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Book
xxxiii, 294 pages ; 24 cm.
  • Introduction
  • Fundamentals
  • Crime
  • Equity
  • Contract
  • Tort
  • Defences
  • Remedies
  • Conclusions.
Accessory liability in the private law is of great importance. Claimants often bring claims against third parties who participate in wrongs. For example, the 'direct wrongdoer' may be insolvent, so a claimant might prefer a remedy against an accessory in order to obtain satisfactory redress. However, the law in this area has not received the attention it deserves. The criminal law recognises that any person who 'aids, abets, counsels or procures' any offence can be punished as an accessory, but the private law is more fragmented. One reason for this is a tendency to compartmentalise the law of obligations into discrete subjects, such as contract, trusts, tort and intellectual property. This book suggests that by looking across such boundaries in the private law, the nature and principles of accessory liability can be better understood and doctrinal confusion regarding the elements of liability, defences and remedies resolved.
(source: Nielsen Book Data)
  • Introduction
  • Fundamentals
  • Crime
  • Equity
  • Contract
  • Tort
  • Defences
  • Remedies
  • Conclusions.
Accessory liability in the private law is of great importance. Claimants often bring claims against third parties who participate in wrongs. For example, the 'direct wrongdoer' may be insolvent, so a claimant might prefer a remedy against an accessory in order to obtain satisfactory redress. However, the law in this area has not received the attention it deserves. The criminal law recognises that any person who 'aids, abets, counsels or procures' any offence can be punished as an accessory, but the private law is more fragmented. One reason for this is a tendency to compartmentalise the law of obligations into discrete subjects, such as contract, trusts, tort and intellectual property. This book suggests that by looking across such boundaries in the private law, the nature and principles of accessory liability can be better understood and doctrinal confusion regarding the elements of liability, defences and remedies resolved.
(source: Nielsen Book Data)
Law Library (Crown)
Status of items at Law Library (Crown)
Law Library (Crown) Status
Basement
KD720 .D383 2015 Unknown
Book
xxiii, 447 pages ; 24 cm
  • Part I. The final act : its main features and contents. An overview of the agreement : contents and features / Frederick M. Abbott
  • ACTA initial provisions and general definitions / Xavier Seuba
  • ACTA general obligations with respect to enforcement / Xavier Seuba
  • Provisions on civil enforcement : Section 2 of ACTA / Anselm Kamperman Sanders
  • Legal framework for enforcement : border measures / Henning Grosse Ruse-Khan
  • ACTA and beyond : towards a differentiated approach to criminal enforcement of intellectual property rights at the global level / Christopher Geiger
  • ACTA's digital chapter : remaining concerns and what can be done / Rita Matulionyte
  • The ACTA committee / Peter K. Yu
  • Part II. Domestic legislative challenges. ACTA's constitutional problem in the United States / Sean Flynn
  • Trick or treaty?: the Australian debate over the Anti-Counterfeiting Trade Agreement / Matthew Rimmer
  • A Brazilian perspective : res inter alios ACTA / Denis Borges Barbosa
  • Lessons to be drawn from the ACTA process : an African perspective / Andrew Rens
  • Part III. Impact on related processes. Three steps taken toward a reinterpreted three-step test : the impact of ACTA and SOPA on TPP / Jonathan Band
  • ACTA and the future of access to knowledge in the digital environment : US enforcement trends as a global predictor / Annemarie Bridy
  • ACTA, East African enforcement legislation and generic medicines : a comparison / Christoph Spennemann
  • The EU and its IP policies : ACTA and third countries / Anselm Kampermann Sanders
  • Part IV. Views from stakeholders : Lessons. Lessons learned from the ACTA process : an industry perspective / Candice Li
  • Lessons learned from the ACTA process : the view of creators / Adriana Moscoso del Prado
  • ACTA, a view from the eye of the storm / Marietje Schaake
  • ACTA, EU, and economic, social, and cultural rights in the digital environment / Ante Wessels
  • Part V. What lies ahead ACTA. Assessing the implications of ACTA for the European Union : legitimate aim but wrong means / Christophe Geiger
  • ACTA : anatomy of a failed agreement / Bryan Mercurio
  • What was left out of ACTA / Kimberlee Weatherall
  • Slaying the ACTA myths / Michael Geist
  • Developing countries and the contestation of ACTA at the TRIPS Council / Ahmed Abdel-Latif
  • ACTA : what lessons for future plurilateral trade agreements? / Ricardo Melendez-Ortiz and Ahmed Abdel Latif.
The Anti-Counterfeiting Trade Agreement (ACTA) is the most important effort undertaken to lay down a plurilateral legal framework for the enforcement of intellectual property rights. With the view to learn more about the origins of this treaty, the process leading to its conclusion and its implications for law making in this field, The ACTA and the Plurilateral Enforcement Agenda: Genesis and Aftermath analyses in great depth both the context and the content of the agreements. In order to attain this objective, a large and diverse group of experts - renowned scholars, policy makers, civil society and industry actors - who represent different perspectives on the necessary balance between intellectual property enforcement and other economic and social interests have been gathered together. This book is the most comprehensive analysis of ACTA, and of its relation with ongoing initiatives to improve enforcement of intellectual property and norms pertaining to a range of international legal regimes, conducted so far.
(source: Nielsen Book Data)
  • Part I. The final act : its main features and contents. An overview of the agreement : contents and features / Frederick M. Abbott
  • ACTA initial provisions and general definitions / Xavier Seuba
  • ACTA general obligations with respect to enforcement / Xavier Seuba
  • Provisions on civil enforcement : Section 2 of ACTA / Anselm Kamperman Sanders
  • Legal framework for enforcement : border measures / Henning Grosse Ruse-Khan
  • ACTA and beyond : towards a differentiated approach to criminal enforcement of intellectual property rights at the global level / Christopher Geiger
  • ACTA's digital chapter : remaining concerns and what can be done / Rita Matulionyte
  • The ACTA committee / Peter K. Yu
  • Part II. Domestic legislative challenges. ACTA's constitutional problem in the United States / Sean Flynn
  • Trick or treaty?: the Australian debate over the Anti-Counterfeiting Trade Agreement / Matthew Rimmer
  • A Brazilian perspective : res inter alios ACTA / Denis Borges Barbosa
  • Lessons to be drawn from the ACTA process : an African perspective / Andrew Rens
  • Part III. Impact on related processes. Three steps taken toward a reinterpreted three-step test : the impact of ACTA and SOPA on TPP / Jonathan Band
  • ACTA and the future of access to knowledge in the digital environment : US enforcement trends as a global predictor / Annemarie Bridy
  • ACTA, East African enforcement legislation and generic medicines : a comparison / Christoph Spennemann
  • The EU and its IP policies : ACTA and third countries / Anselm Kampermann Sanders
  • Part IV. Views from stakeholders : Lessons. Lessons learned from the ACTA process : an industry perspective / Candice Li
  • Lessons learned from the ACTA process : the view of creators / Adriana Moscoso del Prado
  • ACTA, a view from the eye of the storm / Marietje Schaake
  • ACTA, EU, and economic, social, and cultural rights in the digital environment / Ante Wessels
  • Part V. What lies ahead ACTA. Assessing the implications of ACTA for the European Union : legitimate aim but wrong means / Christophe Geiger
  • ACTA : anatomy of a failed agreement / Bryan Mercurio
  • What was left out of ACTA / Kimberlee Weatherall
  • Slaying the ACTA myths / Michael Geist
  • Developing countries and the contestation of ACTA at the TRIPS Council / Ahmed Abdel-Latif
  • ACTA : what lessons for future plurilateral trade agreements? / Ricardo Melendez-Ortiz and Ahmed Abdel Latif.
The Anti-Counterfeiting Trade Agreement (ACTA) is the most important effort undertaken to lay down a plurilateral legal framework for the enforcement of intellectual property rights. With the view to learn more about the origins of this treaty, the process leading to its conclusion and its implications for law making in this field, The ACTA and the Plurilateral Enforcement Agenda: Genesis and Aftermath analyses in great depth both the context and the content of the agreements. In order to attain this objective, a large and diverse group of experts - renowned scholars, policy makers, civil society and industry actors - who represent different perspectives on the necessary balance between intellectual property enforcement and other economic and social interests have been gathered together. This book is the most comprehensive analysis of ACTA, and of its relation with ongoing initiatives to improve enforcement of intellectual property and norms pertaining to a range of international legal regimes, conducted so far.
(source: Nielsen Book Data)
Law Library (Crown)
Status of items at Law Library (Crown)
Law Library (Crown) Status
Basement
K1577.5 .A38 A28 2015 Unknown
Book
x, 215 pages ; 22 cm.
  • Setting the context
  • Dispute settlement under the WTO
  • Tariffs and the most favoured nation principle
  • Preferential trade agreements
  • The national treatment principle
  • Antidumping laws
  • Subsidies, countervailing duties and government procurement
  • Safeguards and adjustment assistance policies
  • Trade and agriculture
  • Trade in services
  • Trade and investment
  • Trade-related intellectual property rights
  • Trade policy and domestic health and safety regulation
  • Trade policy and the environment
  • Trade policy, labour standards and human rights
  • Trade policy and developing countries
  • Future challenges for the world trading system.
Elgar Advanced Introductions are stimulating and thoughtful introductions to major fields in the social sciences and law, expertly written by the world's leading scholars. Designed to be accessible yet rigorous, they offer concise and lucid surveys of the substantive and policy issues associated with discrete subject areas.
