Advances in Imaging Biomarkers: Innovative Technologies, Applications in R&D and Clinical Practice, and Informatics and Regulatory Requirements

Date: July 22, 2010
Pages: 198
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)

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Advances in Imaging Biomarkers: Innovative Technologies, Applications in R&D and Clinical Practice, and Informatics and Regulatory Requirements
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?
Advances in Imaging Biomarkers
Executive summary
Imaging biomarkers: discovery, development & supporting technologies
R&D applications of imaging biomarkers
Clinical applications of imaging biomarkers
Informatics supporting the clinical application of imaging biomarkers
Imaging centers
Validation, qualification and regulation of imaging biomarkers
The future of the imaging biomarker market


Overview of imaging modalities
Imaging biomarkers in research and clinical practice
Prognostic imaging biomarkers
Imaging biomarkers of response
Imaging biomarkers of efficacy and dosing
Imaging biomarkers of safety
Therapeutic areas
Importance of imaging biomarkers
Report outline


Discovering and developing new imaging biomarkers
Advances in imaging technologies and molecular probes
Molecular imaging probes
NIH-sponsored projects driving molecular imaging
Accessibility of molecular imaging probes for PET imaging
Combined imaging modalities
Technical advances in the field of MRI
High field MRI
Functional MRI
Magnetic resonance spectroscopy
Diffusion weighted MRI
Targeted probes for MRI
Improving MRI resolution with hyperpolarization
Spectral CT
Advances in optical imaging
Photoacoustic imaging


Imaging biomarkers in drug discovery
Imaging biomarkers in preclinical development
Molecular imaging in preclinical development
Imaging toxicity in the preclinical setting
Preclinical optical imaging
Imaging biomarkers in clinical drug development
Imaging biomarkers in Phase 0 clinical studies
Imaging biomarkers in Phase I and II clinical trials
Imaging in late stage clinical trials
Imaging in clinical studies in oncology
Imaging biomarkers in clinical studies of CNS therapeutics
Imaging in cardiovascular clinical trials
Pharma’s imaging centers
Case study: the GlaxoSmithKline Clinical Imaging Centre
Case study: imaging biomarker development at AstraZeneca
Contract research organizations for imaging clinical trials
The Society for Nuclear Medicine’s Clinical Trials Network
Pre-competitive consortia developing imaging biomarkers
The Biomarkers Consortium


Imaging biomarkers in clinical practice: oncology
Breast cancer screening with mammography
Established imaging biomarkers for oncology
Molecular imaging biomarkers for cancer diagnosis, prognosis and treatment monitoring
Molecular imaging for HER-2 screening and treatment response
18F-HX4 (Siemens)
18F-ML-10 (Aposense)
Cell>Point imaging biomarkers for SPECT
Collaborative efforts to develop novel imaging biomarkers at the
Centre for Translational Molecular Medicine
Case study: the Cancer Imaging Program, National Cancer Institute
Future growth in MRI-based diagnostic imaging biomarkers
Imaging biomarkers in clinical practice: neurology
Imaging biomarkers for Alzheimer’s disease diagnosis and treatment monitoring
The Alzheimer’s Disease Neuroimaging Initiative (ADNI)
Commercial PET ligands in development for AD diagnosis
Imaging biomarkers for Parkinson’s disease
Imaging biomarkers in clinical practice: cardiovascular disease
AdreView (123I-Iobenguane); GE Healthcare
KI-0002: Kereos
BMS747158; Lantheus Medical Imaging
CardioPET, BFPET and VasoPET; FluoroPharma
ThromboView (Agen Biomedical)
Imaging biomarkers in clinical practice: metabolic disorders


Software innovation improving the discovery of imaging biomarkers
Pattern recognition and image analysis
Management of digital images
Medical imaging informatics and networking


Imaging centers
Imaging in the US
Imaging in the UK
Imaging in India
Accessibility of radiopharmaceuticals


Image quantification and standards
The Quantitative Imaging Biomarkers Alliance
Imaging biomarker qualification
Drug-diagnostic co-development
Regulatory guidelines for developing novel molecular imaging agents
Case study: 18F-labeled sodium fluoride


Trends in the use of imaging biomarkers in R&D
Imaging clinical trials in drug development
Saving costs
The future: imaging biomarkers and companion diagnostics
Trends in the clinical use of imaging biomarkers
Prevention and prediction
Radiation exposure
Costs and reimbursement
Imaging biomarker market
Overall conclusion
Primary research methodology
Bibliography & Endnotes


