Biomarkers Diagnostics and Precision Medicine in the Drug Industry

Biomarkers  Diagnostics and Precision Medicine in the Drug Industry
Author: Abdel Halim
Publsiher: Academic Press
Total Pages: 294
Release: 2019-06-08
ISBN 10: 0128161221
ISBN 13: 9780128161227
Language: EN, FR, DE, ES & NL

Biomarkers Diagnostics and Precision Medicine in the Drug Industry Book Review:

The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations

Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine
Author: Claudio Carini,Mark Fidock,Alain van Gool
Publsiher: CRC Press
Total Pages: 631
Release: 2019-04-16
ISBN 10: 0429576730
ISBN 13: 9780429576737
Language: EN, FR, DE, ES & NL

Handbook of Biomarkers and Precision Medicine Book Review:

"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Predictive Biomarkers in Oncology

Predictive Biomarkers in Oncology
Author: Sunil Badve,George Louis Kumar
Publsiher: Springer
Total Pages: 642
Release: 2018-12-06
ISBN 10: 3319952285
ISBN 13: 9783319952284
Language: EN, FR, DE, ES & NL

Predictive Biomarkers in Oncology Book Review:

“Precision/personalized or stratified medicine” refers to the tailoring of medical treatment or drug administration to the individual characteristics of each patient treatment. It does not literally mean that a pharmaceutical company makes a drug for an individual patient for consumption and treatment but rather means the ability to stratify (or classify) individuals into sub-populations that differ in their responsiveness to a specific drug. A marker that provides information on the likely response to therapy, i.e., either in terms of tumor shrinkage or survival of the patient is termed “predictive biomarker”. Despite their promise in precision medicine and the explosion of knowledge in this area, there is not a single source on this subject that puts all this evidence together in a concise or richly illustrated and easy to understand manner. This book provides a collection of ingeniously organized, well-illustrated and up-to-date authoritative chapters divided into five sections that are clear and easy to understand. Section one provides an overview of biomarkers, introduces the basic terminologies, definitions, technologies, tools and concepts associated with this subject in the form of illustrations/graphics, photographs and concise texts. Several recent biomarker endeavors that have been initiated and funded by the National Cancer Institute, National Institutes of Health, FDA and other International organizations are presented. Section two involves the signaling pathways controlling cell growth and differentiation altered in cancer. This section analyzes how predictive biomarkers are altered (expressed or amplified) across cancer types. Section three explores how predictive biomarkers play a role in patient stratification and tailored treatment in relationship to specific cancers. In addition, it includes discussion on the various precision medicine initiatives that are going on across the globe (e.g. TARGET, NCI-MATCH, BATTLE, SHIVA, etc.). Section four discusses: (a) how pharmaceutical companies validate predictive biomarker assays and accompanying companion diagnostics either internally or externally with partner companies such as central laboratories or clinical research organizations, and (b) how predictive biomarker tests fall under the oversight of US FDA, Centers for Medicare & Medicaid Services (CMS) and state laws. Section five wraps up novel agents and targets that are being used as targets for cancer therapeutics. The biomarkers associated with these protocols will also be presented. Throughout the book, sidebars, special interest boxes and illustrations are used to explain terms that are either newly introduced, uncommon, or specialized. Predictive Biomarkers in Oncology will serve as a definitive guide for practicing pathologists, oncologists, basic researchers, and personnel in the pharmaceutical or diagnostic industry interested in learning how “predictive biomarkers” are used in precision cancer therapy.

The Handbook of Biomarkers

The Handbook of Biomarkers
Author: Kewal K. Jain
Publsiher: Springer Science & Business Media
Total Pages: 492
Release: 2010-02-06
ISBN 10: 9781607616856
ISBN 13: 1607616858
Language: EN, FR, DE, ES & NL

The Handbook of Biomarkers Book Review:

Of the thousands of biomarkers that are currently being discovered, relatively few are being validated for further applications, and the potential of a biomarker can be quite difficult to evaluate. To aid in this imperative research, Dr. Kewal K. Jain’s Handbook of Biomarkers thoroughly describes many different types of biomarkers and their discovery using various "-omics" technologies, such as proteomics and metabolomics, along with the background information needed for the evaluation of biomarkers as well as the essential procedures for their validation and use in clinical trials. With biomarkers described first according to technologies and then according to various diseases, this detailed book features the key correlations between diseases and classifications of biomarkers, which provides the reader with a guide to sort out current and future biomarkers. Comprehensive and cutting-edge, The Handbook of Biomarkers serves as a vital guide to furthering our understanding of biomarkers, which, by facilitating the combination of therapeutics with diagnostics, promise to play an important role in the development of personalized medicine, one of the most important emerging trends in healthcare today.

