China, India and personalised medicine

Stuart Hogarth, Department of Social Science, Health and Medicine,

King’s College London

Overview

• Governing biomedical innovation

• The evolving personalised medicine landscape

• Governance challenges: India and China

– Targeted therapeutics and companion diagnostics

– Early detection/screening

What’s in a name?

• Personalised medicine

• Stratified medicine

• Precision medicine

• P4 medicine

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

Which ‘omics?

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Growth in 'omics research 2000-2014

genomics

proteomics

metabolomics

microbiome

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

Technological trajectories

• High throughput

– Next generation sequencing

– Microarrays

• Automation

– sample to results

– deskilling

– cost reduction

– POC

Point of Care DNA Dx

Targeted Rx + companion Dx

1998 - FDA approval of Herceptin and HercepTest for breast cancer patients with HER2+ tumors

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

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

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

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

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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