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Imaging biomarkers, those quantified using imaging modalities including Magnetic Resonance Imaging and Positron Emission Tomography, are attractive for a variety of reasons: the methods of measurement used are non-invasive, and can provide information that cannot be obtained in other ways including a drug’s pharmacology and side effect profile, interaction of a drug and its target, delivery of a drug to its target, and the drug’s pharmacokinetic profile. In the clinical setting, imaging biomarkers can be used as a screening, diagnostic or prognostic tool as well as for monitoring treatment response.

Researchers have a vision that the introduction of imaging biomarkers will revolutionize basic research, drug development and treatment by providing non-invasive approaches that are translatable from the laboratory to the clinic and by allowing researchers and clinicians to see in great detail how drugs are behaving. The discovery and development of imaging biomarkers is an exciting and growing area and researchers across the globe are working to develop this vision.

The imaging technologies available today offer a variety of methods that can be used to quantify information and thus create useful biomarkers. Discovering the biomarker is perhaps the easy step, whilst the clinical follow up studies required to gain a better understanding of the utility of the biomarker are more complex, time consuming and expensive. This report discusses advances in key technologies, the use of imaging biomarkers in drug discovery and development and current use in clinical practice. It also outlines key collaborative initiatives in standardizing imaging technologies and informatics, improving quantification and qualification without which the vision will not be realized.

Key features of this report

• Highlight some of the key technologies for imaging biomarker development in different research or clinical settings, as well as pivotal technology developments.
• Analysis of the potential for using these technologies to improve drug discovery and clinical trials. The different organizational structures within pharmaceutical companies are discussed.
• Analysis of imaging biomarkers currently used in clinical practice as well as the future of imaging biomarkers in this setting.
• Case studies of individual imaging biomarkers and the companies or research collaborations responsible for their development.

Scope of this report

• Identify key technologies for development of imaging biomarkers to assist in biomarker discovery and development
• Identify the relevance of imaging biomarkers to drug discovery and development and the different organization structures being adopted by pharmaceutical companies to the implement them
• Learn about the important efforts of public-private consortia that are working to develop new imaging biomarkers, qualify existing imaging biomarkers and develop standards and clarify qualification processes
• Understand the potential for imaging biomarkers to improve diagnostic processes, enabling earlier disease identification and promoting preventive medicine
• Discover the potential of imaging biomarkers for improving decision making and terminating unsuitable drug projects at an early stage, as well as reducing costs in clinical care

Key Market Issues

• Improvements to the drug discovery and development process are needed urgently: Imaging biomarkers can be applied across the spectrum of drug discovery and development activities for validating targets, confirming mechanism of action, obtaining early indicators of bioactivity, assessing pharmacokinetic profiles, providing prognostic indicators and supporting regulatory filings and will help to improve decision making and success rates.
• Improved, non-invasive clinical diagnostic tools are required to help reduce the rising costs of health care: Currently around 95% of healthcare costs go towards treatment rather than prevention. However, if more money was spent on effective prevention the economic benefit could be considerable. Imaging biomarkers may provide diagnostic tools that identify diseases earlier in their pathology, enabling preventive measures to be taken.
• The development of imaging biomarkers relies on quantitative methods: whilst some imaging modalities are quantitative already, such as PET, others require specialist software or must be developed to incorporate quantification. Imaging technology developers are actively working in this field.
• The development, validation and qualification of imaging biomarkers is a large task: collaborative efforts that involve all stakeholders will be required if the full potential of imaging biomarkers in clinical medicine is to be realized.

Key findings from this report

• Imaging biomarkers are attractive: and are now widely used in drug discovery development and in clinical care. Imaging biomarkers provide non-invasive approaches that are translatable from the laboratory to the clinic and allow researchers and clinicians to see in great detail how drugs are behaving in vivo.
• Image quantification is improving: Nuclear imaging methods – PET and SPECT – are some of the most important to the field of imaging biomarkers because they have the required sensitivity and are potentially quantitative. The development of new molecular imaging probes is a growing and exciting area. MRI has limitations in terms of sensitivity as opposed to nuclear methods, although the methods are often non-proprietary and more MRI scanners are available in clinical practice. Sensitive contrast agents for MRI need to be very sophisticated. Future improvements in sensitivity, computer aided diagnostics and standardization will improve the potential for imaging biomarkers.
• Small animal imaging is a rapidly growing area in the preclinical development of new pharmaceuticals. Instrumentation to allow CT, PET, SPECT, MRI, ultrasound or optical imaging of small animals is available from a large number of suppliers and the largest pharma companies are actively developing their capabilities in this area. Some large pharma companies have also invested in dedicated clinical imaging centers, while others have chosen to outsource to specialist academic centers.
• In the clinical setting, MRI represents the most highly utilized technology and includes the diversity of methods available under the MRI banner, such as MRS, DCE-MRI, diffusion weighted MRI, fMRI and arterial spin labeling. The wide availability of MRI machines in hospital settings and imaging centers also makes this an attractive technique for biomarker detection. The use of nuclear imaging methods, such as PET and SPECT, is growing. This is catalyzed by the growing availability of targeted ligands that highlight particular pathways or metabolic events.

Key questions answered

• What has driven the increasing interest in imaging biomarkers in recent years?
• Which imaging modalities are at the forefront of the effort to develop and utilize imaging biomarkers for clinical practice now and in the future?
• To what extent can imaging biomarkers improve drug development? At which points should they be utilized and how?
• What is the role of public-private consortia in driving the discovery of methods and biomarkers? What is the membership of these consortia, what are their goals and how much have they achieved to date?
• What improvements in the provision of imaging services are required to enable the future use of imaging biomarkers? How does this differ in different locations?

