Download or read book A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry written by Nuala Calnan and published by CRC Press. This book was released on 2017-06-26 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.
Download or read book A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry written by Nuala Calnan and published by CRC Press. This book was released on 2017-06-26 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.
Download or read book Biopharmaceuticals written by Basanta Kumara Behera and published by CRC Press. This book was released on 2020-12-07 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals: Challenges and Opportunities This book highlights how the traditional microbial process technology has been upgraded for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the guidelines of internally recognized regulatory bodies. It also carries information on how, armed with a deeper understanding of life-threatening diseases, biopharmaceutical companies and the life sciences industry have developed formal and informal partnerships with researchers in institutes, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects of this book is the conceptual development of personalized medicine (or precision medicine) to provide the right treatment to the right patient, at the right dose at an earlier stage of development, for genetic diseases. Besides this, it also highlights the most challenging aspects of modern biopharmaceutical science, focusing on the hot topics such as design and development of biologic drugs; the use of diversified groups of host cells belonging to animals, plants, microbes, insects, and mammals; stem cell therapy and gene therapy; supply chain management of biopharmaceuticals; and the future scope of biopharmaceutical industry development. This book is the latest resource for a wide circle of scientists, students, and researchers involved in understanding and implementing the knowledge of biopharmaceuticals to develop life-saving biologic drugs and to bring awareness to the development of personalized treatment that can potentially offer patients a faster diagnosis, fewer side effects, and better outcomes. Features: Explains how the traditional cell culture methodology has been changed to a fully continuous or partially continuous process Explains how to design and fabricate living organs of body by 3D bioprinting technology Focuses on how a biopharmaceutical company deals with various problems of regulatory bodies and develops innovative biologic drugs Narrates in detail the updated information on stem cell therapy and gene therapy Explains the development strategies and clinical significance of biosimilars and biobetters Highlights the supply chain management of biopharmaceuticals
Download or read book Innovation and Commercialisation in the Biopharmaceutical Industry written by Bruce Rasmussen and published by Edward Elgar Publishing. This book was released on 2010-01-01 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: The processes of discovery, testing and distribution of new medicines have undergone radical change in recent decades, from a focus on small molecule drugs to biomedicine and related technologies. Bruce Rasmussen very effectively draws upon modern theories of the firm, data analysis, and case studies to provide important insights into the consequences of this change. He offers convincing evidence that contradicts the widely-held view that the biopharmaceutical sector has not generated considerable economic value. Frank R. Lichtenberg, Columbia University, US Bio- and pharmaceutical industry discovery is a distressed asset today. Why? Bruce Rasmussen s book is a timely and very informative work, building on rich data sources and extensive economic research, on a subject of concern to us all. Is medicine discovery in permanent decline? Are the biotechnology and traditional pharma groups on a collision course, will the traditional group absorb the new, will integration take place, will a new discovery model emerge? I commend Bruce s book to all who wish to understand what is happening. David W. Anstice, Merck & Co., Inc. This path-breaking book addresses the ongoing implications for traditional pharmaceutical companies and biopharmaceutical start-ups of the realignment of the industry knowledge-base. The theoretical approach draws on the modern theory of the firm and related ideas in order to better define the concept of the business model, which is employed to guide the case studies and empirical analysis in the book. The author shows that while traditional pharmaceutical companies have successfully adjusted their business models to meet the challenges of biotechnology, biopharmaceutical start-ups have experienced more problems. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. However, this has been captured disproportionately by a handful of large, fully-integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical companies. This highly focused book will be a captivating read for innovation and biopharmaceutical industry analysts, as well as advisers formulating policies to support the development of the biopharmaceutical sector. Academics working on innovation and biotechnology, as well as scientists engaged in research in the life sciences, will also find this book of particular interest.