Cancer Biomarkers

Cancer Biomarkers
Author: Institute of Medicine,Committee on Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment
Publsiher: National Academies Press
Total Pages: 250
Release: 2007-03-27
ISBN 10: 0309133998
ISBN 13: 9780309133999
Language: EN, FR, DE, ES & NL

Cancer Biomarkers Book Review:

Many cancer patients are diagnosed at a stage in which the cancer is too far advanced to be cured, and most cancer treatments are effective in only a minority of patients undergoing therapy. Thus, there is tremendous opportunity to improve the outcome for people with cancer by enhancing detection and treatment approaches. Biomarkers will be instrumental in making that transition. Advances in biotechnology and genomics have given scientists new hope that biomarkers can be used to improve cancer screening and detection, to improve the drug development process, and to enhance the effectiveness and safety of cancer care by allowing physicians to tailor treatment for individual patients—an approach known as personalized medicine. However, progress overall has been slow, despite considerable effort and investment, and there are still many challenges and obstacles to overcome before this paradigm shift in oncology can become a reality.

Genomic and Personalized Medicine

Genomic and Personalized Medicine
Author: Anonim
Publsiher: Academic Press
Total Pages: 1350
Release: 2012-10-30
ISBN 10: 0123822289
ISBN 13: 9780123822284
Language: EN, FR, DE, ES & NL

Genomic and Personalized Medicine Book Review:

Genomic and Personalized Medicine, Second Edition — winner of a 2013 Highly Commended BMA Medical Book Award for Medicine — is a major discussion of the structure, history, and applications of the field, as it emerges from the campus and lab into clinical action. As with the first edition, leading experts review the development of the new science, the current opportunities for genome-based analysis in healthcare, and the potential of genomic medicine in future healthcare. The inclusion of the latest information on diagnostic testing, population screening, disease susceptability, and pharmacogenomics makes this work an ideal companion for the many stakeholders of genomic and personalized medicine. With advancing knowledge of the genome across and outside protein-coding regions of DNA, new comprehension of genomic variation and frequencies across populations, the elucidation of advanced strategic approaches to genomic study, and above all in the elaboration of next-generation sequencing, genomic medicine has begun to achieve the much-vaunted transformative health outcomes of the Human Genome Project, almost a decade after its official completion in April 2003. Highly Commended 2013 BMA Medical Book Award for Medicine More than 100 chapters, from leading researchers, review the many impacts of genomic discoveries in clinical action, including 63 chapters new to this edition Discusses state-of-the-art genome technologies, including population screening, novel diagnostics, and gene-based therapeutics Wide and inclusive discussion encompasses the formidable ethical, legal, regulatory and social challenges related to the evolving practice of genomic medicine Clearly and beautifully illustrated with 280 color figures, and many thousands of references for further reading and deeper analysis

Clinical Laboratory Management

Clinical Laboratory Management
Author: Anonim
Publsiher: John Wiley & Sons
Total Pages: 1096
Release: 2020-08-06
ISBN 10: 1555817289
ISBN 13: 9781555817282
Language: EN, FR, DE, ES & NL

Clinical Laboratory Management Book Review:

This totally revised second edition is a comprehensive volume presenting authoritative information on the management challenges facing today's clinical laboratories. Provides thorough coverage of management topics such as managerial leadership, personnel, business planning, information management, regulatory management, reimbursement, generation of revenue, and more. Includes valuable administrative resources, including checklists, worksheets, forms, and online resources. Serves as an essential resource for all clinical laboratories, from the physician's office to hospital clinical labs to the largest commercial reference laboratories, providing practical information in the fields of medicine and healthcare, clinical pathology, and clinical laboratory management, for practitioners, managers, and individuals training to enter these fields.

Oxford Textbook of Old Age Psychiatry

Oxford Textbook of Old Age Psychiatry
Author: Tom Dening,Alan Thomas,Robert Stewart,John-Paul Taylor
Publsiher: Oxford University Press
Total Pages: 912
Release: 2020-10-29
ISBN 10: 0192534149
ISBN 13: 9780192534149
Language: EN, FR, DE, ES & NL

Oxford Textbook of Old Age Psychiatry Book Review:

The Oxford Textbook of Old Age Psychiatry, Third Edition, has been thoroughly updated to keep pace with the developments that have taken place in old age psychiatry since publication of the Second Edition in 2013, including the publication of the DSM-5/ICD-11 classification criteria. The Third Edition also includes new chapters on the ageing brain; the experience of dementia; carers' issues; biomarkers; and old age psychiatry in low- and middle-income countries. This new edition introduces two new co-editors, Robert Stewart, Professor of Psychiatric Epidemiology & Clinical Informatics at King's College London (and a Co-Editor of Practical Psychiatric Epidemiology), and John-Paul Taylor, Professor of Translational Dementia Research at Newcastle University. Part of the authoritative Oxford Textbooks in Psychiatry series, this comprehensive resource is an essential reference for old age psychiatrists, geriatricians, and other clinicians who are interested in the mental health care of older people.

