title: The development of biomarkers to reduce attrition rate in drug discovery focused on oncology and central nervous system.
abstract: BACKGROUND
  The task of discovery and development of novel therapeutic agents remains an expensive, uncertain, time-consuming, competitive, and inefficient enterprise. Due to a steady increase in the cost and time of drug development and the considerable amount of resources required, a predictive tool is needed for assessing the safety and efficacy of a new chemical entity.
  
  
  METHODS
  This study is focused on the high attrition rate in discovery and development of oncology and central nervous system (CNS) medicines, because the failure rate of these medicines is higher than others. Some approaches valuable in reducing attrition rates are proposed and the judicious use of biomarkers is discussed.
  
  
  CONCLUSIONS
  Unlike the significant progress made in identifying and characterizing novel mechanisms of disease processes and targeted therapies, the process of novel drug development is associated with an unacceptably high attrition rate. The application of clinically qualified predictive biomarkers holds great promise for further development of therapeutic targets, improved survival, and ultimately personalized medicine sets for patients. Decisions such as candidate selection, development risks, dose ranging, early proof of concept/principle, and patient stratification are based on the measurements of biologically and/or clinically validated biomarkers.
authors.affiliation: a Department of Biotechnology , Iranian Research Organization for Science and Technology , Tehran , Iran.
authors.forename: Maliheh
authors.initials: M
authors.lastname: Safavi
authors.affiliation: b Faculty of Pharmacy and Pharmaceutical Sciences Research Center , Tehran University of Medical Sciences , Tehran , Iran.
authors.forename: Reyhaneh
authors.initials: R
authors.lastname: Sabourian
authors.affiliation: b Faculty of Pharmacy and Pharmaceutical Sciences Research Center , Tehran University of Medical Sciences , Tehran , Iran.|c Toxicology Interest Group , Tehran University of Medical Sciences , Tehran , Iran.|d Endocrinology & Metabolism Research Institute , Tehran University of Medical Sciences , Tehran , Iran.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Abdollahi
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000494:pharmacology*; D015415:Biomarkers / Q000378:metabolism; D002491:Central Nervous System Agents / Q000494:pharmacology*; D002493:Central Nervous System Diseases / Q000188:drug therapy; D015195:Drug Design; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000188:drug therapy
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers; D002491:Central Nervous System Agents
keywords: Attrition; biomarkers; drug discovery; expert review; oncology and central nervous system