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
MD, PhD
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
Anna Flynn
Director of Quality System Compliance and EH&S
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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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Anna Flynn
Director of Quality System Compliance and EH&S
- Responsible for Quality Control 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.
- 15-years of experience in regulated medical device companies as Site Quality Manager, Management Representative, and Environmental, Health, and Safety Leader
- GE Healthcare, Product Quality Leader & EHS Manager for medical device capital equipment
- BiomericsATL (CRI), Site Quality Manager & EHS Manager for medical devices as a contract manufacturer and OEM
- Indigo BioAutomation, Inc., site Quality Manager for medical device software used in clinical laboratories
- Specialties:
- Medical Device compliance and management
- Auditing and Inspections
- Complaint and CAPA
- Process Improvement
- Change Control and Document Management
- Education:
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BS, Health Science and Public Health: Ball State University
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- Certifications: Six Sigma, OSHA