Download or read book Understanding Legal Trends in the Life Sciences Industry written by Aspatore, Inc and published by Aspatore Books. This book was released on 2014-04-01 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding Legal Trends in the Life Sciences Industry provides an authoritative, insiders perspective on assisting clients with navigating domestic and international regulatory changes. Featuring experienced partners from law firms across the nation, these experts discuss various issues impacting the life sciences industry, such as transparency, technological advances, marketing regulations, and safety practices. These top lawyers offer specific advice on building portfolios to withstand competition, implementing strong security practices to protect information, and helping clients overcome enforcement challenges. From understanding the Mayo Collaborative Services v. Prometheus Labs, Inc. decision on patentability to updating clients about ongoing compliance issues, these experts discuss the impact of Supreme Court cases on the industry and help develop risk programs to prevent future problems. The different niches represented and the breadth of perspectives presented enable readers to get inside some of the great legal minds of today, as these experienced lawyers offer up their thoughts on the keys to success within this ever-changing field.
Download or read book AHLA The Fundamentals of Life Sciences Law Non Members written by and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, Second Edition, provides a solid grounding in the legal principles and issues inherent in this complex area. Both new practitioners and experienced attorneys alike will benefit from this unparalleled coverage.This new edition features contributions from some of the most experienced and respected practitioners of life sciences and health law. Whether you're looking for an introduction to this area, or you need a go-to reference on your shelf, the coverage includes:Regulation of DrugsRegulation of Medical DevicesRegulation of BiologicsClinical TrialsFraud and AbuseFederal AgenciesRegulation of Advertising, and Promotion of Drugs, Medical Devices, and BiologicsAntitrustPrivacyState RegulationIntellectual PropertyPayment and ReimbursementInternational IssuesLife Sciences Licensing Transaction
Download or read book Securities Law Practice written by Wendell De Keesee, 3rd and published by . This book was released on 2021-08-15 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The world is witnessing the big bang of scientific discovery, and biotech stocks are on fire!The bio-pharma industry employs over 4 million people just in the US. Potentially 100's of new little biotech companies will develop new generations of medicines and medical devices while creating vast numbers of new millionaires. The new Masters of Bioscience Law & Technology Mini-MBA certificate program, provides leading edge business skills, and leadership training to help propel your career forward. In recent years entrepreneurship has been added to many MBA curriculums, but starting your own business doesn't have to take two years in school and $100,000+ in tuition. To stimulate prospective leaders, this new program will encourage all applicants to be reviewed for scholarship opportunities. Register now for the online Bioscience Law & Technology Mini-MBA certificateNow is the time to jump in!The Biotech "Gold Rush" is On! What are you waiting for?VISIT us online.https://newlondoncrownpublishing.com/ Biomedical Business and Legal Management StrategiesLearn the business of biotechnology, how to start and manage biotechnology companies, and how to better service the needs of biotechnology companies.Going beyond simple 'science for non-scientists' or 'Mini-MBA' offerings, these four (4) parts books series describe the convergence of scientific, political, regulatory, and commercial factors that drive the biotechnology industry and define its scope.Study, learn, and explore biotechnology law, science and the biopharma industry! 1.Assess the potential therapeutic value of discoveries emanating from advanced research in the life sciences and understand ways to accelerate these discoveries into therapeutics, and medical devices. 2.Lead science-based organizations, including businesses and non-profits, with an understanding of research, business models, intellectual property and regulatory strategies. 3.Determine the most promising strategy for science-based organizations, including novel ways for expanding access to crucial investment funds and securities offerings. 4.Understand the financial underpinnings of investment decisions in the life sciences, including real-option approaches to investments, as well as the role of scientific, commercial, and regulatory uncertainties affecting biopharma companies.5.Develop approaches to novel therapeutics, including investment in neglected diseases, AI, nano technology, new biologics and medical devices.
Download or read book Life Sciences Law written by Barbara Schroeder de Castro Lopes and published by Dike Publishers. This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview and practical guidance in life sciences law to readers in Switzerland and worldwide. Focusing on medicinal products and medical devices, it follows the value chain from the bench to the market. The main topics addressed include recent regulatory developments and cross-cutting issues relevant for any phase of a product life cycle, such as intellectual property rights, commercial agreements, dispute resolution, incorporation and fundraising, competition law and data protection. Written for readers with diverse backgrounds such as in-house and external counsel, scientists, entrepreneurs, technology transfer professionals, engineers, investors and students, the book provides practical advice, case studies, references to further information, a glossary, and numerous graphs and tables to highlight key points. Though focusing on Swiss law, the book also reflects the international scope of life sciences-related transactions by referencing European Union law and presenting selected topics relevant for operations in the USA and China.