Table of Contents

Advances in Imaging Biomarkers

Executive summary 10

Introduction 10

Imaging biomarkers: discovery, development & supporting technologies 11

R&D applications of imaging biomarkers 12

Clinical applications of imaging biomarkers 13

Informatics supporting the clinical application of imaging biomarkers 14

Imaging centers 15

Validation, qualification and regulation of imaging biomarkers 16

The future of the imaging biomarker market 17

Chapter 1 Introduction 20

Summary 20

Introduction 21

Overview of imaging modalities 21

Imaging biomarkers in research and clinical practice 26

Prognostic imaging biomarkers 28

Imaging biomarkers of response 28

Imaging biomarkers of efficacy and dosing 29

Imaging biomarkers of safety 30

Therapeutic areas 30

Importance of imaging biomarkers 30

Report outline 32

Chapter 2 Imaging biomarkers: discovery, development & supporting technologies 34

Summary 34

Discovering and developing new imaging biomarkers 35

Advances in imaging technologies and molecular probes 37

Molecular imaging probes 38

NIH-sponsored projects driving molecular imaging 39

Accessibility of molecular imaging probes for PET imaging 40

Combined imaging modalities 42

Technical advances in the field of MRI 43

High field MRI 43

Functional MRI 43

Magnetic resonance spectroscopy 44

Diffusion weighted MRI 45

Targeted probes for MRI 46

Improving MRI resolution with hyperpolarization 46

Spectral CT 50

Advances in optical imaging 51

Photoacoustic imaging 51

Conclusions 52

Chapter 3 R&D applications of imaging biomarkers 54

Summary 54

Introduction 55

Imaging biomarkers in drug discovery 56

Imaging biomarkers in preclinical development 57

Molecular imaging in preclinical development 58

Imaging toxicity in the preclinical setting 60

Preclinical optical imaging 61

Imaging biomarkers in clinical drug development 61

Imaging biomarkers in Phase 0 clinical studies 62

Imaging biomarkers in Phase I and II clinical trials 63

Imaging in late stage clinical trials 64

Imaging in clinical studies in oncology 65

Imaging biomarkers in clinical studies of CNS therapeutics 65

Imaging in cardiovascular clinical trials 66

Pharma’s imaging centers 67

Case study: the GlaxoSmithKline Clinical Imaging Centre 67

Case study: imaging biomarker development at AstraZeneca 68

Contract research organizations for imaging clinical trials 68

The Society for Nuclear Medicine’s Clinical Trials Network 69

Pre-competitive consortia developing imaging biomarkers 70

The Biomarkers Consortium 71

Conclusion 74

Chapter 4 Clinical applications of imaging biomarkers 78

Summary 78

Introduction 79

Imaging biomarkers in clinical practice: oncology 81

Breast cancer screening with mammography 81

Established imaging biomarkers for oncology 82

Molecular imaging biomarkers for cancer diagnosis, prognosis and treatment monitoring 83

Molecular imaging for HER-2 screening and treatment response 87

18F-HX4 (Siemens) 88

18F-ML-10 (Aposense) 89

Cell>Point imaging biomarkers for SPECT 91

Collaborative efforts to develop novel imaging biomarkers at the

Centre for Translational Molecular Medicine 92

Case study: the Cancer Imaging Program, National Cancer Institute 93

Future growth in MRI-based diagnostic imaging biomarkers 94

Imaging biomarkers in clinical practice: neurology 95

Imaging biomarkers for Alzheimer’s disease diagnosis and treatment monitoring 96

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) 96

Commercial PET ligands in development for AD diagnosis 98

Imaging biomarkers for Parkinson’s disease 102

Imaging biomarkers in clinical practice: cardiovascular disease 104

AdreView (123I-Iobenguane); GE Healthcare 106

KI-0002: Kereos 108

BMS747158; Lantheus Medical Imaging 109

CardioPET, BFPET and VasoPET; FluoroPharma 110

ThromboView (Agen Biomedical) 112

Imaging biomarkers in clinical practice: metabolic disorders 113

Conclusion 113

Chapter 5 Informatics supporting the clinical application of imaging biomarkers 116

Summary 116

Software innovation improving the discovery of imaging biomarkers 117

Pattern recognition and image analysis 117

Management of digital images 120

Medical imaging informatics and networking 120

Teleradiology 121

Conclusion 122

Chapter 6 Imaging centers 126

Summary 126

Imaging centers 127

Imaging in the US 128

Quality 129

Appropriateness 129

Reimbursement 130

Imaging in the UK 131

Imaging in India 134

Accessibility of radiopharmaceuticals 135

PET 135

SPECT 136

Conclusions 137

Chapter 7 Validation, qualification and regulation of imaging biomarkers 140

Summary 140

Introduction 141

Image quantification and standards 143

The Quantitative Imaging Biomarkers Alliance 144

Imaging biomarker qualification 146

Drug-diagnostic co-development 150

Regulatory guidelines for developing novel molecular imaging agents 150

Case study: 18F-labeled sodium fluoride 152

Conclusions 153

Chapter 8 The future of the imaging biomarker market 156

Summary 156

Introduction 157

Trends in the use of imaging biomarkers in R&D 158

Imaging clinical trials in drug development 158

Saving costs 161

The future: imaging biomarkers and companion diagnostics 162

Trends in the clinical use of imaging biomarkers 164

Prevention and prediction 164

Radiation exposure 165

Costs and reimbursement 167

Imaging biomarker market 170

Overall conclusion 174

Appendices 175

Primary research methodology 175

Glossary 175

Acknowledgements 181

Index 182

Bibliography & Endnotes 184

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