Our Laboratory & Quality teams:
With 100+ combined years of clinical laboratory and quality/regulatory leadership experience, our team was hand-picked to help drive the future of kidney health.
Michael J. Donovan
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
Christopher Scott
SVP, Operations
Joseph Hutson
Vice President, Quality Assurance & Regulatory Affairs
Nancy Heidman
Director of Quality, Laboratory Controls
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Michael J. Donovan
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
- Education:
- 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
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Christopher Scott
SVP, Operations
- Responsible for overseeing the day-to-day operations across all KidneyIntelX labs and the program management team, ensuring efficient and effective processes, and driving strategic initiatives to achieve our business objectives.
- 17-years of experience in the clinical diagnostic setting, leading teams from development through commercialization of LDT and FDA products.
- Head of PMO at Ambry Genetics
- Education:
- BS, Biology: Stonehill College
- MBA: University of Scranton
- Certifications: PMP, Six Sigma, ASCP
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Joseph Hutson
Vice President, Quality Assurance & Regulatory Affairs
- 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
- Worldwide Vice President, Quality Assurance & Regulatory Affairs, Becton Dickinson
- Global Vice President, Quality Assurance & Regulatory Affairs, CareFusion
- Education:
- BS, Biological Science: University of Texas, El Paso
- Certifications: Lean Six Sigma Black Belt
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Nancy Heidman
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
- Specialties:
- Public health reporting
- Laboratory compliance and management
- Internal/external regulatory audits
- Technical/SOP writing
- Education:
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BS, Medical Laboratory Science: University of Utah
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- Certifications: ASCP