Published Date: 01/09/2011
Category: Drug Delivery & Devices
Biomarkers research is gainning momentum as stakeholders work together to discover, develop and validate new markers of disease. This white paper discusses the recent advances in biomarker research and their application in drug discovery, development and diagnostics.
Biomarkers: Predicting risk & aiding drug development & diagnostics
Author: Kritika Chaudhari
Table of Contents
Introduction 3
Tools for biomarker research 4
Application of biomarkers 5
Recent advances in biomarker research 5
Case study I – Oncology Biomarkers 7
Case study II – Cardiovascular Biomarkers 7
Case study III - Neurologic Biomarkers 7
Multi-marker research approach 8
Interdisciplinary approach 10
Collaboration is the name of the game 10
Challenges & opportunities in biomarker development 13
Challenges 13
Opportunities 13
Regulatory considerations in biomarker development 14
FDA guidelines 15
EMA Guidelines 16
Harmonization 16
Biomarker market trends & outlook 16
Conclusions 19
The promise of biomarkers 19
Limitations of biomarkers 19
The future of biomarkers 20
Companies mentioned 21
Useful websites 21
Bibliography & Endnotes 22Â
List of Figures
Figure 1: Importance of Biomarkers for the Pharma Industry 3
Figure 2: Challenges& Opportunities in Biomarker Development 14
Figure 3: Biomarkers Shift from Therapeutics to Personalized Medicine. 17
Figure 4: Growth Drivers for the Biomarker Market 18
Figure 5: Areas of Biomarker Research over Time 18Â
List of Tables
Table 1: Examples of Tools for Biomarker Discovery & Development 4
Table 2: Examples of Biomarkers under Investigation 6
Table 3: Multi markers for Drug Discovery & Development 8
Table 4: Leading Players in Biomarker Discovery & Validation. 9
Table 5: Examples of Recent Partnerships to Promote Biomarker Research 10
Table 6: Major Consortia in Biomarker Research 11
Table 7: Recent Research Projects Utilizing Biomarkers 12
Table 8: Development& Validation of Biomarkers in Clinical Trials 15