imaging perspective ge healthcare - efpia.eu€¦ · ge healthcare life sciences accelerating...
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Imagination at work.
Jan Wolber EFPIA Annual Meeting, 5 June 2015
Imaging Perspective GE Healthcare
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$17 Bn global business unit of GE
53,000 employees worldwide
$1 Bn annual investment in R&D
Core strengths in biomedical sciences, technology & business
GE Healthcare
Serving healthcare systems hospitals clinics governments pharmaceutical & biopharmaceutical industries genetics & bio-science researchers academia
EFPIA Annual Meeting | 05 June 2015 2
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GE Healthcare Life Sciences
Accelerating precision medicine with tools for biotechnology R&D, biopharma manufacturing, cell therapy & regenerative medicine, diagnostic imaging, molecular & precision diagnostics
Research & Applied Markets
BioProcess
In Vitro Diagnostics
Core Imaging
Five product business units 10 000 people 100+ countries UK HQ Manufacturing, research & development in US, Europe and Asia
Services
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β-Amyloid PET Imaging in Dementia: The Need for an Innovation Ecosystem
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VIZAMYLTM: β-Amyloid PET Imaging Agent Aβ PET imaging indicates Aβ neuritic plaque density
Title or Job Number | XX Month 201X See tutorial regarding confidentiality disclosures.
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• None or sparse plaque deposition
• Decreases AD likelihood
• Inconsistent with diagnosis of AD
• Moderate or frequent plaque deposition
• May be present in other neurological conditions
• May be present in older people with
normal cognition
• Is an adjunct to clinical evaluations
1. Vizamyl® [package insert]. Arlington Heights, IL: GE Healthcare, Medi-Physics, Inc; 2013.
2. Bacskai BJ, et al. Arch Neurol. 2007;64(3):431-434.
Negative Scan1 Positive Scan1-2
CHMP VIZAMYL opinion/EMA press release
“The benefits with Vizamyl are its ability to help detect with a high accuracy the beta-amyloid deposition, and therefore contribute valuable additional information in the diagnostic process in Alzheimer’s disease.”
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β-Amyloid PET Imaging – The Challenges Individual stakeholders have different needs
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GE Healthcare
•Need to demonstrate utility of β-amyloid PET imaging •Difficult to gain
reimbursement without disease-modifying treatments
Regulatory
authorities
Require evidence to support patient management and diagnostic workflow
Pharmaceutical industry
•Are developing drugs targeting β-amyloid •Need to stratify populations •Need outcome measures • Looking for suitable
biomarkers
Academia
•Conducting clinical research •Seeking access to
imaging agents •Developing other
biomarkers
Payers
Need to see added value of PET imaging; looking for health-economic benefits
Clinicians
•Have medical need for unequivocal diagnosis •Seeking to improve
patient outcomes
Other β-
amyloid PET providers
Similar needs to GEHC
EFPIA Annual Meeting | 05 June 2015
Stakeholders need each other; impossible to create a win-win situation alone
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Clinical and academic research partners
Establishing Utility of β-Amyloid PET Imaging Vision of an integrated approach
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Synergistic value proposition :
• Joined-up approach between
EFPIA companies, Partners in
Research and other collaborators
• Addressing cross-industry needs
(consortium of several EFPIA and
PiR entities)
• Potential for therapeutic &
diagnostic co-development
• Economies of scale
• Enabling synergies with existing
programmes (e.g. clinical cohorts)
• Potential for joint interactions with regulators and payers
EFPIA Annual Meeting | 05 June 2015
Pharmaceutical industry
EFPIA companies
Integration of imaging component through ‘Partners in Research’ mechanism
β-amyloid PET imaging
providers
Partners in Research
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