Download or read book Pharmaceutical and Biotech Patent Law written by Arnold & Porter Kaye Scholer Llp and published by . This book was released on 2019-06-07 with total page 1204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.
Download or read book Intellectual Property Rights and the Life Science Industries written by Graham Dutfield and published by World Scientific. This book was released on 2009 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to OC inventOCO life forms from scratch.
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 Navigating Legal Issues in the Biotechnology Industry written by and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book LIFE SCIENCES AND INTELLECTUAL PROPERTY written by BIRD & BIRD. LLP and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Research and Development in the Pharmaceutical Industry A CBO Study written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
Download or read book ANDA Litigation written by Kenneth L. Dorsney and published by American Bar Association. This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.
Download or read book Dual Use Research of Concern in the Life Sciences written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-10-01 with total page 115 pages. Available in PDF, EPUB and Kindle. Book excerpt: The potential misuse of advances in life sciences research is raising concerns about national security threats. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies examines the U.S. strategy for reducing biosecurity risks in life sciences research and considers mechanisms that would allow researchers to manage the dissemination of the results of research while mitigating the potential for harm to national security.
Download or read book The Law and Policy of Healthcare Financing written by Wolf Sauter and published by Edward Elgar Publishing. This book was released on 2019 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the ways and extent to which systemic factors affect health outcomes with regard to quality, affordability and access to curative healthcare, this explorative book compares tax-funded Beveridge systems and insurance-based Bismarck systems. Containing contributions from national experts, The Law and Policy of Healthcare Financing charts and compares the merits of healthcare systems throughout 11 countries, from the UK to Colombia.
Download or read book Medical Devices Law and Regulation Answer Book written by Susan Onel and published by . This book was released on 2016-11 with total page 1112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Download or read book A User s Guide to Intellectual Property in Life Sciences written by Paul England and published by Bloomsbury Publishing. This book was released on 2021-04-08 with total page 877 pages. Available in PDF, EPUB and Kindle. Book excerpt: Life Sciences is one of the most innovative and complex areas of law. It is currently undergoing a period of intense transformation, with companies facing an ever-increasing level of regulation as well as strict cost management in order to remain competitive and profitable. The latest in "A User's Guide to..." series it covers life sciences in relation to: - patents - copyright - trade marks; and - data protection The book covers UK law with references to significant EPO cases. A key part of the book is the coverage of case law. Case studies and detailed analysis of the key cases, eg the Kymab mouse case, the human genome sciences case, and the pregabalin case feature heavily helping to put this often complex area of law into context. Where appropriate and for comparison purposes, approaches of key foreign jurisdictions are summarised and for ease of use there are clearly signposted. A key text for practitioners specialising in life sciences and intellectual property in general and patents officers dealing with life sciences applications.
Download or read book Life Sciences in Transition written by Halldor Stefansson and published by Elsevier. This book was released on 2002-08-30 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: These essays grew out of an effort at the EMBL to promote a new form of science communication on the social, ethical, and political issues that surround rapid change in the life sciences. Published in the Journal of Molecular Biology, these eighteen essays address the main topics of the future of the biosciences, biosciences and basic values, genomics and the globalization of biology, science miscommunication, and reproductive technologies. Hot topics such as cloning, genomics, reproductive technologies, heatlh care costs are addressed. Key Features * Significant to those in the life sciences and social sciences * Features an Introduction by Halldór Stefánsson * Published in conjunction with the prestigious European Molecular Biology Laboratory (EMBL)
Download or read book Intellectual Property Rights and the Life Science Industries written by Graham Dutfield and published by World Scientific. This book was released on 2009 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to ?invent? life forms from scratch.Contents: Seven Tales of a Patent; Patents and the Life Science Industries in the Modern Economy; Past: Dyes, Drugs and Domagk; Adrenaline Rushes ? Isolate, Purify ? and Patent; Science and Drug Discovery ? Ignorance, Serendipity and Rational Drug Design; Aspirin; Insulin; Penicillin and the Antibiotics; Cortisone and the Steroids; Polymerase Chain Reaction; The Gene Patent Wars; Innovations without Patents? The Polio Vaccine and Monoclonal Antibodies; Present: Big Pharma, Small Biotech; Crises, Backlashes and Counter-backlashes; Would We Have Got Where We are Today without Patents?; Future: Systems Biology, Stem Cells, ?Synbio? and the Future of Patents.
