China, India and personalised medicine · is ascribed to the financial constraints that are common...
Transcript of China, India and personalised medicine · is ascribed to the financial constraints that are common...
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China, India and personalised medicine
Stuart Hogarth, Department of Social Science, Health and Medicine,
King’s College London
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Overview
• Governing biomedical innovation
• The evolving personalised medicine landscape
• Governance challenges: India and China
– Targeted therapeutics and companion diagnostics
– Early detection/screening
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What’s in a name?
• Personalised medicine
• Stratified medicine
• Precision medicine
• P4 medicine
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What’s in a name
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Changing terminology
pharmacogenomics
pharmacogenetics
personalis/zed medicine
stratified medicine
precision medicine
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pharmacogenomics pharmacogenetics personalis/zed medicine stratified medicine precision medicine
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News coverage Aug 2013- Aug 2015
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Which ‘omics?
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Growth in 'omics research 2000-2014
genomics
proteomics
metabolomics
microbiome
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Genomic determinism
• Cheaper, faster sequencing critical goal
• Will inevitably lead to a revolution in medicine
• One model of implementation – universal incorporation of genome sequence in medical record
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Technological trajectories
• High throughput
– Next generation sequencing
– Microarrays
• Automation
– sample to results
– deskilling
– cost reduction
– POC
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Point of Care DNA Dx
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Targeted Rx + companion Dx
1998 - FDA approval of Herceptin and HercepTest for breast cancer patients with HER2+ tumors
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FDA approved Rx with companion Dx
Non-small cell lung cancer Iressa (gefitinib) Xalkori (crizotinib) Gilotrif (afatinib) Tarceva (erlotinib) Colorectal cancer Erbitux (cetuximab) Vectibix (panitumumab) Ovarian cancer Lynparza (olaparib) Gastrointestinal stromal
tumors Gleevec/Glivec (imatinib
mesylate)
Cystic Fibrosis Kalydeco (ivacaftor) Thalassemia Exjade (deferasirox)
Breast cancer Herceptin (trastuzumab) Perjeta (pertuzumab); Kadcyla (ado-trastuzumab emtansine) Melanoma Mekinist (tramatenib); Tafinlar (dabrafenib) Zelboraf
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Access issues
... an estimated 441 patients were eligible to receive HER2-targeted therapy in the year 2008 in our institution. However, only 8.61% of these patients were able to receive such treatment and nearly half (4.54%) of the HER2-targeted therapy was through patient participation in clinical trials. The low usage of a highly effective treatment is ascribed to the financial constraints that are common in our patients and a healthcare delivery model wherein the majority of patients have no access to any form of health insurance.
Ghosh et al Ind Jnl Cancer, 2011
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GLOBOCAN estimates of worldwide burden of cervical cancer 2008
International Journal of Cancer Volume 127, Issue 12, pages 2893-2917, 17 JUN 2010 DOI: 10.1002/ijc.25516 http://onlinelibrary.wiley.com/doi/10.1002/ijc.25516/full#fig12
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Australia, 1
Belgium, 1 Canada, 2
China, 5
Denmark, 1
France, 1
Germany, 7
Hong Kong, 2
Hungary, 1
Italy, 5
Japan, 3
Netherlands, 3
Norway, 1 Russia, 2
South Korea, 13
Spain, 5
Switzerland, 2
Taiwan, 2
UK, 1
USA, 12
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careHPV
• 2003 - Digene partner with PATH and Bill & Melinda Gates Foundation on test for LMIC
• 2012 – SFDA approve careHPV test for use in China – Stable at extreme temperatures
– Simple robust procedure
– Works in low-resource setting
– Low cost
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The broader medtech market