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Author : Michael J. Malinowski
Publisher :
ISBN 13 : 9781634601535
Total Pages : 0 pages
Book Rating : 4.6/5 (15 download)
Download or read book Handbook on Biotechnology Law, Business, and Policy written by Michael J. Malinowski and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Softbound - New, softbound print book.
Author : Michael J. Malinowski
Publisher : Aspen Publishers
ISBN 13 : 9780735503090
Total Pages : 994 pages
Book Rating : 4.5/5 (3 download)
Download or read book Biotechnology written by Michael J. Malinowski and published by Aspen Publishers. This book was released on 1999 with total page 994 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology: Law, Business, and Regulation offers comprehensive analysis on the advancement of a biotech discovery into a commercial product, making it easy for you to identify legal issues as they arise in the R & D and commercialization process; anticipate forthcoming legal and regulatory challenges; and develop an effective strategy for efficient commercialization. Real product and industry examples are used throughout the handbook and pending legislation is discussed and analyzed. This is the first book to pull together all the legal issues associated with the burgeoning biotechnology industry. The author explains and analyzes the current dimensions of biotechnology law, with in-depth attention to: the markets for biotech products -- patent protection -- confidentiality and other intellectual property issues -- government-supported cooperative R & D agreements -- corporate securities issues -- clinical trial agreements, including informed consent, liability, and insurance issues -- FDA regulation and tracks to speed product approval and commercialization -- legal implications of foreign R & D -- public health and policy considerations -- legislation prohibiting discrimination on the basis of genetic information -- and ethical norms of the scientific and medical communities.
Author : Hugh B. Wellons
Publisher : American Bar Association
ISBN 13 : 9781590317617
Total Pages : 1016 pages
Book Rating : 4.3/5 (176 download)
Download or read book Biotechnology and the Law written by Hugh B. Wellons and published by American Bar Association. This book was released on 2007 with total page 1016 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.
Download or read book Biotechnology Law written by and published by . This book was released on 2001 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Yali Friedman
Publisher : Logos Press
ISBN 13 : 9781934899281
Total Pages : 388 pages
Book Rating : 4.8/5 (992 download)
Download or read book Building Biotechnology written by Yali Friedman and published by Logos Press. This book was released on 2014-01-01 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, policy, regulatory, and commercial factors that drive the biotechnology industry and define its scope. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in dozens of advanced biotechnology programs. This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.
Author : Yali Friedman
Publisher :
ISBN 13 : 9781934899298
Total Pages : 367 pages
Book Rating : 4.8/5 (992 download)
Download or read book Building Biotechnology written by Yali Friedman and published by . This book was released on 2014 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, policy, regulatory, and commercial factors that drive the biotechnology industry and define its scope. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in dozens of advanced biotechnology programs. This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.
Author : Alan J. Morrison
Publisher : Columbia University Press
ISBN 13 : 0231550928
Total Pages : 466 pages
Book Rating : 4.2/5 (315 download)
Download or read book Biotechnology Law written by Alan J. Morrison and published by Columbia University Press. This book was released on 2020-02-04 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and law are inextricable. Patent, regulatory, and contract law profoundly shape the biotech industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in this industry lack even a basic grasp of these laws, jeopardizing their business success as a result. This book is an essential introduction to biotechnology law for scientists, startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other nonattorneys with biotech backgrounds. It covers core topics such as patentability, patent prosecution and infringement, patent opinions, the development and FDA approval of small-molecule and biologic drugs, regulatory exclusivity, generic drugs and ANDA litigation, biosimilars and the patent dance, patent licenses, and collaboration agreements. Written with scientists in mind, Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. Understanding the legal machinery through which science becomes business is not a luxury—it is a crucial part of a scientist’s training. Alan J. Morrison’s expert treatment embraces this new reality.
