دانلود کتاب نانوپزشکی بالینی: قانون، تجارت، مقررات، ایمنی و خطر
Handbook of Clinical Nanomedicine: Law, Business, Regulation, Safety, and Risk, 1ed

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This unique handbook (60 chapters) examines the entire “product life cycle,” from the creation of nanomedical products to their final market introduction. While focusing on critical issues relevant to nanoproduct development and translational activities, it tackles topics such as regulatory science, patent law, FDA law, ethics, personalized medicine, risk analysis, toxicology, nano-characterization and commercialization activities. A separate section provides fascinating perspectives and editorials from leading experts in this complex interdisciplinary field.

Review

Reviews for Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications (Volume 1) “Dr. Bawa and his team have meticulously gathered the distilled experience of world-class researchers, clinicians and business leaders addressing the most salient issues confronted in product concept development and translation. Knowledge is power, particularly in nanomedicine translation, and this handbook is an essential guide that illustrates and clarifies our way to commercial success.”-Gregory Lanza, MD, PhD, Professor of Medicine and Oliver M. Langenberg Distinguished Professor, Washington University Medical School, USA “This is an outstanding, comprehensive volume that crosscuts disciplines and topics fitting individuals from a variety of fields looking to become knowledgeable in medical nanotech research and its translation from the bench to the bedside.” -Shaker A. Mousa, PhD, MBA, Vice Provost and Professor of Pharmacology, Albany College of Pharmacy and Health Sciences, USA “Masterful! This handbook will have a welcome place in the hands of students, educators, clinicians and experienced scientists alike. In a rapidly evolving arena, the authors have harnessed the field and its future by highlighting both current and future needs in diagnosis and therapies. Bravo!” -Howard E. Gendelman, MD, Margaret R. Larson Professor and Chair, University of Nebraska Medical Center, USA “It is refreshing to see a handbook that does not merely focus on preclinical aspects or exaggerated projections of nanomedicine. Unlike other books, this handbook not only highlights current advances in diagnostics and therapies but also addresses critical issues like terminology, regulatory aspects and personalized medicine.” -Gert Storm, PhD, Professor of Pharmaceutics, Utrecht University, The Netherlands Reviews for Handbook of Clinical Nanomedicine: Law, Business, Regulation, Safety, and Risk (Volume 2) “The distinguished editors have secured contributions from the leading experts in nanomedicine law, business, regulation and policy. This handbook represents possibly the most comprehensive and advanced collections of materials on these critical topics. An invaluable standard resource.”-Gregory N. Mandel, JD, Peter J. Liacouras Professor of Law and Associate Dean, Temple University Beasley School of Law, USA “This is an outstanding volume for those looking to become familiar with nanotechnology research and its translation from the bench to market. Way ahead of the competition, a standard reference on any shelf.” -Shaker A. Mousa, PhD, MBA, Vice Provost and Professor of Pharmacology, Albany College of Pharmacy, USA “The editors have gathered the distilled experience of leaders addressing the most salient issues confronted in R&D and translation. Knowledge is power, particularly in nanotechnology translation, and this handbook is an essential guide that illustrates and clarifies our way to commercial success.” -Gregory Lanza, MD, PhD, Professor of Medicine and Oliver M. Langenberg Distinguished Professor, Washington University Medical School, USA “The title of the handbook reflects its broad-ranging contents. The intellectual property chapters alone are worthy of their own handbook. Dr. Bawa and his coeditors should be congratulated for gathering the important writings on nanotech law, business and commercialization.” -Richard J. Apley, JD, Chief Patent Officer, Litman Law Offices/Becker & Poliakoff, USA “It is clear that this handbook will serve the interdisciplinary community involved in nanomedicine, pharma and biotech in a highly comprehensive way. It not only covers basic and clinical aspects but the often missing, yet critically important, topics of safety, risk, regulation, IP and licensing. The section titled `Perspectives and Editorials’ is superb.” -Yechezkel (Chezy) Barenholz, PhD, Professor Emeritus of Biochemistry and Daniel Miller Professor of Cancer Research, Hebrew University-Hadassah Medical School, Israel

