title: Drug discovery and development tomorrow -- changing the mindset.
abstract: Today's drug discovery and development paradigm is not working, and something needs to be done about it. There is good reason to believe that a move away from reliance on animal surrogates for human subjects in the Pharma Industry's R&D programmes could provide an important step forward. However, no serious move will be made in that direction until there is some hard evidence that it will be rewarded with improved productivity outcomes. The Safer Medicines Trust are proposing that a study be undertaken, involving a range of drugs that have been approved for human use, but have subsequently proved to have limitations in terms of safety and/or efficacy. The aim is to determine the efficiency of a battery of human-based test methods to identify a compound's safety and efficacy profiles, and to compare this with that of the more traditional, largely animal-based methods that were employed in their original development. Should such an approach prove more reliable, the authorities will be faced with important decisions relating to the role of human biological test data in regulatory submissions, while the Pharma Industry will be faced with the key logistical issue of how to acquire the human biomaterials necessary to make possible the routine application of such test methods.
authors.affiliation: Consultant, Falmouth, UK. robt.coleman@btinternet.com
authors.forename: Robert A
authors.initials: RA
authors.lastname: Coleman
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D055808:Drug Discovery / Q000941:ethics / Q000639:trends*; D004345:Drug Industry; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D006805:Human Experimentation; D006801:Humans; D035842:Research Subjects; D014019:Tissue Donors; D017211:Treatment Failure