Drug Discovery and Evaluation Methods in Clinical Pharmacology

Drug Discovery and Evaluation  Methods in Clinical Pharmacology
Author: H.Gerhard Vogel,Jochen Maas,Alexander Gebauer
Publsiher: Springer Science & Business Media
Total Pages: 564
Release: 2010-12-15
ISBN 10: 3540898905
ISBN 13: 9783540898900
Language: EN, FR, DE, ES & NL

Drug Discovery and Evaluation Methods in Clinical Pharmacology Book Review:

Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

Handbook of Drug Monitoring Methods

Handbook of Drug Monitoring Methods
Author: Amitava Dasgupta
Publsiher: Springer Science & Business Media
Total Pages: 445
Release: 2007-10-23
ISBN 10: 1588297802
ISBN 13: 9781588297808
Language: EN, FR, DE, ES & NL

Handbook of Drug Monitoring Methods Book Review:

In Handbook of Drug Monitoring Methods: Therapeutics and Drug Abuse, authors discuss the different analytical techniques used in today’s practice of therapeutic drug monitoring and drugs of abuse as well as alcohol testing with relevant theory, mechanism, and in-depth scientific discussion on each topic. This volume is the perfect handbook and quick reference for any clinical laboratory, allowing clinicians to find the potential source of a false-positive or a false-negative result in the daily operation of a toxicology laboratory. At the same time, this book can also be used as a reference for medical technologists, supervisors, laboratory directors, clinical chemists, toxicologists, and pathologists to find in-depth cause of a potential interference and what tests can be ordered to circumvent such problem. The volume’s first half focuses on various issues of therapeutic drug monitoring. Additional chapters cover analysis of heavy metals, alcohol testing, and issues of drugs of abuse testing. These chapters are written by experts in their relative sub-specialties and also by the editor. Comprehensive and timely, Handbook of Drug Monitoring Methods: Therapeutics and Drug Abuse is the ideal text for clinicians and researchers monitoring alcohol and drug testing and other important tasks of toxicological laboratory services.

Textbook of Personalized Medicine

Textbook of Personalized Medicine
Author: Kewal K. Jain
Publsiher: Springer Nature
Total Pages: 744
Release: 2020-12-05
ISBN 10: 3030620808
ISBN 13: 9783030620806
Language: EN, FR, DE, ES & NL

Textbook of Personalized Medicine Book Review:

This book is for personalized medicine as a prescription of specific treatments and therapeutics best suited for an individual and considers genetic as well as environmental factors that influence responses to therapy. Best approaches are described for integration of all available technologies for optimizing the therapy of individual patients. This comprehensive third edition covers the latest advances in personalized medicine and several chapters are devoted to various specialties, particulary cancer which is the largest area of application. The book discusses the development of personalized medicine and various players in it such as companies, academic institutions, the government, and the public as the consumer of healthcare. Additionally, the roles of bioinformatics, electronic health records, and digital technologies for personalized medicine are discussed. Textbook of Personalized Medicine, 3rd Edition serves as a convenient source of information for students at many levels and in a wide range of fields, including physicians, scientists, and decision makers in the biopharmaceutical and healthcare industries.

Enabling Precision Medicine

Enabling Precision Medicine
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Roundtable on Genomics and Precision Health,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 144
Release: 2017-10-17
ISBN 10: 0309462665
ISBN 13: 9780309462662
Language: EN, FR, DE, ES & NL

Enabling Precision Medicine Book Review:

Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical trial designs that enroll participants based on their genetics represent a potentially disruptive change that could improve patient outcomes, reduce costs associated with drug development, and further realize the goals of precision medicine. On March 8, 2017, the Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development. Participants examined successes, challenges, and possible best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. This publication summarizes the presentations and discussions from the workshop.

