Marie has over thirty years of business experience with a successful track record in Healthcare. Marie held positions such as VP/General Manager, VP Marketing, Area VP of Sales, Product Manager, throughout her twenty year career at Cardinal/Baxter/American Hospital Supply Company. In her role as General Manager of the Scientific Products, an $850 million business, her responsibilities included management of a national sales and marketing team comprised of more than 140 people. Throughout her career she has had opportunities to launch $100 million diagnostic product lines, negotiate partnership agreements, manage key accounts, as well as facilitate the integration of teams for acquisitions and divestitures. During her years at Humana Hospital she was both a Laboratory Director and Medical Technologist. She also has experience with several healthcare start-up companies in her work at the Arizona Center for Innovation. She graduated from the University of Wisconsin with a BS in Medical Technology and completed an MBA at the University of Chicago.
Ramesh has had a thirty year career in Immunology and Neurology. He received his Bachelor of Science in Biological Sciences & Cell Biology from the University of Plymouth and a PhD in Biochemistry from the Institute of Neurology, Queen Square, University of London, both in Great Britain. He has published more than thirty original publications, more than fifteen editorials/reviews and fifty abstracts on Immunohistochemistry, Immunocytology and Autoimmunity. He was a doctoral student in the Department of Neurochemistry, Institute of Neurology, Queens Square London, Research Fellow, Harvard Medical School, Assistant Professor, Harvard Medical School and Tufts University College of Medicine and Staff Investigator, Joslin Diabetes Center in Boston and Research Associate Professor, Department of Ophthalmology, University of Arizona
Ray has more than twenty years of experience in reagent development and product manufacturing, working for ten years at Becton Dickinson Bio Science and then Forming AREXB Consulting in Oro Valley, AZ focused in the immunological reagent field. Ray was responsible for immunochemistry, immunoassay development, purification, conjugation and evaluation of more than 150 monoclonal antibodies, 100+ Research Reagent products, and numerous IVDP product releases. He was a contributor to one of the first FDA-approved monoclonal antibody for use in Flow Cytometry. He graduated from San Jose State University in 1985 with a Bachelors of Art in Microbiology and a Minor in Biochemistry.
Melita held Corporate Director-level leadership positions in Quality and Regulatory Compliance for Medical Device and Diagnostic companies for 17 years before she opened her consulting firm in 2006. Melita brings expertise in Project Management, Regulatory Compliance, Quality System Development, 21 CFR Part 11, Software Validation, Supplier Qualification & Management, Quality Auditing, Regulatory & Quality Training, CAPA, and Management Controls. Melita has worked with companies such as: Third Wave Technologies (now Hologic), Madison, WI; Siemens Healthcare, Erlangen, Germany; Ethicon Endo Surgery (a J & J company), Cincinnati, OH; Boston Scientific, Natick, MA; Ventana Medical Systems, Tucson, AZ; Life Technologies, Carlsbad, CA; and Tolera Therapeutics, Kalamazoo, MI. As Director of RAQA, Melita Ball works with the company to implement of cGMP Quality System and lead our FDA pathway of a Class II , 510K cleared product. She provides regulatory oversight of the clinical study protocols, site audits, and regulatory adherence.
has over 15 years in public accounting with a regional firm in the Dallas/Fort Worth area including several years as principal of her own accounting firms in both Arizona and Texas. She provided tax, review, and consulting to both public and private companies. Her career also includes over 11 years in industry. Industry experience includes both public and private companies in Operations Management, and as Controller or Chief Financial Officer. She provided Texas Instruments, Inc of Dallas consulting services for 4 years and then worked in operations management as an employee. She was employed as Chief Financial Officer for Tubac Management, LLC and its affiliated companies. As Controller, Betty Weaver provides financial management of MSDx.