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

Abstract

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