Drug Development In Psychiatry

The book reviews clinical trial methodology as it pertains to drug development in psychiatry. The reader will understand the process of drug development in psychiatry from discovery through marketing with the help of clinically relevant examples. The reader will appreciate the history of drug development in psychiatry dating back to the era of serendipitous discovery and culminating in an era of new and highly focused targets. Readers will understand how drug development in psychiatry has changed and adapted with the discovery of novel mechanism of action drugs. Novel drugs and disease targets have changed the way developers and regulatory agencies think about clinical trial methodology. The book elucidates how biomarkers, genetics and advances in neuroscience and neuroimaging have influenced drug development approaches, which will ultimately change the practice of psychiatry. The book will be broken down into the following sections: a. Prior to the 1960s - Drug discovery by chance observation b. The last 50 years – refined targeting of CNS drugs without the discovery of mechanistically new drugs c. The future – the discovery and development of mechanistically new drugs. The examination of new targets, genetics and biomarkers.

This book contains the papers from invited lecturers as well as selected contributions presented at the 6th International Meeting on Clinical Pharmacology in Psychiatry (I.M.C.P.P.) held in Geneva, Switzerland, 5-7 June 1991. At this meeting the basic theme of the previous meetings in this series (Chicago 1979, Troms0 1980, Odense 1982, Bethesda 1985, Troms0 1988) was continued, namely, to bridge the gap between experimental development and clinical reality in psychopharmacology. After more than 25 years of intensive research in biological psychiatry, basic understanding of the biological mechanisms underlying major psychiatric diseases has advanced significantly but is still far from complete. Likewise, the hypotheses underlying the development of new psychotropics have been refined and produced a wide spectrum of novel, yet designed compounds. The crucial condition for all progress in this field is reliable, informative clinical testing of new compounds. It is our hope that this book, as a continuation of the earlier publications in this series, provides further evidence of the ongoing interaction between preclinical and clinical scientists, who only together can assure progress in this exciting area of research and clinical practice.

This is a wide scope and in-depth coverage of the state of the art and future directions in drug discovery for major psychiatric disorders.

This book overturns the idea that psychiatric drugs work by correcting chemical imbalance and analyzes the professional, commercial and political vested interests that have shaped this view. It provides a comprehensive critique of research on drugs including antidepressants, antipsychotics and mood stabilizers.

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

The Age of Psychopharmacology began with a brilliant rise in the 1950s, when for the first time science entered the study of drugs that affect the brain and mind. But, esteemed historian Edward Shorter argues that there has been a recent fall, as the field has seen its drug offerings impoverished and its diagnoses distorted by the "Diagnostic and Statistical Manual of Mental Disorders." The new drugs, such as Prozac, have been less effective than the old. The new diagnoses, such as "major depression," have strayed increasingly from the real disorders of most patients. Behind this disaster has been the invasion of the field by the pharmaceutical industry. This invasion has paid off commercially but not scientifically: There have been no new classes of psychiatry drugs in the last thirty years. Given that psychiatry's diagnoses and therapeutics have largely failed, the field has greatly declined from earlier days. Based on extensive research discovered in litigation, Shorter provides a historical perspective of change and decline over time, concluding that the story of the psychopharmacology is a story of a public health disaster.

Covering the latest advances in CNS drug development, this bookwill guide all those involved in pre-clinical to early clinicaltrials. The authors describe how recent innovations can acceleratethe development of novel CNS compounds, improve early detection ofefficacy and toxicity signals, and increase the safety oflater-stage clinical trials. The current crisis in the drug development industry iscritically reviewed, as well as the steps needed to correct theproblems, including new government-backed regulations andindustry-based innovations designed to accelerate CNS drugdevelopment in the future. Animal-based models of major CNS disorders are described indetail, and the ability of the latest in vitro and computer-basedmodels to simulate CNS disease states and predict drug efficacy andside-effects are examined. Particular attention is given tothe growing use of biomarkers and how they can be used effectivelyin early human trials as signals of potential drug efficacy, aswell as the increasingly important role of imaging studies to guidedose selection. Cognitive assessments that can be useful indicatorsof effect in patient populations are also discussed. Written by a team of clinical scientists involved in CNS drugtrials for over 20 years, and based on a wealth of drug developmentand clinical trial experience, Critical Pathways to Success inCNS Drug Developmentis full of practical advice forsuccessfully designing and executing CNS drug trials, avoidingpotential pitfalls, and complying with government regulations