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Biomarkers in Late Stage Clinical Trials: Applications, Opportunities and Activities of Leading Players
Date:11/8/2010

s. late stage 23

Impact of drug failure in last stage clinical trials 24

Case 1: Vicriviroc - Merck 25

Case 2: Flurizon – Myriad Pharmaceutical 26

Technologies influencing drug success ratio 26

Genomics 26

Proteomics 26

Pharmacogenomics 27

Nanotechnology 27

Emerging technology integration (biomarker and bioinformatics) 27

Impact of omics and increasing adoption of biomarkers in clinical trials 28

Key market drivers & restraints 29

Increasing presence of CROs 29

Biomarkers in oncology clinical trials 30

Genomics and proteomics developments 30

Cost and reliability issues 30

Patent analysis 30

Competitive landscape 32

Regulatory environment 35

Introduction 35

Role of FDA 35

European Medicines Agency 37

Regulatory impact on drug safety 38

Chapter 2 Biomarker activity at leading pharma companies 40

Summary 40

Trends in the biomarker market for late stage clinical trials 41

Ongoing biomarker late stage clinical trials 43

Abbott 43

Astra Zeneca 45

Bristol-Myers Squibb 47

Eli Lilly 48

GlaxoSmithKline 49

Merck & Co., Inc. 51

Novartis 52

Pfizer 53

Roche 54

Sanofi-Aventis 55

Overview of pharmaceutical sector and biomarker use 57

Overview of contract research organizations and biomarker use 58

Overview of biomarker industry and biomarker use 59

Chapter 3 Applications of biomarkers in clinical trials 62

Summary 62

Early stage clinical trials 63

Toxicity determination 63

Dosage level 66

Drug efficacy 68

Late stage clinical trials 68

Phase III 68

Phase IV 69

Competitive landscape for late stage clinical trials 69

Application by therapy area 72

Oncology 72

Cardiovascular 73

Neurological disorders 74


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