Figure 1.1: Imaging techniques and their uses
Figure 1.2: Imaging biomarkers in drug development and clinical care
Figure 1.3: Types of biomarker and their uses in drug development and disease management
Figure 1.4: The potential of imaging biomarkers
Figure 2.5: Examples of imaging biomarkers in oncology
Figure 2.6: Steps in biomarker development
Figure 2.7: Functional magnetic resonance imaging of the brain
Figure 2.8: Diffusion MRI - CNS
Figure 2.9: Images of the lungs with conventional MRI and hyperpolarized gas MRI
Figure 2.10: Schematic of Spectral CT technology
Figure 3.11: Pharma industry productivity decline, 2000-2009
Figure 3.12: Uses of imaging in preclinical drug development
Figure 3.13: Areas of interest for the Society for Nuclear Medicine’s Clinical Trials Network
Figure 3.14: The ‘learn and confirm’ model of drug discovery and development
Figure 4.15: Imaging modalities for biomarker detection in oncology, neurology and cardiology
Figure 4.16: Chemical structure of 18F-ML-10 (Aposense)
Figure 4.17: Structures of PET ligands for Alzheimer’s disease diagnosis
Figure 4.18: Structures of norepinephrine and AdreView
Figure 4.19: Results of the primary endpoint in the ADMIRE-HF study of AdreView (GE Healthcare)
Figure 4.20: Kereos’ targeted nanoparticles
Figure 4.21: PET images obtained during the Phase I study of CardioPET (FluoroPharma)
Figure 6.22: Impact analysis of the CMS 2010 Physician Fee Schedule Final Rule Summary on global imaging payments
Figure 6.23: CT, MRI and radio-isotope procedures carried out in the UK annually
Figure 6.24: Locations of static PET scanners in the UK
Figure 6.25: Commercial delivery of 18FDG in the British Isles
Figure 7.26: Evolution of biomarkers: towards clinical utility
Figure 7.27: Imaging biomarker qualification
Figure 7.28: ‘Fit-for-purpose’ qualification of biomarkers
Figure 7.29: Pilot biomarker qualification process
Figure 8.30: Key stakeholders in the development and use of imaging biomarkers
Figure 8.31: Key factors in the shift towards preventive and predictive medicine
Figure 8.32: Costs related to imaging equipment
Figure 8.33: Imaging biomarkers: lower cost and less invasive than biopsy
Figure 8.34: Drivers and resistors for the imaging biomarker market
Figure 8.35: Drivers for growth in healthcare markets in emerging economies
Figure 8.36: Government healthcare stimulus plans in emerging economies


Table 1.1: Common PET positron-emitting tracer isotopes
Table 1.2: Common SPECT radionuclides
Table 1.3: Advantages and disadvantages of different imaging modalities
Table 2.4: Desirable characteristics of molecular imaging probes
Table 2.5: Academic laboratories researching hyperpolarization in MRI
Table 3.6: Advantages of molecular imaging of whole animals for preclinical studies
Table 3.7: Partners of the Biomarker Consortium
Table 3.8: Imaging biomarker projects being carried out by the Biomarkers Consortium
Table 4.9: Examples of commercial developmental molecular imaging biomarkers in oncology (preclinical)
Table 4.10: Examples of commercial developmental molecular imaging biomarkers in oncology (Phase II, II and III)
Table 4.11: Examples of imaging biomarker clinical trials of the Cancer Imaging Program
Table 4.12: Examples of molecular imaging biomarkers for the diagnosis and management of Alzheimer’s disease
Table 4.13: Examples of molecular imaging biomarkers for the diagnosis and management of Parkinson’s disease
Table 4.14: Examples of commercial developmental molecular imaging biomarkers for cardiovascular disease diagnosis
Table 5.15: Companies developing computer aided diagnostic software
Table 6.16: Predicted growth rates for outpatient MRI and CT in the US, 2008–2013
Table 6.17: The 20 largest academic imaging centers in the US
Table 6.18: Examples of companies supplying PET radiopharmaceuticals
Table 7.19: FDA fee rates ($) for the 2010 financial year
Table 8.20: Examples of the different types of industry clinical trials involving PET
Table 8.21: Examples of the different types of industry clinical trials involving MRI
Table 8.22: Effect of HER2 testing on the development of Herceptin
Table 8.23: Radiation doses from various types of medical imaging procedures
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