The National Centralized Repository for Alzheimer’s Disease and Related Dementia’s Biomarker Assay Laboratory: A Resource for the Alzheimer’s Disease Research Community

Product:

CNS Disease Panel 120, Inflammation Panel 250

Topic:

Disease Area:

Alzheimer's Disease, Neurology

Sample Type:

Plasma

Topic/Product:

CNS Disease Panel 120, Inflammation Panel 250

Disease Area:

Alzheimer's Disease, Neurology

Sample Type:

Plasma

Abstract

Developments in Alzheimer’s disease blood-based biomarkers research have provided critical information as to their use in early detection and assessments of progression in patients. The National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD) Biomarker Assay Laboratory (BAL) was developed to provide expertise and access to robust and reliable research-use-only biomarkers (not for medical decision making) for the Alzheimer’s disease and related dementias (ADRD) research community. The NCRAD BAL is a quality-focused laboratory delivering biomarker data through the use of highly standardized procedures and highly automated instrumentation with the goal of limiting pre-analytical variability while preparing samples for analysis, including limiting lot-to-lot variability of the assays. As biomarkers become United States Food and Drug Administration (FDA) -approved and move into use in CLIA labs, the NCRAD BAL will bring forward new platforms and assays reflecting the most current research-use-only biomarkers to support the research mandate of the ADRD research community.

Highlights

The National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD) has developed a Biomarker Assay Laboratory to support research of robust and reliable fluid biomarkers for Alzheimer’s disease and neurodegeneration.
NCRAD supports Alzheimer’s Disease Research Centers by providing biomarker analyses on samples with clinical and imaging data through the National Institute on Aging (NIA) -funded Alzheimer’s Disease Center Fluid Biomarker Initiative.
The NCRAD Biomarker Assay Laboratory focuses on decreasing variability that will affect study results by utilizing highly standardized and automated procedures, strict monitoring of control measures, and controlling for lot-to-lot and instrument-to-instrument variability.

Authors & Affiliations

Kristen A. Russ¹², Kaci Lacy¹², Jeffrey L. Dage¹²³⁴, and Tatiana Foroud¹²³

¹ National Centralized Repository for Alzheimer’s Disease and Related Dementias, Indianapolis, IN, USA
² Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA
³ Stark Neurosciences Institute, Indiana University School of Medicine, Indianapolis, IN, USA
⁴ Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA

Steve Williams, MD, PhD

CSO

Dr. Willams serves as the company’s Chief Scientific Officer. He was previously Chief Medical Officer at Standard Biotools and at SomaLogic where he pioneered the discipline for discovery and validation of predictive, diagnostic and prognostic models using machine-learning applied to large-plex proteomics. 20 such tests were used for drug characterization, safety and efficacy when incorporated in clinical drug trials at Pharma/Biotech and 17 different multivariate tests were validated and translated into regulated healthcare uses. Prior to SomaLogic, Dr. Williams was at Pfizer in the UK and the USA as a clinical triallist in Translational Medicine, and subsequently as VP, Global Clinical Technology. He sat on the National Advisory Council for the National Institute of Biomedical Imaging and Bioengineering, the Executive Committee for the FNIH Biomarkers Consortium, and worked with FDA and PhRMA on developing evidentiary standards for biomarker qualification. Dr. William’s medical training was in London, at Charing Cross and Westminster Medical School, followed by a PhD in medicine/physiology at the same institution and training in Radiology at the University of Newcastle Upon Tyne. Steve is co-inventor on 26 proteomics patents and author/coauthor on multiple foundational proteomics manuscripts.

Justin McAnear

CFO

Mr. McAnear serves as the company’s Chief Financial Officer. He brings over 25 years of operational and financial leadership experience across various sectors and was instrumental in taking 10x Genomics public in 2019, serving as its CFO for over five years. Mr. McAnear served for over 3 years as Tesla’s VP of Worldwide Finance and Operations, supporting landmark initiatives such as the Model X and Model 3 launches and Solar City acquisition. He also held various roles at Apple and J&J earlier in his career and served as a naval officer and aviator for over 9 years.