The Development of New Drug Treatments for Functional Recovery After Neurological Damage Based Upon a Novel Hypothesis Driven-Technological Platform

摘要

The global pharmaceutical industry is facing unprecedented challenges that are increasingly influenced byfinancial, political, demographical and ecological issues. As shown by the significant reduction of new drug applicationsor NDAs (U.S. Food and Drug Administration-approved new molecular entities) in recent years, the industry isprofoundly affected by the increasing cost of development of new drugs, the large number of existing drugs that havebegun to go off patent (reduced revenues), increasingly stringent regulations and corresponding increased developmenttime. As a response, we have created a technological platform aimed at accelerating the development of new drugtreatments for central nervous system indications. It allows a rapid identification of leads and drug candidates suitable forclinical development based upon a novel in vivo drug screening and hypothesis-driven approach that reduces the time ofdrug discovery and development. Furthermore, the platform is adapted to specifically identify synergistic (or new) effectsinduced by combination products with known molecular entities rather than with new molecular entities which reducesrisks and costs of development. In less than five years, we have identified with minimal investment, two (2) combinationproduct candidates for functional recovery after spinal cord injury that are suitable for preclinical and clinicaldevelopment. These results provide evidence suggesting that it is feasible with alternative approaches and small researchfacilities to efficiently identify leads and drug candidates and, thus, to provide the industry with new drug treatmentssuitable for clinical development.