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Advanced Imaging in Drug Development

Advanced Imaging for Clinical Trials. Examples of advanced imagingTarget-specific PETFLT for cell proliferationCu-64 ATSM for hypoxic regionsAlzheimer-specific amyloid targetingDCE-MRI for anti-angiogenic and vascular destructive agentsMRSLipids for hepatic fat contentGlutamate for glioblast

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Advanced Imaging in Drug Development

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    1. 9/17/2012 1

    2. Advanced Imaging in Drug Development Bruce J. Hillman, M.D., FACR ACR Image Metrix Cambridge, Massachusetts September 2010

    3. Advanced Imaging for Clinical Trials Examples of advanced imaging Target-specific PET FLT for cell proliferation Cu-64 ATSM for hypoxic regions Alzheimer-specific amyloid targeting DCE-MRI for anti-angiogenic and vascular destructive agents MRS Lipids for hepatic fat content Glutamate for glioblastoma Noble gas MRI imaging for destructive lung diseases

    4. Advanced Imaging Unique information to guide drug development Across all therapeutic areas At all phases of clinical research Properly employed imaging: Mechanisms of action Early assessment of effectiveness Fewer subjects Faster trial completion More accurate drug development decisions Lower drug development costs

    5. Imaging Innovation Progressing Rapidly Major shifts in imaging innovation: Gross anatomy/pathology to cellular and subcellular imaging Anatomic to functional imaging General functional imaging to imaging specific targeted receptors Qualitative to quantitative The linking of diagnostics to therapeutics

    6. P4 Medicine Promoting Imaging Innovation Predictive of individual patient risks to support better disease surveillance Preemptive diagnosis and treatment to improve outcomes Personalized diagnosis and treatment based on history and the genome Participatory care in consideration of patient preferences

    7. Imaging and P4 Medicine Predict susceptibility to specific diseases Predict biological aggressiveness/treatability Predict susceptibility to treatment Determine likelihood of toxic effects Monitor response to treatment early and accurately Link surveillance, diagnosis, staging, and treatment in an efficient, convenient, patient friendly paradigm to aid accrual

    8. The Future of Imaging and Trials The year is 2020 26 year old Nancy Wardby evaluated for a trial of pancreas cancer prevention Omniscient exam Safe radiant energy discovered during the 2002-18 Middle East wars Safe gaseous contrast agents

    9. The Omniscient The Omniscient: Predicts predilection for serious disease Determines if the disease is present and biological aggressiveness Stages the extent of disease Predicts whether the experimental agent will be effective No discomfort or convalescence Convenient, one-stop technology for risk assessment through curative treatment Expensive

    10. The Omniscient Omniscient scans become routine practice in clinical trials because Selects subjects At greatest risk of contracting target disease Most likely to need treatment Most likely to respond to the specific therapeutic agent Improves accrual Fewer subjects, faster trials, lower costs

    11. The Benefits of Imaging Applicable across all imaging applications and all therapeutic areas Earlier, more accurate assessment of response Non-invasive and repeatable

    12. Applicable in All Phases Phases I/II Mechanisms of drug activity Evaluate suspected pathways Identify possible alternative applications Insight into efficacy Possible evaluative approaches to later phase trials Key information for go/no go decisions

    13. Applicable in All Phases Phases III/IV Assessment of effectiveness Assessment of safety Surrogate endpoint for FDA submissions RECIST (effectiveness) MRS of hepatic fat content (safety)

    14. The Pharmaceutical Industry Challenge

    15. Imaging and Efficiency

    16. Advanced Imaging for Clinical Trials More effective and efficient clinical trials Requires expertise: Applications and protocol development Technical understanding of acquisition. processing, quality assurance, and interpretation/measurement Normalization Standardization Measurement methods and reduction in variability Sophisticated data extraction tools

    17. An idea can turn to dust or magic, depending on the talent that rubs up against it. - William Berbach

    18. 9/17/2012 18

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