(source: Nielsen Book Data)
  • Setting the context
  • Dispute settlement under the WTO
  • Tariffs and the most favoured nation principle
  • Preferential trade agreements
  • The national treatment principle
  • Antidumping laws
  • Subsidies, countervailing duties and government procurement
  • Safeguards and adjustment assistance policies
  • Trade and agriculture
  • Trade in services
  • Trade and investment
  • Trade-related intellectual property rights
  • Trade policy and domestic health and safety regulation
  • Trade policy and the environment
  • Trade policy, labour standards and human rights
  • Trade policy and developing countries
  • Future challenges for the world trading system.
Elgar Advanced Introductions are stimulating and thoughtful introductions to major fields in the social sciences and law, expertly written by the world's leading scholars. Designed to be accessible yet rigorous, they offer concise and lucid surveys of the substantive and policy issues associated with discrete subject areas.
(source: Nielsen Book Data)
Law Library (Crown)
Status of items at Law Library (Crown)
Law Library (Crown) Status
Basement
K3943 .T723 2015 Unknown
Book
91 p. ; 21 cm.
  • La face publique de la querelle -- L'affaire avant l'affaire -- De la salle de spectacle à la salle d'audience -- Jeu et enjeux.
  • La face publique de la querelle -- L'affaire avant l'affaire -- De la salle de spectacle à la salle d'audience -- Jeu et enjeux.
Green Library
Status of items at Green Library
Green Library Status
Stacks Find it
PN2635.2 .D47 2015 Unavailable On order Request
Book
1 online resource.
This dissertation offers a theory of rewriting as a personal and political practice for black writers nineteenth-century America. Literary scholars have linked the prevalence of reprinting and the proliferation of textual versions during the nineteenth century to cultural attitudes towards intellectual property and literariness. In the study of textual iteration, scholars of literature have theorized intertextuality and revisionism between and among writers or identified aspects of the literary marketplace as motivating factors in the production of multiple textual versions. Textual scholars who have examined textual multiplicity during the nineteenth century and beyond, have often searched for the most correct textual version or the one that can be said to most closely align with the writer's original intention. Always a Second Edition argues that while nineteenth-century African American writers produced multiple textual versions, they did so under a distinct set of conditions and that the resulting texts constitute rewrites. The writers under study in this dissertation rewrote and republished their own texts—a distinguishing and defining facet of rewriting—and they used textual multiplicity to question and protest the social and political conditions they faced and to publically constitute themselves as free, literate individuals in creative control of their texts and their selves. In practice, I read across and between the published versions of William Wells Brown's quartet of Clotel novels, Frederick Douglass's three autobiographies, and Charles Chesnutt's rewrites of his conjure tales to decouple textual changes from historical change. Brown's rewrites and republications of his novel—it appeared in four versions between 1853 and 1867—expose the conditional nature of both text and race and, at the same time, Brown's own multiple self-fashioning. Reading the Clotel novels as rewrites, I show how Brown addresses himself to the idea that enslavement is a fixed condition and challenges that notion through his shifting series of texts. Frederick Douglass's three autobiographies demonstrate increasing ownership over self and text. Douglass's first autobiographical act, 1845's Narrative, is commonly understood to have brought him into being as a free and literate man, but that first autobiography is only one text in a series. With each subsequent rewrite, the textual history of Douglass's literacy becomes more complicated; he becomes his own critic and editor, taking and retaking possession of his stories and of himself. Reading Chesnutt's multiple textual versions as rewrites reveals a neglected sense of authorship based on racial hybridity and offers an opportunity to view concerns internal to Chesnutt as author. Further, rewriting provides a way in which to understand the complexity of Chesnutt's identity. By holding both versions of Chesnutt's rewritten stories in mind, we come to appreciate the dynamic relationship between versions as a dialectic internal to Chesnutt himself rather than projecting that relationship outward onto broader, binary black-or-white racial concerns. Always a Second Edition ultimately offers a conceptualization of rewriting that attends to the particular nature and prevalence of rewriting among black writers in the nineteenth century.
This dissertation offers a theory of rewriting as a personal and political practice for black writers nineteenth-century America. Literary scholars have linked the prevalence of reprinting and the proliferation of textual versions during the nineteenth century to cultural attitudes towards intellectual property and literariness. In the study of textual iteration, scholars of literature have theorized intertextuality and revisionism between and among writers or identified aspects of the literary marketplace as motivating factors in the production of multiple textual versions. Textual scholars who have examined textual multiplicity during the nineteenth century and beyond, have often searched for the most correct textual version or the one that can be said to most closely align with the writer's original intention. Always a Second Edition argues that while nineteenth-century African American writers produced multiple textual versions, they did so under a distinct set of conditions and that the resulting texts constitute rewrites. The writers under study in this dissertation rewrote and republished their own texts—a distinguishing and defining facet of rewriting—and they used textual multiplicity to question and protest the social and political conditions they faced and to publically constitute themselves as free, literate individuals in creative control of their texts and their selves. In practice, I read across and between the published versions of William Wells Brown's quartet of Clotel novels, Frederick Douglass's three autobiographies, and Charles Chesnutt's rewrites of his conjure tales to decouple textual changes from historical change. Brown's rewrites and republications of his novel—it appeared in four versions between 1853 and 1867—expose the conditional nature of both text and race and, at the same time, Brown's own multiple self-fashioning. Reading the Clotel novels as rewrites, I show how Brown addresses himself to the idea that enslavement is a fixed condition and challenges that notion through his shifting series of texts. Frederick Douglass's three autobiographies demonstrate increasing ownership over self and text. Douglass's first autobiographical act, 1845's Narrative, is commonly understood to have brought him into being as a free and literate man, but that first autobiography is only one text in a series. With each subsequent rewrite, the textual history of Douglass's literacy becomes more complicated; he becomes his own critic and editor, taking and retaking possession of his stories and of himself. Reading Chesnutt's multiple textual versions as rewrites reveals a neglected sense of authorship based on racial hybridity and offers an opportunity to view concerns internal to Chesnutt as author. Further, rewriting provides a way in which to understand the complexity of Chesnutt's identity. By holding both versions of Chesnutt's rewritten stories in mind, we come to appreciate the dynamic relationship between versions as a dialectic internal to Chesnutt himself rather than projecting that relationship outward onto broader, binary black-or-white racial concerns. Always a Second Edition ultimately offers a conceptualization of rewriting that attends to the particular nature and prevalence of rewriting among black writers in the nineteenth century.
Book
xviii, 307 pages ; 24 cm.
  • Foreword by Gerard V. Bradley Preface by Ronald J. Rychlak Chapter 1: Religion and Roman Catholicism in American Legal History Michael Ariens Chapter 2: The Ethics of Lawyers & Judges Perspectives from Catholic Social Teaching Robert A. Destro Chapter 3: A Brief History of American Catholic Legal Education: The Arc of an Uncertain Identity John M. Breen & Lee J. Strang Chapter 4: Philosophy of Law Robert P. George Chapter 5: Tort Law from a Catholic Perspective Ronald J. Rychlak Chapter 6: American Corporate Law and Catholic Social Thought John M. Czarnetzky Chapter 7: Constitutional Law: The Meaning of Person- A Catholic, Legal Perspective Fr. Robert John Araujo Chapter 8: Constitutional Law: Church and State Richard S. Myers Chapter 9: Constitutional Law: First Amendment Freedoms and the Right of Privacy: The Necessary Connection Between Rights and Human Dignity that the U.S. Supreme Court Often Fails to Make Stephen M. Krason Chapter 10: Constitutional Law: Equal Protection, Free Speech, and Religious Worship Timothy J. Tracey Chapter 11: United States Immigration Law and Policy Through a Catholic Lens Michael A. Scaperlanda Chapter 12: Human Dignity and the Death Penalty: Comparing Catholic Social Teaching and Eighth Amendment Jurisprudence Dorie Klein Chapter 13: Fidelity and Fairness In Marital Commitments, Covenants, and Contractual Relationships: Mulieris Dignitatem's Wisdom Kevin H. Govern Chapter 14: Catholic Perspectives on Family Law Bill Piatt Chapter 15: The Odd Couple: Comparing U.S. Military Law & Roman Catholic Ideology Richard V. Meyer Chapter 16: Property Law D. Brian Scarnecchia Chapter 17: The Call to Stewardship: A Catholic Perspective on Environmental Responsibility Lucia A. Silecchia Chapter 18: American Bankruptcy Law and Catholic Social Theory John M. Czarnetzky Chapter 19: Intellectual Property Thomas C. Berg Chapter 20: Labor and Employment Law David L. Gregory Chapter 21 : International Human Rights, Catholic Social Teaching, and American Practice: The Case of Human Rights Treaty Committees William L. Saunders Chapter 22: Bioethics and the Law Hadley Arkes Index Contributor Biographies.
