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Organ Specific Proteomics as Presented by Paul Kearney, PhD; CSO, Integrated Diagnostics at the 2010 Personalized Health Care National Conference at Ohio State.

Organ Specific Proteomics as Presented by Paul Kearney, PhD; CSO, Integrated Diagnostics at the 2010 Personalized Health Care National Conference at Ohio State.

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Organ Specific Proteomics Organ Specific Proteomics Presentation Transcript

  • Realizing P4 Medicine: First Steps
    Paul Kearney, Ph.D.
    President, CSO and Founder
    Integrated Diagnostics
    October 14, 2010
    1
  • Integrated Diagnostics
    Spin out from the Institute for Systems Biology and based in Seattle.
    Founded September 2009 raising $30M in venture capital from InterWest, Wellcome Trust and BioTechCube.
    Focus is on the development of early diagnostics for lung cancer and Alzheimer’s.
    Founding concepts include large scale system measurements and organ-specific proteins.
    2
  • The Power of Vision: The First Step
    3
    enables
    The value of visionary ideas, such as P4 medicine, is that they
    compel us (researchers, policy makers, entrepreneurs, etc.)
    to innovate and take those important first steps to realizing the vision.
    Advances in
    technology, policy, knowledge
    Visionary Idea
    compels/directs
  • The Power of Vision: The First Step
    4
    first steps
    longer term
    The Vision: Location Awareness
    • self-navigating cars
    • Raytheon (1950s)
    Personal GPS Devices
    • car navigation devices
    • cell phone location apps
    • portable devices (iPad)
    GPS ($12B, 1970s)
    • enabling tech
    Google’s self navigating car
  • The Power of Vision: The First Step
    5
    first step
    longer term
    P4 Medicine
    • system wellness assays
    • monitor thousands of markers
    • from a drop of blood.
    ?$
    Today
    The first step is tactical:
    What can we do tomorrow with today’s innovations?
  • Some ‘First Step’ Challenges for P4 Medicine
    6
    Technology
    Technology
    • Need for massively parallel measurements
    • Reducing ‘Loss in Translation’
    Commercialization
    • Developing market channels
    • Working within the existing environment
    • Adoption by clinicians
    Clinical
    • Identifying the right clinical problems
    • Acquiring high value content markers
    • Regulatory hurdles
    P4
    Commercial
    Clinical
    What has Integrated Diagnostics done to address these challenges?
  • Challenge #1: Finding the Right Application
    7
    Determine if a lung cancer lesion detected
    by imaging is benign or malignant.
    Patrick Nana-Sinkham, MD The Ohio State University School of Medicine
  • What Makes This Application Ideal?
    estimated 2.7 million lung lesions are seen by imaging every year in the US
    current protocol is ‘watchful waiting’
    if the lesion grows (operate – ~30% error rate) or
    if the lesion does not grow after 2 years then do nothing (97% of cases; 4-5 CT scans per patient on average)
    hard to biopsy (blood-based Dx test is ideal)
    market research indicates that this is the #1 diagnostic need in lung cancer among pulmonologists (the end-users)
    High unmet need drives
    adoption of new ideas, technologies and solutions.
    8
  • Challenge #2: Intelligently Selecting Markers to Monitor
    1. Lung-specific proteins (expressed only by the lung) *
    Sentinels of system health and disease of the lung only
    Lung-specific proteins are highly modulated by lung disease (statistical disease association analysis across GEO database)
    2. Lung cancer tumor-specific cell surface markers **
    Proteins expressed on the cell-surface of tumor cells but not healthy cells
    Likely to be found in blood.
    3. Lung cancer tumor-specific secreted proteins **
    Proteins secreted by tumor cells but not by normal cells
    Likely to be found in blood.
    9
    Total: ~750 proteins
    * licensed from the Institute for Systems Biology
    ** licensed from Caprion Proteomics
  • Challenge #3: Massively Parallel System Measurements
    Diagnosing/monitoring/treating complex diseases in a complex system (humans) with high population variability requires broad sampling across organs, pathways, biological functions, etc. One gene or one protein is not enough for a high resolution picture of an individual’s state of health.
    Massively parallel biological system queries are going to be the norm for P4 medicine
    10
  • Challenge #3:The Power of Massively Parallel System Measurements
    11
    As the number of random blood analytes profiled increases,
    segregation of healthy and disease type occurs.
  • Challenge #3:Select a Technology that can Assay 750 Proteins
    MRM (Multiple Reaction Monitoring) is targeted, hypothesis driven mass spectrometry
    Focusing resources of the MS on a small number of proteins, not on sample surveys
    Emerging clinical tool pioneered at Institute for Systems Biology
    Largest lung cancer assay ever created (750 proteins)
    12
  • Challenge #4: Avoid ‘Loss in Translation’
    ‘Loss in Translation’ occurs when discovery results cannot be translated into clinical tools.
    discovery technology platforms (e.g. mass spectrometry) differ from commercial platforms (e.g. Luminex assays)
    technologies vary greatly in performance and in what they can detect and measure reliably
    often large panels of discovery-stage markers cannot be translated onto a commercially viable platform because of cost or multiplexing limitations
    Solution: Use the same platform technology (mass spec)
    discovery  validation  commercialization
    13
  • Tactical First Step Solutions
    14
    Market
    Research
    Discovery
    Studies
    MRM Assay Development
    Validation
    Studies
    Commercial-
    ization
    1
    2
    3
    4
    Select an indication of large market size and of high clinical unmet need. Validate with front line clinicians (end-users).
    License large systems-based discovery data sets.
    Select a highly multiplexed technology platform (MRM) that enables massively parallel system measurements.
    Select a technology platform (MRM) that avoids ‘loss in translation’.
    100+ of the 750 MRM assays developed to date (completed in 6 months)
    76% success rate in assay development
    ~ $2000 per MRM assay to develop
    high correlation between discovery data and assay verification data
  • Other Challenges …
    Regulation of IVDMIA Dx tests
    Developing a market channel to end users (e.g. pulmonologists)
    New use of MRM in the clinic (previously only used for single analyte monitoring such as vitamin D levels).
    Working within the existing environment. Who saves and who gains with each P4 innovation?
    15
  • Concluding Remarks
    What are the first steps for the P4 vision?
    What are the demonstration projects?
    What are the emerging technologies that can be leveraged?
    What are the performance measures for P4 Medicine?
    What are the challenges that must be overcome in these demonstration projects?
    16