Imagination at work.
Alex Gibson, Head of Research Alliances GE Healthcare Life Sciences
Life Sciences - Enabling Development & Production of Future Medicines
RESEARCH INSTRUMENTS & CONSUMABLES
REGENERATIVE MEDICINE & CELL TECHNOLOGIES
BIOPROCESSING CAPACITY & CAPABILITY
MOLECULAR & IN-VITRO
DIAGNOSTICS
CLINICAL IMAGING
DISCOVERY PRE-CLINICAL &
CLINICAL DEVELOPMENT
APPROVAL & COMPANION DIAGNOSTICS
THERAPY SELECTION & MONITORING
3 JSB Earnings 101714
GE Healthcare Life Sciences Addressing tomorrow’s needs today
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Enabling Precision Medicine with Precision Diagnostics
Industrializing Tools & Systems for Regenerative Medicine
Enabling Biotech and Pharma Research
Driving Biopharma
Capacity & Productivity
Biopharmaceutical market growing 8% CAGR (‘12-’16F)
6 of the top 10 drugs are Biopharmaceuticals
Emerging market demand for diagnostics & biopharma manufacturing
Precision medicine in the future
A century of ‘mass market’ medicine comes to an end…
Moving to ‘personalized’ patient-based decisions
Precision medicine needs precision diagnostics and uses all available clinically useful data
Typically 40% to 75% of cancers do not
respond to bio-marker targeted therapies
Match a patient’s disease to the best
diagnosis & treatment
Therapies should have an accompanying
biomarker
Biomarker combinations & multiple-
parameter tests increase response rates
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Clinical evidence-based value & utility will detemine price Development cost in
evidence generation Must serve global patient, not just US & Europe
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From content – in vivo and in vitro information (e.g., biomarkers, companion diagnostics)
And generated by technology (e.g. PET, sequencing, Multiomyx) and analytics (e.g. bioinformatics, integrated reporting)
What Are ‘Precision Diagnostics’?
‘Precision diagnostics’ = actionable diagnostic information that enables precision medicine
From single biomarkers to integrated data
Why Precision Diagnostics?
To enable:
Earlier & more accurate diagnoses- often before symptoms develop
Treatment that is right for the individual
Improved compliance and outcomes
System savings of $ billions in unnecessary tests and ineffective treatment
Pharma to conduct smaller, faster, cheaper & more successful clinical trials
Quality… Affordability…Access
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Demand From Driven By
• Physicians • Complexity
• Patients • Outcomes
• Payors • Cost
• Pharma • New therapy development
Diagnostic data get more complex … but can provide far better therapy guidance than ever before
Personalized Medicine
“Relatively Easy” Dx • Single Sample • Single Result
• Single Interpretation
• Lower value/reimburse.
• Low hurdle reg. approv.
“Complex” Dx • Multi-omics
• Multiplexed
• Multisource interpretation
• High Value/reimburse. risk
• Regulated based on risk
Is there something?
Molecular pathway?
Which stage?
Which subtype?
What is it?
Risk profile?
Which treatment will work?
Is it under control?