Author : Robert A. Bohrer
Publisher :
ISBN 13 : 9781594600876
Total Pages : 0 pages
Book Rating : 4.6/5 (8 download)
Download or read book A Guide to Biotechnology Law and Business written by Robert A. Bohrer and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a guide to the "big picture" of biotechnology law and business, presenting and analyzing the issues that arise throughout the life cycle of the biotechnology product. The book focuses primarily on the pharmaceutical field, from university research through the development process and into the marketplace. The aim of the book is to provide guidance to the biotechnology legal and business communities by providing a practical and integrated discussion of the many different topics that arise in developing biotechnology products. It is intended to be used by I.P. lawyers, FDA lawyers, business lawyers and biotech executives who want a concise introduction to the most fundamental issues in biotechnology law and business. "Understanding the molecular pathways in disease processes is critical to discovering new drugs. The equally important task is to understand the legal pathways that enable biotechnology commercialization. This book charts the course in a way that greatly improves the odds of success."--Drew Senyei, M.D., Managing Director, Enterprise Partners Venture Capital, La Jolla, CA "Bob Bohrer has provided a thorough and thoughtful guide to the biotech industry. His experience, which is based on years of examining the biotech sector, is shared in this book and provides a comprehensive and organized overview for the scientist, investor, service provider and anyone else associated with the biotech industry. This is a must-read for both the experienced biotech executives and those new to the industry."--Lisa A. Haile, J.D., Ph.D., Partner and Co-Chair, Life Sciences Group, DLA Piper US LLP "Professor Bohrer is well positioned to write this comprehensive volume. He was most likely the first legal academician to definitively determine what biotechnology incorporates, and has never stopped reflecting upon the scientific, legal, and social/ethical issues involved. Not only will person now interested in biotechnology benefit from this book, but future historians will thank him."--Douglas Dale Busch, Former General Counsel of The Salk Institute
Author : Victoria Sutton
Publisher :
ISBN 13 :
Total Pages : 512 pages
Book Rating : 4.F/5 ( download)
Download or read book Law and Biotechnology written by Victoria Sutton and published by . This book was released on 2007 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: This casebook addresses a broad range of issues in many areas of law which are affected by recent advances in biotechnology. The book seeks to examine the law and the underlying science and policy of biotechnology in addressing these issues. This interdisciplinary book will include biotechnology issues in biologically engineered plants and foods, genetically engineered organisms, cloning, DNA, the Human Genome Project, patenting, property law, criminal law, evidence, and international aspects of law and biotechnology. The governmental management of these issues through the Executive Branch, the Legislative Branch and the Judicial Branch, as well as the private sector interaction, is examined. Several appendices are included in the casebook, which are useful reference tools for the student or the practitioner.
Author : Alessandro Stasi
Publisher :
ISBN 13 : 9789819921362
Total Pages : 0 pages
Book Rating : 4.9/5 (213 download)
Download or read book Biotechnology Law and Policy written by Alessandro Stasi and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers an extensive range of issues raised by biotechnological advancements from a regulatory perspective. Written in a clear and readable style, its main objective is to give readers an idea of the relationship between biotechnology and law. Biotechnology advancements and their ethical, moral, economic, and social implications in different fields and the consequential normative demands on the law are crucial to this book. The chapters cover a multitude of themes and some of the most important legal issues arising in relation to biotechnology, including the historical development of a legal framework sufficient to protect public safety, the current biotechnology regulatory system, and the rules directing the primary agencies that regulate the products of biotechnology, namely the US Food and Drug Administration, the US Department of Agriculture, and the US Environmental Protection Agency, patents and IP rights in biotechnology, the regulation of human genome editing and its impact on health research, law and emerging genome editing technologies from recombinant DNA to CRISPR/Cas9, the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and legal issues arising from the use of genetic engineered plants and animals. Presenting arguments that have been drawn from careful examination of various international documents and decisions made by legal institutions and judicial bodies, this book would be a valuable read for practitioners as well as academics of biotechnology law.
