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The Funding Of Biopharmaceutical Research And Development

Author: David R Williams
Publisher: Elsevier
ISBN: 1908818387
Size: 27.50 MB
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The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decrease in the near future. A lack of understanding of the scale, scope, and inner workings of the funding aspects of R&D can, at times, act as a barrier for all involved, and can slow down or even eliminate the R&D process. The book lessens these barriers by describing the theoretical underpinnings, present practice, and trends in R&D funding in this market sector, both in the US and internationally. This includes a review and discussion of public-private partnership activity and their inner-workings, noting the complementary relationship between public and private funding. The book also contains an overview of the inner-workings of strategic alliance activity, including the advantages and disadvantages for each party. It goes on to provide an outline of venture capital activity, detailing the methods by which venture capital firms raise capital and are organized, a description of the venture capital-entrepreneur arrangement, and the effects of this arrangement. The book also presents an overview of the IPO process and the various fates of firms going public. Presents a comprehensive view of the funding issues of R&D in this market sector, adopting a theory-to-practice approach A comprehensive and analytical review of the biopharmaceutical R&D literature and practice An overview of the various and competing/complementary theories of the firm and valuation methods as they apply to biopharmaceutical R&D

Outsourcing Biopharma R D To India

Author: P R Chowdhury
Publisher: Elsevier
ISBN: 1908818018
Size: 55.32 MB
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The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. Constitutes the first ever comprehensive insight on the Indian biopharma sector Provides a perspective based on practical hands-on legal experience Simply structured, clearly presented and free from excessive legal jargon

A Biotech Manager S Handbook

Author: M O'Neill
Publisher: Elsevier
ISBN: 1908818158
Size: 13.21 MB
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A biotech manager's handbook lays out - in a simple, straightforward manner - for the manager or would-be entrepreneur the basic principles of running a biotech company. Most managers in biotechnology companies are working in their first company or in their first managerial role. Their expertise and experience in the scientific part of the work can be taken as a given but there is a whole range of other skills to be learned and areas of expertise to come to terms with. Small companies do not have big budgets to hire people or time to become an expert in so many areas. The book starts by outlining the state of the biopharmaceutical industry and goes on to explain the importance of planning (no matter what the size of the company). Succeeding chapters deal with the basics of intellectual property, perspectives from a university technology transfer office and how to raise some initial funding from an investor and entrepreneur. No other 'how to' manual exists for this sector Written by a range of expert professionals in each area, all in one book Is the only 'bench to bedside' book covering the whole spectrum of development

Nanoparticulate Drug Delivery

Author: Vandana Patravale
Publisher: Elsevier
ISBN: 1908818190
Size: 33.60 MB
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Nanotechnology-based therapeutics, operating at scales of billionths of a metre, have great potential for future expansion in altering the scale and methods of drug delivery. The availability of these novel formulations to once-inaccessible areas of the body has greatly expanded the therapeutic window of existing drug molecules. Nanoparticulate drug delivery highlights and examines the transition of nanoparticulate drug delivery systems from the laboratory into a commercially viable sector. The first chapters of the book provide an overview of the use and characterization of nanoparticulate systems as drug carriers, including the assessment of their morphology, sterility and potential toxicity. In the latter part of the book, chapters cover nanotoxicology, regulatory aspect and clinical trials, ending with an overview of several case studies and a look towards future developments. Discusses the issues surrounding nanoparticulate products, based on personal experience of their formulation Provides an overview of new application areas, including RNA interference Outlines the pros and cons of nanoparticulate products, and discusses how these may influence their route into the commercial sector

Lean Biomanufacturing

Author: Nigel J Smart
Publisher: Elsevier
ISBN: 1908818409
Size: 44.54 MB
Format: PDF
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With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful. Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. A focus on the issues associated with the application of lean principles to biomanufacturing Practical examples of factors which can affect biopharmaceutical processes Coverage of key factors which require integration to run an efficient biopharmaceutical process

Patently Innovative

Author: R A Bouchard
Publisher: Elsevier
ISBN: 1908818085
Size: 11.70 MB
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Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products. Includes empirical research to relate innovation to drug law A multidisciplinary approach is taken, including the intersection of IP (intellectual property) law, drug law and innovation Discusses the impact of government regulation on firm innovation

Stimuli Responsive Polymeric Nanocarriers For Drug Delivery Applications

Author: Abdel Salam Hamdy Makhlouf
Publisher: Woodhead Publishing
ISBN: 0081019963
Size: 13.25 MB
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Stimuli Responsive Polymeric Nanocarriers for Drug Delivery Applications: Volume Two: Advanced Nanocarriers for Therapeutics discusses, in detail, the recent trends in designing dual and multi-responsive polymers and nanoparticles for safe drug delivery. Chapters cover dual-responsive polymeric nanocarriers for drug delivery and their different stimuli, multi-responsive polymeric nanocarriers, and the therapeutic applications of stimuli-responsive polymers. With an emphasis on advanced medical applications and synergistic operational and technological methodologies for the improvement of polymers systems for the production of stimuli-responsive polymers, this book is essential reading for materials scientists and researchers working in the drug delivery and pharmaceutical industries. As innovation and development in the area of stimuli responsive polymer-based nanomaterials for drug delivery is moving fast and there is an increased global demand for biodegradable and biocompatible responsive polymers and nanoparticles for safe drug delivery, users will find this to be a timely resource. Focusses on the most advanced technologies, recent evaluation methods, technical aspects, and advanced synthesis techniques stimuli-responsive polymers Examines advanced medical applications of stimuli responsive polymers Analyzes synergistic operational and technological methodologies for the improvement of polymer systems for the production of stimuli-responsive polymers in drug delivery

Core Shell Nanostructures For Drug Delivery And Theranostics

Author: Maria Focarete
Publisher: Woodhead Publishing
ISBN: 0081021992
Size: 69.37 MB
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Core-Shell Nanostructures for Drug Delivery and Theranostics: Challenges, Strategies and Prospects for Novel Carrier Systems contains valuable chapters that deal with the fundamentals of nanotechnology for drug delivery, recent developments and research in core-shell nanoparticles for drug-delivery and theranostic applications, and the potential and applications of core-shell nanofiber. This book is a highly valuable resource for scientists interested in the design and development of innovative drug delivery systems, researchers and graduate/postdoctoral students engaged in biomaterials for drug delivery, and R&D managers in the biomaterials and pharmaceutical industry. Focuses on core-shell nanoparticles and nanofiber for innovative applications, including cancer therapy, controlled release and multi-drug release Considers future prospects and potential new applications of core-shell nanostructures for drug delivery and theranostics Explains the principles and essential concepts of nanotechnology for drug delivery systems