The Past The Future
Diagnostics for Successful Therapeutic Outcome
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Precision Dx technology offerings
Global Challenges Clinical Utility
DMD Availability Reimbursement
Dementia Landscape – rapidly developing
0
10
20
30
40
50
60
70
N u
m b
e r o f d r
u g
s
Phase 1
Phase 2
Phase 3
Launched
NT Release
Amyloid Modulator
Tau Modulator
Unknown Neuro Protection
Market Feedback: • Disease modifying drugs (DMD) struggle to
reach market; no objective criteria • Biomarker Diagnostics without therapy is
challenging
• Diagnostics are failing to get reimbursement • Therapy without Biomarker Diagnostics is
challenging
• Both Pharma and Imaging need a model to work together to accelerate products
Improved patient outcomes increasingly dependent on combination diagnostic & therapy Pharma & diagnostic industry need to collaborate to pro-
actively manage care across disciplines
For Neuroscience research, anatomical location makes PET neurology imaging a natural companion to therapy development
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Improved patient outcomes at lower
cost
Assess multiple parameters
• e.g. Lesion size, fuzzy vs. smooth edges, composition
Combine with in-vitro and other patient data
Demonstrate clinical utility
Take net-cost out of the care pathway
Precision Diagnostics
GE’s MultiOmyxTM
Multi-molecular multiplexing
Assess proteins & other molecules
(DNA) at a single-cell level
Maximizes limited tissue sample examining < 175 proteins
1st offered in Hodgkin’s Lymphoma
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Enable clinical development Better patient selection & target engagement
Better understanding of PK/PD parameters
Companion diagnostic development
Competitive differentiator Better knowledge of disease & improved health
economics
Better therapeutic efficiency & improved reimbursement
Participate in value creation Directly influence diagnostic R&D and invest in segment
of future growth
GE PET tracers in amyloid, tau & neuro-inflammation
Precision diagnostics enables therapeutic development
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The Benefits of the Neuroincubator R&D Past vs Present
Discovery Clinical Trials
Clinical Research
Clinical Product
PET Amyloid - DMD studies started just before approval
2000 2002 2003 2005 2007 2009 2010 2012 2008 2011 2013
Discovery
Pittsburgh
PiB / F-18
In-licensing
Phase I
(2007/8)
Approval
Oct ’13
Phase II
(2008/9)
Phase III
(2009 - 11)
Discovery Clinical Research Clinical Trials
Clinical Product
PET Tau – DMD studies could start during PoC (phase II)
Support DMD
Devt.
AIM: Support DMD Development
10+ years at GE
Earlier Access to PET Tau ligand for DMD Development Studies
Neuroincubator
Clinical Potential But … Uncertainty
Proven Clinical Application
Neuroincubator
GE Healthcare Life Sciences –Core Imaging R&D
Pharma
Materials, methods, licenses, know-how Data, clinical
insight
Academics
• Open Innovation model with early and broad access to GEHC PET tracers to
enable investigator-led clinical research
• Three tracers currently available: GE-179 NMDA, GE-180 Neuroinflammation,
GE-216 (THK5351) Tau
Collaborative groups to accelerate qualification for therapeutic drug development
Opportunity for research community to access interesting research tools early to explore multiple applications
Autologous Therapy – Emerging Therapeutic Modality
Autologous Therapies
Scale out
Tissue
Engineering
Cellular
Immunotherapy
Gene
Therapies
iPSCs
Big Data
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Data data everywhere… 1750-present
1750 Industrial Revolution
1950
continuous combustion engine that is the basis for the gas turbine
1750-1950: Rise industrial machines, fleets and networks
1965-1980 Creation of ArpaNet and other precursors to the Internet
1990-2010: Rise of personal computers; World Wide Web, private networks; e-commerce and eventually social media
Big data and the cloud emerge
Internet Revolution
1960 2010
1950s: Rise of Mainframe computers
2012-and beyond: Expansion of the Internet across industrial enterprises
Intelligent devices
Intelligent networks
Intelligent automation
Industrial Internet
Future
networks
Advanced machines
Fleets
Historic Waves of innovation and productivity
Global data boom
55% of the datacenters that will be processing data
around the world in 2025 have not yet been built
Data production will be 44X greater in 2020 than it was
in 2009
Big data market estimated to be $16.9B in 2015
Source: IDC
Source: Wikibon
Precision Dx + Big Data + Industrial Internet
Integrate huge diverse data sets
Transform multiple data sets into actionable information
Analytics to enable sharper insights & improve performance
Unexpected insights & gains become commonplace
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All the available relevant data to make the best possible decision for this patient now
Radiology
Risk profile
Family history
Medical records
Behavioural data
In-vitro diagnostics
Genomic sequencing
Pathology & tissue analysis
Multi-drug interaction data
Long-term population outcomes
Aggregated Google search data?
What more? 22
Precision medicine makes non-clinical demands
Physician & patient care
Understand
complex Dx
pathways
Effective use of
clinical decision
tools
Payor & policymaker
Forward-thinking
proactivity in
approvals
Holistic health-
economic
thinking
Pharma & biotech
Re-think R&D,
and partnership
More openness &
collaboration
Demonstrate
real value
Title or Job Number | XX Month 201X 23
Innovate, refine, improve, collaborate
Alex Gibson – Head of Research Alliances Core Imaging R&D [email protected]