  • (source: Nielsen Book Data)
As Gerard V. Bradley, Professor of Law at the University of Notre Dame, asks in his foreword: "What then should one expect to learn from a volume about American law from a Catholic perspective?" His answer is a straightforward one: "One should expect a critical guide to the moral evaluation of laws, " noting of the essays collected in American Law from a Catholic Perspective: Through a Clearer Lens: "The moral evaluative perspective which unfolds in succeeding pages illumines, justifies, and critiques America's laws." Edited by Ronald Rychlak, American Law from a Catholic Perspective is one of the most comprehensive surveys of American legal topics by a gathering of major Catholic legal scholars. Contributors explore, among other subjects, bankruptcy, bioethics, corporate law, environmental law, ethics, family law, immigration, intellectual property, international human rights, labor law, legal education, legal history, military law, the philosophy of law, property, torts, and several different aspects of constitutional law, including religious freedom, privacy rights, and free speech.
(source: Nielsen Book Data)
  • Foreword by Gerard V. Bradley Preface by Ronald J. Rychlak Chapter 1: Religion and Roman Catholicism in American Legal History Michael Ariens Chapter 2: The Ethics of Lawyers & Judges Perspectives from Catholic Social Teaching Robert A. Destro Chapter 3: A Brief History of American Catholic Legal Education: The Arc of an Uncertain Identity John M. Breen & Lee J. Strang Chapter 4: Philosophy of Law Robert P. George Chapter 5: Tort Law from a Catholic Perspective Ronald J. Rychlak Chapter 6: American Corporate Law and Catholic Social Thought John M. Czarnetzky Chapter 7: Constitutional Law: The Meaning of Person- A Catholic, Legal Perspective Fr. Robert John Araujo Chapter 8: Constitutional Law: Church and State Richard S. Myers Chapter 9: Constitutional Law: First Amendment Freedoms and the Right of Privacy: The Necessary Connection Between Rights and Human Dignity that the U.S. Supreme Court Often Fails to Make Stephen M. Krason Chapter 10: Constitutional Law: Equal Protection, Free Speech, and Religious Worship Timothy J. Tracey Chapter 11: United States Immigration Law and Policy Through a Catholic Lens Michael A. Scaperlanda Chapter 12: Human Dignity and the Death Penalty: Comparing Catholic Social Teaching and Eighth Amendment Jurisprudence Dorie Klein Chapter 13: Fidelity and Fairness In Marital Commitments, Covenants, and Contractual Relationships: Mulieris Dignitatem's Wisdom Kevin H. Govern Chapter 14: Catholic Perspectives on Family Law Bill Piatt Chapter 15: The Odd Couple: Comparing U.S. Military Law & Roman Catholic Ideology Richard V. Meyer Chapter 16: Property Law D. Brian Scarnecchia Chapter 17: The Call to Stewardship: A Catholic Perspective on Environmental Responsibility Lucia A. Silecchia Chapter 18: American Bankruptcy Law and Catholic Social Theory John M. Czarnetzky Chapter 19: Intellectual Property Thomas C. Berg Chapter 20: Labor and Employment Law David L. Gregory Chapter 21 : International Human Rights, Catholic Social Teaching, and American Practice: The Case of Human Rights Treaty Committees William L. Saunders Chapter 22: Bioethics and the Law Hadley Arkes Index Contributor Biographies.
  • (source: Nielsen Book Data)
As Gerard V. Bradley, Professor of Law at the University of Notre Dame, asks in his foreword: "What then should one expect to learn from a volume about American law from a Catholic perspective?" His answer is a straightforward one: "One should expect a critical guide to the moral evaluation of laws, " noting of the essays collected in American Law from a Catholic Perspective: Through a Clearer Lens: "The moral evaluative perspective which unfolds in succeeding pages illumines, justifies, and critiques America's laws." Edited by Ronald Rychlak, American Law from a Catholic Perspective is one of the most comprehensive surveys of American legal topics by a gathering of major Catholic legal scholars. Contributors explore, among other subjects, bankruptcy, bioethics, corporate law, environmental law, ethics, family law, immigration, intellectual property, international human rights, labor law, legal education, legal history, military law, the philosophy of law, property, torts, and several different aspects of constitutional law, including religious freedom, privacy rights, and free speech.
(source: Nielsen Book Data)
Law Library (Crown)
Status of items at Law Library (Crown)
Law Library (Crown) Status
Stacks 1
KF358 .A44 2015 Unknown
Book
online resource (x, 252 pages) : illustrations (some color).
  • 1 Antibody-Drug Conjugates: A Historical Review
  • 2 Payloads of Antibody-Drug Conjugates
  • 3 Selecting an Optimal Antibody for Antibody-Drug Conjugate Therapy
  • 4 Linker Design for Antibody-Drug Conjugates
  • 5 Formulation Development for Antibody-Drug Conjugates
  • 6 Bioanalytical Assay for Characterization of Antibody Drug Conjugates
  • 7 Pharmacokinetics/Pharmacodynamics and Disposition of Antibody-Drug Conjugates
  • 8 Regulatory Considerations
  • 9 Major ADC Companies, Current Clinical Trials, Recent Patents Issued and Patent Applications, and Cost Analysis of Drug Therapy
  • 10 Mylotarg: Revisiting its Clinical Potential Post-Withdrawal
  • 11 ADCETRIS: A Regulatory Case Study of a New Generation Antibody Drug Conjugate
  • 12 Ado-Trastuzumab Emtansine
  • 13 The Antibody-Drug Conjugate Glembatumumab Vedotin (CDX-011) and its Use in Treatment of Breast Cancer
  • 14 Summary and Future Directions.
This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case studies, and the future of the field. The book examines everything from the selection of the antibody, the drug, and the linker to a discussion of developmental issues such as formulations, bio-analysis, pharmacokinetic-pharmacodynamic relationships, and toxicological and regulatory challenges. It also explores pharmacoecomonics and intellectual properties, including recently issued patents and the cost analysis of drug therapy. Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg®), Brentuximab vedotin (Adcetris®), and ado-trastuzumab emtansine (Kadcyla®), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011). Finally, the volume presents a perspective by the editors on the future directions of ADC development and clinical applications. Antibody-Drug Conjugates is a practical and systematic resource for scientists, professors, and students interested in expanding their knowledge of cutting-edge research in this exciting field.
  • 1 Antibody-Drug Conjugates: A Historical Review
  • 2 Payloads of Antibody-Drug Conjugates
  • 3 Selecting an Optimal Antibody for Antibody-Drug Conjugate Therapy
  • 4 Linker Design for Antibody-Drug Conjugates
  • 5 Formulation Development for Antibody-Drug Conjugates
  • 6 Bioanalytical Assay for Characterization of Antibody Drug Conjugates
  • 7 Pharmacokinetics/Pharmacodynamics and Disposition of Antibody-Drug Conjugates
  • 8 Regulatory Considerations
  • 9 Major ADC Companies, Current Clinical Trials, Recent Patents Issued and Patent Applications, and Cost Analysis of Drug Therapy
  • 10 Mylotarg: Revisiting its Clinical Potential Post-Withdrawal
  • 11 ADCETRIS: A Regulatory Case Study of a New Generation Antibody Drug Conjugate
  • 12 Ado-Trastuzumab Emtansine
  • 13 The Antibody-Drug Conjugate Glembatumumab Vedotin (CDX-011) and its Use in Treatment of Breast Cancer
  • 14 Summary and Future Directions.
This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case studies, and the future of the field. The book examines everything from the selection of the antibody, the drug, and the linker to a discussion of developmental issues such as formulations, bio-analysis, pharmacokinetic-pharmacodynamic relationships, and toxicological and regulatory challenges. It also explores pharmacoecomonics and intellectual properties, including recently issued patents and the cost analysis of drug therapy. Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg®), Brentuximab vedotin (Adcetris®), and ado-trastuzumab emtansine (Kadcyla®), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011). Finally, the volume presents a perspective by the editors on the future directions of ADC development and clinical applications. Antibody-Drug Conjugates is a practical and systematic resource for scientists, professors, and students interested in expanding their knowledge of cutting-edge research in this exciting field.
Medical Library (Lane)
Status of items at Medical Library (Lane)
Medical Library (Lane) Status
Check Medical Library (Lane) catalog for status
SPRINGER Unknown
Book
1 online resource : illustrations
  • Preface
  • Law, Regulation and Guidance
  • Pharmaceutical Intellectual Property Rights in China
  • The China Food and Drug Administration (CFDA)
  • Registration
  • Guidance for Application Materials/Booklets (Chemical)
  • New Investigational Drug Application
  • Clinical Development of Investigational New Drug
  • Strategic Drug Development in China and Surrounding Countries
  • Drug Safety Monitoring and Reporting Systems in China
  • In Vitro Diagnostic Development
  • Index.
This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)--including its regulations and registration procedures--and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China's pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.
  • Preface
  • Law, Regulation and Guidance
  • Pharmaceutical Intellectual Property Rights in China
  • The China Food and Drug Administration (CFDA)
  • Registration
  • Guidance for Application Materials/Booklets (Chemical)
  • New Investigational Drug Application
  • Clinical Development of Investigational New Drug
  • Strategic Drug Development in China and Surrounding Countries
  • Drug Safety Monitoring and Reporting Systems in China
  • In Vitro Diagnostic Development
  • Index.
This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)--including its regulations and registration procedures--and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China's pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.
