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This textbook provides a comprehensive overview of the currently used concepts, approaches and technologies in the discovery and development of new treatments for the full spectrum of disorders of the central nervous system. It guides the reader through all essential steps, from finding an innovative idea, to the registration of a new drug.
Divided into four sections, the book starts by presenting a broad perspective on current approaches in central nervous system (CNS) drug discovery. The second section addresses the generation of ideas for the identification of targets and novel treatment strategies; covers core functions in early discovery, and provides an example of a novel treatment paradigm: brain stimulation. The third section highlights strategies and technologies in translational CNS drug discovery. In an effort to bridge the gap between discovery and clinical development, it also covers brain imaging, EEG and cognitive testing approaches. The fourth section extensively discusses the clinical phase of drug development, covering the basics of early clinical testing for psychopharmacological drugs. The book's final chapter addresses the registration for newly developed drugs.
Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments in drug discovery. Offering in-depth insights into the world of drug development, it represents essential reading for early researchers who want to prepare for a career in drug discovery in academia or industry.
Rudy Schreiber got his B.S. in Medicinal Biology and his Ph.D. in Neuropharmacology from the University of Groningen in the Netherlands. He started his career in central nervous system drug discovery in 1993. Subsequently he progressed from bench scientist to senior leadership roles at global pharmaceutical companies, including Servier (France), Bayer (Germany), Roche (CA) and Sepracor (now Sunovion Pharmaceuticals, MA). From 2010 till 2012 he was the SVP of the Neurobiology group of the contract research organization, Evotec (Germany). Rudy's drug discovery experience covers a wide range of psychiatric and neurologic indications. He also worked with many different classes of molecular targets and led projects ranging from the idea stage throughout proof of principle testing. He has published about 80 papers and 30 patents. In 2012 he founded Suadeo Drug Discovery Consulting LLC in Boston. Rudy joined Maastricht University in 2018 and is the coordinator of the 2-year research masterprogram Drug Development and NeuroHealth . He is a Homo Aquaticus who lives on a boat in Maastricht Marina and spends his free time rowing on the Maas river or sailing offshore.
PART I - Introduction .- Innovator, Entrepreneur, Leader: The Tripartite Drug Discovery Neuroscientist.- PART II - Innovation in the Discovery of Novel Therapeutic Approaches.- Drug Discovery in CNS: Finding a Target for What?.- Neurogenomics with Application to Schizophrenia and Other Major Neuropsychiatric Diseases with Complex Heredity.- Epigenetics in Drug Discovery: Achievements and Challenges.- Conventional Behavioral Models and Readouts in Drug Discovery: The Importance of Improving Translation.- Safety and Drug Metabolism: Toward NCE and First in Human.- The Various Forms of Non-invasive Brain Stimulation and Their Clinical Relevance.- Is Non-invasive Brain Stimulation the Low-Hanging Fruit?.- PART III - Translational Medicine and Technology.- Electrophysiology: From Molecule to Cognition, from Animal to Human.- MRI in CNS Drug Development.- Positron Emission Tomography in Drug Development.- Application of Cognitive Test Outcomes for Clinical Drug Development.- Exciting Research in the Field of Sexual Psychopharmacology: Treating Patients with Inside Information.- A Paradigm Shift from DSM-5 to Research Domain Criteria: Application to Translational CNS Drug Development.- PART IV - Clinical Development and Regulatory Approval.- The Special Challenges of Developing CNS Drugs.- Phase 1 Clinical Trials in Psychopharmacology.- Early Development of Erenumab for Migraine Prophylaxis.- Microdosing Psychedelics as a Promising New Pharmacotherapeutic.- Partnering with the FDA.
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