Stephen T Holgate, Faculty of Medicine, University of Southampton

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Stephen T Holgate, Faculty of Medicine, University of Southampton. Personalized medicine for the European Citizen. [email protected] But we now face very serious problems: Reductionist models are failing to account for much of the chronic inflammatory and degenerative disease facing society. - PowerPoint PPT Presentation

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How research contributes to improving health strategies in lung diseases

Stephen T Holgate,Faculty of Medicine,University of Southampton

[email protected]

Personalized medicine for the European Citizen

Medicine became a science by combining clinical observation with pathology and function and through the application of chemical, biological and physical sciences.William Osler: the Father of modern medicine

But we now face very serious problems:

Reductionist models are failing to account for much of the chronic inflammatory and degenerative disease facing society.

These non-communicable diseases are increasing as we survive longer and as developing nations adopt aspects of the Western lifestyle.

After years of improvement in public health, lifestyle influences (sedentary, smoking, diet, recreational drugs, stress ), especially on the young are creating a health time-bomb in NC diseases (e.g. cancer, obesity, diabetes, hypertension, COPD, asthma).

Unsustainable drug development industry based on blockbuster, one size fits all business model.

2R&D for a New Medicine: 10+ years, $1 bn+Source: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org;

IndefiniteDrug DiscoveryPreclinicalClinical TrialsRegulatoryReviewScale-Up to ManufacturePost-MarketingSurveillance1Approved NewMedicine0.5 2 Years6 7 Years3 6 YearsNumber Of Patients / SubjectsPhaseIPhaseIIPhaseIII5250~ 5,000 10,000CompoundsPre-Discovery20 100100 5001,000 5,000IND SubmittedNDA SubmittedDrug discovery: a big challenge for addressing both developed and developing world diseases Set against this is:

The explosion of new technology to interrogate complex cellular processes the omics (genomomics, transcriptomics, proteomics, epigenomics, microbiomics, metabolomics) and the exposome.

New non-hierarchical approaches to phenotyping complex disease (e.g. cluster analyses, machine learning).

Applications of informatics to interrogate large data-sets from biological collections, clinical trials and linked population-based case records and prescribing practice.

33The Changing Focus of Healthcare:

Information and knowledgeHealth practitionerPatientInformation and knowledgePatientHealth practitionerMassive cultural change to shift focus to pulling patients through whole pathways not just managing stages of diagnosis and treatment The emergence and rapid developmental evolution of omics technology platforms

Next GenomicsThe omics cascadeWhat can happen

What appears to be happening

What makes itHappen

What has happened & is happening

The plummeting cost of complete genome sequencingTowards the $1000 genomeHow do these developments impact upon healthcare and drug development?Days in Active TreatmentMalmstrom et al. Ann Intern Med. 1999; 130: 487-95. Comparison of inhaled corticosteroid, leukotriene receptor antagonist and placebo in asthmatic patients (15 Years) not controlled on as required inhaled b2-agonists bronchodilators

-100102030405013579111315171921am-PEF(Mean ChangeFrom Baseline; L/min SE)BeclomethasoneMontelukastPlaceboP