Book
xxviii, 354 pages ; 25 cm
  • Legal framework / Ali Yeşilırmak
  • ADR mechanisms : negotiation, mediation and expert determination / Ali Yeşilırmak
  • Drafting arbitration agreements and arbitrability / Eda Cerrahoğlu Balssen & Efe Kınıkoğlu
  • Appointment of and challenge to arbitrators / Murat Karkın
  • Arbitration procedure / Musa Aygül and Doğan Gültutan
  • Courts' support and supervision prior to the rendering of the award / Bilgehan Yeşilova
  • Challenges to arbitral awards / Bilgin Tiryakioğlu and Aslı Bayata Canyaş
  • Recognition and enforcement of foreign arbitral awards / Cemal Şanlı & Emre Esen
  • Investment treaty arbitration involving Turkey and Turkish parties / Stephan Wilske & Sarah Kimberly Hughes
  • Arbitrating M&A disputes / İsmail G. Esin, Özgün Çelebi, Sevgin Erker & Demet Kaşarcıoğlu
  • Arbitrating intellectual property disputes / Mehmet Gün, Hande Hançer & Basak Gürbüz
  • Appendix I: International arbitration law, Law No. 4686
  • Appendix II: Turkish private international law, Law No. 5718.
  • Legal framework / Ali Yeşilırmak
  • ADR mechanisms : negotiation, mediation and expert determination / Ali Yeşilırmak
  • Drafting arbitration agreements and arbitrability / Eda Cerrahoğlu Balssen & Efe Kınıkoğlu
  • Appointment of and challenge to arbitrators / Murat Karkın
  • Arbitration procedure / Musa Aygül and Doğan Gültutan
  • Courts' support and supervision prior to the rendering of the award / Bilgehan Yeşilova
  • Challenges to arbitral awards / Bilgin Tiryakioğlu and Aslı Bayata Canyaş
  • Recognition and enforcement of foreign arbitral awards / Cemal Şanlı & Emre Esen
  • Investment treaty arbitration involving Turkey and Turkish parties / Stephan Wilske & Sarah Kimberly Hughes
  • Arbitrating M&A disputes / İsmail G. Esin, Özgün Çelebi, Sevgin Erker & Demet Kaşarcıoğlu
  • Arbitrating intellectual property disputes / Mehmet Gün, Hande Hançer & Basak Gürbüz
  • Appendix I: International arbitration law, Law No. 4686
  • Appendix II: Turkish private international law, Law No. 5718.
Law Library (Crown)
Status of items at Law Library (Crown)
Law Library (Crown) Status
Basement
KKX1829 .A96 2015 Unknown
Book
xii, 241 p. : ill. ; 25 cm
  • What is art?
  • What is intellectual property?
  • International law, choice of law and the international and domestic application of intellectual property
  • What is protected by copyright?
  • Issues relating to ownership of copyright
  • Requirements for copyright protection
  • Exceptions to copyright
  • Related rights : performances
  • Digitization
  • The rights of privacy and publicity
  • Moral rights
  • Artist's resale right and art collecting societies
  • Traditional cultural expressions
  • Art and fashion design
  • Art and trademark law and domain names
  • Art, industrial design and works of artistic craftsmanship
  • Contracts and dispute resolution.
  • What is art?
  • What is intellectual property?
  • International law, choice of law and the international and domestic application of intellectual property
  • What is protected by copyright?
  • Issues relating to ownership of copyright
  • Requirements for copyright protection
  • Exceptions to copyright
  • Related rights : performances
  • Digitization
  • The rights of privacy and publicity
  • Moral rights
  • Artist's resale right and art collecting societies
  • Traditional cultural expressions
  • Art and fashion design
  • Art and trademark law and domain names
  • Art, industrial design and works of artistic craftsmanship
  • Contracts and dispute resolution.
Law Library (Crown)
Status of items at Law Library (Crown)
Law Library (Crown) Status
Basement
K1460 .T67 2015 Unknown
Book
313 pages ; 24 cm
  • American and European perspectives on antitrust
  • Welfare, monopolization, dominance, and judicial review
  • Merger policy and efficiencies
  • Price discrimination
  • Predatory pricing
  • Exclusive-supply contracts
  • Single-product loyalty rebates: is a large gap narrowing?
  • Bundled discounts
  • Intellectual property, the two Microsoft decisions, and antitrust in dynamic industries
  • A summing up.
How is it that two broadly similar systems of competition law have reached different results across a number of significant antitrust issues? While the United States and the European Union share a commitment to maintaining competition in the marketplace and employ similar concepts and legal language in making antitrust decisions, differences in social values, political institutions, and legal precedent have inhibited close convergence. With The Atlantic Divide in Antitrust, Daniel J. Gifford and Robert T. Kudrle explore many of the main contested areas of contemporary antitrust, including mergers, price discrimination, predatory pricing, and intellectual property. After identifying how prevailing analyses differ across these areas, they then examine the policy ramifications. Several themes run throughout the book, including differences in the amount of discretion firms have in dealing with purchasers, the weight given to the welfare of various market participants, and whether competition tends to be viewed as an efficiency-generating process or as rivalry. The authors conclude with forecasts and suggestions for how greater compatibility might ultimately be attained.
(source: Nielsen Book Data)
  • American and European perspectives on antitrust
  • Welfare, monopolization, dominance, and judicial review
  • Merger policy and efficiencies
  • Price discrimination
  • Predatory pricing
  • Exclusive-supply contracts
  • Single-product loyalty rebates: is a large gap narrowing?
  • Bundled discounts
  • Intellectual property, the two Microsoft decisions, and antitrust in dynamic industries
  • A summing up.
How is it that two broadly similar systems of competition law have reached different results across a number of significant antitrust issues? While the United States and the European Union share a commitment to maintaining competition in the marketplace and employ similar concepts and legal language in making antitrust decisions, differences in social values, political institutions, and legal precedent have inhibited close convergence. With The Atlantic Divide in Antitrust, Daniel J. Gifford and Robert T. Kudrle explore many of the main contested areas of contemporary antitrust, including mergers, price discrimination, predatory pricing, and intellectual property. After identifying how prevailing analyses differ across these areas, they then examine the policy ramifications. Several themes run throughout the book, including differences in the amount of discretion firms have in dealing with purchasers, the weight given to the welfare of various market participants, and whether competition tends to be viewed as an efficiency-generating process or as rivalry. The authors conclude with forecasts and suggestions for how greater compatibility might ultimately be attained.
(source: Nielsen Book Data)
Law Library (Crown)
Status of items at Law Library (Crown)
Law Library (Crown) Status
Basement
K3850 .G54 2015 Unknown
Book
pages.
Stanford University Libraries
Status of items at Stanford University Libraries
Stanford University Libraries Status
On order
(no call number) Unavailable On order Request
Book
xi, 135 pages ; 25 cm
  • EU copyright law between property and fundamental rights : a proposal to connect the dots / Caterina Sganga
  • Online exhaustion and the boundaries of interpretation / Giorgio Spedicato
  • Effects of culture on judicial decisions : personal data protection vs. copyright enforcement / Federica Giovanella
  • Academic freedom, copyright, and access to scholarly works : a comparative perspective / Valentina Moscon.
This book focuses on the thorny and highly topical issue of balancing copyright in the digital age. The idea for it sprang from the often heated debates among intellectual property scholars on the possibilities and the limits of copyright. Copyright law has been broadening its scope for decades now, and as a result it often clashes with other rights (frequently, fundamental rights), raising the question of which right prevails. The papers represent the product of intensive research by experts, who employ rigorous interpretative methodologies while keeping an eye on comparison and on the impacts of new technologies on law. The contributions concentrate on the "propertization" of copyright; on the principle of exhaustion of the distribution right; on the conflict between users' privacy and personal data needs; and on the balance between copyright and academic freedom. Starting from the difficulties inherently connected to the difficult task of balancing rights that respond to opposing interests, each essay analyzes techniques and arguments applied by institutional decision-makers in trying to solve this dilemma. Each author applies a specific methodology involving legal comparison, while taking into account the European framework for copyright and related rights. This work represents a unique piece of scholarship, in which a single issue is read through different lenses, demonstrating the need to reconcile copyright with other fundamental areas of law.
(source: Nielsen Book Data)
  • EU copyright law between property and fundamental rights : a proposal to connect the dots / Caterina Sganga
  • Online exhaustion and the boundaries of interpretation / Giorgio Spedicato
  • Effects of culture on judicial decisions : personal data protection vs. copyright enforcement / Federica Giovanella
  • Academic freedom, copyright, and access to scholarly works : a comparative perspective / Valentina Moscon.
This book focuses on the thorny and highly topical issue of balancing copyright in the digital age. The idea for it sprang from the often heated debates among intellectual property scholars on the possibilities and the limits of copyright. Copyright law has been broadening its scope for decades now, and as a result it often clashes with other rights (frequently, fundamental rights), raising the question of which right prevails. The papers represent the product of intensive research by experts, who employ rigorous interpretative methodologies while keeping an eye on comparison and on the impacts of new technologies on law. The contributions concentrate on the "propertization" of copyright; on the principle of exhaustion of the distribution right; on the conflict between users' privacy and personal data needs; and on the balance between copyright and academic freedom. Starting from the difficulties inherently connected to the difficult task of balancing rights that respond to opposing interests, each essay analyzes techniques and arguments applied by institutional decision-makers in trying to solve this dilemma. Each author applies a specific methodology involving legal comparison, while taking into account the European framework for copyright and related rights. This work represents a unique piece of scholarship, in which a single issue is read through different lenses, demonstrating the need to reconcile copyright with other fundamental areas of law.
(source: Nielsen Book Data)
Law Library (Crown)
Status of items at Law Library (Crown)
Law Library (Crown) Status
Basement
K1447.95 .B35 2015 Unknown
Book
1 online resource.
