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The pharmaceutical R&D process

10-12 years, costly ($30 Mn – $1300Mn). The pharmaceutical R&D process. Development. Discovery. Use. Discovery research = innovative part. development. Compound libraries. Drug candidate. Risks in research and development of pharmaceutical drugs. Reasons for failure include:

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The pharmaceutical R&D process

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  1. 10-12 years, costly ($30 Mn – $1300Mn) The pharmaceutical R&D process Development Discovery Use

  2. Discovery research = innovative part development Compound libraries Drug candidate

  3. Risks in research and development of pharmaceutical drugs • Reasons for failure include: • Lack of bioavailability • Toxicity • Lack of efficacy • But also: • Patent position • Market prospect / competitors • Mergers/acquisitions development

  4. Therapeutic innovation :many different ways to innovate including new or better uses of existing molecules / treatments • Existing compounds: Library screening & compound mining • New compounds through medicinal chemistry • New uses of existing compounds • New indications of existing drugs • Improved formulationsof existing drugs • Completing registration dossier • Geographical extension • Combination treatments • Simplifying use • Changing guidelines • EML

  5. Compound mining:creative utilization of existing knowledge Nitroimidazoles: rediscovered drug candidates for protozoal diseases Extensive literature / patent review, including personal consultations with researchers (previously) active on this class of compounds to uncover possible compounds of interest >600 compounds identified from >15 sources; assessed in in vitro / in vivo disease models; several series with promising activity identified 1 new drug candidate in clinical development for sleeping sickness: fexinidazole (off-patent):

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