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The Horizons of Predictive Medicine

The Horizons of Predictive Medicine. Dr Ian Gilham Worldwide Director, Predictive Medicine Glaxo Wellcome Research and Development. What is a diagnostic?. “A device or service that provides specific information on the current health status of an individual”. However……….

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The Horizons of Predictive Medicine

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  1. The Horizons of Predictive Medicine Dr Ian Gilham Worldwide Director, Predictive Medicine Glaxo Wellcome Research and Development

  2. What is a diagnostic? “A device or service that provides specific information on the current health status of an individual”

  3. However………... Newer technologies can be used to determine • Predisposition to future change in health status • Monitoring of health status • Suitability for specific medicines A better description would be…...

  4. Predictive Medicine “A device or service that can predict a change in the health status of an individual, either towards the onset of disease or towards the likely response to a therapeutic intervention.”

  5. What is Predictive Medicine? Diagnostics Prognostics Surrogates

  6. 20th Century SYMPTOMS OF DISEASE DIAGNOSTICS (IVD, IMAGING) THERAPEUTIC INTERVENTION OUTCOME

  7. 21st Century PREDISPOSITION PROFILING (GENETICS, FUNCTIONAL GENOMICS) MONITORING AND PREVENTION (BEHAVIOUR MODIFICATION, SURROGATES, VACCINES ETC) DIAGNOSTICS (IVD, IMAGING) TREATMENT SELECTION (PHARMACOGENETICS) THERAPEUTIC INTERVENTION TREATMENT MONITORING (THERAPEUTIC RESPONSE, SURROGATES, COMPLIANCE)

  8. Right Medicine Right Patient Right Disease Right Time Right Dose Right Response PREDICTIVE MEDICINE INNOVATIVE MEDICINES PATIENT-TARGETED THERAPIES

  9. Prediction Prevention The drivers and enablers of Predictive Medicine -- Today -- -- Tomorrow -- • Payer pressures (governments/insurance firms): more prevention, more effective cures • Regulator pressure to try to eliminate adverse events • Demand for better healthcare from the patient • Demand for more accurate healthcare predictions for the patient • Shareholder expectation of growth - getting better medicines to the market faster Diagnosis Drivers Treatment • Development of Genetics and Functional Genomics knowledge • New technologies (e.g. genechips, bioinformatics, molecular diagnostics, etc.) • New regulation on Intellectual Property Rights, genomic ethics, data protection & consent Enablers

  10. Potential areas of interest Genetics Diagnostics Molecular Diagnostics Predisposition Profiling In Vitro Diagnostics Imaging Gene Therapy Monitoring Devices Health Outcomes Population Stratification Non-Therapeutic Intervention Therapeutic Intervention Vaccines Proteins Compliance Pharmacoeconomics Small Molecules Therapeutics Disease Management

  11. Application of Predictive Medicine • Disease Detection • Disease Intervention

  12. Susceptibility Gene Strategy Alzheimer Disease

  13. Human Genetics • Over the past two decades, disease genes have been identified for hundreds of rare, inherited diseases that are seen in families • Susceptibility genes underlie common diseases (e.g. diabetes, heart disease, asthma) • To date, only one susceptibility gene linked to a common, polygenic disease (APOE, Alzheimer)

  14. Glaxo Wellcome Genetics Strategy • To identify susceptibility genes contributing to the risk and age of onset of common diseases with high unmet need • Identify the 20-30 most relevant genes for specific diseases, using genetics and genomic tools. • Focusing to find specific susceptibility genes is the art

  15. Genetics Research - Outcomes Gene Analysis Development of “mechanism-based” medicines Definition of underlying Disease Mechanisms Right medicines to Right Patient Gene Expression Analysis Disease Segmentation Development of Diagnostics to detect Disease segment

  16. Changing technology will accelerate susceptibility gene discovery Current genomic screening technology (today) Database of wellcharacterisedpatients &their DNA Gene - Diseaseassociations Geneticepidemiology Database of geneticpolymorphism and high capacity resequencing technology(in development)

  17. Alzheimer costs a lot today…... • 2.3 million Alzheimer cases in the US • 4% of 75 year olds • 8.5% of 80 year olds • 28.5% of 90 year olds • 360,000 new US cases each year • US costs estimated at $90bn annually Source: Reuters 1998

  18. Alzheimer will cost more tomorrow…. • 1992 - 7.0% of population over 75 years old • 2051 - 13.6% of population over 75 years old • Estimated 7.5m to 14.3m Alzheimer sufferers in the US by 2050 Source: Prevention of Alzheimer Disease JAMA (262): p251

  19. APOE in Alzheimer disease - a susceptibility Gene 1.0 0.8 0.6 0.4 0.2 0 Mean age of onset of Alzheimer disease as a function of the inheritance of the five common APOE genotypes 2/3 2/4 3/3 Proportion of each genotype unaffected 3/4 4/4 60 65 70 75 80 85 90 Age at onset

  20. Significance of APOE • Predictive Medicine • Drug Discovery

  21. Symptomatic Alzheimer Disease Source: Reiman et al NEJM 334 p752

  22. APOE4 Homozygotes Source: Reiman et al NEJM 334 p752

  23. APOE as a Predictive Medicine Tool in Alzheimer Disease • Value in assigning more accurate diagnoses, not simply whether a patient is APOE4 “positive” or APOE4 “negative” • If a patient is cognitively impaired, and fits the current clinical diagnosis of possible AD, the diagnostic accuracy goes from 60-70% to >95% if the patient carries an APOE4 allele

  24. APOE as a potential diagnosticConsiderations • Rigorous test validation • Role of APOE in other neurological conditions • Value of a diagnostic in the absence of an effective therapy • Outcomes analysis • Regulatory considerations

  25. Significance of APOE • Predictive Medicine • Drug Discovery

  26. Disease Mechanism and Target Identification Strategy • Create a transgenic animal with the only difference being the human polymorphism isoform associated with disease • Determing differences in appropriate organs • Differential Gene Expression • Proteomics • Others

  27. APOE KO VS. GeneCalling NORMAL AD “Rescue” Genes APOE GeneCalling Study • APOE knock out (KO) mouse = normal • ID “rescue” genes in APOE KO mouse (compensate for APOE loss)

  28. APOE3 APOE4 APOE GeneCalling Study • APOE3 form = normal • ID mechanism whereby APOE4  AD VS. GeneCalling Other AD Genes

  29. True Value In Treating Disease APOE in Alzheimer Disease Predictive Testing Therapy

  30. Today Tomorrow Prediction Diagnosis Prevention Treatment Summary

  31. What are the consequences to the Global Healthcare? • How will the Healthcare look in the 21st Century? • The gate keeping role of patient-specific information • Selection of intervention method and timing • An integrated health management approach

  32. Summary • Clear trends in Genetics and Predictive Medicine will lead to broader options in therapeutic interventions • Traditional healthcare paradigm will be impacted by new technologies and ever-expanding disease knowledge • An integrated approach could be a key feature of 21st Century Healthcare

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