  • EU Copyright Law Between Property and Fundamental Rights. A Proposal to Connect the Dots by Caterina Sganga.- Online Exhaustion and the Boundaries of Interpretation by Giorgio Spedicato.- Effects of Culture on Judicial Decisions. Personal Data Protection vs. Copyright Enforcement by Federica Giovanella.- Copyright, Academic Freedom and Right of Access to Scholarly Works. A Comparative Perspective by Valentina Moscon.
  • (source: Nielsen Book Data)
This book focuses on the thorny and highly topical issue of balancing copyright in the digital age. The idea for it sprang from the often heated debates among intellectual property scholars on the possibilities and the limits of copyright. Copyright law has been broadening its scope for decades now, and as a result it often clashes with other rights (frequently, fundamental rights), raising the question of which right prevails. The papers represent the product of intensive research by experts, who employ rigorous interpretative methodologies while keeping an eye on comparison and on the impacts of new technologies on law. The contributions concentrate on the "propertization" of copyright; on the principle of exhaustion of the distribution right; on the conflict between users' privacy and personal data needs; and on the balance between copyright and academic freedom. Starting from the difficulties inherently connected to the difficult task of balancing rights that respond to opposing interests, each essay analyzes techniques and arguments applied by institutional decision-makers in trying to solve this dilemma. Each author applies a specific methodology involving legal comparison, while taking into account the European framework for copyright and related rights. This work represents a unique piece of scholarship, in which a single issue is read through different lenses, demonstrating the need to reconcile copyright with other fundamental areas of law.
(source: Nielsen Book Data)
  • EU Copyright Law Between Property and Fundamental Rights. A Proposal to Connect the Dots by Caterina Sganga.- Online Exhaustion and the Boundaries of Interpretation by Giorgio Spedicato.- Effects of Culture on Judicial Decisions. Personal Data Protection vs. Copyright Enforcement by Federica Giovanella.- Copyright, Academic Freedom and Right of Access to Scholarly Works. A Comparative Perspective by Valentina Moscon.
  • (source: Nielsen Book Data)
This book focuses on the thorny and highly topical issue of balancing copyright in the digital age. The idea for it sprang from the often heated debates among intellectual property scholars on the possibilities and the limits of copyright. Copyright law has been broadening its scope for decades now, and as a result it often clashes with other rights (frequently, fundamental rights), raising the question of which right prevails. The papers represent the product of intensive research by experts, who employ rigorous interpretative methodologies while keeping an eye on comparison and on the impacts of new technologies on law. The contributions concentrate on the "propertization" of copyright; on the principle of exhaustion of the distribution right; on the conflict between users' privacy and personal data needs; and on the balance between copyright and academic freedom. Starting from the difficulties inherently connected to the difficult task of balancing rights that respond to opposing interests, each essay analyzes techniques and arguments applied by institutional decision-makers in trying to solve this dilemma. Each author applies a specific methodology involving legal comparison, while taking into account the European framework for copyright and related rights. This work represents a unique piece of scholarship, in which a single issue is read through different lenses, demonstrating the need to reconcile copyright with other fundamental areas of law.
(source: Nielsen Book Data)
Book
1 online resource : text file, PDF
  • A Big Data Primer for Executives-- James R. Kalyvas and David R. Albertson What Is Big Data? Characteristics of Big Data Volume The Internet of Things and Volume Variety Velocity Validation Cross-Disciplinary Approach, New Skills, and Investment Acquiring Relevant Data The Basics of How Big Data Technology Works Summary Notes Overview of Information Security and Compliance: Seeing the Forest for the Trees-- Michael R. Overly Introduction What Kind of Data Should Be Protected? Why Protections Are Important Common Misconceptions about Information Security Compliance Finding Common Threads in Compliance Laws and Regulations Conclusion Note Information Security in Vendor and Business Partner Relationships-- Michael R. Overly Introduction Chapter Overview The First Tool: A Due Diligence Questionnaire The Second Tool: Key Contractual Protections Warranties Specific Information Security Obligations Indemnity Limitation of Liability Confidentiality Audit Rights The Third Tool: An Information Security Requirements Exhibit Conclusion Privacy and Big Data-- Chanley T. Howell Introduction Privacy Laws, Regulations, and Principles that Have an Impact on Big Data The Foundations of Privacy Compliance Notice Choice Access Fair Credit Reporting Act Consumer Reports Increased Scrutiny from the FTC Implications for Businesses Monetizing Personal Information: Are You a Data Broker? The FTC's Reclaim Your Name Initiative Deidentification Online Behavioral Advertising Best Practices for Achieving Privacy Compliance for Big Data Initiatives Data Flow Mapping Illustration Notes Federal and State Data Privacy Laws and Their Implications for the Creation and Use of Health Information Databases-- M. Leeann Habte Introduction Chapter Overview Key Considerations Related to Sources and Types of Data PHI Collected from Covered Entities Without Individual Authorization Analysis for Covered Entities' Health Care Operations Creation and Use of Deidentified Data Strategies for Aggregation and Deidentification of PHI by Business Associates Marketing and Sale of PHI Creation of Research Databases for Future Research Uses of PHI Sensitive Information Big Data Collected from Individuals Personal Health Records Mobile Technologies and Web-Based Applications Conclusion State Laws Limiting Further Disclosures of Health Information State Law Restrictions Generally Genetic Data: Informed Consent and Data Ownership Conclusion Notes Big Data and Risk Assessment-- Eileen R. Ridley Introduction What Is the Strategic Purpose for the Use of Big Data? How Does the Use of Big Data Have an Impact on the Market? Does the Use of Big Data Result in Injury or Damage? Does the Use of Big Data Analysis Have an Impact on Health Issues? The Impact of Big Data on Discovery Notes Licensing Big Data-- Aaron K. Tantleff Overview Protection of the Data/Database Under Intellectual Property Law Copyright Trade Secrets Contractual Protections for Big Data Ownership Rights License Grant Anonymization Confidentiality Salting the Database Termination Fees/Royalties Revenue Models Price Protection Audit Warranty Indemnification Limitation of Liability Conclusion Notes The Antitrust Laws and Big Data-- Alan D. Rutenberg, Howard W. Fogt, and Benjamin R. Dryden Introduction Overview of the Antitrust Laws Big Data and Price-Fixing Price-Fixing Risks "Signaling" Risks Steps to Reduce Price-Fixing and Signaling Risks Information-Sharing Risks Data Privacy and Security Policies as Facets of Nonprice Competition Price Discrimination and the Robinson-Patman Act Conclusion Notes The Impact of Big Data on Insureds, Insurance Coverage, and Insurers-- Ethan D. Lenz and Morgan J. Tilleman Introduction The Risks of Big Data Traditional Insurance Likely Contains Significant Coverage Gaps for the Risks Posed by Big Data Cyber Liability Insurance Coverage for the Risks Posed by Big Data Considerations in the Purchase of Cyber Insurance Protection Issues Related to Cyber Liability Insurance Coverage The Use of Big Data by Insurers Underwriting, Discounts, and the Trade Practices Act The Privacy Act Access to Personal Information Correction of Personal Information Disclosure of the Basis for Adverse Underwriting Decisions Third-Party Data and the Privacy Act The Privacy Regulation Conclusion Notes Using Big Data to Manage Human Resources-- Mark J. Neuberger Introduction Using Big Data to Manage People Absenteeism and Scheduling Identifying Attributes of Success for Various Roles Leading Change Managing Employee Fraud Regulating the Use of Big Data in Human Resource Management Antidiscrimination under Title VII The Genetic Information and Nondiscrimination Act of 2007 National Labor Relations Act Fair Credit Reporting Act State and Local Laws Conclusion Notes Big Data Discovery-- Adam C. Losey Introduction Big Data, Big Preservation Problems Big Data Preservation The Duty to Preserve: A Time-Tested Legal Doctrine Meets Big Data Avoiding Preservation Pitfalls Failure to Flip the Off Switch The Spreadsheet Error The Never-Ending Hold The Fire and Forget Deputizing Custodians as Information Technology Personnel Pulling the Litigation Hold Trigger Big Data Preservation Triggers Big Database Discovery The Database Difference Databases in Litigation Cooperate Where You Can Object to Unreasonable Demands Be Specific Talk about Database Discovery Early in the Process Big Data Digging Driving the CAR Process The Clawback Judicial Acceptance of CAR Methods Conclusion Notes Glossary Index.
  • (source: Nielsen Book Data)
Big Data: A Business and Legal Guide supplies a clear understanding of the interrelationships between Big Data, the new business insights it reveals, and the laws, regulations, and contracting practices that impact the use of the insights and the data. Providing business executives and lawyers (in-house and in private practice) with an accessible primer on Big Data and its business implications, this book will enable readers to quickly grasp the key issues and effectively implement the right solutions to collecting, licensing, handling, and using Big Data. The book brings together subject matter experts who examine a different area of law in each chapter and explain how these laws can affect the way your business or organization can use Big Data. These experts also supply recommendations as to the steps your organization can take to maximize Big Data opportunities without increasing risk and liability to your organization. * Provides a new way of thinking about Big Data that will help readers address emerging issues * Supplies real-world advice and practical ways to handle the issues * Uses examples pulled from the news and cases to illustrate points * Includes a non-technical Big Data primer that discusses the characteristics of Big Data and distinguishes it from traditional database models Taking a cross-disciplinary approach, the book will help executives, managers, and counsel better understand the interrelationships between Big Data, decisions based on Big Data, and the laws, regulations, and contracting practices that impact its use. After reading this book, you will be able to think more broadly about the best way to harness Big Data in your business and establish procedures to ensure that legal considerations are part of the decision.
