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Author : Alexander Alex,C. John Harris,Dennis A. Smith Publisher : John Wiley & Sons Page : 370 pages File Size : 41,7 Mb Release : 2015-12-02 Category : Medical ISBN : 9781118679678
Attrition in the Pharmaceutical Industry by Alexander Alex,C. John Harris,Dennis A. Smith Pdf
With a focus on case studies of R&D programs in a variety of disease areas, the book highlights fundamental productivity issues the pharmaceutical industry has been facing and explores potential ways of improving research effectiveness and efficiency. • Takes a comprehensive and holistic approach to the problems and potential solutions to drug compound attrition • Tackles a problem that adds billions of dollars to drug development programs and health care costs • Guides discovery and development scientists through R&D stages, teaching requirements and reasons why drugs can fail • Discusses potential ways forward utilizing new approaches and opportunities to reduce attrition
Risk-sharing in the Pharmaceutical Industry by Gerrit Reepmeyer Pdf
The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.
In Transforming Big Pharma John Ansell addresses critically how strategy works in the pharmaceutical industry. The long-standing dearth of new products has led to a growing shortfall in revenues. Ansell assesses the wide range of alternative strategies big pharma companies have been pursuing in recent years in attempting to overcome this. He shows that there is sound evidence to expect the recent upturn in the number of new products reaching the market to go on to greater heights. Chapters assess the complex trends in attrition rates, show how rife spectacular sales underestimation in the industry remains, and explain how conventional wisdom on the chances of product profitability also seriously undersells the industry. The surest route to transforming the prospects for big pharma, Ansell contends, is to step up activity in acquiring and developing new products. This is now realistic because, as he shows, the amount of intellectual property available is much greater than it was a decade ago. Ansell believes that no other strategies have sufficient transformative powers, though they may be useful as a stopgap whilst the sales of forthcoming new products mature. He argues for a reversal of big pharma’s recent cutbacks in R&D and licensing, and re-focussing on new product development. Transforming Big Pharma is intended for those in senior and middle management in the pharmaceutical industry. It will also be valuable to students, as well as to all those dealing with the industry, including biotech companies and those providing services and products to the pharmaceutical industry.
Leading Pharmaceutical Innovation by Oliver Gassmann,Gerrit Reepmeyer,Maximilian von Zedtwitz Pdf
Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.
Industrialization of Drug Discovery by Jeffrey S. Handen Pdf
The pharmaceutical industry suffers from an innovation deficit, with clinical attrition and safety-related market-withdrawal rates at the same level as twenty years ago. This book scrutinizes this problem in detail, contrasting the promise of technology and industrialization with the apparent inability of industry to fully realize the tools that ar
Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Publisher : National Academies Press Page : 107 pages File Size : 42,9 Mb Release : 2014-02-06 Category : Medical ISBN : 9780309292498
Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf
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 Era of Artificial Intelligence, Machine Learning, and Data Science in the Pharmaceutical Industry by Stephanie K. Ashenden Pdf
The Era of Artificial Intelligence, Machine Learning and Data Science in the Pharmaceutical Industry examines the drug discovery process, assessing how new technologies have improved effectiveness. Artificial intelligence and machine learning are considered the future for a wide range of disciplines and industries, including the pharmaceutical industry. In an environment where producing a single approved drug costs millions and takes many years of rigorous testing prior to its approval, reducing costs and time is of high interest. This book follows the journey that a drug company takes when producing a therapeutic, from the very beginning to ultimately benefitting a patient’s life. This comprehensive resource will be useful to those working in the pharmaceutical industry, but will also be of interest to anyone doing research in chemical biology, computational chemistry, medicinal chemistry and bioinformatics. Demonstrates how the prediction of toxic effects is performed, how to reduce costs in testing compounds, and its use in animal research Written by the industrial teams who are conducting the work, showcasing how the technology has improved and where it should be further improved Targets materials for a better understanding of techniques from different disciplines, thus creating a complete guide
Institute of Medicine,Committee on Technological Innovation in Medicine
Author : Institute of Medicine,Committee on Technological Innovation in Medicine Publisher : National Academies Press Page : 241 pages File Size : 47,9 Mb Release : 1990-02-01 Category : Medical ISBN : 9780309042864
Modern Methods of Clinical Investigation by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author : David J. am Ende,Mary T. am Ende Publisher : John Wiley & Sons Page : 1168 pages File Size : 46,9 Mb Release : 2019-03-28 Category : Technology & Engineering ISBN : 9781119285885
Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients by David J. am Ende,Mary T. am Ende Pdf
A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: • Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety • Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying • Presents updated and expanded example calculations • Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industry focuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.
