PhD, MD Chief Medical Officer & Laboratory Director, Renalytix Professor of Experimental Pathology & Director of Biorepository and Pathology at the Icahn School of Medicine at Mount Sinai, NYC
Responsible for overseeing the daily clinical laboratory operations and ensuring all patients receive the highest-quality medical care
Board certified, anatomic, clinical and pediatric pathology
20-years of experience in the biotechnology industry in various senior management roles, including at Millenium Pharmaceuticals and Incyte Pharmaceuticals
Chief Medical Officer at various life sciences companies: PreciseDx, VericiDx, Aureon Biosciences, MetaStat Inc., Exosome Diagnostics, Inc, Vigilant Biosciences
Spearheaded the utilization of multiple tissue and fluid-based assays and coupled mathematical applications to produce clinically relevant diagnostic/prognostic outcome models for a variety of disease states
Extensive experience in designing/implementing clinical studies for various disease states
Academic Career: Harvard Medical School and Boston Children’s Hospital, Professor of Pathology at Icahn School of Medicine, Mount Sinai NYC and Vice-Chair of Translational Research & Professor of Pathology, University of Miami
BS, Zoology: Rutgers University
MD: University of Medicine & Dentistry of New Jersey
Master of Science, Endocrinology: Rutgers University
PHD, Cell & Developmental Biology: Rutgers University
Post-Doctoral studies: Harvard Medical School
Your Content Goes Here
Head of Clinical Laboratory Operations
Responsible for clinical laboratory operation activities across all KidneyIntelX labs
Held various leadership roles at Quest Diagnostics, a worldwide provider of IVD diagnostics
Held science and technical operation roles, ARUP Laboratories and Labcorp
BS, Clinical Lab Science; University of Nebraska Medical Center
MBA: University of Utah, David Eccles School of Business
Responsible for ensuring compliance with U.S. and international Quality Management System regulations and standards and driving efficient FDA and EMA approvals for a series of products under the KidneyIntelX portfolio brand
24-years of experience in senior Quality & Regulatory leadership roles
Head of Quality Assurance, Abbott Molecular Diagnostics
Global Vice President, Quality Assurance & Regulatory Affairs, CareFusion
BS, Biological Science: University of Texas, El Paso
Certifications: Lean Six Sigma Black Belt
Your Content Goes Here
Director of Quality, Laboratory Controls
Responsible for Quality Control procedures and processes for all clinical laboratories. Ensures full compliance with CLIA and FDA regulations, CAP and ISO standards and New York State Department of Health requirements.
20-years of experience in the clinical laboratory field
10-years of experience in clinical laboratory compliance
CLIA Program Manager, State of Utah; brings extensive laboratory auditing and assistance in ensuring laboratories achieve compliance
Manager, Utah Department of Public Health
Variety of clinical laboratory and compliance roles, ARUP Laboratories
Public health reporting
Laboratory compliance and management
Internal/external regulatory audits
BS, Medical Laboratory Science: University of Utah
Get access to the blog, webinars and podcasts with the ideas, perspectives and innovations that matter most in kidney health.
You are now subscribed to Well Filtered. We’ll be in touch soon.
If you need additional assistance, contact our Client Services Team at 888.203.2725.
If you have any questions, call our Patient Support Team at 844.870.8870.
Renalytix is seeking FDA De Novo marketing authorization for KidneyIntelX. The test is not FDA approved nor cleared for any use at this time. KidneyIntelX yields a custom risk score that identifies which adult diabetic patients in early stages of chronic kidney disease are at low, intermediate or high risk for rapid progressive decline in kidney function within a period of up to five years. To report a product concern or suspected Adverse Event, please contact Renalytix Client Service at 1-888.203.2725.