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  5. > Biomarkers: Discovery and Development for a Diagnostic Approach to Neurodegenerative Disorders - Overview

Biomarkers: Discovery and Development for a Diagnostic Approach to Neurodegenerative Disorders has a focus in biomarkers for neurodegenerative diseases and diagnostic applications in development. Biomarkers have been a heavily studied topic of interest, and recently on the rise is the interest in neurodegenerative disorders. Although there are many techniques used to track neurodegenerative disease progression, this report will primarily focus on blood-based and cerebrospinal fluid-based biomarkers. In addition to covering background information, this report will highlight several technologies that have been developed for employing the use of biomarkers for neurodegenerative disease detection, analysis and therapeutic development. Including substantial background information, illustrated with graphics and figures, this report captures market growth of biomarkers, advantages, disadvantages, and validation techniques.

Three neurodegenerative disorders that are heavily focused on in this report include: Alzheimer’s Disease/Mild Cognitive Impairment, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis. Part II of the report will include all three of these disorders, highlighting specifics including background, history, and development of the disease. Deeper into the chapters, the report will unfold biomarkers under investigation, genetic targets, and an analysis of multiple studies investigating these elements.

Experts interviewed in these chapters include:
Dr. Jens Wendland, Head of Neuroscience Genetics, Precision Medicine, Clinical Research, Pfizer Worldwide R&D
Dr. Howard J. Federoff, Executive Vice President for Health Sciences, Georgetown University
Dr. Andrew West, Associate Professor of Neurology and Neurobiology and Co-Director, Center for Neurodegeneration and Experimental Therapeutics
Dr. Merit Ester Cudkowicz, Chief of Neurology at Massachusetts General Hospital
Part III of the report makes a shift from neurobiomarkers to neurodiagnostics. This section highlights several diagnostics in play and in the making from a number of companies, identifying company strategies, research underway, hypotheses, and institution goals. Elite researchers and companies highlighted in this part include:
Dr. Xuemei Huang, Professor and Vice Chair, Department of Neurology; Professor of Neurosurgery, Radiology, Pharmacology, and Kinesiology Director; Hershey Brain Analysis Research Laboratory for Neurodegenerative Disorders, Penn State University-Milton, S. Hershey Medical Center Department of Neurology
Dr. Andreas Jeromin, CSO and President of Atlantic Biomarkers
Julien Bradley, Senior Director, Sales & Marketing, Quanterix
Dr. Scott Marshall, Head of Bioanalytics, and Dr. Jared Kohler, Head of Biomarker Statistics, BioStat Solutions, Inc.

Further analysis appears in Part IV. This section includes a survey exclusively conducted for this report. With over 30 figures and graphics and an in depth analysis, this part features insight into targets under investigation, challenges, advantages, and desired features of future diagnostic applications. Furthermore, the survey covers more than just the featured neurodegenerative disorders in this report, expanding to Multiple Sclerosis and Huntington’s Disease.

Furthermore, Insight Pharma Reports also put together a generous amount of data compiling clinical trial information and pipeline data related to Alzheimer’s Disease, Parkinson’s Disease and Amyotrophic Lateral Sclerosis. This is the fifth and final part of this report and it contains the most current information in the aforementioned disease areas.

Table Of Contents

Biomarkers: Discovery and Development for a Diagnostic Approach to Neurodegenerative Disorders - Overview
Executive Summary

PART I: INTRODUCTION AND BACKGROUND INFORMATION

CHAPTER 1: The Focus of this Report

CHAPTER 2: Biomarkers and Their Clinical Utility
What are Biomarkers?
Advantages of Biomarkers
Clinical Endpoints vs. Surrogate Endpoints
Advantages of Biomarkers as Surrogate Endpoints
Disadvantages to Biomarkers as Surrogate Endpoints
How are Biomarkers Validated?

CHAPTER 3: Biomarkers in Neurodegenerative Disorders

PART II: NEUROBIOMARKER DISCOVERY AND DEVELOPMENT

CHAPTER 4: Mild Cognitive Impairment and Alzheimer's Disease
How is it Related to Alzheimer's Disease?
Conflicting Evidence: Mild Cognitive Impairment or Alzheimer's Disease?
Biomarkers and Candidates for Alzheimer's Disease
Cerebrospinal fluid Analysis vs. Plasma Analysis
Current Biomarkers
Phospholipid Biomarkers
Single Nucleotide Polymorphisms and Apolipoprotein E
Testosterone and Hormone Levels
Interview with Dr. Howard Federoff
Interview with Dr. Jens Wendland

CHAPTER 5: Parkinson's Disease
What is Parkinson's Disease?
Genetic Factors Linked to Parkinson's Disease
PARK2 (parkin/ubiquitin E3 ligase)
PINK1 (PTEN-induced kinase 1 protein)
GBA (glucocerebrosidase)
Promising Biomarkers for Parkinson's Disease
SNCA (?-synuclein)
PARK7 (DJ-1 protein)
LRRK2 (dardarin protein)
Other biomarkers
Interview with Dr. Andrew West
Research Background
LRRK2 Protein Kinase
Advantages
Challenges and Limitations
Parkinson's Disease Outlook

CHAPTER 6: Amyotrophic Lateral Sclerosis
What is Amyotrophic Lateral Sclerosis?
Genetic Markers Identifying ALS
SOD1
C9orf72
Fused in Sarcoma (FUS)
TDP-43
Potential Biomarker Candidates for ALS
TDP-43
pNF-H
Cystatin C
Other biomarkers
Interview with Dr. Merit Ester Cudkowicz
Research Background
ALS Research
Research advantages and challenges
ALS outlook

PART III: NEURODIAGNOSTICS AND BIOMARKER TECHNOLOGIES

CHAPTER 7: Neurodiagnostics and Biomarker Technologies

CHAPTER 8: Penn State Hershey Medical Center
Research Background
MRI for Parkinson's Disease Diagnosis
Interview with Dr. Xuemei Huang
Research Background
Non-Invasive Imaging Tool
Advantages
Challenges and Limitations
Parkinson's Disease Outlook

CHAPTER 9: Atlantic Biomarkers
Research Background
Mass-Spectrometry Assays for Biomarkers
Impact on Healthcare
Interview with Dr. Andreas Jeromin
Company Background
Neurobiomarker Research
Mass Spectrometry-Based Assays

CHAPTER 10: Quanterix
Company Background 5
Simoa Science Technology
Expected Impact on Healthcare
Interview with Julien Bradley
Quanterix Background
Simoa Science Technology

CHAPTER 11: BioStat Solutions, Inc. (BSSI)
Company Background
Statistical Support
Impact on Healthcare
Interview with Dr. Scott Marshall/Dr. Jared Kohler

PART IV: SURVEY RESULTS

CHAPTER 12: Survey Results

PART V: CLINICAL TRIALS AND PIPELINE INFORMATION
References
About Cambridge Healthtech Institute

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