A Comprehensive Guide to Toxicology in Nonclinical Drug Development by Ali S. Faqi Pdf
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
Handbook of Pharmaceutical Biotechnology by Shayne Cox Gad Pdf
A practical overview of a full rangeof approaches to discovering, selecting, and producing biotechnology-derived drugs The Handbook of Pharmaceutical Biotechnology helps pharmaceutical scientists develop biotech drugs through a comprehensive framework that spans the process from discovery, development, and manufacturing through validation and registration. With chapters written by leading practitioners in their specialty areas, this reference: Provides an overview of biotechnology used in the drug development process Covers extensive applications, plus regulations and validation methods Features fifty chapters covering all the major approaches to the challenge of identifying, producing, and formulating new biologically derived therapeutics With its unparalleled breadth of topics and approaches, this handbook is a core reference for pharmaceutical scientists, including development researchers, toxicologists, biochemists, molecular biologists, cell biologists, immunologists, and formulation chemists. It is also a great resource for quality assurance/assessment/control managers, biotechnology technicians, and others in the biotech industry.
Dermal Drug Selection and Development by Lionel Trottet,Howard Maibach, MD Pdf
The authors show how the pharmaceutical industry faces the development of dermal drugs and provide the only book of its kind that describes how the industry develops and selects dermal drugs, complete with the challenges and opportunities of the field. Delivery of drugs through the skin has been an attractive and challenging area for research, and advances in modern technologies have resulted in a larger number of drugs being delivered transdermally, including conventional hydrophobic small molecule drugs, hydrophilic drugs and macromolecules. Offering the perspective from the industrial side of selection and development of drugs, the primary audience is geared towards the pharmaceutical industry but can also offer valuable information to clinicians, compounding pharmacists, and similarly pharmacy students. Dermal Drug Selection and Development covers the scientific gaps that exist in terms of dermal pharmacokinetics and the resulting uncertainty by clinicians when choosing a drug candidate.
Emerging Approaches in Food, Biotechnology & Pharmaceutical Technology development by Dr. Khusbhu Verma & Preeti Singh Pdf
Honey is a sugary food substance having high sugar concentration (reduced water activity), hydrogen peroxide and low pH 3-4 (acidic). There are various types of honey, which are classified on different basis such as based on origin, based on the floral source etc. It is a supersaturated sugar solution predominantly glucose and fructose. It’s colour varies from colourless to dark brown. It is a natural antimicrobial substance that kills microbes by acidity, osmolarity and enzymatic production of hydrogen peroxide. In ancient time, it was valued for its medicinal properties. Now days it is still used as preservative and make a different kind of dishes also alcoholic drinks. It has a greater sweetening ability that sugar does not have. The antimicrobial activity of honey has known since 19th century with a big history. Recently, many studies on honey has done for its antimicrobial properties. The antimicrobial and antioxidant strength depends on the darkness of the honey. Raw honey at different concentration used as natural preservative in food products to increase their self-life, because raw honey has more minerals, vitamins and antifungal and antibacterial properties and it prevents from many diseases. Manuka honey derived from New Zealand used for medicinal purpose in recent time but also can be used as natural preservative instead of using artificial preservative.
