Leann Mikesh, Ph.D. Email & Phone Number

Charlottesville, Va, Us

Charlottesville, Va, Us

Developed and teach online graduate level courses in clinical mass spectrometry and an in person laboratory course leading to a Certificate from Michigan State University in Clinical Mass Spectrometry.BLD870 - Clinical Mass Spectrometry TheoryBLD871 - Applied Clinical Mass SpectrometryBLD872 - Clinical Mass Spectrometry Laboratory

• Wrote peer-reviewed journal articles, poster presentations, and literature reviews and summaries for major pharmaceutical, biotechnology, and other industries.• Developed white papers, in-house training materials, company courses for customers, and marketing material as well as presented seminars for multinational biotechnology company.• Lead and managed literature reviews for companies submitting FDA product applications.• Authored medical and health related articles focusing on clinical laboratory testing.• Peer-reviewed and edited medical and scientific peer-reviewed journal articles.• Published/delivered several medical and health-based articles, interviews, and seminars.

• Identified and provided data analysis of key opinion leaders (KOL) for pharmaceutical industry.• Ensured quality control of comprehensive physician profiles. Prepared and delivered product. • Performed federal (including Office of Inspector General & FDA) and state physician screening.• Assisted in the development of an interactive database for social media compliance to identify corporate integrity, off-label promotion, adverse events and anti-kickback.

*Performed Prior Art searches and summarized biomedical patent literature using PatentLens. *Researched biomedical technologies and drafted non-confidential summaries in the fields of Diagnostics & Assays and Therapeutics. *Performed market analyses using ZoomInfo and SalesForce and marketed technologies in the area of healthcare and medical devices to biotechnology and pharmaceutical companies. *Initiated relationships for inventors to acquire additional funding and development opportunities.

Investigate properties of the melanoma tumor microenvironment using laser capture microdissection, mass spectrometry (SRM/MRM), immunohistochemistry, immunofluorescence, and a variety of other techniques. Identified several proteins that are potential biomarkers in melanoma and breast cancer.

Fellowship training in the Department of Pathology at the University of Virginia Medical Center in biomedical/clinical laboratory medicine to include in-depth knowledge of medical laboratory and clinical testing. Integrated into clinical laboratory activities to include clinical test selection, quality control/quality assurance, and regulatory requirements in the Department of Pathology and in the Divisions of General Medicine, Endocrinology and Infectious Disease in the Department of Internal Medicine. Attended Internal Medicine Morning Report and Endocrinology Clinical Case Conference. ABCC diplomate eligible. Also investigated mesenchymal transition in melanoma as it relates to immune therapy in the laboratory of Craig L. Slingluff, Jr., M.D.• Served as Laboratory Director on call for clinical laboratory testing at the University of Virginia Medical Laboratories.• Investigated false-positive results for cardiac troponin that led to errors in diagnosis and then monitored cardiac troponin I immunoassay patient results for several months after reagent was recalled by the FDA. • Addressed inconsistent CBC and INR values in some renal dialysis patients at local dialysis center by meeting with physician and nurses and reviewing patient laboratory test results to determine cause.• Resolved patient laboratory testing issues with physicians at the University of Virginia Health System.• Assisted physicians in ordering non-routine laboratory tests at the University of Virginia Medical Laboratory.• Inspected the University of Virginia Medical Laboratories as part of the CAP self-inspection regulatory process to maintain CAP certification.

Post-doctoral work in the laboratory of Donald F. Hunt, Ph.D. at the University of Virginia Department of Chemistry in Biological Mass Spectrometry. Worked with collaborators worldwide to identify MHC class I and class II antigens involved in cancer, autoimmune disease, graft vs. host disease, and infectious disease. These antigens are currently being evaluated for their immunotherapeutic properties in clinical vaccine trials.• Discovered novel MHC class I associated phosphorylated peptides as potential immunotherapy targets for cancer (Proc Natl Acad Sci U S A 2006;103:14889-94). • Developed sample-specific mass spectrometric strategies (LTQ, LTQ-FT, FTMS, ETD) to characterize MHC class I epitopes from complex clinical samples or low-abundance disease-related antigens (Int Immunol. 2010 Mar;22(3):191-203). • Identified and analyzed technically challenging disease-related peptides to include peptides with labile post-translational modifications or highly basic peptides. • Identified labile post-translational modifications such as sulfonation, glycosylation, and nitrosylation using the novel mass spectrometry technique, ETD. (Biochim Biophys Acta 2006;1764:1811-22).

Provided MHC compatibility testing for kidney and bone marrow transplants for several hospitals in Michigan. My major accomplishment in the laboratory was setting up, validating, protocol development, and assisting in the certification of molecular (DNA) histocompatibility typing. The addition of molecular typing to the laboratory was essential for obtaining a more immunologically similar match for bone marrow transplants reducing graft vs. host disease. Also developed human research studies to include obtaining IRB approval, patient consent, sample collection, and data analysis to characterize major histocompatibility complex peptides from individuals with Idiopathic Thrombocytopenia Purpura (a platelet autoimmune disorder).• Accredited by the American Board of Histocompatibility and Immunogenetics (ABHI) in 1995 as a Certified Histocompatibility Technologist (CHT), which I still maintain.• Assisted in the implementation of molecular histocompatibility typing in the laboratory to include its development, validation, and ABHI certification (Hum Immunol 1997; 53:183-87).• Performed routine molecular and serological MHC typing of clinical samples for local hospitals and the American Red Cross.• Participated in national proficiency testing (CAP) and ABHI (CLIA recognized) certification of the laboratory. • Supervised, trained, and interviewed numerous students, graduate students, medical students, veterinary students, fellows, and laboratory staff. • Elected committee member to the Graduate Study and Research Committee to review internal grant applications for College of Veterinary Medicine at Michigan State University.

Ph.D., Pathology

M.S., Clinical Laboratory Science

B.S., Zoology