmentHeaded R&D program for diagnostic and therapeutic applications of novel bioactive lipids for the detection and treatment of ovarian and breast cancer. Managed the recruitment of initial core R&D staff. Also managed relocation of the company from an out-of-state academic site to the Irvine site and had oversight for the construction of the laboratory facility. Identified, recruited and collaborated with key academic research investigators to advance the clinical biomarker program. Initiated research and clinical studies and dialogue with the FDA for product submission.

Director of Research (Hybritech/Beckman Coulter)Programs included Diagnostics R&D efforts in prostate, bladder and breast cancer, metabolic bone disease, Alzheimer’s disease, and sexually transmitted diseases. Led R&D efforts to support the use of PSA as a screening tool for prostate cancer. • Developed prostate cancer diagnostic test, “Free-PSA” and other patented detection methods for prostate cancer. • Developed assay and received U.S. patent for osteoporosis monitoring and metabolic bone disease, bone-specific alkaline phosphatase (OstaseTM)• Developed assays for detection and monitoring of Alzheimer’s disease, amyloid beta peptide• Developed assays for breast and ovarian cancer susceptibility (BRCA1)• Led successful R&D collaborations with external industry partners, including Myriad Genetics (breast/ovarian cancer), Athena Diagnostics (Alzheimer’s disease) and Matritech (bladder cancer)

Ba, Chemistry

Phd, Biochemistry & Immunology

Post-Doctoral Fellowship, Molecular Immunology