About the Author

Raj Bawa, MS, PhD, is president of Bawa Biotech LLC, a biotech/pharma consultancy and patent law firm based in Ashburn, Virginia that he founded in 2002. He is an inventor, entrepreneur, professor and registered patent agent licensed to practice before the US Patent & Trademark Office. Trained as a biochemist and microbiologist, he has been an active researcher for over two decades. He has extensive expertise in the pharmaceutical sciences, biotechnology, nanomedicine, drug delivery, biodefense, FDA regulatory issues, and patent law. Since 1999, he has held various adjunct faculty positions at Rensselaer Polytechnic Institute in Troy, NY, where he is currently an adjunct professor of biological sciences and where he received his doctoral degree in three years (biophysics/biochemistry). Since 2004, he has been an adjunct professor of natural and applied sciences at NVCC in Annandale, VA. He is a scientific advisor to Teva Pharmaceutical Industries, Ltd., Israel. He has served as a principal investigator of National Cancer Institute SBIRs and reviewer for both the National Institutes of Health and the National Science Foundation. In the 1990s, Dr. Bawa held various positions at the US Patent & Trademark Office, including primary examiner for 6 years. He is a life member of Sigma Xi, co-chair of the Nanotech Committee of the American Bar Association and serves on the Global Advisory Council of the World Future Society. He has authored over 100 publications, co-edited four texts and serves on the editorial boards of numerous peer-reviewed journals, including serving as a special associate editor of Nanomedicine (Elsevier) and an editor-in-chief of the Journal of Interdisciplinary Nanomedicine (Wiley). Some of Dr. Bawa’s awards include the Innovations Prize from the Institution of Mechanical Engineers, London, UK (2008), the Key Award from Rensselaer’s Office of Alumni Relations (2005) and the Lifetime Achievement Award from the American Society for Nanomedicine (2014).

Gerald F. Audette, PhD, has been a faculty member at York University in Toronto, Canada, since 2006. Currently, he is an associate professor in the Department of Chemistry and acting director of the Centre for Research on Biomolecular Interactions at York University. He received his doctorate in 2002 from the Department of Biochemistry at the University of Saskatchewan in Saskatoon, Canada. Working with Drs. Louis T. J. Delbaere and J. Wilson Quail (1995–۲۰۰۱), Dr. Audette’s research focused on the elucidation of the protein– carbohydrate interactions that occur during blood-group recognition (in particular during the recognition of O blood type) using high-resolution X-ray crystallography. Dr. Audette conducted his postdoctoral research at the University of Alberta (2001–۲۰۰۶) in Edmonton, Canada. Working with Drs. Bart Hazes and Laura Frost; his research again utilized high-resolution protein crystallography to examine the correlation between protein structure and biological activity of type IV pilins that are assembled into pili used by bacteria for multiple purposes, including cellular adhesion during infection. It was during these studies that Dr. Audette identified the generation of protein nanotubes from engineered pilin monomers. Dr. Audette also studied the process of bacterial conjugation (or lateral gene transfer) using the F-plasmid conjugative system of Escherichia coli. Current research directions include: structure/function studies of proteins involved in bacterial conjugation systems, the structural and functional characterization of several type IV pilins (the monomeric subunit of the pilus), their assembly systems, and adapting these unique protein systems for applications in bionanotechnology. Dr. Audette has previously served as co-editor- in-chief of the Journal of Bionanoscience (۲۰۰۷–۲۰۱۰), and is currently a subject editor of structural chemistry and crystallography for the journal FACETS.

Brian E. Reese, PhD, JD, MBA, is an associate at the law firm of Choate, Hall, and Stewart in Boston, Massachusetts since 2012. Dr. Reese has extensive experience in intellectual property law, particularly patenting and trademark issues in the life sciences, and brings a practical knowledge of business strategy to his practice. As a former stock analyst, Dr. Reese has a strong appreciation for the business realities his clients face and how intellectual property can help them achieve their objectives. Dr. Reese graduated with a BS in cellular biochemistry from the State University of New York at Plattsburgh, where he received the Chancellor’s Award for academic excellence. He subsequently obtained his PhD from Pennsylvania State University for his research in the areas of neuroscience, molecular biology and toxicology. He also completed his MBA at Pennsylvania State University. Dr. Reese attended Albany Law School in Albany, NY, where he graduated magna cum laude. As a trained neuroscientist, Dr. Reese has authored several scientific and legal research papers in peer- reviewed journals. Each year, he moderates the American Bar Association’s panel on science and technology law at the Current Issues in Medicine and Pharma conference held at Rensselaer Polytechnic Institute in Troy, NY. Dr. Reese is active in providing pro bono services in intellectual property for several entities in the Boston area and currently serves as co-chair of the Nanotech Committee of the American Bar Association.

