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The development of new therapies has significantly changed during the last years.The complexity of present regulatory demands is different, the development of products has been made global and the number of patients, studies and needs have continuously increased year by year, while the number of approved products continues to diminish, or in best case maintains the same as in the 90s.This situation has made the development of new drugs a real challenge, even for large pharmaceutical companies.Biotechnology companies are even more exposed to this situation, as they mostly have only one or two target compounds and limited financial resources.How can this paradigm be resolved? How are we going to guarantee the future development of treatments? This is a situation in which all the parties involved need to collaborate with a common goal, that is to facilitate the development of new therapies for society.Therefore,the biotechnology and pharmaceutical industry, the investigators and the regulatory bodies need to understand that this is a common team effort against disease, and for the better health of society.The present automated combinatorial chemistry can now synthesize a nearly infinite number of compounds.The problem is narrowing down the possibilities to a reasonable subset to synthesize and screen.The present ratio of success is low, and here is where the better definition of parameters and the development of companion diagnostics especially in oncology products come to improve this ratio.The key objective of translational medicine is to improve the success rate of compounds and biological moving from discovery to the clinic.In short, the goal over the next 10 years will be to turn the existing 80% failure rate into a 80% success rate.The use of the new technologies that are available to challenge this paradigm is probably the better selection and preparation of compounds for the clinical phase.Improved target validation,improved understanding of PD and PK at the molecular target, selection of models with sufficient insight into human disease, patient selection based on genomics, indication of high rate of success for early efficacy and safety based on biomarkers are some of the approaches of modern drug development to better solve this paradigm.