This report discusses advances in key technologies, the use of imaging biomarkers in drug discovery and development and current use in clinical practice.

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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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