Intellectual Property Issues in Biotechnology

Intellectual Property Issues in Biotechnology
Author: Harikesh Bahadur Singh,Alok Jha,Chetan Keswani
Publsiher: CABI
Total Pages: 276
Release: 2016-09-26
ISBN 10: 1780646534
ISBN 13: 9781780646534
Language: EN, FR, DE, ES & NL

Intellectual Property Issues in Biotechnology Book Review:

This book integrates a science and business approach to provide an introduction and an insider view of intellectual property issues within the biotech industry, with case studies and examples from developing economy markets. Broad in scope, this book covers key principles in pharmaceutical, industrial, and agricultural biotechnology within four parts. Part 1 details the principles of intellectual property and biotechnology. Part 2 covers plant biotechnology, including biotic and abiotic stress tolerance, GM foods in sustainable agriculture, microbial biodiversity and bioprospecting for improving crop health and productivity, and production and regulatory requirements of biopesticides and biofertilizers. The third part describes recent advances in industrial biotechnology, such as DNA patenting, and commercial viability of the CRISPR/Cas9 system in genome editing. The final part describes intellectual property issues in drug discovery and development of personalized medicine, and vaccines in biodefence. This book is an ideal resource for all postgraduates and researchers working in any branch of biotechnology that requires an overview of the recent developments of intellectual property frameworks in the biotech sector.

Pharmaceutical Biotechnology

Pharmaceutical Biotechnology
Author: Daan J. A. Crommelin,Robert D. Sindelar,Bernd Meibohm
Publsiher: Springer
Total Pages: 653
Release: 2019-04-13
ISBN 10: 3030007103
ISBN 13: 9783030007102
Language: EN, FR, DE, ES & NL

Pharmaceutical Biotechnology Book Review:

This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fifth Edition completely updates the previous edition, and also includes additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech and enzyme replacement therapy.

New Health Technologies Managing Access Value and Sustainability

New Health Technologies Managing Access  Value and Sustainability
Author: OECD
Publsiher: OECD Publishing
Total Pages: 228
Release: 2017-01-16
ISBN 10: 9264266437
ISBN 13: 9789264266438
Language: EN, FR, DE, ES & NL

New Health Technologies Managing Access Value and Sustainability Book Review:

This report discusses the need for an integrated and cyclical approach to managing health technology in order to mitigate clinical and financial risks, and ensure acceptable value for money.

The Future of Drug Discovery

The Future of Drug Discovery
Author: Tamas Bartfai,Graham V. Lees
Publsiher: Academic Press
Total Pages: 376
Release: 2013-05-18
ISBN 10: 0124095194
ISBN 13: 9780124095199
Language: EN, FR, DE, ES & NL

The Future of Drug Discovery Book Review:

The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer’s disease, untreatable pain, antibiotics and more. This book carefully exposes the gap between the medicines and therapies we need and the current business path. By analyzing the situation and discussing prospects for the next decade, the The Future of Drug Discovery is a timely book for all those who care about the development needs for drugs for disease. Provides an in-depth, broad perspective on the crisis in drug industry Exposes the disconnect between what society needs and what the drug companies are working on Analyses and projects over 10 years into the future Explains what it means for scientists and society Determines what is needed to be done to make sure that the industry responds to society's needs, remains commercially attractive and answers the question as to who decides which diseases to treat

Networks in Systems Biology

Networks in Systems Biology
Author: Fabricio Alves Barbosa da Silva,Nicolas Carels,Marcelo Trindade dos Santos,Francisco José Pereira Lopes
Publsiher: Springer Nature
Total Pages: 377
Release: 2020-10-03
ISBN 10: 3030518620
ISBN 13: 9783030518622
Language: EN, FR, DE, ES & NL

Networks in Systems Biology Book Review:

This book presents a range of current research topics in biological network modeling, as well as its application in studies on human hosts, pathogens, and diseases. Systems biology is a rapidly expanding field that involves the study of biological systems through the mathematical modeling and analysis of large volumes of biological data. Gathering contributions from renowned experts in the field, some of the topics discussed in depth here include networks in systems biology, the computational modeling of multidrug-resistant bacteria, and systems biology of cancer. Given its scope, the book is intended for researchers, advanced students, and practitioners of systems biology. The chapters are research-oriented, and present some of the latest findings on their respective topics.

Biotechnology Entrepreneurship

Biotechnology Entrepreneurship
Author: Craig Shimasaki
Publsiher: Academic Press
Total Pages: 488
Release: 2014-04-08
ISBN 10: 0124047475
ISBN 13: 9780124047471
Language: EN, FR, DE, ES & NL

Biotechnology Entrepreneurship Book Review:

As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a ‘how-to’ for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars Case studies are interspersed throughout each chapter to support key concepts and best practices. Enhanced by use of numerous detailed graphics, tables and flow charts

Pharmacogenomics

Pharmacogenomics
Author: Yui-Wing Francis Lam,Stuart R. Scott
Publsiher: Academic Press
Total Pages: 442
Release: 2018-11-27
ISBN 10: 0128126272
ISBN 13: 9780128126271
Language: EN, FR, DE, ES & NL

