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Essential CNS Drug Development
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Book description

Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.


'The experienced authors admirably describe the art and skills of managing the constraints of recruitment criteria, prioritising participant welfare, and balancing budgetary concerns … The volume can be recommended for the libraries of senior investigators who are training the next generation as a stimulus in the supervisory process. The text also offers a springboard for discussions among policy makers themselves, hopefully promoting an insight that they are overdue in their effort to overhaul a system nearly imploding under ponderous, regulatory, protectionistic, and, unfortunately, often minimally scientific burdens of multiple financial and other interests. The brief format is highly readable, more concise than comprehensive in scope, providing more of an overview of the issues than would be expected from a formal reference text … Overall, the editors offer a timely discussion of many strengths and weaknesses of a highly regulated and cumbersome process.'

Ronald M. Salomon Source: Journal of Clinical Psychiatry

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  • Chapter 9 - Clinical trials management at the site level
    pp 148-155
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    This chapter focuses on drug development for psychiatric as opposed to other central nervous system (CNS) indications such as neurological conditions, pain, and sleep. It provides an overview of how CNS drug development has evolved over its relatively short history of perhaps 50-100 years as well as to provide some sense of how it might evolve in the not-too-distant future. Chlorpromazine and other phenothiazine molecules were synthesized around the turn of the last century and some were initially used to treat pinworm infestation. However, chlorpromazine over the last 50 years has come to play a pivotal role in the modern era of clinical psychopharmacology. CNS drug development principally focused on serotonin selective reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors SNRIs, atypical antipsychotics, and cholinesterase inhibitors. The current development of drugs for Alzheimer's and other neurodegenerative diseases could be a model for how future CNS drug development might proceed.
  • Chapter 10 - Medical writing for CNS indications
    pp 156-168
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    This chapter discusses how new psychotropic drugs are approved for clinical use. While the FDA regulates other therapeutics such as biologics, over-the-counter drugs, and medical devices, the chapter provides an overview of the FDA's regulation of prescription drug products. The FDA's authorities are largely devoted to pre-marketing and post-marketing risk-benefit evaluation. An investigational new drug (IND) is used in a clinical investigation. The IND is unique to the regulatory process for drug approval. Center for Drug Evaluation and Research (CDER) classifies New Drug Applications (NDAs) with a code that reflects both the type of drug being submitted as well as the intended use. To monitor the safety of marketed drugs, the FDA maintains a complex system of postmarketing surveillance and risk-assessment systems to investigate the occurrence of serious and unexpected adverse drug experiences. The FDA's Adverse Event Reporting System (AERS) is an important drug safety tool.
  • Chapter 11 - Dissemination of clinical trial information: multiple audiences, multiple formats
    pp 169-176
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    The technological advances in molecular neuropharmacology and structural biology and the potential of large molecule therapeutics increase the number of potential drug targets and the ways in which these targets can be addressed to design novel therapeutic agents for CNS disorders. The target class approach has generated a large number of potential targets. Considerable progress has been made in exploiting an understanding of disease pathophysiology to identify novel targets for the treatment of neurodegenerative disorders. During the drug discovery process, target validation can be performed initially using in vitro or in vivo models but ultimately relies on demonstrating a clinical effect in patients. In Alzheimer's disease, two approaches to animal modeling are of interest: disease modification and cognition enhancement. An effective interface between basic research into disease mechanisms and the identification and validation of targets of interest to pre-clinical drug development is one of the key challenges.
  • Chapter 12 - The importance of treating cognition in schizophrenia and other severe mental illnesses: background, strategies, and findings to date
    pp 177-191
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    CNS drug development is rapidly evolving to meet the unique and changing demands of the fields of psychiatry and neurology. Phase I studies are traditionally focused on determining the safety, tolerability, and pharmacokinetics of a new molecular entity in young healthy volunteers: first in a single ascending dose (SAD) study and then in a multiple ascending dose (MAD) study. The use of an adaptive design to examine data and modify the study in real time may also promote time- and cost-efficient identification of novel molecular entities (NMEs) that have the characteristics necessary to be successful in confirm stages of drug development research. This chapter discusses how use of biomarkers as surrogate endpoints can be incorporated into early clinical trials to determine if a drug modulates the appropriate targets, which enhances the likelihood of demonstrating efficacy in the confirm phase of clinical testing.
  • Chapter 13 - Leveraging disruptive technologies to drive innovation in CNS clinical drug development
    pp 192-199
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    This chapter addresses general Phase II clinical development issues and pitfalls and the relationship of Phase II to the preceding and subsequent phases of development, and then focuses on the new issues introduced into Phase II development by the emergence of personalized medicine. The dosing frequency to test should be derived from preclinical data and from human biomarker evidence of the development of and recovery from tolerance to intended effect. Indication selection, matching targets to patients, can be facilitated by collecting appropriate genetic or other biological information about the proposed subject population, and assuring that the biology of the subjects is matched to the drug candidate's proposed mechanism. Biomarker technologies have proven their mettle in a number of applications, and practical methods are now available that enable the drug development process. CNS drug developers and their development plans need to adapt to incorporate the changes brought by personalized medicines.


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