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March 2005 

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Biomarkers in Clinical Development: 
Implications for Personalized Medicine and Streamlining R&D

Richard Fisler
Contributing Author: Olivia Scaros, PharmD

New Page 1
Figure 1.1: Phases of the Drug Development Process That Are Impacted by Biomarkers

Figure 1.2: Effective Profitability of Approved and Released Pharmaceuticals

Figure 1.3: Value Proposition of Biomarkers Throughout the Therapeutic Development and Application Phases

Figure 1.4: Reasons Cited for Compound Failure

Figure 1.5: The Biomarker Research and Development Process

Figure 2.1: Linkage of a Basic Systems Biology Research Cycle with Drug Discovery and Treatment

Figure 2.2: How Technologies Can Better Connect Discovery and Clinical Research

Table 1.1: Biomarker/Surrogate Endpoints That Have Aided Drug Development

Table 1.2: Classification of Biomarkers as Described by the FDA

Table 2.1: Comparative Throughput of Biomarker Technologies

Table 2.2: Gene Expression as a Prognostic Tool in Breast Cancer

Table 2.3: Genes for Early-Onset Alzheimer’s Disease

Table 2.4: Genes for Late-Onset Alzheimer’s Disease

Table 2.5: Comparison of Proteomic Technologies Used for Biomarker Discovery

Table 2.6: Comparison of Advantages and Disadvantages of Selected Molecular Imaging Technologies

Table 4.1: Pharmacological MRI Studies Involving Psychiatric and Neurological Conditions

Table 5.1: Selected Pharmaceutical Company Partnerships

 


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