Biomarker and Diagnostic Opportunities in Clinical Research for Neurological Diseases

Published by: Decision Resources

Published: Oct. 13, 2009 - 32 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Diagnosing Neurological Diseases

Diagnostic Imaging Applications

Biomarkers in Clinical Trials

Indication-Specific Biomarkers of Interest

Alzheimer’s Disease and Mild Cognitive Impairment

Multiple Sclerosis

Parkinson’s Disease

Amyotrophic Lateral Sclerosis

Huntington’s Disease

Biomarker and Diagnostic Neurology Deals

Indication-Specific Deals

Company-Specific Deals

Outlook

Sidebar

Commonly Used Imaging Technologies in Clinical Neurology

Expert Commentary

“Value of Licensing Biomarkers of Alzheimer’s Disease.”

Q&A with Rainer Voegeli, Ph.D., Commercial Director at Proteome Sciences

Tables

1. Descriptions of Select Neurological Diseases

2. Top Five Currently Recruiting Clinical Trials in Neurology, Largest Enrollment

3. Diagnostic Tests for Multiple Sclerosis

4. Inheritance Patterns of Huntington’s Disease

5. Biomarker and Diagnostic Neurology Deals in the First Half of 2009

6. Biomarker and Diagnostic Deals Involving Large-Cap Healthcare Companies, 2004- First Half 2009

Figures

1. Biomarker-Based, Closed-Enrollment, Completed Neurology Clinical Trials by Phase and Indication, September 2009

2. Biomarker-Based, Closed-Enrollment, Active Neurology Clinical Trials by Phase and Indication, September 2009

3. Biomarker-Based, Open-Enrollment, Currently Recruiting Neurology Clinical Trials by Phase and Indication, September 2009

4. Biomarker-Based, Open-Enrollment, Not Currently Recruiting Neurology Clinical Trials by Phase and Indication, September 2009

5. Amyloid Plaques and Neurofibrillary Tangles in Alzheimer’s Disease

6. Rate of Dopaminergic Neuron Loss over the Course of Parkinson’s Disease

7. Number of Neurology Biomarker and Diagnostic Deals, 2004-First Half 2009

8. Neurology Deals: Biomarkers vs. Diagnostics, 2004-First Half 2009

9. Number of Neurology Biomarker and Diagnostic Deals, by Deal Focus, 2004-First Half 2009

10. Number of Neurology Biomarker and Diagnostic Deals, by Indication, 2004-First Half 2009

11. Companies with the Most Neurology Biomarker and Diagnostic Deals, 2004-First Half of 2009

12. Number of Neurology Biomarker and Diagnostic Deals, by Company Type, 2004-First Half 2009

Abstract

• The uses of biomarkers in neurology are varied-drug discovery, monitoring disease progression/drug action, and diagnostic development-and can depend on the indication. In what ways are biomarkers being explored in Parkinson's disease compared with Alzheimer's disease? How has the use of biomarkers aligned with an outcome measure for a study in ALS?
• Clearly defined biomarkers in the neurology therapeutic area are missing. Are we close to discovering appropriate biomarkers for use in diagnostic tests to detect diseases early enough to truly change the therapeutic landscape in neurology?
• Imaging modalities are used frequently in neurological drug and diagnostic research. How many industry- sponsored active studies are employing imaging tools as their biomarker intervention? Which indication(s) relies on imaging the most?

• High-interest neurological diseases: Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS), Huntington's disease (HD), multiple sclerosis (MS), and Parkinson's disease (PD).
• Analysis of 117 biomarker-based clinical trials as of September 2009: Study type, phase in development, indication.
• A look at 75 biomarker/diagnostics-based deals across six years: Company type (large-cap, midcap, small-cap), deal type, and indication-specific.

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