Contents

۱. An Intellectual Property Primer for Nanomedical Researchers and Engineers 3
۲. Strategic Intellectual Property Management: Building IP Portfolios 43
۳. Extending Patent Term for Nanomedical Inventions: A Nexus between the FDA and the Patent System 61
۴. When Patented Technologies Get Put to Experimental Use: Practical Considerations for Nanotech R&D 73
۵. Bridging Diagnostics Research, Development and Commercialization 85
۶. What the Supreme Court’s Myriad Decision Means for Nanotechnology Patents 103
۷. Managing the Expense of Patent Litigation in Nanotechnology 115
۸. Technology Transfer: An Overview 123
۹. Licensing Issues in Nanotechnology 141
۱۰. Commercializing Your Intellectual Property: Steps to Take and Pitfalls to Avoid 167
۱۱. Overcoming Nanotechnology Commercialisation Challenges: Case Studies of Nanotechnology Ventures 187
۱۲. The Commercialisation of Nanotechnology: The Five Critical Success Factors to a Nanotech-Enabled Whole Product 223
۱۳. Overcoming the Odds: How to Incubate Fledging Bioscience Companies 261
۱۴. Market Opportunity for Molecular Diagnostics in Personalized Cancer Therapy 273
۱۵. Nanotechnology Implications for Labor 303
۱۶. Insurance Market Perception of Nanotechnology and Nanomaterials Risks 323
۱۷. FDA and Nano: Baby Steps, Regulatory Uncertainty and the Bumpy Road Ahead 339
۱۸. EU Regulation of Nanobiotechnology 385
۱۹. Regulating Nanomedicine 401
۲۰. Nanomedicines: Addressing the Scientific and Regulatory Gap 413
۲۱. Regulation of Combination Products in the United States 471
۲۲. Regulation of Combination Products in the European Union 485
۲۳. Brief Overview of Current Developments in Nanotechnology EHS Regulation in the U.S. 499
۲۴. EPA Targets Nanotechnology: Hi-Ho, Nanosilver, Away? 515
۲۵. Graphene: Regulatory Considerations for the “Wonder Material” ۵۳۵
۲۶. The Enduring Embrace: The Regulatory Ancien Régime and Governance of Nanomaterials in the U.S. 545
۲۷. Safety of Engineered Nanomaterials and Occupational Health and Safety Issues for Commercial-Scale Production 569
۲۸. Engineered Nanoparticle Release, Exposure Pathway and Dose, Measures and Measuring Techniques for Nanoparticle Exposure in Air 621
۲۹. Managing Environmental and Health Risks in the Nanotechnology Industry 659
۳۰. Risk Perception and Risk Communication on the Issue of Nanotechnology 683
۳۱. In vitro Risk Assessment of Nanoparticles 719
۳۲. Biological Responses to Nanoparticles 745
۳۳. Cell and Protein Interactions with Diamond 809
۳۴. Intracellular Transport and Unpacking of Polyplex Nanoparticles 823
۳۵. Complement Activation: A Capricious Immune Barrier to the Clinical Use of Nanomedicines 845
۳۶. Nanotoxicology: Focus on Nanomedicine 873
۳۷. Toxicity and Genotoxicity of Metal and Metal Oxide Nanomaterials: A General Introduction 901
۳۸. Toxicity of Silicon Dioxide Nanoparticles in Mammalian Neural Cells 931
۳۹. Future Concepts in Nanomedicine 961
۴۰. Is Translational Medicine the Future of Therapy? 997
۴۱. Nanomedical Cognitive Enhancement: Challenges and Future Possibilities 1013
۴۲. Nanomedicine: Ethical Considerations 1031
۴۳. Clinical Nanobioethical Problems: A Value Approach 1057
۴۴. Nanomedicine: Shadow and Substance 1081
۴۵. The Tower of Babel: Miscommunication within and about Nanomedicine 1091
۴۶. Is Nanotechnology Toxic? Was Prince Charles Correct? 1101
۴۷. The Audience Is the Message: Nanomedicine as Apotheosis or Damnatio Memoriae 1117
۴۸. A Sample of Religious Thought on Nanotechnology 1141
۴۹. Iron Oxide Nanoparticles for Treatment of Anemia of Chronic Kidney Disease: Too Much of a Good Thing? 1163
۵۰. Perspectives on Legal Challenges in the Development and Commercialization of Nanotechnology 1175
۵۱. Nanomedicine and the Fight against HIV/AIDS: Expert Perspectives 1191
۵۲. Interdisciplinary Nanomedicine Publications through Interdisciplinary Peer-Review 1223
۵۳. Nanopharmaceutics Innovations in Gene Therapy: Moving towards Non-Viral and Non-Invasive Delivery Methods 1239
۵۴. Recent Developments in Ocular Nanotherapy: An Editorial 1245
۵۵. The Promise of Nanoneuromedicine: An Editorial 1253
۵۶. Principles of Nanoethics: Theoretical Models and Clinical Practice 1269
۵۷. The Tree and the Forest: A Need for Dialogue and a Collaboratve Approach in the Safety of Nanomedicines 1281
۵۸. The Translational Challenge in Medicine at the Nanoscale 1291
۵۹. Nanotechnology toward Advancing Personalized Medicine     ۱۳۴۷
۶۰. Science, Business, and Impact of Nanomedicine: Final Thoughts     ۱۴۱۳

قیمت : 5000 تومان
لینک کوتاه : https://bookbaz.ir/?p=39517
نویسنده : Raj Bawa , Gerald F. Audette
ناشر : Pan Stanford
سال انتشار : 2016
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 1472
(ISBN) شابک : 9814669229
قیمت کتاب درآمازون : $439.21
حجم فایل : 16 MB

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