(source: Nielsen Book Data)
  • A Big Data Primer for Executives-- James R. Kalyvas and David R. Albertson What Is Big Data? Characteristics of Big Data Volume The Internet of Things and Volume Variety Velocity Validation Cross-Disciplinary Approach, New Skills, and Investment Acquiring Relevant Data The Basics of How Big Data Technology Works Summary Notes Overview of Information Security and Compliance: Seeing the Forest for the Trees-- Michael R. Overly Introduction What Kind of Data Should Be Protected? Why Protections Are Important Common Misconceptions about Information Security Compliance Finding Common Threads in Compliance Laws and Regulations Conclusion Note Information Security in Vendor and Business Partner Relationships-- Michael R. Overly Introduction Chapter Overview The First Tool: A Due Diligence Questionnaire The Second Tool: Key Contractual Protections Warranties Specific Information Security Obligations Indemnity Limitation of Liability Confidentiality Audit Rights The Third Tool: An Information Security Requirements Exhibit Conclusion Privacy and Big Data-- Chanley T. Howell Introduction Privacy Laws, Regulations, and Principles that Have an Impact on Big Data The Foundations of Privacy Compliance Notice Choice Access Fair Credit Reporting Act Consumer Reports Increased Scrutiny from the FTC Implications for Businesses Monetizing Personal Information: Are You a Data Broker? The FTC's Reclaim Your Name Initiative Deidentification Online Behavioral Advertising Best Practices for Achieving Privacy Compliance for Big Data Initiatives Data Flow Mapping Illustration Notes Federal and State Data Privacy Laws and Their Implications for the Creation and Use of Health Information Databases-- M. Leeann Habte Introduction Chapter Overview Key Considerations Related to Sources and Types of Data PHI Collected from Covered Entities Without Individual Authorization Analysis for Covered Entities' Health Care Operations Creation and Use of Deidentified Data Strategies for Aggregation and Deidentification of PHI by Business Associates Marketing and Sale of PHI Creation of Research Databases for Future Research Uses of PHI Sensitive Information Big Data Collected from Individuals Personal Health Records Mobile Technologies and Web-Based Applications Conclusion State Laws Limiting Further Disclosures of Health Information State Law Restrictions Generally Genetic Data: Informed Consent and Data Ownership Conclusion Notes Big Data and Risk Assessment-- Eileen R. Ridley Introduction What Is the Strategic Purpose for the Use of Big Data? How Does the Use of Big Data Have an Impact on the Market? Does the Use of Big Data Result in Injury or Damage? Does the Use of Big Data Analysis Have an Impact on Health Issues? The Impact of Big Data on Discovery Notes Licensing Big Data-- Aaron K. Tantleff Overview Protection of the Data/Database Under Intellectual Property Law Copyright Trade Secrets Contractual Protections for Big Data Ownership Rights License Grant Anonymization Confidentiality Salting the Database Termination Fees/Royalties Revenue Models Price Protection Audit Warranty Indemnification Limitation of Liability Conclusion Notes The Antitrust Laws and Big Data-- Alan D. Rutenberg, Howard W. Fogt, and Benjamin R. Dryden Introduction Overview of the Antitrust Laws Big Data and Price-Fixing Price-Fixing Risks "Signaling" Risks Steps to Reduce Price-Fixing and Signaling Risks Information-Sharing Risks Data Privacy and Security Policies as Facets of Nonprice Competition Price Discrimination and the Robinson-Patman Act Conclusion Notes The Impact of Big Data on Insureds, Insurance Coverage, and Insurers-- Ethan D. Lenz and Morgan J. Tilleman Introduction The Risks of Big Data Traditional Insurance Likely Contains Significant Coverage Gaps for the Risks Posed by Big Data Cyber Liability Insurance Coverage for the Risks Posed by Big Data Considerations in the Purchase of Cyber Insurance Protection Issues Related to Cyber Liability Insurance Coverage The Use of Big Data by Insurers Underwriting, Discounts, and the Trade Practices Act The Privacy Act Access to Personal Information Correction of Personal Information Disclosure of the Basis for Adverse Underwriting Decisions Third-Party Data and the Privacy Act The Privacy Regulation Conclusion Notes Using Big Data to Manage Human Resources-- Mark J. Neuberger Introduction Using Big Data to Manage People Absenteeism and Scheduling Identifying Attributes of Success for Various Roles Leading Change Managing Employee Fraud Regulating the Use of Big Data in Human Resource Management Antidiscrimination under Title VII The Genetic Information and Nondiscrimination Act of 2007 National Labor Relations Act Fair Credit Reporting Act State and Local Laws Conclusion Notes Big Data Discovery-- Adam C. Losey Introduction Big Data, Big Preservation Problems Big Data Preservation The Duty to Preserve: A Time-Tested Legal Doctrine Meets Big Data Avoiding Preservation Pitfalls Failure to Flip the Off Switch The Spreadsheet Error The Never-Ending Hold The Fire and Forget Deputizing Custodians as Information Technology Personnel Pulling the Litigation Hold Trigger Big Data Preservation Triggers Big Database Discovery The Database Difference Databases in Litigation Cooperate Where You Can Object to Unreasonable Demands Be Specific Talk about Database Discovery Early in the Process Big Data Digging Driving the CAR Process The Clawback Judicial Acceptance of CAR Methods Conclusion Notes Glossary Index.
  • (source: Nielsen Book Data)
Big Data: A Business and Legal Guide supplies a clear understanding of the interrelationships between Big Data, the new business insights it reveals, and the laws, regulations, and contracting practices that impact the use of the insights and the data. Providing business executives and lawyers (in-house and in private practice) with an accessible primer on Big Data and its business implications, this book will enable readers to quickly grasp the key issues and effectively implement the right solutions to collecting, licensing, handling, and using Big Data. The book brings together subject matter experts who examine a different area of law in each chapter and explain how these laws can affect the way your business or organization can use Big Data. These experts also supply recommendations as to the steps your organization can take to maximize Big Data opportunities without increasing risk and liability to your organization. * Provides a new way of thinking about Big Data that will help readers address emerging issues * Supplies real-world advice and practical ways to handle the issues * Uses examples pulled from the news and cases to illustrate points * Includes a non-technical Big Data primer that discusses the characteristics of Big Data and distinguishes it from traditional database models Taking a cross-disciplinary approach, the book will help executives, managers, and counsel better understand the interrelationships between Big Data, decisions based on Big Data, and the laws, regulations, and contracting practices that impact its use. After reading this book, you will be able to think more broadly about the best way to harness Big Data in your business and establish procedures to ensure that legal considerations are part of the decision.
(source: Nielsen Book Data)
Book
p. ; cm.