Author :
Publisher :
ISBN 13 : 9781402403385
Total Pages : 928 pages
Book Rating : 4.4/5 (33 download)
Download or read book Biotechnology Law, 2003 written by and published by . This book was released on 2003 with total page 928 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Wen De Keesee
Publisher : wil keesee
ISBN 13 : 1736209515
Total Pages : 316 pages
Book Rating : 4.7/5 (362 download)
Download or read book Biotechnology Law and Practice written by Wen De Keesee and published by wil keesee . This book was released on 2021-04-15 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Biotech "Gold Rush" is On! What are you waiting for? We are entering an explosive new era of medical and scientific discovery and the opportunities are huge for those who grasp the moment This Biotechnology Law and Practice Four book series is the most current, and informative work of its kind, and heralded by lawyers, scientists, and entrepreneurs as a must-have guidebook which simplifies complex issues at the frontiers of the law and biomedicine. With over 1600 power-packed pages of bioscience-biotech law, intellectual property, biomedicine, pharmaceuticals, regulatory, business strategies, and entrepreneurship, these books will launch you into this explosive new field, and you will have a precious asset, which you may routinely consult on your great new quest. Biotech Stocks are on fire! Potentially 100’s of new little biotech companies will develop new generations of medicines and medical devices while creating vast numbers of new millionaires.
Author : John C. Miller
Publisher : John Wiley & Sons
ISBN 13 : 0471699918
Total Pages : 384 pages
Book Rating : 4.4/5 (716 download)
Download or read book The Handbook of Nanotechnology written by John C. Miller and published by John Wiley & Sons. This book was released on 2004-11-11 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the first attempt to fully explore the controversial issues associated with the commercial application of nanotechnology, you'll find a thorough analysis of intellectual property and patents, financing and legal concerns, regulatory measures particularly in the field of nanomedicine, and environmental regulations. The authors include a set of guideposts you can follow in your due diligence of the business and legal issues pertaining to the technology.
Author : Gale R. Peterson
Publisher : CRC Press
ISBN 13 : 9780824789350
Total Pages : 502 pages
Book Rating : 4.7/5 (893 download)
Download or read book Understanding Biotechnology Law written by Gale R. Peterson and published by CRC Press. This book was released on 1993-05-27 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt: Detailing the intellectual-property aspects of biotechnology law - from initial identification and reporting through licensing - this comprehensive reference explains the rules, regulations and procedures typically encountered by researchers in the development of their innovations.;Focusing on the fundamental legal concepts that should be understood by scientists, academicians and technicians working in the field, Understanding Biotechnology Law: considers the role of the inventor in the preparation of a patent application; describes the patent application process from discovery of an invention to issuance of a patent; discusses the law governing ownership of laboratory discoveries and products; examines intellectual-property policies, research agreements, consulting agreements, and conflicts of interest; presents the rules for determining inventorship; reviews patent infringement laws, including claim interpretation, literal infringement, and infringement under the doctrine of equivalents; and outlines modern license agreements, providing the principal terms encountered in biotechnology licenses.;Written by authorities in the field, Understanding Biotechnology Law is a reference for molecular and cell biologists, microbiologists, virologists, bioprocess technologists, biochemists, food scientists and technologists, pharmacologists, and pharmacists.
Author : Roger Brownsword
Publisher : Oxford University Press
ISBN 13 : 0191502235
Total Pages : 1216 pages
Book Rating : 4.1/5 (915 download)
Download or read book The Oxford Handbook of Law, Regulation and Technology written by Roger Brownsword and published by Oxford University Press. This book was released on 2017-07-24 with total page 1216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The variety, pace, and power of technological innovations that have emerged in the 21st Century have been breathtaking. These technological developments, which include advances in networked information and communications, biotechnology, neurotechnology, nanotechnology, robotics, and environmental engineering technology, have raised a number of vital and complex questions. Although these technologies have the potential to generate positive transformation and help address 'grand societal challenges', the novelty associated with technological innovation has also been accompanied by anxieties about their risks and destabilizing effects. Is there a potential harm to human health or the environment? What are the ethical implications? Do this innovations erode of antagonize values such as human dignity, privacy, democracy, or other norms underpinning existing bodies of law and regulation? These technological developments have therefore spawned a nascent but growing body of 'law and technology' scholarship, broadly concerned with exploring the legal, social and ethical dimensions of technological innovation. This handbook collates the many and varied strands of this scholarship, focusing broadly across a range of new and emerging technology and a vast array of social and policy sectors, through which leading scholars in the field interrogate the interfaces between law, emerging technology, and regulation. Structured in five parts, the handbook (I) establishes the collection of essays within existing scholarship concerned with law and technology as well as regulatory governance; (II) explores the relationship between technology development by focusing on core concepts and values which technological developments implicate; (III) studies the challenges for law in responding to the emergence of new technologies, examining how legal norms, doctrine and institutions have been shaped, challenged and destabilized by technology, and even how technologies have been shaped by legal regimes; (IV) provides a critical exploration of the implications of technological innovation, examining the ways in which technological innovation has generated challenges for regulators in the governance of technological development, and the implications of employing new technologies as an instrument of regulatory governance; (V) explores various interfaces between law, regulatory governance, and new technologies across a range of key social domains.