Download or read book Multivariate Analysis in the Pharmaceutical Industry written by Ana Patricia Ferreira and published by Academic Press. This book was released on 2018-04-24 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come
Download or read book Process Validation in Manufacturing of Biopharmaceuticals written by Anurag Singh Rathore and published by CRC Press. This book was released on 2023-12-18 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
Download or read book ECKM 2023 24th European Conference on Knowledge Management Vol 2 written by Alvaro Rosa and published by Academic Conferences and publishing limited. This book was released on 2023-09-07 with total page 834 pages. Available in PDF, EPUB and Kindle. Book excerpt: These proceedings represent the work of contributors to the 24th European Conference on Knowledge Management (ECKM 2023), hosted by Iscte – Instituto Universitário de Lisboa, Portugal on 7-8 September 2023. The Conference Chair is Prof Florinda Matos, and the Programme Chair is Prof Álvaro Rosa, both from Iscte Business School, Iscte – Instituto Universitário de Lisboa, Portugal. ECKM is now a well-established event on the academic research calendar and now in its 24th year the key aim remains the opportunity for participants to share ideas and meet the people who hold them. The scope of papers will ensure an interesting two days. The subjects covered illustrate the wide range of topics that fall into this important and ever-growing area of research. The opening keynote presentation is given by Professor Leif Edvinsson, on the topic of Intellectual Capital as a Missed Value. The second day of the conference will open with an address by Professor Noboru Konno from Tama Graduate School and Keio University, Japan who will talk about Society 5.0, Knowledge and Conceptual Capability, and Professor Jay Liebowitz, who will talk about Digital Transformation for the University of the Future. With an initial submission of 350 abstracts, after the double blind, peer review process there are 184 Academic research papers, 11 PhD research papers, 1 Masters Research paper, 4 Non-Academic papers and 11 work-in-progress papers published in these Conference Proceedings. These papers represent research from Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lithuania, Malaysia, México, Morocco, Netherlands, Norway, Palestine, Peru, Philippines, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, UK, United Arab Emirates and the USA.
Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Download or read book Innovation in the Biopharmaceutical Industry written by Rifat A. Atun and published by World Scientific. This book was released on 2007 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovation is at the heart of all advances and has the capacity to solve problems facing humanity. Societies which have turned away from innovation and technological development have failed in their ability to support their populations. Understanding the nature of innovation in the life sciences and in particular healthcare, how it operates, what enables and hinders it is therefore of great importance to meeting the challenges ahead. This book, originally and concurrently published in the International Journal of Innovation Management, Vol. 11, No. 2, 2007, offers the latest research and insights concerning innovation in the biopharmaceutical industry.
Download or read book The Palgrave Handbook of Knowledge Management written by Jawad Syed and published by Springer. This book was released on 2018-05-11 with total page 718 pages. Available in PDF, EPUB and Kindle. Book excerpt: This international Handbook provides a comprehensive overview of key topics, debates and issues within the now well-established field of Knowledge Management (KM). With contributions from a range of highly-skilled authors, diverse and multi-disciplinary approaches towards KM are explored in this fantastic new reference work. Topics covered include performance, ethics, sustainability and cross-cultural management, making this an equally important read to academics and practitioners working in areas such as technology, education and engineering. By analysing how the field of KM has developed over the years, as well as presenting new methods to be implemented in the workplace, this Handbook outlines a research agenda for the future of organisational learning and innovation.
Download or read book Redefining Innovation written by Ruchin Kansal and published by Taylor & Francis. This book was released on 2018-05-11 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most people marvel at the level of innovation demonstrated by the biopharmaceutical industry in bringing new products to the market – especially in the past 20 years. However, there is a crisis looming in the industry that should be a concern to all of us who take for granted the constant pace at which new treatments, and increasingly cures, have emerged from the laboratories of current sector incumbents. In the book, we examine the evolution of the biopharmaceutical industry to understand how it became what we term a "unicorn industry" with a unique, US-centered business model that has led to multiple blockbuster products (aka, unicorns) year after year. We explore how past success has created perceived barriers to innovation diversification beyond the chemical or biological-based biopharmaceutical product, and highlight the warning signs of the industry’s decline. We define a potential pathway for transforming the industry’s business model by broadening the definition, sources, and enablers of innovation beyond the traditional biopharmaceutical product. We introduce and advocate for the 80-80 Rule - "Being 80% confident that you will only be 80% right the first time should feel normal." The 80-80 Rule is a theme that emphasizes speed and willingness to embrace uncertainty and overcome internal barriers to change. It sets the standard for redefining innovation as a platform to reignite growth of the biopharmaceutical industry.
Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Download or read book Re inventing Drug Development written by Jeffrey S. Handen and published by CRC Press. This book was released on 2014-10-28 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Knowledge Management in the Pharmaceutical Industry written by Elisabeth Goodman and published by Routledge. This book was released on 2016-04-22 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pharmaceutical Industry has been undergoing a major transformation since the heady days of 'big pharma' in the 1970s and 80s. Patent expiry, the rise of generics, and the decline of the blockbuster drug have all changed the landscape over the last 10-15 years. It's an environment where products can take 10 years or more to come to market, billions are spent on research and development, jobs are being shed in the western pharma homelands and regulators and the public are more demanding than ever. So what part is Knowledge Management playing and going to play in this vital international industry? Knowledge Management (KM) has many facets from providing comprehensive knowledge bases for workers, through the sharing of advice and problem solving, to providing an environment for innovation and change. This book, focusing on research and development, and manufacturing-based companies, explores how a range of techniques and approaches have been applied in the unique environment of the Pharmaceutical Industry, and examine how it can help the industry in the 21st century. Whilst the book is centered on the Pharmaceutical Industry, its objective will be to discuss and demonstrate how Knowledge Management can be applied in a variety of environments, and with a range of cultural issues. KM practitioners, and potential practitioners, both within and outside the Pharmaceutical Industry, will be able to gain valuable guidance and advice from both the examples of good practice and the lessons learned by the authors and contributors.
