Essam A. SHETA, PhD
Dedicated, resourceful Professional Clinical Scientist with extensive research and management experience in pre-clinical/clinical studies and bioanalytical technologies. Practical innovator with broad experience in strategic thinking and management of multitask clinical and bioanalytical operations. Outstanding records in business development and complex operation management with CAP credits of ISO15189 Quality Management System. Aiming to leverage my experience and knowledge to bring success to my organization.
CAP-ISO QMS 15189
Biomarker & Drug Target Discovery
Biostatistics (JMP, Analyze-it, SAS)
Tandem Hospital Partners 2017-present
Corporate Lab Director-Technical Consultant Houston, TX
Set up and Managed 10 mid-complexity CLIA labs of St. Vincent Neighborhood Hospitals (Indiana) and Saint
Luke’s Community Hospitals (Kansas). Supervising 400 lab users including Nurses, Paramedics and Rad Techs.
Structured the Lab strategies for quality data management, work flow and staff education and competencies.
Little River Healthcare-Rockdale and Cameron Hospitals 2016-2017
Director of Laboratory Services-Technical Consultant Rockdale, TX
Managed high complexity CLIA lab performing blood/ urine analyses, urine culture, blood bank and drug screen.
Implemented short and long-term plans for reference lab development and expansions.
Improved lab quality services and educational level of 25 lab staff MTs and MLTs to highest clinical standards.
ONCOLOGY CONSULTANTS 2009-2015
Director of Laboratory Services-Technical Consultant Houston, TX
Managed the compliance of 8 CLIA-certified laboratories performing >100,000 blood analysis/year.
Implemented IQCP program and structured the risk management, QC and QA plans to comply with federal
Generated income revenue by introducing new diagnostic tests services to the lab.
Improved the educational knowledge, evaluation level and communication activities of 26 Medical
Shared in clinical trial research management, data analyses, and article writing.
Power3 Medical products, Inc.
2001 - 2008
Director of Biochemistry / CLIA-Grandfather certified Laboratory Director
The Woodlands, TX
Managed $2.4 Millions/yr CLIA lab operation for the development of 3 diagnostic tests. Directed the compliance with high complexity-CLIA Regulatory Affair Standards.
Organized and Coordinated 3 clinical trials (> 2000 patients) for discovery and validation of biomarkers utilized for drug target discovery and development of early diagnostic tests for Breast Cancer, ALS, Alzheimer’s and Parkinson’s diseases. Trials were conducted in 3 National and 3 International sites.
Field monitored the clinical trial sites. Built, managed and maintained budget, timelines and contracts of each trial. Established team contacts, roles, responsibilities and objectives for each study.
Managed clinical planning, executed and interpreted clinical studies as well as associated data collection activities, in compliance with GCP/ICH Regulatory Standards. Developed SOP, QA/QC and GLP programs,
Implemented the scientific strategy for the development of diagnostic tests through biomarkers discovery (Phase I), validation (Phase II) and commercialization (Phase III). The progress in the company was featured by the Best small business performance award from Frost & Sullivan 2005, in the Houston Business Journal “Largest Houston Area Bioscience Companies” for 2005-2007, Fox26 news channel 01/2008 and by Popular Science magazine, 12/2007.
Founded and stimulated the strategic science and business development with several prestigious American and International Institutions. Shared in writing over 20 patent applications and numerous peer review journal publications and white papers and represented the company through speaking engagements and conferences.
Led the science team (BSc-PhD) for discovery of >300 protein biomarkers and managed the patent portfolio of the company. Submitted several research grant and SBIR proposals to NSF, NIA, NCI & MJ Fox Foundation.
GRANT REVIEW BOARD EXPERIENCE:
American Institute of Biological Sciences (AIBS) 2006-present
Worked with panel of 15 expert scientists in Parkinson’s disease to review and evaluate grant proposals submitted to the Department of Defense (DOD) for novel and innovative research proposals related to Parkinson’s disease. A $10 million award to the top 20 research proposals averaging $500,000 each in order to enhance understanding of the mechanism of Parkinson’s disease and provide innovative methods for diagnosis of this devastating disease.
Bi-National Fulbright Commission in Cairo 1994-1998
Shared a panel of 5 Fulbright expert scientists for reviewing and evaluating biology and biochemistry grant proposals submitted to the Fulbright Commission and interviewed elected candidates. Successful candidates were awarded 6-month research grant in US laboratories.
Lone Star College, Adjunct Faculty of Chemistry (2003- present), The Woodlands, TX.
University of Virginia, Research Fellow (1998-2003), Charlottesville, VA.
Alexandria University, Associate Professor of Biochemistry (1987-2001), Alexandria, Egypt.
University of Texas HSC, Visiting Assistant Professor-Fulbright (1992-1994), San Antonio, TX.
Washington State University, Visiting Assistant Professor (1989-1990), Pullman, WA.
EDUCATION: Department of Biochemistry, Alexandria University, Alexandria, Egypt
PhD (1987), Master of Science (1982), Bachelor of Science (1977)
AWARDS: Fulbright Scholarship (1992 - 1994)
Alexandria University Award for Excellence in Science (1996)
PATENTS / PUBLICATIONS
Co-author of 14 patent applications in clinical proteomics and protein biomarker discoveries.
Co-author of 17 scientific articles, 1 Book Chapter, 2 reviews and 18 abstracts on protein biochemistry, cancer cell signaling, clinical proteomics, and human pathological conditions, published in prestigious peer reviewed journals.
Co-author of a book chapter discussing the domain structure aspects and regulation of nitric oxide Synthase.