  • A Big Data Primer for Executives-- James R. Kalyvas and David R. Albertson What Is Big Data? Characteristics of Big Data Volume The Internet of Things and Volume Variety Velocity Validation Cross-Disciplinary Approach, New Skills, and Investment Acquiring Relevant Data The Basics of How Big Data Technology Works Summary Notes Overview of Information Security and Compliance: Seeing the Forest for the Trees-- Michael R. Overly Introduction What Kind of Data Should Be Protected? Why Protections Are Important Common Misconceptions about Information Security Compliance Finding Common Threads in Compliance Laws and Regulations Conclusion Note Information Security in Vendor and Business Partner Relationships-- Michael R. Overly Introduction Chapter Overview The First Tool: A Due Diligence Questionnaire The Second Tool: Key Contractual Protections Warranties Specific Information Security Obligations Indemnity Limitation of Liability Confidentiality Audit Rights The Third Tool: An Information Security Requirements Exhibit Conclusion Privacy and Big Data-- Chanley T. Howell Introduction Privacy Laws, Regulations, and Principles that Have an Impact on Big Data The Foundations of Privacy Compliance Notice Choice Access Fair Credit Reporting Act Consumer Reports Increased Scrutiny from the FTC Implications for Businesses Monetizing Personal Information: Are You a Data Broker? The FTC's Reclaim Your Name Initiative Deidentification Online Behavioral Advertising Best Practices for Achieving Privacy Compliance for Big Data Initiatives Data Flow Mapping Illustration Notes Federal and State Data Privacy Laws and Their Implications for the Creation and Use of Health Information Databases-- M. Leeann Habte Introduction Chapter Overview Key Considerations Related to Sources and Types of Data PHI Collected from Covered Entities Without Individual Authorization Analysis for Covered Entities' Health Care Operations Creation and Use of Deidentified Data Strategies for Aggregation and Deidentification of PHI by Business Associates Marketing and Sale of PHI Creation of Research Databases for Future Research Uses of PHI Sensitive Information Big Data Collected from Individuals Personal Health Records Mobile Technologies and Web-Based Applications Conclusion State Laws Limiting Further Disclosures of Health Information State Law Restrictions Generally Genetic Data: Informed Consent and Data Ownership Conclusion Notes Big Data and Risk Assessment-- Eileen R. Ridley Introduction What Is the Strategic Purpose for the Use of Big Data? How Does the Use of Big Data Have an Impact on the Market? Does the Use of Big Data Result in Injury or Damage? Does the Use of Big Data Analysis Have an Impact on Health Issues? The Impact of Big Data on Discovery Notes Licensing Big Data-- Aaron K. Tantleff Overview Protection of the Data/Database Under Intellectual Property Law Copyright Trade Secrets Contractual Protections for Big Data Ownership Rights License Grant Anonymization Confidentiality Salting the Database Termination Fees/Royalties Revenue Models Price Protection Audit Warranty Indemnification Limitation of Liability Conclusion Notes The Antitrust Laws and Big Data-- Alan D. Rutenberg, Howard W. Fogt, and Benjamin R. Dryden Introduction Overview of the Antitrust Laws Big Data and Price-Fixing Price-Fixing Risks "Signaling" Risks Steps to Reduce Price-Fixing and Signaling Risks Information-Sharing Risks Data Privacy and Security Policies as Facets of Nonprice Competition Price Discrimination and the Robinson-Patman Act Conclusion Notes The Impact of Big Data on Insureds, Insurance Coverage, and Insurers-- Ethan D. Lenz and Morgan J. Tilleman Introduction The Risks of Big Data Traditional Insurance Likely Contains Significant Coverage Gaps for the Risks Posed by Big Data Cyber Liability Insurance Coverage for the Risks Posed by Big Data Considerations in the Purchase of Cyber Insurance Protection Issues Related to Cyber Liability Insurance Coverage The Use of Big Data by Insurers Underwriting, Discounts, and the Trade Practices Act The Privacy Act Access to Personal Information Correction of Personal Information Disclosure of the Basis for Adverse Underwriting Decisions Third-Party Data and the Privacy Act The Privacy Regulation Conclusion Notes Using Big Data to Manage Human Resources-- Mark J. Neuberger Introduction Using Big Data to Manage People Absenteeism and Scheduling Identifying Attributes of Success for Various Roles Leading Change Managing Employee Fraud Regulating the Use of Big Data in Human Resource Management Antidiscrimination under Title VII The Genetic Information and Nondiscrimination Act of 2007 National Labor Relations Act Fair Credit Reporting Act State and Local Laws Conclusion Notes Big Data Discovery-- Adam C. Losey Introduction Big Data, Big Preservation Problems Big Data Preservation The Duty to Preserve: A Time-Tested Legal Doctrine Meets Big Data Avoiding Preservation Pitfalls Failure to Flip the Off Switch The Spreadsheet Error The Never-Ending Hold The Fire and Forget Deputizing Custodians as Information Technology Personnel Pulling the Litigation Hold Trigger Big Data Preservation Triggers Big Database Discovery The Database Difference Databases in Litigation Cooperate Where You Can Object to Unreasonable Demands Be Specific Talk about Database Discovery Early in the Process Big Data Digging Driving the CAR Process The Clawback Judicial Acceptance of CAR Methods Conclusion Notes Glossary Index.
  • (source: Nielsen Book Data)
Big Data: A Business and Legal Guide supplies a clear understanding of the interrelationships between Big Data, the new business insights it reveals, and the laws, regulations, and contracting practices that impact the use of the insights and the data. Providing business executives and lawyers (in-house and in private practice) with an accessible primer on Big Data and its business implications, this book will enable readers to quickly grasp the key issues and effectively implement the right solutions to collecting, licensing, handling, and using Big Data. The book brings together subject matter experts who examine a different area of law in each chapter and explain how these laws can affect the way your business or organization can use Big Data. These experts also supply recommendations as to the steps your organization can take to maximize Big Data opportunities without increasing risk and liability to your organization. * Provides a new way of thinking about Big Data that will help readers address emerging issues * Supplies real-world advice and practical ways to handle the issues * Uses examples pulled from the news and cases to illustrate points * Includes a non-technical Big Data primer that discusses the characteristics of Big Data and distinguishes it from traditional database models Taking a cross-disciplinary approach, the book will help executives, managers, and counsel better understand the interrelationships between Big Data, decisions based on Big Data, and the laws, regulations, and contracting practices that impact its use. After reading this book, you will be able to think more broadly about the best way to harness Big Data in your business and establish procedures to ensure that legal considerations are part of the decision.
(source: Nielsen Book Data)
  • A Big Data Primer for Executives-- James R. Kalyvas and David R. Albertson What Is Big Data? Characteristics of Big Data Volume The Internet of Things and Volume Variety Velocity Validation Cross-Disciplinary Approach, New Skills, and Investment Acquiring Relevant Data The Basics of How Big Data Technology Works Summary Notes Overview of Information Security and Compliance: Seeing the Forest for the Trees-- Michael R. Overly Introduction What Kind of Data Should Be Protected? Why Protections Are Important Common Misconceptions about Information Security Compliance Finding Common Threads in Compliance Laws and Regulations Conclusion Note Information Security in Vendor and Business Partner Relationships-- Michael R. Overly Introduction Chapter Overview The First Tool: A Due Diligence Questionnaire The Second Tool: Key Contractual Protections Warranties Specific Information Security Obligations Indemnity Limitation of Liability Confidentiality Audit Rights The Third Tool: An Information Security Requirements Exhibit Conclusion Privacy and Big Data-- Chanley T. Howell Introduction Privacy Laws, Regulations, and Principles that Have an Impact on Big Data The Foundations of Privacy Compliance Notice Choice Access Fair Credit Reporting Act Consumer Reports Increased Scrutiny from the FTC Implications for Businesses Monetizing Personal Information: Are You a Data Broker? The FTC's Reclaim Your Name Initiative Deidentification Online Behavioral Advertising Best Practices for Achieving Privacy Compliance for Big Data Initiatives Data Flow Mapping Illustration Notes Federal and State Data Privacy Laws and Their Implications for the Creation and Use of Health Information Databases-- M. Leeann Habte Introduction Chapter Overview Key Considerations Related to Sources and Types of Data PHI Collected from Covered Entities Without Individual Authorization Analysis for Covered Entities' Health Care Operations Creation and Use of Deidentified Data Strategies for Aggregation and Deidentification of PHI by Business Associates Marketing and Sale of PHI Creation of Research Databases for Future Research Uses of PHI Sensitive Information Big Data Collected from Individuals Personal Health Records Mobile Technologies and Web-Based Applications Conclusion State Laws Limiting Further Disclosures of Health Information State Law Restrictions Generally Genetic Data: Informed Consent and Data Ownership Conclusion Notes Big Data and Risk Assessment-- Eileen R. Ridley Introduction What Is the Strategic Purpose for the Use of Big Data? How Does the Use of Big Data Have an Impact on the Market? Does the Use of Big Data Result in Injury or Damage? Does the Use of Big Data Analysis Have an Impact on Health Issues? The Impact of Big Data on Discovery Notes Licensing Big Data-- Aaron K. Tantleff Overview Protection of the Data/Database Under Intellectual Property Law Copyright Trade Secrets Contractual Protections for Big Data Ownership Rights License Grant Anonymization Confidentiality Salting the Database Termination Fees/Royalties Revenue Models Price Protection Audit Warranty Indemnification Limitation of Liability Conclusion Notes The Antitrust Laws and Big Data-- Alan D. Rutenberg, Howard W. Fogt, and Benjamin R. Dryden Introduction Overview of the Antitrust Laws Big Data and Price-Fixing Price-Fixing Risks "Signaling" Risks Steps to Reduce Price-Fixing and Signaling Risks Information-Sharing Risks Data Privacy and Security Policies as Facets of Nonprice Competition Price Discrimination and the Robinson-Patman Act Conclusion Notes The Impact of Big Data on Insureds, Insurance Coverage, and Insurers-- Ethan D. Lenz and Morgan J. Tilleman Introduction The Risks of Big Data Traditional Insurance Likely Contains Significant Coverage Gaps for the Risks Posed by Big Data Cyber Liability Insurance Coverage for the Risks Posed by Big Data Considerations in the Purchase of Cyber Insurance Protection Issues Related to Cyber Liability Insurance Coverage The Use of Big Data by Insurers Underwriting, Discounts, and the Trade Practices Act The Privacy Act Access to Personal Information Correction of Personal Information Disclosure of the Basis for Adverse Underwriting Decisions Third-Party Data and the Privacy Act The Privacy Regulation Conclusion Notes Using Big Data to Manage Human Resources-- Mark J. Neuberger Introduction Using Big Data to Manage People Absenteeism and Scheduling Identifying Attributes of Success for Various Roles Leading Change Managing Employee Fraud Regulating the Use of Big Data in Human Resource Management Antidiscrimination under Title VII The Genetic Information and Nondiscrimination Act of 2007 National Labor Relations Act Fair Credit Reporting Act State and Local Laws Conclusion Notes Big Data Discovery-- Adam C. Losey Introduction Big Data, Big Preservation Problems Big Data Preservation The Duty to Preserve: A Time-Tested Legal Doctrine Meets Big Data Avoiding Preservation Pitfalls Failure to Flip the Off Switch The Spreadsheet Error The Never-Ending Hold The Fire and Forget Deputizing Custodians as Information Technology Personnel Pulling the Litigation Hold Trigger Big Data Preservation Triggers Big Database Discovery The Database Difference Databases in Litigation Cooperate Where You Can Object to Unreasonable Demands Be Specific Talk about Database Discovery Early in the Process Big Data Digging Driving the CAR Process The Clawback Judicial Acceptance of CAR Methods Conclusion Notes Glossary Index.
