Drug Discovery and Preclinical Development

drug Discovery and Preclinical DevelopmentNeal G Simon Ph DNeal G. Simon, of Biological Sciences Disclaimer Thh hkl dd tdi t Those who have knowledge, don t predict. Those who predict, don t have knowledge. Lao Tzu, 6thCentury BC Chinese PoetDiscovery and Preclinical The R&D and TransformationIV. The Preclinical Development ProcessV. Case Study: Stress-related Affective DisordersSerendipity or Good Science: Building OpportunityHoffmanOsterhofI. BackgroundDrug Development ProcessBiopharmaceutical drug Development : Attrition drug DiscoveryPre-ClinicalClinical TrialsFDA ReviewLarge Scale Manufacturing/ Phase IVPhase I20100 Phase IIIubmittedubmitted250 Compounds5 Compounds10,000 Com-1 FDA Ad20-100 Volunteersase1000-5000 VolunteersIND SuNDA Su250 Compounds5 CompoundspoundsApproved DrugPhase II100-5005 years6 years2 years2 years100500 VolunteersQuelle: Burrell Report Biotechnology Industry 2006 Capitalized Cost Estimates per New Molecule*All R&D costs (basic research and Preclinical Development ) prior to initiation of clinical testing** Based on a 5-year shift and prior growth rates for the Preclinical and clinical and Grabowski (2007)II.

Biopharmaceutical Drug Development: Attrition Drug Discovery Pre-Clinical Clinical Trials FDA Review Large Scale Manufacturing / Phase IV Phase I 20 100 Phase III u bmitted ubmitted 250 Compounds 5 Compounds 10,000 Com- 1 FDA Ad - Volunteers 1000-5000 Volunteers IND S NDA S 250 Compounds 5 Compounds u pound s Approved Drug Phase II 100-500

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  Development, Drug, Discovery, Drug development, Drug discovery

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