Advance or stagnation in CNS drug development?

Abstract

For the past 10 years, more than one sector of society—not only clinicians and scientists, but also patients, their relatives and carers, and people at risk of developing a CNS disease—has been waiting for the introduction of effective CNS drugs on to the market. These drugs are urgently needed to treat a wide range of neurological disorders; for example, Alzheimer's disease, the incidence of which is ever increasing with the ageing population. Neurologists and researchers are working hard to identify diagnostic markers that can be used to reliably diagnose neurological diseases as early as possible; the amount of publications on biomarkers increases incessantly. But, for the moment, there are no treatments that are able to slow or stop the progression of cognitive decline associated with Alzheimer's disease. This stagnation in CNS drug development is now leading to frustration, and in the first chapter of Critical Pathways to Success in CNS Drug Development, the authors critically discuss the present situation, underlining the lack of success in the search for effective therapies for CNS disorders. But in the same chapter the authors promise readers not only to give a well organised analysis on “the latest advances in early CNS drug development”, providing “concise, relevant summaries and reviews of the newest techniques, markers, and models being introduced into the CNS drug development pipeline”; but also to determine “how they can best utilised”. The six authors, as clinical scientists from a leading global company in early-stage and late-stage drug discovery, are all directly involved in preclinical and clinical trials. The authors—all of whom have experience of the problems faced during CNS drug development—depict the complex procedure of drug development for four major CNS disorders: depression, anxiety, schizophrenia, and Alzheimer's disease. The book encompasses the main steps that need to be addressed during CNS drug development, which are summarised in seven clearly and concisely written chapters. The authors offer an inclusive overview of the topic and describe comprehensively the large, expensive, and not always successful process that must be worked through before the approval of a new CNS drug. Only very few textbooks related to CNS drug development have been published in recent years. Two of these, Animal and Translational Models for CNS Drug Discovery and Imaging in CNS Drug Discovery and Development, which were released in 2008 and 2009, respectively, cover topics that are condensed into two of the seven chapters in Critical Pathways to Success in CNS Drug Development. The most extensive chapter of the book discusses biomarkers and surrogate markers in drug development and includes almost 500 references. The result is an excellent summary in which the authors not only discuss the currently accepted biomarkers, but also emphasise the need to detect further biomarkers for use in CNS disorders. The book is primarily directed at professionals who are interested in CNS drug development research. However, it will be likewise worthwhile and useful for clinicians and research scientists, all of whom will benefit from this first-hand account of where the pharmaceutical industry stands right now with respect to the development of new drugs for the treatment of CNS disorders.