Biomarkers: Applications and Trends

Date: August 22, 2010
Pages: 138
Price:
US$ 1,215.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: BB85ED3F406EN
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Biomarkers: Applications and Trends
Few would contest the need for pharmaceutical research to be productive. Despite significant increases in the cost of drug discovery and drug development, the number of new NCE and biological products reaching the market has not improved. A new way of conducting research has to be found and much hope and investment is being set by Biomarkers.
The Business Implications

CHAPTER 1 - BIOMARKERS DEFINED

Executive Summary
  Biomarkers defined

BIOMARKERS DEFINED
  Table 1: Fit for purpose criteria
A Solution to Failing Pharma Productivity?
  Figure 1: Pharma R&D activity & attrition rates (1995-2009)
  Figure 2: Advantages of biomarker discovery in drug discovery & development
Potential Value of Biomarkers in Drug Discovery
  Figure 3: Role of Biomarkers in drug discovery & development
  Figure 4: Initiatives in biomarker discovery & development
  Figure 5: Shift in attrition rates to early phase
New clinical diagnostic tools
  Figure 6: Risk-based classification of IVDs
Conclusions

CHAPTER 2 - REGULATORY SUPPORT: IMPLICATIONS FOR PHARMA

Executive Summary
  Regulatory support: implications for pharma

REGULATORY SUPPORT: IMPLICATIONS FOR PHARMA
Regulatory drivers
Where are we now?
  Figure 7: Voluntary genomic data submissions: process & outcomes
  Figure 8: Preliminary biomarker qualification process
EXPERT COMMENTARY: Spiros Vamvakas, MD,
What do new biomarker guidelines mean for the pharma industry?
Where are we going?
Conclusions

CHAPTER 3 - CHALLENGES OF BIOMARKER DISCOVERY & DEVELOPMENT

Executive Summary
  Challenges of biomarker discovery & development

CHALLENGES OF BIOMARKER DISCOVERY & DEVELOPMENT
  Figure 9: Multidisciplinary biomarker discovery, validation & qualification process
Biomarker discovery & validation
  Figure 10: Multidisciplinary biomarker discovery – a collaborative effort
Technological challenges
  Figure 11: Types of R&D biomarkers
  Table 2: Biomarker sample types – advantages, limitations & recommendations
Sample collection & preparation
  Table 3: Pre-analytical & analytical bias of samples & data
Multiplex Assays
Immunoassays
Mass Spectrometry
  Figure 12: Protein Quantitation - MS based proteomics
Bioinformatics
  Figure 13: Technological advances in proteomics increases data generation
EXPERT COMMENTARY: Dr Conrad Bessant
Systems biology
  Figure 14: Systems biology approach to biomarkers
Conclusions

CHAPTER 4 - APPLICATIONS OF BIOMARKERS IN DRUG DISCOVERY & DEVELOPMENT

Executive Summary
  Application of biomarkers in drug discovery & development

APP LICATION OF BIOMARKERS IN DRUG DISCOVERY & DEVELOPMENT
Overcoming bottlenecks in the R&D process
Biomarker Implementation in R&D
Translational Medicine
  Figure 15: Migration from traditional R&D model to translational R&D Model
  Figure 16: Different phases of translational research
Application of biomarkers in identifying new drug targets
Functional genomics
  Table 4: Drug discovery & development based on genomics targets
Proteomics
Metabolomics
Application in improving safety and efficacy of new drugs
Case Study: Cellular Dynamics & stem cell derived iCell Cardiomyocytes
EXPERT COMMENTARY: Dr Michael Merz, SAFE-T Consortium
Mechanism of action studies
Case Study: PBS-Bio real-time computer imaging technology
  Figure 17: PBS-Bio real-time computer imaging technology
Conclusions

CHAPTER 5 - APPLICATIONS OF BIOMARKERS IN THE CLINIC & CLINICAL DIAGNOSTICS

Executive Summary
  Application of biomarkers in the clinic & clinical diagnostics

IMPLICATIONS & APP LICATIONS OF BIOMARKERS IN THE CLINIC
  Figure 18: Percent risk associated with different stages of drug development
  Figure 19: Early drug development process
Types of clinical biomarkers
  Phase 0
  Phase I/II
  Phase III
  Phase IV /V
EXPERT COMMENTARY: Sam LaBrie, Ph.D
Application of biomarkers in clinical drug development
Risk biomarkers
Patient enrichment
  Figure 20: Patient enrichment trial designs
Response markers
Prognostic biomarkers
Prognostic imaging biomarkers
Surrogate biomarkers
  Figure 21: Relationship between biomarker and clinical outcome dependent on biomarker
  Figure 22: Relationship between biomarker and clinical outcome independent of biomarker
  Figure 23: Relationship between biomarker and clinical outcome on long term prognosis
  Table 5: Biomarkers surrogate endpoints for safety
Predictive biomarkers
Co-development of drugs and diagnostics
  Figure 24: Medical product (Rx)/Diagnostic (Dx) development models
  Figure 25: Traditional medical product (Rx)/Diagnostic (Dx) development models
Personalisation of medicine
  Table 6: Personalised medicine vs. traditional medicine
  Table 7: Approved personalised medicines
  Table 8: Personalised medicine market
EXPERT COMMENTARY: Dr Scott Allocco, B.A.
Conclusions

