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筋萎縮性側索硬化症(ALS)におけるバイオマーカー

Biomarkers in Amyotrophic Lateral Sclerosis

発行 Insight Pharma Reports 商品コード 309636
出版日 ページ情報 英文 57 Pages
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筋萎縮性側索硬化症(ALS)におけるバイオマーカー Biomarkers in Amyotrophic Lateral Sclerosis
出版日: 2014年08月01日 ページ情報: 英文 57 Pages
概要

当レポートでは、筋萎縮性側索硬化症(ALS)の特定および診断に用いられるバイオマーカーについて調査し、バイオマーカーの概要、神経変性疾患全般におけるバイオマーカーの動向、ALSを特定する既存の遺伝子マーカーとバイオマーカー候補の概要、バイオマーカー研究に関する専門家へのインタビュー、治験およびパイプラインの動向などをまとめています。

エグゼクティブサマリー

第1章 本書の焦点

第2章 バイオマーカーとその臨床的有用性

  • バイオマーカーとは
  • バイオマーカーの長所
  • 臨床的エンドポイントとサロゲートエンドポイント
  • サロゲートエンドポイントとしてのバイオマーカーの長所
  • サロゲートエンドポイントとしてのバイオマーカーの短所
  • バイオマーカーの有効性の確認

第3章 神経変性疾患におけるバイオマーカー

第4章 筋萎縮性側索硬化症(ALS)

  • 筋萎縮性側索硬化症(ALS)とは
  • ALSを特定する遺伝子マーカー
    • SOD1
    • C9orf72
    • FUS(Fused in Sarcoma)
    • TDP-43
  • ALSのバイオマーカー候補
    • TDP-43
    • pNF-H
    • シスタチンC
    • その他
  • Merit Ester Cudkowicz博士へのインタビュー
    • 研究の背景
    • ALSの研究
    • 研究のメリットと課題
    • ALSの展望

第5章 診断用バイオマーカー

  • Atlantic Biomarkers:研究の背景
    • バイオマーカーのための質量分析アッセイ
    • 医療への影響
  • Andreas Jeromin博士へのインタビュー
  • 企業概要
    • ニューロバイオマーカー研究
    • 質量分析に基づくアッセイ

第6章 調査結果

第7章 ALSの治験およびパイプラインの情報

参考

Cambridge Healthcare Instituteについて

図表

目次

Biomarkers in Amyotrophic Lateral Sclerosis is focused on the biomarker identification and development in patients with Amyotrophic Lateral Sclerosis (ALS). As a spin-off of Biomarkers: Discovery and Development for a Diagnostic Approach to Neurodegenerative Disorders, this report focuses on the ALS space featured in the parent report, highlighting several biomarker targets under investigation and the progress that has been made in the industry. With regards to employing the use of biomarkers for Parkinson's Disease, Biomarkers in Amyotrophic Lateral Sclerosis captures market growth of biomarkers, advantages, disadvantages, and validation techniques.

Experts interviewed in this report include:

  • Dr. Merit Ester Cudkowicz, Chief of Neurology at Massachusetts General Hospital
  • Dr. Andreas Jeromin, CSO and President of Atlantic Biomarkers

Also available in this report is extensive survey data exclusively conducted for this report. Illustrated by 30 figures captured by an in-depth analysis, this section features insight into targets under investigation, challenges, advantages, and desired features of future diagnostic applications.

To add even more to the robustness of this report, Insight Pharma Reports also engineered a table of clinical trial information and pipeline data from multiple databases related to ALS. This table features companies, targets, clinical phases, and brief target/product descriptions.

Executive Summary

iomarkers have been a heavily studied topic of interest, and recently on the rise is the interest in neurodegenerative disorders, specifically Amyotrophic Lateral Sclerosis (ALS). This report covers extensive background information, highlights market growth and outlook, and features clinical trial and pipeline information.

After the introduction, Chapters 2 and 3 highlight background information relevant to the rest of this report and include definitions and elaborate examples of different types of biomarkers used in the clinic. Chapter 2 concludes with market growth, advantages of biomarkers, disadvantages of biomarkers, and validation techniques. Chapters 3 gives a brief overview of neurodegenerative disorders, also speaking to the market growth and rise in interest in biomarkers over the years.

Chapter 4 gives specifics on ALS, also known as Lou Gehrig's disease. This chapter features definitions, symptoms, genetic markers, and current research regarding informative background information in this disease space. In this chapter, Dr. Merit Ester Cudkowicz, Chief of Neurology at Massachusetts General Hospital, discusses her progress on discovering biomarkers for therapeutic development and understanding the biology of ALS. This is further complemented by Dr. Andreas Jeromin, CSO and President of Atlantic Biomarkers. He provides insight on the diagnostic applications that biomarkers possess, and the company's impact on healthcare.