Pharmacogenomics Book Review:

Pharmacogenomics: Challenges and Opportunities in Therapeutic Implementation, Second Edition, provides comprehensive coverage of the challenges and opportunities facing the therapeutic implications of pharmacogenomics from academic, regulatory, pharmaceutical, socio-ethical and economic perspectives. While emphasis is on the limitations in moving the science into drug development and direct therapeutic applications, this book also focuses on clinical areas with successful applications and important initiatives that have the ability to further advance the discipline. New chapters cover important topics such as pharmacogenomic data technologies, clinical testing strategies, cost-effectiveness, and pharmacogenomic education and practice guidelines. The importance of ethnicity is also discussed, which highlights phar,acogenomic diversity across Latin American populations. With chapters written by interdisciplinary experts and insights into the future direction of the field, this book is an indispensable resource for academic and industry scientists, graduate students and clinicians engaged in pharmacogenomics research and therapeutic implementation. Provides viewpoints that focus on the scientific and translational challenges and opportunities associated with advancing the field of pharmacogenomics Highlights progress in both the research and clinical areas of pharmacogenomics, as well as relevant implementation experience, challenges, and perspectives on direct-to-consumer genetic testing Includes, where applicable, discussion points, review questions, and cases for self-assessment purposes and to facilitate in-depth discussion

Managing Biotechnology

Managing Biotechnology
Author: Francoise Simon,Glen Giovannetti
Publsiher: John Wiley & Sons
Total Pages: 320
Release: 2017-10-16
ISBN 10: 1119216176
ISBN 13: 9781119216179
Language: EN, FR, DE, ES & NL

Managing Biotechnology Book Review:

A comprehensive overview of the new business context for biopharma companies, featuring numerous case studies and state-of-the-art marketing models Biotechnology has developed into a key innovation driver especially in the field of human healthcare. But as the biopharma industry continues to grow and expand its reach, development costs are colliding with aging demographics and cost-containment policies of private and public payers. Concurrently, the development and increased affordability of sophisticated digital technologies has fundamentally altered many industries including healthcare. The arrival of new information technology (infotech) companies on the healthcare scene presents both opportunities and challenges for the biopharma business model. To capitalize on new digital technologies from R&D through commercialization requires industry leaders to adopt new business models, develop new digital and data capabilities, and partner with innovators and payers worldwide. Written by two experts, both of whom have had decades of experience in the field, this book provides a comprehensive overview of the new business context and marketing models for biotech companies. Informed by extensive input by senior biotech executives and leading consultancies serving the industry, it analyzes the strategies and key success factors for the financing, development, and commercialization of novel therapeutic products, including strategies for engagement with patients, physicians and healthcare payers. Throughout case studies provide researchers, corporate marketers, senior managers, consultants, financial analysts, and other professionals involved in the biotech sector with insights, ideas, and models. JACQUALYN FOUSE, PhD, RETIRED PRESIDENT AND CHIEF OPERATING OFFICER, CELGENE “Biotech companies have long been innovators, using the latest technologies to enable cutting edge science to help patients with serious diseases. This book is essential to help biotech firms understand how they can–and must–apply the newest technologies including disruptive ones, alongside science, to innovate and bring new value to the healthcare system.” BRUCE DARROW, MD, PhD, CHIEF MEDICAL INFORMATION OFFICER, MOUNT SINAI HEALTH SYSTEM “Simon and Giovannetti have written an essential user’s manual explaining the complicated interplay of the patients who deserve cutting-edge medical care, the biotechnology companies (big and small) creating the breakthroughs, and the healthcare organizations and clinicians who bridge those worlds.” EMMANUEL BLIN, FORMER CHIEF STRATEGY OFFICER AND SENIOR VICE PRESIDENT, BRISTOL-MYERS SQUIBB “If you want to know where biopharma is going, read this book! Our industry is facing unprecedented opportunities driven by major scientific breakthroughs, while transforming itself to address accelerated landscape changes driven by digital revolutions and the emergence of value-based healthcare worldwide. In this ever-changing context, we all need to focus everything we do on the patients. They are why we exist as an industry, and this is ultimately what this insightful essay is really about.” JOHN MARAGANORE, PRESIDENT AND CHIEF EXECUTIVE OFFICER, ALNYLAM PHARMACEUTICALS “Since the mapping of the human genome was completed nearly 15 years ago, the biotechnology industry has led the rapid translation of raw science to today’s innovative medicines. However, the work does not stop in the lab. Delivering these novel medicines to patients is a complex and multifaceted process, which is elegantly described in this new book.”