  • (source: Nielsen Book Data)
Big Data: A Business and Legal Guide supplies a clear understanding of the interrelationships between Big Data, the new business insights it reveals, and the laws, regulations, and contracting practices that impact the use of the insights and the data. Providing business executives and lawyers (in-house and in private practice) with an accessible primer on Big Data and its business implications, this book will enable readers to quickly grasp the key issues and effectively implement the right solutions to collecting, licensing, handling, and using Big Data. The book brings together subject matter experts who examine a different area of law in each chapter and explain how these laws can affect the way your business or organization can use Big Data. These experts also supply recommendations as to the steps your organization can take to maximize Big Data opportunities without increasing risk and liability to your organization. * Provides a new way of thinking about Big Data that will help readers address emerging issues * Supplies real-world advice and practical ways to handle the issues * Uses examples pulled from the news and cases to illustrate points * Includes a non-technical Big Data primer that discusses the characteristics of Big Data and distinguishes it from traditional database models Taking a cross-disciplinary approach, the book will help executives, managers, and counsel better understand the interrelationships between Big Data, decisions based on Big Data, and the laws, regulations, and contracting practices that impact its use. After reading this book, you will be able to think more broadly about the best way to harness Big Data in your business and establish procedures to ensure that legal considerations are part of the decision.
(source: Nielsen Book Data)
Book
xiii, 839 pages : color illustrations, charts ; 29 cm
  • Machine generated contents note: Preface; Focus on value; Global perspectives; Process insights; Part I. Identify: Stage 1. Needs Finding: 1.1 Strategic focus; 1.2 Needs exploration; 1.3 Need statement development; Case study; Stage 2. Needs Screening: 2.1 Disease state fundamentals; 2.2 Existing solutions; 2.3 Stakeholder analysis; 2.4 Market analysis; 2.5 Needs selection; Case study; Part II. Invent: Stage 3. Concept Generation: 3.1 Ideation; 3.2 Initial concept selection; Case study; Stage 4. Concept Screening: 4.1 Intellectual property basics; 4.2 Regulatory basics; 4.3 Reimbursement basics; 4.4 Business models; 4.5 Concept exploration and testing; 4.6 Final concept selection; Case study; Part III. Implement: Stage 5. Strategy Development: 5.1 IP strategy; 5.2 R & D strategy; 5.3 Clinical strategy; 5.4 Regulatory strategy; 5.5 Quality management; 5.6 Reimbursement strategy; 5.7 Marketing and stakeholder strategy; 5.8 Sales and distribution strategy; 5.9 Competitive advantage and business strategy; Case study; Stage 6. Business Planning: 6.1 Operating plan and financial model; 6.2 Strategy integration and communication; 6.3 Funding approaches; 6.4 Alternate pathways; Case study; About the author team; Image credits; Glossary; Index.
"This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering, and business experts, the authors provide a comprehensive resource that leads students, researchers, and entrepreneurs through a proven process for the identification, invention, and implementation of new solutions. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work. A wealth of additional material supports the book, including a collection of nearly 100 videos created for the second edition, active links to external websites, supplementary appendices, and timely updates on the companion website at ebiodesign.org. Readers can access this material quickly, easily, and at the most relevant point in the text from within the ebook"--Provided by publisher.
  • Machine generated contents note: Preface; Focus on value; Global perspectives; Process insights; Part I. Identify: Stage 1. Needs Finding: 1.1 Strategic focus; 1.2 Needs exploration; 1.3 Need statement development; Case study; Stage 2. Needs Screening: 2.1 Disease state fundamentals; 2.2 Existing solutions; 2.3 Stakeholder analysis; 2.4 Market analysis; 2.5 Needs selection; Case study; Part II. Invent: Stage 3. Concept Generation: 3.1 Ideation; 3.2 Initial concept selection; Case study; Stage 4. Concept Screening: 4.1 Intellectual property basics; 4.2 Regulatory basics; 4.3 Reimbursement basics; 4.4 Business models; 4.5 Concept exploration and testing; 4.6 Final concept selection; Case study; Part III. Implement: Stage 5. Strategy Development: 5.1 IP strategy; 5.2 R & D strategy; 5.3 Clinical strategy; 5.4 Regulatory strategy; 5.5 Quality management; 5.6 Reimbursement strategy; 5.7 Marketing and stakeholder strategy; 5.8 Sales and distribution strategy; 5.9 Competitive advantage and business strategy; Case study; Stage 6. Business Planning: 6.1 Operating plan and financial model; 6.2 Strategy integration and communication; 6.3 Funding approaches; 6.4 Alternate pathways; Case study; About the author team; Image credits; Glossary; Index.
"This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering, and business experts, the authors provide a comprehensive resource that leads students, researchers, and entrepreneurs through a proven process for the identification, invention, and implementation of new solutions. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work. A wealth of additional material supports the book, including a collection of nearly 100 videos created for the second edition, active links to external websites, supplementary appendices, and timely updates on the companion website at ebiodesign.org. Readers can access this material quickly, easily, and at the most relevant point in the text from within the ebook"--Provided by publisher.
Medical Library (Lane)
Status of items at Medical Library (Lane)
Medical Library (Lane) Status
Check Medical Library (Lane) catalog for status
R856 .B56 2015 Unknown
Book
xii, 839 pages : illustrations ; 28 cm
  • Preface-- Focus on value-- Global perspectives-- Process insights-- Part I. Identify: Stage 1. Needs Finding: 1.1 Strategic focus-- 1.2 Needs exploration-- 1.3 Need statement development-- Case study-- Stage 2. Needs Screening: 2.1 Disease state fundamentals-- 2.2 Existing solutions-- 2.3 Stakeholder analysis-- 2.4 Market analysis-- 2.5 Needs selection-- Case study-- Part II. Invent: Stage 3. Concept Generation: 3.1 Ideation-- 3.2 Initial concept selection-- Case study-- Stage 4. Concept Screening: 4.1 Intellectual property basics-- 4.2 Regulatory basics-- 4.3 Reimbursement basics-- 4.4 Business models-- 4.5 Concept exploration and testing-- 4.6 Final concept selection-- Case study-- Part III. Implement: Stage 5. Strategy Development: 5.1 IP strategy-- 5.2 R&D strategy-- 5.3 Clinical strategy-- 5.4 Regulatory strategy-- 5.5 Quality management-- 5.6 Reimbursement strategy-- 5.7 Marketing and stakeholder strategy-- 5.8 Sales and distribution strategy-- 5.9 Competitive advantage and business strategy-- Case study-- Stage 6. Business Planning: 6.1 Operating plan and financial model-- 6.2 Strategy integration and communication-- 6.3 Funding approaches-- 6.4 Alternate pathways-- Case study-- About the author team-- Image credits-- Glossary-- Index.
  • (source: Nielsen Book Data)
This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering, and business experts, the authors provide a comprehensive resource that leads students, researchers, and entrepreneurs through a proven process for the identification, invention, and implementation of new solutions. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work. A wealth of additional material supports the book, including a collection of nearly 100 videos created for the second edition, active links to external websites, supplementary appendices, and timely updates on the companion website at ebiodesign.org. Readers can access this material quickly, easily, and at the most relevant point in the text from within the ebook.
(source: Nielsen Book Data)
  • Preface-- Focus on value-- Global perspectives-- Process insights-- Part I. Identify: Stage 1. Needs Finding: 1.1 Strategic focus-- 1.2 Needs exploration-- 1.3 Need statement development-- Case study-- Stage 2. Needs Screening: 2.1 Disease state fundamentals-- 2.2 Existing solutions-- 2.3 Stakeholder analysis-- 2.4 Market analysis-- 2.5 Needs selection-- Case study-- Part II. Invent: Stage 3. Concept Generation: 3.1 Ideation-- 3.2 Initial concept selection-- Case study-- Stage 4. Concept Screening: 4.1 Intellectual property basics-- 4.2 Regulatory basics-- 4.3 Reimbursement basics-- 4.4 Business models-- 4.5 Concept exploration and testing-- 4.6 Final concept selection-- Case study-- Part III. Implement: Stage 5. Strategy Development: 5.1 IP strategy-- 5.2 R&D strategy-- 5.3 Clinical strategy-- 5.4 Regulatory strategy-- 5.5 Quality management-- 5.6 Reimbursement strategy-- 5.7 Marketing and stakeholder strategy-- 5.8 Sales and distribution strategy-- 5.9 Competitive advantage and business strategy-- Case study-- Stage 6. Business Planning: 6.1 Operating plan and financial model-- 6.2 Strategy integration and communication-- 6.3 Funding approaches-- 6.4 Alternate pathways-- Case study-- About the author team-- Image credits-- Glossary-- Index.
  • (source: Nielsen Book Data)
This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering, and business experts, the authors provide a comprehensive resource that leads students, researchers, and entrepreneurs through a proven process for the identification, invention, and implementation of new solutions. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work. A wealth of additional material supports the book, including a collection of nearly 100 videos created for the second edition, active links to external websites, supplementary appendices, and timely updates on the companion website at ebiodesign.org. Readers can access this material quickly, easily, and at the most relevant point in the text from within the ebook.
(source: Nielsen Book Data)
Business Library
Status of items at Business Library
Business Library Status
Stacks
R856 .B563 2015 Unknown

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