Chapter 6 includes an elaborate survey analysis exclusively done for this report. Qualifying participants worked with neurobiomarkers, neurodiagnostics, or both. With over 30 survey figures depicting the general R&D group working in this space, this section provides information including: research demographics, targets under investigation, challenges, advantages, and desired features of future diagnostic applications.

Finally, Insight Pharma Reports also engineered a table of clinical and pipeline information related to Amyotrophic Lateral Sclerosis.

Table of Contents

Executive Summary

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

CHAPTER 4: 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

CHAPTER 5: Biomarkers for Diagnostics

  • 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 6:Survey Results

CHAPTER 7: Clinical Trials and Pipeline Information for Amyotrophic Lateral Sclerosis*

References

About Cambridge Healthtech Institute

FIGURES

  • Figure 2.1: Growth of Interest in Biomarkers
  • Figure 2.2: Biomarker Presence in Diagnostic Development vs. Therapeutic Development
  • Figure 3.1: Comparison of Disease Categories
  • Figure 3.2: Growth of Interest in Biomarkers for Neurology
  • Figure 3.3: Growth of Interest in Biomarkers for Amyotrophic Lateral Sclerosis
  • Figure 6.1: How Would You Categorize Your Organization?
  • Figure 6.2: Which Neurodegenerative Condition are You Currently Studying?
  • Figure 6.3: Which Targets for Huntington's Disease (HD) are You Currently Studying?*
  • Figure 6.4: What is the Clinical Status of Your Target(s) for HD?*
  • Figure 6.5: When Do You Expect Your Targets for HD to Enter Clinical Trials?
  • Figure 6.6: When Do You Expect Your Target to be an Available Therapeutic for HD?
  • Figure 6.7: Which Targets for Amyotrophic Lateral Sclerosis (ALS) are You Currently Studying?*
  • Figure 6.8: What is the Clinical Status of Your Target(s) for ALS?*
  • Figure 6.9: When Do You Expect Your Targets for ALS to Enter Into Clinical Trials?
  • Figure 6.10: When Do You Expect Your Target to be an Available Therapeutic for ALS?
  • Figure 6.11: Which Targets for Multiple Sclerosis (MS) are You Currently Studying?*
  • Figure 6.12: What is the Clinical Status of Your Target(s) for MS?*
  • Figure 6.13: When Do You Expect Your Targets for MS to Enter Into Clinical Trials?
  • Figure 6.14: When Do You Expect Your Target for MS to be an Available Therapeutic?
  • Figure 6.15: Which Signatures for Alzheimer's Disease (AD) are You Currently Studying?*
  • Figure 6.16: What is the Clinical Status of Your Target(s) for AD?*
  • Figure 6.17: When Do You Expect Your Targets for AD to Enter Into Clinical Trials?
  • Figure 6.18: When Do You Expect Your Target to be an Available Therapeutic for AD?
  • Figure 6.19: Which Signatures for Parkinson's Disease (PD) are You Currently Studying?* 37
  • Figure 6.20: What is the Clinical Status of Your Target(s) for PD?*
  • Figure 6.21: When Do You Expect Your Targets for PD to Enter Into Clinical Trials?
  • Figure 6.22: When Do You Expect Your Targets for PD to be an Available Therapeutic?
  • Figure 6.23: How Would You Describe Your Line of Research?
  • Figure 6.24: With Respect to Neurodiagnostics, Which Diagnostic Tools are You Developing for Biomarker Signatures?*
  • Figure 6.25: With Respect to Neurodiagnostics, What are Challenges You Have Encountered with Your Diagnostic Development?*
  • Figure 6.26: With Respect to Biomarker Development, What Tools are You Using to Identify Biomarker Signatures?*
  • Figure 6.27: With Respect to Biomarker Development, What are Challenges You Have Encountered with Your Therapeutic Discovery/Development?*
  • Figure 6.28: With Respect to Biomarker Therapeutics, What Tools are You Using to Identify Biomarker Signatures?*
  • Figure 6.29: With Respect to Biomarker Therapeutics, What are Challenges You Have Encountered with Your Therapeutic Discovery/Development?*
  • Figure 6.30: Which Imaging Techniques do You Feel are the Most Beneficial for Studying the Effects of Neurodegenerative Diseases?*
  • Figure 6.31: Which Therapeutics do You Feel will be the Most Beneficial for Neurodegenerative Diseases?*

TABLES

  • Table 2.1: Clinical Applications of Biomarkers as Surrogate Endpoints
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