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The development of a drug is a lengthy and expensive process that requires extensive testing of activity and toxicological parameters in different preclinical models, frequently involving in vivo approaches using vertebrate animals before entering in human evaluation. Still, the success rate of drug candidates through clinical trials and reaching the market is low, being only 12% over 20 years with an average cost of $172 million/trial. To efficiently tackle diseases, reduce the disease burden, and help patients faster and more effectively, it is an old demand to find out and implement new mechanisms and strategies to facilitate the decrease of drug development timeframes and costs.
Every year, millions of experimental animals are used all over the world, a debating issue for a long time because of the pain, distress and death experienced by the animals during scientific experiments. Besides the major concern of ethics, there are additional disadvantages of vertebrate animal experimentation like requirement of skilled manpower, time consuming protocols, high costs, and being common the no translation of data to decent correlation with human studies The application of the strategy of 3 Rs, specifically reduction and refinement, is commonly accurately aimed for laboratories using of animals, being the third R, replacement, the most complex to reach because implies the development and application of new approaches. For the last, large efforts on alternative methods, such as in silico and in vitro modeling, or the use of small organisms is pursued trying to recapitulate largely elusive complex and diverse clinical disease parameters.
The FLY3D-ON proposal aims to characterize first-hand protocols and tools for superior supporting to ON-based drug developments. An in-built goal will be facilitating the implementation of the 3Rs, thus looking for significantly reducing experimentation with vertebrate models throughout evaluation programs. Explicitly, the project intends to implement two different tools: (A) the small organism Drosophila melanogaster (fruit fly), and (B) 3D cell cultures focusing on the muscular disease therapeutic area.