CHAPTER 6 - PLAYERS, ALLIANCES & ACQUISITIONS

Executive Summary
  Players, alliances & acquisitions

PLAYERS, ALLIANCES & ACQUISITIONS
Company activities at a glance
  Table 9: Leading biomarker discovery & development companies
Alliances with market leaders
  Table 10: Summary of major pharmaceutical company biomarker alliances
Therapeutic Activity
Cancer
  Table 11: Exploratory biomarkers for cancer
Cardiovascular
  Table 12: Exploratory biomarkers for cardiovascular diseases
CNS disorders
  Table 13: Exploratory biomarkers for CNS disorders
Inflammatory disorders
  Table 14: Exploratory biomarkers of inflammatory diseases
Infectious diseases
Alliance between biomarker-diagnostic companies
  Table 15: Key biomarker-diagnostic company alliances
Alliances with academia & consortia
  Table 16: Key academia & consortia alliances
Start-ups & acquisitions
Recent start-ups
Acquisitions
Conclusions

CHAPTER 7 - OUTLOOK & FUTURE OF BIOMARKER RESEARCH

Executive Summary
  Outlook & Future of Biomarker Research

OUTLOOK & FUTURE OF BIOMARKER RESEARCH
Market trends & forecasts
  Increased collaboration
  Increased numbers of qualified biomarkers & surrogate endpoints
  Explore new therapeutic areas & rare diseases
  Adoption of new technologies in biomarker identification & qualification
  Increased number of companion-diagnostic programmes
  Regulatory guidance & harmonisation
  Financial investment in biomarker R&D
  Biomarker impact near, mid and long-term
    Table 17: Factors affecting the impact of biomarkers on the industry over the near, mid & long-term
Market Forecasts
  Table 18: Biomarker market forecast (US$m)
Ones to watch
  Table 19: Summary of ones to watch in biomarker R&D & commercialisation
Overall Conclusions

CHAPTER 8 - APPEN DICES, GLOSSARY, BIBLIOGRAPHY, ACKNOWLEDGEMENTS

Appendix 1
  Table 20: Recent biomarker alliances & developments in cancer
Appendix 2
  Table 21: Recent biomarker alliances and developments in cardiovascular disease
Appendix 3
  Table 22: Recent biomarker alliances & developments in CNS disorders
Appendix 4
  Table 23: Recent biomarker alliances & developments in immune/ inflammatory disorders
Acknowledgements
Glossary
Bibliography & Endnotes
Endnotes

LIST OF TABLES

Table 1: Fit for purpose criteria
Table 2: Biomarker sample types – advantages, limitations & recommendations
Table 3: Pre-analytical & analytical bias of samples & data
Table 4: Drug discovery & development based on genomics targets
Table 5: Biomarkers surrogate endpoints for safety
Table 6: Personalised medicine vs. traditional medicine
Table 7: Approved personalised medicines
Table 8: Personalised medicine market
Table 9: Leading biomarker discovery & development companies
Table 10: Summary of major pharmaceutical company biomarker alliances
Table 11: Exploratory biomarkers for cancer
Table 12: Exploratory biomarkers for cardiovascular diseases
Table 13: Exploratory biomarkers for CNS disorders
Table 14: Exploratory biomarkers of inflammatory diseases
Table 15: Key biomarker-diagnostic company alliances
Table 16: Key academia & consortia alliances
Table 17: Factors affecting the impact of biomarkers on the industry over the near, mid & long-term
Table 18: Biomarker market forecast (US$m)
Table 19: Summary of ones to watch in biomarker R&D & commercialisation
Table 20: Recent biomarker alliances & developments in cancer
Table 21: Recent biomarker alliances and developments in cardiovascular disease
Table 22: Recent biomarker alliances & developments in CNS disorders
Table 23: Recent biomarker alliances & developments in immune/ inflammatory disorders

LIST OF CHARTS

Figure 1: Pharma R&D activity & attrition rates (1995-2009)
Figure 2: Advantages of biomarker discovery in drug discovery & development
Figure 3: Role of Biomarkers in drug discovery & development
Figure 4: Initiatives in biomarker discovery & development
Figure 5: Shift in attrition rates to early phase
Figure 6: Risk-based classification of IVDs
Figure 7: Voluntary genomic data submissions: process & outcomes
Figure 8: Preliminary biomarker qualification process
Figure 9: Multidisciplinary biomarker discovery, validation & qualification process
Figure 10: Multidisciplinary biomarker discovery – a collaborative effort
Figure 11: Types of R&D biomarkers
Figure 12: Protein Quantitation - MS based proteomics
Figure 13: Technological advances in proteomics increases data generation
Figure 14: Systems biology approach to biomarkers
Figure 15: Migration from traditional R&D model to translational R&D Model
Figure 16: Different phases of translational research
Figure 17: PBS-Bio real-time computer imaging technology
Figure 18: Percent risk associated with different stages of drug development
Figure 19: Early drug development process
Figure 20: Patient enrichment trial designs
Figure 21: Relationship between biomarker and clinical outcome dependent on biomarker
Figure 22: Relationship between biomarker and clinical outcome independent of biomarker
Figure 23: Relationship between biomarker and clinical outcome on long term prognosis
Figure 24: Medical product (Rx)/Diagnostic (Dx) development models
Figure 25: Traditional medical product (Rx)/Diagnostic (Dx) development models
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