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Hit the Mark

Increasing pressure is being placed on the pharmaceutical industry to limit the costs and time associated with delivering a drug to the market. First-in-human and other early phase studies are a critical step in the complex process. Normally limited to objectives based around pharmacokinetics, safety and tolerability, early phase studies provide an underutilised opportunity to obtain valuable pharmacodynamic data regarding a drug’s mechanism of action, pharmacological activity and potential dosing regimens. Carefully chosen biomarkers are able to be easily incorporated into early phase drug studies and provide guidance for important decisions concerning a drug’s future.

Analyses show that the largest part of the development costs are spent on failures, particularly in the latter part of the process because of the high costs of large-scale clinical trials (1,2). Consequently, there is much pressure on the drug development process to ‘kill failures early’ by showing that the compound does not have the characteristics of a proper drug – or vice versa – and preferably to show that it does (3). Thus, drug development has become a much more continuous process than is suggested by the ‘classic’ separation into distinct phases. In fact, modern ICH guidelines, as implemented by the regulatory authorities, stipulate the intelligent use of pharmacodynamic drug effect measurements during all stages of development (4-6).


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Professor Joop van Gerven is Director of CNS Studies at CHDR. Joop studied English and Medicine at Utrecht University. After obtaining his MD in 1984, he worked in the Department of Internal Medicine of Leiden University Medical Center (LUMC). In 1990 he completed a PhD thesis on aldose reductase inhibitor treatment in diabetes mellitus. He was trained as a Neurologist in Dijkzigt University Hospital in Rotterdam from 1988 to 1994. During that period, he was also a consultant for Wyeth on diabetic complications. Since 1994 he has been responsible for CNS research at CHDR in Leiden, and is responsible for consultancy and research on central nervous system drugs and methods. He is also active clinically as a Consultant Neurologist at LUMC. In 2004 he was appointed Professor of Clinical Psychoneuropharmacology at Leiden University.

Justin Hay is Senior Clinical Scientist, CNS Studies at CHDR. Justin completed his BSc (Biomed Science) with majors in Pharmacology, Microbiology & Immunology (2001) and graduated with First Class Honours (2002). In 2007 he was conferred his PhD in Pharmacology from the University of Adelaide, Australia. His thesis investigated the pain sensitivity of chronic opioid users. Since March 2007, Justin has held his current position, where he is investigating how pain tests can be used as a screening tool in early drug development.

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Professor Joop van Gerven
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Justin Hay
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