Download or read book Industrialization of Biology written by National Research Council and published by National Academies Press. This book was released on 2015-06-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.

Download or read book The Business of Healthcare Innovation written by Lawton Robert Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Download or read book Understanding Pharma written by John J. Campbell and published by Pharmaceutical Press. This book was released on 2008-01-01 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-30 with total page 638 pages. Available in PDF, EPUB and Kindle. Book excerpt: What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Download or read book ECIE2015 10th European Conference on Innovation and Entrepreneurship written by Renata Paola Dameri, Roberto Garelli and Marina Resta and published by Academic Conferences and publishing limited. This book was released on 2015-08-24 with total page 866 pages. Available in PDF, EPUB and Kindle. Book excerpt: These proceedings represent the work of contributors to the 10th European Conference on Innovation and Entrepreneurship (ECIE 2015), hosted this year by The University of Genoa, Italy on the 17-18 September 2015. The Conference Chair is Prof Luca Beltrametti and the Programme Co-chairs are Prof Renata Paola Dameri, Prof. Roberto Garelli and Prof. Marina Resta, all from the University of Genoa. ECIE continues to develop and evolve. Now in its 10th 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 growing area of research. The opening keynote presentation is given by Marco Doria – Mayor of Genoa on the topic of Innovation and entrepreneurship in Genoa: past, present and future. A second keynote will be given by Flavia Marzano from the National board for innovation and Italian digital agenda on the topic of Innovation: New visions not just new technologies. The second day Keynote will be given by Roberto Santoro, President of the European Society of Concurrent Engineering Network (ESoCE Net) on the topic of People Olympics for healthy and active living: A people driven social innovation platform. In addition to the main themes of the conference there are a number of specialist mini tracks on topics including Innovation and strategy, Entrepreneurship education in action, The theory and practice of collaboration in entrepreneurship and Challenges for entrepreneurship and innovation n the 21st Century. With an initial submission of 275 abstracts, after the double blind, peer review process there are 88 Academic research papers, 6 PhD research papers, 1 Masters Research paper, 4 work-in-progress papers and 1 Non-academic paper published in these Conference Proceedings. These papers represent research from Australia, Brazil, Bulgaria, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, , France, Germany, Ghana, Greece, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, , Kuwait, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Poland, Portugal, Romania, Romania, Russia, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Thailand, Thailand, UK and USA

Download or read book Biosimilars written by Hiten J. Gutka and published by Springer. This book was released on 2018-12-13 with total page 713 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Download or read book Enhancing the Effectiveness of Team Science written by National Research Council and published by National Academies Press. This book was released on 2015-07-15 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past half-century has witnessed a dramatic increase in the scale and complexity of scientific research. The growing scale of science has been accompanied by a shift toward collaborative research, referred to as "team science." Scientific research is increasingly conducted by small teams and larger groups rather than individual investigators, but the challenges of collaboration can slow these teams' progress in achieving their scientific goals. How does a team-based approach work, and how can universities and research institutions support teams? Enhancing the Effectiveness of Team Science synthesizes and integrates the available research to provide guidance on assembling the science team; leadership, education and professional development for science teams and groups. It also examines institutional and organizational structures and policies to support science teams and identifies areas where further research is needed to help science teams and groups achieve their scientific and translational goals. This report offers major public policy recommendations for science research agencies and policymakers, as well as recommendations for individual scientists, disciplinary associations, and research universities. Enhancing the Effectiveness of Team Science will be of interest to university research administrators, team science leaders, science faculty, and graduate and postdoctoral students.

Download or read book Parenteral Medications Fourth Edition written by Sandeep Nema and published by CRC Press. This book was released on 2019-07-19 with total page 1145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Download or read book White Biotechnology written by Roland Ulber and published by Springer. This book was released on 2007-01-30 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions by numerous experts

Download or read book Yearbook of International Organizations 2014 2015 Volumes 1a 1b Set written by Union Of International Associations and published by . This book was released on 2014-06-16 with total page 1452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Volume 1 (A and B) covers international organizations throughout the world, comprising their aims, activities and events.

Download or read book Biosimilar Drug Product Development written by Laszlo Endrenyi and published by CRC Press. This book was released on 2017-02-24 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Download or read book Introduction to Biotech Entrepreneurship From Idea to Business written by Florentina Matei and published by Springer. This book was released on 2019-08-16 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: Primarily intended for biotechnology graduates, this handbook provides an overview of the requirements, opportunities and drawbacks of Biotech Entrepreneurship, while also presenting valuable training materials tailored to the industrial and market reality in the European Biotech Business. Potential investors and business consultants will find essential information on the benefits and potential risks involved in supporting biotech businesses. Further, the book addresses a broad range of Biotechnology fields, e.g. food biotech, industrial biotech, bioinformatics, animal and human health. Readers will learn the essentials of creating innovations, founding a biotech start-up, business management strategies, and European funding sources. In addition, the book discusses topics such as intellectual property management and innovation transfer. The book offers a comparative analysis of different countries’ perspectives and reviews the status quo in Western and Eastern European regions, also in comparison with other leading biotech countries such as the USA and Canada. A long list of potentially profitable biotech start-up ideas and a collection of success stories involving European companies are also included. The book is based on the Erasmus+ Strategic Partnership project “Supporting biotechnology students oriented towards an entrepreneurial path” (www.supbioent.usamv.ro), which involved the collaboration of Life Sciences and Economics departments at higher education institutions throughout Western and Eastern Europe.

Download or read book The Science and Regulations of Naturally Derived Complex Drugs written by Ram Sasisekharan and published by Springer. This book was released on 2019-04-23 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.

Download or read book Biosimilars written by Valderilio Feijó Azevedo and published by BoD – Books on Demand. This book was released on 2022-06-08 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduced in the 1980s, biologic medications have since become important tools in modern medicine. However, biologics are expensive, greatly affecting the healthcare budgets of both underdeveloped and developed countries. Fortunately, biosimilars, which are highly similar, reverse-engineered versions of existing biological medicines and their active ingredients, are now available as more affordable options for patients treated with biologics. This book discusses biosimilars with chapters on clinical trials, regulation, pharmacovigilance, and the interchangeability of biosimilars with biologics. It also addresses future trends in the biosimilars market.

Download or read book The Measurement of Scientific Technological and Innovation Activities Frascati Manual 2015 Guidelines for Collecting and Reporting Data on Research and Experimental Development written by OECD and published by OECD Publishing. This book was released on 2015-10-08 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The internationally recognised methodology for collecting and using R&D statistics, the OECD's Frascati Manual is an essential tool for statisticians and science and innovation policy makers worldwide. It includes definitions of basic concepts, data collection guidelines, and classifications ...

Download or read book Venture Capital and the European Biotechnology Industry written by W. Bains and published by Springer. This book was released on 2008-11-20 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book opens up the world on private equity investment in one of the hottest industries – Biotechnology. The book describes how Europe has fallen behind the US due to under-investment and bad management by the VCs who control the companies. Detailed analysis shows why it is in VCs' interests to damage the very companies they invest in.