Re-inventing Drug Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Re-inventing Drug Development write by Jeffrey S. Handen. This book was released on 2014-10-28. Re-inventing Drug Development available in PDF, EPUB and Kindle. The biopharmaceutical industry has entered an era of unprecedented change and challenge, characterized by increasing pricing pressures, rising rates of attrition in the product development lifecycle, and decreasing scientific innovation. The most successful products are losing patent protection, and pipelines have been unable to fill the gap. This book explores the evolving definition of innovation in therapeutic product development and begins to examine its effects on the life sciences R&D industry. Historically, scientific innovation alone was sufficient to maintain ROI and deliver on unmet medical needs. However, with many forces now conspiring to increase pressures on the commoditization of drug development, industry support for truly novel, often high-risk development has eroded. This calls for a drastic redefinition of what "innovation" is. While innovation in the pharmaceutical R&D industry has historically been applied to major advances in therapy and unmet medical needs, we now need to see innovation increasingly defined in terms of financial, marketing (e.g. branded generics and emerging markets), pharmacoeconomic, and operational innovation. In this book, contributors drawn from the executive ranks of clinical development practitioners and stakeholders—from biopharmaceutical companies, clinical research organizations, academia, the financial community, and the patient perspective—have all come together to provide their expertise and visions. Their goal is to start a dialogue about ways to radically improve therapeutics development and get more and better medicines to the patients who need them, as fast as possible, in the most cost-efficient manner.
Modern CNS Drug Discovery
Modern CNS Drug Discovery - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Modern CNS Drug Discovery write by Rudy Schreiber. This book was released on 2021-06-17. Modern CNS Drug Discovery available in PDF, EPUB and Kindle. 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.
The Role of NIH in Drug Development Innovation and Its Impact on Patient Access
The Role of NIH in Drug Development Innovation and Its Impact on Patient Access - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook The Role of NIH in Drug Development Innovation and Its Impact on Patient Access write by National Academies of Sciences, Engineering, and Medicine. This book was released on 2020-01-27. The Role of NIH in Drug Development Innovation and Its Impact on Patient Access available in PDF, EPUB and Kindle. To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Pharmaceutical & Medical Products
Pharmaceutical & Medical Products - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Pharmaceutical & Medical Products write by Andersen Consulting. This book was released on 1997. Pharmaceutical & Medical Products available in PDF, EPUB and Kindle.
Improving and Accelerating Therapeutic Development for Nervous System Disorders
Improving and Accelerating Therapeutic Development for Nervous System Disorders - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Improving and Accelerating Therapeutic Development for Nervous System Disorders write by Institute of Medicine. This book was released on 2014-02-06. Improving and Accelerating Therapeutic Development for Nervous System Disorders available in PDF, EPUB and Kindle. 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.
