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

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

  • Published: July 2010
  • 198 Pages
  • Scripp Business Insights

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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 READ MORE >

Executive summary
Introduction
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

Chapter 1 Introduction
Summary
Introduction
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

Chapter 2 Imaging biomarkers: discovery, development & supporting technologies
Summary
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
Conclusions

Chapter 3 R&D applications of imaging biomarkers
Summary
Introduction
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
Conclusion

Chapter 4 Clinical applications of imaging biomarkers
Summary
Introduction
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
Conclusion

Chapter 5 Informatics supporting the clinical application of imaging biomarkers
Summary
Software innovation improving the discovery of imaging biomarkers
Pattern recognition and image analysis
Management of digital images
Medical imaging informatics and networking
Teleradiology
Conclusion

Chapter 6 Imaging centers
Summary
Imaging centers
Imaging in the US
Quality
Appropriateness
Reimbursement
Imaging in the UK
Imaging in India
Accessibility of radiopharmaceuticals
PET
SPECT
Conclusions

Chapter 7 Validation, qualification and regulation of imaging biomarkers
Summary
Introduction
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
Conclusions

Chapter 8 The future of the imaging biomarker market
Summary
Introduction
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

Appendices
Primary research methodology
Glossary
Acknowledgements
Index
Bibliography & Endnotes

List of Figures
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

List of Tables
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

- 3mensio Medical Imaging BV
- Abbott
- Ablynx
- Advanced Biomarker Technologies
- Advion BioSystems
- Affibody
- Agen Biomedical
- Alma IT systems
- Alseres Pharmaceuticals
- AnalyzeDirect Inc
- Aposense
- AstraZeneca
- Avid Radiopharmaceuticals
- Bayer Healthcare
- Beckman
- Bio-imaging Technology Inc
- Bracco
- Bristol-Meyers Squibb
- Caliper Life Sciences
- Cell Point
- Claron Technology Inc
- Cubist Pharmaceuticals
- Definiens AG
- Eli Lilly
- Endra Life Sciences
- Enlight Biosciences
- Epix Pharmaceuticals
- EUSA Pharma
- FluoroPharma
- GE Healthcare
- Genentech
- Geometric Ltd
- GlaxoSmithKline
- Guerbet
- Hologic Inc
- IBA (Ion Beam Applications)
- iCAD Inc
- ICON Medical Imaging
- InHealth
- Intrasense
- Invitrogen
- Invivo Corporation
- Johnson & Johnson
- Kereos
- Kodak
- Lantheus Medical Imaging
- Macrocyclics
- MDS Nordion
- Medipattern Corporation
- Merck & Co
- Molecular Insight Pharmaceuticals
- Nighthawk Radiology Holdings
- Nordic Imaging Lab AS
- Novartis
- Perceptive Informatics
- Perkin Elmer
- Pfizer
- PharmTrace
- Philips Healthcare
- Pie Medical Imaging
- ProScan
- RadPharm
- Siemens
- Synarc
- Synosia Therapeutics
- TeraRecon Inc
- Thermo Fisher Scientific
- Virtual Radiologic
- VirtualScopics
- Wilex AG
- Xceleron

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