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Biotechnology Research in an Age of Terrorism

Author: National Research Council

Publisher: National Academies Press

Published: 2004-03-02

Total Pages: 164

ISBN-13: 0309089778

In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.

Dual Use Research of Concern in the Life Sciences

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-10-01

Total Pages: 115

ISBN-13: 0309458889

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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.

Pharmaceutical and Biotech Patent Law

Author: Arnold & Porter Kaye Scholer Llp

Publisher:

Published: 2019-06-07

Total Pages: 1204

ISBN-13: 9781402431388

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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.

Law in the Laboratory

Author: Robert P. Charrow

Publisher: University of Chicago Press

Published: 2010-07-15

Total Pages: 342

ISBN-13: 0226101665

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The National Institutes of Health and the National Science Foundation together fund more than $40 billon of research annually in the United States and around the globe. These large public expenditures come with strings, including a complex set of laws and guidelines that regulate how scientists may use NIH and NSF funds, how federally funded research may be conducted, and who may have access to or own the product of the research. Until now, researchers have had little instruction on the nature of these laws and how they work. But now, with Robert P. Charrow’s Law in the Laboratory, they have a readable and entertaining introduction to the major ethical and legal considerations pertaining to research under the aegis of federal science funding. For any academic whose position is grant funded, or for any faculty involved in securing grants, this book will be an essential reference manual. And for those who want to learn how federal legislation and regulations affect laboratory research, Charrow’s primer will shed light on the often obscured intersection of government and science.

ANDA Litigation

Author: Kenneth L. Dorsney

Publisher: American Bar Association

Published: 2012

Total Pages: 0

ISBN-13: 9781614384786

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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.

The Canon of American Legal Thought

Author: David Kennedy

Publisher: Princeton University Press

Published: 2018-06-05

Total Pages: 936

ISBN-13: 0691186421

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This anthology presents, for the first time, full texts of the twenty most important works of American legal thought since 1890. Drawing on a course the editors teach at Harvard Law School, the book traces the rise and evolution of a distinctly American form of legal reasoning. These are the articles that have made these authors--from Oliver Wendell Holmes, Jr., to Ronald Coase, from Ronald Dworkin to Catherine MacKinnon--among the most recognized names in American legal history. These authors proposed answers to the classic question: "What does it mean to think like a lawyer--an American lawyer?" Their answers differed, but taken together they form a powerful brief for the existence of a distinct and powerful style of reasoning--and of rulership. The legal mind is as often critical as constructive, however, and these texts form a canon of critical thinking, a toolbox for resisting and unravelling the arguments of the best legal minds. Each article is preceded by a short introduction highlighting the article's main ideas and situating it in the context of its author's broader intellectual projects, the scholarly debates of his or her time, and the reception the article received. Law students and their teachers will benefit from seeing these classic writings, in full, in the context of their original development. For lawyers, the collection will take them back to their best days in law school. All readers will be struck by the richness, the subtlety, and the sophistication with which so many of what have become the clichés of everyday legal argument were originally formulated.

Pharmaceutical and Medical Device Compliance Manual

Author: Ela Bochenek

Publisher:

Published: 2019

Total Pages: 319

ISBN-13: 9781522178026

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A robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today's complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government's expectations of an effective compliance program and ethical business practices, as well as: how the government discovers potential enforcement actions, its approach to pursuing such actions, what behaviors can constitute mitigating factors for a company in the event of a legal violation. Coverage includes new chapters covering:Pharmaceutical industry interactions with patient organizations Compliance 2.0: compliance analytics in the era of big dataThe art and science of health care compliance in the pharmaceutical and medical device industries The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry

CRISPR People

Author: Henry T. Greely

Publisher: MIT Press

Published: 2022-03-01

Total Pages: 395

ISBN-13: 0262543885

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What does the birth of babies whose embryos had gone through genome editing mean--for science and for all of us? In November 2018, the world was shocked to learn that two babies had been born in China with DNA edited while they were embryos—as dramatic a development in genetics as the 1996 cloning of Dolly the sheep. In this book, Hank Greely, a leading authority on law and genetics, tells the fascinating story of this human experiment and its consequences. Greely explains what Chinese scientist He Jiankui did, how he did it, and how the public and other scientists learned about and reacted to this unprecedented genetic intervention. The two babies, nonidentical twin girls, were the first “CRISPR'd” people ever born (CRISPR, Clustered Regularly Interspaced Short Palindromic Repeats, is a powerful gene-editing method). Greely not only describes He's experiment and its public rollout (aided by a public relations adviser) but also considers, in a balanced and thoughtful way, the lessons to be drawn both from these CRISPR'd babies and, more broadly, from this kind of human DNA editing—“germline editing” that can be passed on from one generation to the next. Greely doesn't mince words, describing He's experiment as grossly reckless, irresponsible, immoral, and illegal. Although he sees no inherent or unmanageable barriers to human germline editing, he also sees very few good uses for it—other, less risky, technologies can achieve the same benefits. We should consider the implications carefully before we proceed.