Download or read book Biopharmaceuticals written by Basanta Behera and published by CRC Press. This book was released on 2020-12-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals: Challenges and Opportunities This book highlights how the traditional microbial process technology has been upgraded for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the guidelines of internally recognized regulatory bodies. It also carries information on how, armed with a deeper understanding of life-threatening diseases, biopharmaceutical companies and the life sciences industry have developed formal and informal partnerships with researchers in institutes, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects of this book is the conceptual development of personalized medicine (or precision medicine) to provide the right treatment to the right patient, at the right dose at an earlier stage of development, for genetic diseases. Besides this, it also highlights the most challenging aspects of modern biopharmaceutical science, focusing on the hot topics such as design and development of biologic drugs; the use of diversified groups of host cells belonging to animals, plants, microbes, insects, and mammals; stem cell therapy and gene therapy; supply chain management of biopharmaceuticals; and the future scope of biopharmaceutical industry development. This book is the latest resource for a wide circle of scientists, students, and researchers involved in understanding and implementing the knowledge of biopharmaceuticals to develop life-saving biologic drugs and to bring awareness to the development of personalized treatment that can potentially offer patients a faster diagnosis, fewer side effects, and better outcomes. Features: Explains how the traditional cell culture methodology has been changed to a fully continuous or partially continuous process Explains how to design and fabricate living organs of body by 3D bioprinting technology Focuses on how a biopharmaceutical company deals with various problems of regulatory bodies and develops innovative biologic drugs Narrates in detail the updated information on stem cell therapy and gene therapy Explains the development strategies and clinical significance of biosimilars and biobetters Highlights the supply chain management of biopharmaceuticals
Download or read book Economics and Management in the Biopharmaceutical Industry in the USA written by Rachel Kim and published by Routledge. This book was released on 2018-12-07 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: From a managerial perspective, the biopharmaceutical industry represents a competitive, fast-changing, intellectually-powered, innovation-driven sector. Many management scholars have studied this discontinuous era to make sense of strategic behavior and the cognition of firms and top managers. A past look at the biopharmaceutical industry provides answers to questions that most managers have. For example, what options do you have and what actions do you take when new firms enter your industry? In the 1970s, new biotechnology firms, funded by venture capitalists, appeared in the pharmaceutical industry with new knowledge. Successful pharmaceutical firms decided to collaborate with the new entrants and forge relationships to develop and create new, biotechnology engineered drugs. Thus, the addition of new biotechnology firms ushered in a new business model based on strategic alliances. Strategic alliances have now become an industrial norm called open innovation. The author looks at the historical path of the biopharmaceutical industry, particularly in the United States. While the pharmaceutical industry’s main contributions to society are substantial, there are pressing challenges the industry must face, such as an increase in infectious disease outbreaks or the global aging population, which require new types of care, additionally, mental health care and prescription painkiller addiction are persistent issues with economic repercussions to both federal and local governments. This book presents a holistic view of the biopharmaceutical industry, putting it in a historical context. It will best serve those who are eager to learn about this dynamic, fast-evolving industry and who would like to tackle current biopharmaceutical industry issues in the United States and be prepared for future industry challenges.
Download or read book BREAKTHROUGH INNOVATION IN THE BIOPHARMACEUTICAL INDUSTRY written by Anthony Flammia and published by . This book was released on 2018 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: The road to breakthrough innovation is complicated, lengthy, costly, and risky to shareholders. This research examines the literature for breakthrough innovation across several industries and disciplines to provide a holistic definition of breakthrough innovation for the biopharmaceutical industry in order to best explore the relationship between breakthrough innovation, knowledge sharing, strategic network alliances, and shareholder value. The study design uses multiple-case studies: a small pilot case study, a second in-depth case study, and a third case study that examines the challenges of breakthrough innovation from senior executives perceptive. Our findings provide three new insights of breakthrough innovation. First, we formulate a new model of breakthrough innovation utilizing strategic network alliances centered on small companies focused on the early phases of development, while larger firms leverage their global commercial infrastructures. Interwoven in the new strategic alliance network are venture capital firms, academia, and government. The second finding is that industry executives prefer the approach of knowledge sharing within a formal strategic network alliance due to the confidential framework of the relationship. The third finding is that incremental innovation is a necessary building block toward breakthrough innovation. The relationship of strategic network alliances and knowledge sharing to breakthrough innovation in the biopharmaceutical industry are critical. Finally, a review of breakthrough innovation factors having the most significant positive impact on maximizing shareholder value in the biopharmaceutical industry.