Author : Matthew Rimmer
Publisher : Edward Elgar Publishing
ISBN 13 : 1848440189
Total Pages : 393 pages
Book Rating : 4.8/5 (484 download)
Download or read book Intellectual Property and Biotechnology written by Matthew Rimmer and published by Edward Elgar Publishing. This book was released on 2008-01-01 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dr Rimmer s book is a marvellous introduction to a crucial topic of our time. He writes engagingly, provocatively and always with good humour. A highly technical and complex area of law has been reduced to clear descriptions and searching analysis. Truly, this is an important book on an essential topic that will help define the ethics of a future that includes nothing less than the future of our species. From the foreword by the Hon Justice Michael Kirby AC CMG, the High Court of Australia . . . the author has done an excellent job by explaining the subject in an open and accessible manner. This book is a timely and very thought-provoking analysis of patent law and biotechnology. . . The book is a unique theoretical contribution to the controversial public debate over commercialization of biological inventions. . . there is an extensive bibliography. . . a valuable resource for further reading. The book will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists. Journal of Intellectual Property Rights Rimmer s book is highly recommended for anyone interested in the issues and debate related to biological inventions, regardless of which side the reader is on. Stefan M. Miller, Journal of Commercial Biotechnology . . . this book gives an excellent account of the most celebrated biotechnology cases from three continents, and for this alone is to be thoroughly recommended. David Rogers, European Intellectual Property Review Rimmer has put a great deal of thought and effort into this series of chapters. For those looking at how to reform, direct and develop laws in relation to biotechnology, this book is brimming with ideas, suggestions and recommendations of what to do next. Rebecca Halford-Harrison, Chartered Institute of Patent Attorneys . . . an excellent introduction to a wide range of legal thinking in an increasingly controversial and relevant area to humankind. Sharon Givoni, Australian Intellectual Property Law Bulletin Rimmer s new book is a timely and very thought-provoking analysis of patent law and biotechnology and asks a very serious question: can a 19th century patent system adequately deal with a 21st century industry? Kate McDonald, Australian Life Scientist This book documents and evaluates the dramatic expansion of intellectual property law to accommodate various forms of biotechnology from micro-organisms, plants, and animals to human genes and stem cells. It makes a unique theoretical contribution to the controversial public debate over the commercialization of biological inventions. The author also considers the contradictions between the Supreme Court of Canada rulings in respect of the Harvard oncomouse, and genetically modified canola. He explores law, policy, and practice in both Australia and New Zealand in respect to gene patents and non-coding DNA. This study charts the rebellion against the European Union Biotechnology Directive particularly in respect of Myriad Genetics BRCA1 and BRCA2 patents, and stem cell patent applications. The book also considers whether patent law will accommodate frontier technologies such as bioinformatics, haplotype mapping, proteomics, pharmacogenomics, and nanotechnology. Intellectual Property and Biotechnology will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists.
Author : Stuart J. Smyth
Publisher : Edward Elgar Publishing
ISBN 13 : 0857938355
Total Pages : 881 pages
Book Rating : 4.8/5 (579 download)
Download or read book Handbook on Agriculture, Biotechnology and Development written by Stuart J. Smyth and published by Edward Elgar Publishing. This book was released on 2014-03-28 with total page 881 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a compendium of knowledge, experience and insight on agriculture, biotechnology and development. Beginning with an account of GM crop adoptions and attitudes towards them, the book assesses numerous crucial processes, concluding with detai
