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Advancing Global Drug Development: ICH Harmonization Perspectives

Explore the impact of ICH Harmonization on global drug development, focusing on data acceptability, trial factors, and regional differences, with key insights from FDA, EMEA, Japan, and Asia. Gain knowledge on risk-benefit assessment, market positioning, and the significance of global data diversity towards drug approvals.

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Advancing Global Drug Development: ICH Harmonization Perspectives

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  1. ICH Harmonization The Basis of Global Drug Development Eric W. Lewis, MD GlaxoSmithKline October 3rd, 2002

  2. ICH Harmonization - Globalization - The Present(Europe & US) • FDA & EMEA readily accept data generated in the US/EU for use in registration • Most experience from US, Canada, & Europe • Little Asian experience • Differences may exist in the Risk Benefit Assessment • Differences may exist with respect to “Positioning” in the market

  3. ICH Harmonization - Globalization - The Present(FDA - Global Data) • Important factors for acceptability of data are: • Design of trial • Conduct of the trial • Quality of the data • Not important: • Location of trial

  4. ICH Harmonization - Globalization - The Present (Japan – Global　Data) • Six drugs approved based upon “prospective” bridging • 1 non-sedating antihistamine • 2 migraine • 1 influenza • 2 cancer • Four drugs approved or nearing approval but information lacking

  5. ICH Harmonization - Globalization - The Present (Japan Global　Data) • Let us bear in mind... • 4/6 are “intermittent” therapy • 4/6 are not for chronic diseases like • Hypertension, Hyperlipidemia and other chronic diseases • CCDP included a considerable amount of Japanese data

  6. ICH Harmonization - Globalization - The Present (FDA – “Asian” Data) • New Indication for Kytril recently approved by FDA • PONV • Japanese • European • Iressa (gefitinib) • NSCLC • Pivotal US Study • Global Supportive Study ( 50% Japanese)

  7. ICH Harmonization - Globalization - The Present • Concluding Comments • Globalization of data occurring • Ethnicity is often more spiritual than physical • We are all individuals

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