Fax +41 61 306 12 34 E-Mail karger@karger.ch www.karger.com Minireview Nephron Clin Pract 2009;113:c125–c131 DOI: 10.1159/000232592 Drug Development: From Concept to Marketing! Nihad A.M. Tamimi Peter Ellis Pfizer Inc., Sandwich, UK ty and efficacy in the intended patient population and its benefits must outweigh its risks before it will be approved by the regulatory agencies. Strict regulatory standards gov- ern the conduct of pre-clinical and clinical trials as well as the manufacturing of pharmaceutical products. The assessment of the new medicinal product’s safety continues beyond the initial drug approval through post-marketing monitoring of adverse events. Copyright © 2009 S. Karger AG, Basel Introduction Getting drugs to the market is an expensive and high- risk business which takes on average 10–15 years to com- plete. The Tufts Center for the Study of Drug Develop- ment announced in November 2001 that the average cost to develop a new prescription drug was USD 802 million [1]. When the costs of failed prospective drugs are factored in, the actual cost for discovering, developing and launch- ing a single new drug would have exceeded 1.5 billion. This compares with USD 4 million in 1962 and USD 231 million in 1987 [2, 3] . The problem is compounded by the high attrition rate, as it is estimated that approximately only 1 in 10 drugs that enter clinical trials will make it to the market. In a recent study, it was shown that the aver- age success rate for drugs to be approved for all therapeu- Key Words Drug discovery  Clinical trials  Drug approval  Drug safety Abstract Drug development is an expensive, long and high-risk busi- ness taking 10–15 years and is associated with a high attri- tion rate. It is driven by medical need, disease prevalence and the likelihood of success. Drug candidate selection is an iterative process between chemistry and biology, refining the molecular properties until a compound suitable for ad- vancing to man is found. Typically, about one in a thousand synthesised compounds is ever selected for progression to the clinic. Prior to administration to humans, the pharmacol- ogy and biochemistry of the drug is established using an extensive range of in vitro and in vivo test procedures. It is also a regulatory requirement that the drug is administered to animals to assess its safety. Later-stage animal testing is also required to assess carcinogenicity and effects on the reproductive system. Clinical phases of drug development include phase I in healthy volunteers to assess primarily pharmacokinetics, safety and toleration, phase II in a cohort of patients with the target disease to establish efficacy and dose-response relationship and large-scale phase III studies to confirm safety and efficacy. Experience tells us that ap- proximately only 1 in 10 drugs that start the clinical phase will make it to the market. Each drug must demonstrate safe- Published online: August 12, 2009 Pfizer Laboratories Ramsgate Road Sandwich CT13 9NJ (UK) Tel. +44 1304 641 627, Fax +44 1304 652 629 E-Mail tamimis@gmail.com © 2009 S. Karger AG, Basel 1660–2110/09/1133–0125$26.00/0 Accessible online at: www.karger.com/nec