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bawa raj (curatore); audette gerald f. (curatore); reese brian (curatore) - handbook of clinical nanomedicine

Handbook of Clinical Nanomedicine Law, Business, Regulation, Safety, and Risk

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Dettagli

Genere:Libro
Lingua: Inglese
Pubblicazione: 06/2016
Edizione: 1° edizione





Note Editore

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.




Sommario

LAW, BUSINESS, AND COMMERCIALIZATIONAn Intellectual Property Primer for Nanomedical Researchers and EngineersBrian E. Reese, JD, PhD, MBA Strategic Intellectual Property Management: Building IP PortfoliosJeffery P. Langer, PhD, JD Extending Patent Term for Nanomedical Inventions: A Nexus between the FDA and the Patent SystemSusanne M. Hopkins, JD, and Ari G. Zytcer, JD When Patented Technologies Get Put to Experimental Use: Practical Considerations for Nanotech R&DVictor H. Polk, Jr, JD, and Roman Fayerberg, JD Bridging Diagnostics Research, Development and CommercializationRosanna W. Peeling, PhD What the Supreme Court’s Myriad Decision Means for Nanotechnology PatentsAndrew S. Baluch, JD, Stephen B. Maebius, JD, and Harold C. Wegner, JD Managing the Expense of Patent Litigation in Nanotechnology Todd G. Vare, JD Technology Transfer: An OverviewBruce D. Goldstein, JD, MS Licensing Issues in NanotechnologyJoanna T. Brougher, JD, MPhCommercializing Your Intellectual Property: Steps to Take and Pitfalls to AvoidInna Dahlin, PhD, JD, and Michael J. Pomianek, PhD, JDOvercoming Nanotechnology Commercialisation Challenges: Case Studies of Nanotechnology VenturesElicia Maine, PhDThe Commercialisation of Nanotechnology: The Five Critical Success Factors to a Nanotech-Enabled Whole ProductCraig Belcher, MBA, PhD, Richard Marshall, MBA, Grant Edwards, PhD, and Darren Martin, PhDOvercoming the Odds: How to Incubate Fledging Bioscience CompaniesPatti Breedlove, MSMarket Opportunity for Molecular Diagnostics in Personalized Cancer TherapyElemer Piros, PhD, Istvan Petak, MD, PhD, Attila Erdos, MD, John Hautman, JD, and Julianna Lisziewicz, PhNanotechnology Implications for Labor Noela Invernizzi, PhD, and Guillermo Foladori, PhDInsurance Market Perception of Nanotechnology and Nanomaterials RisksLijana Baublyte, PhD, Martin Mullins, PhD, Finbarr Murphy, PhD, and Syed A.M. Tofail, PhDREGULATORY ISSUES AND NANOGOVERNANCEFDA and Nano: Baby Steps, Regulatory Uncertainty and the Bumpy Road Ahead|Raj Bawa, MS, PhD EU Regulation of Nanobiotechnology John Quinn, LLM Regulating NanomedicineShannon G. Fischer, MS Nanomedicines: Addressing the Scientific and Regulatory GapSally Tinkle, PhD, Scott E. McNeil, PhD, Stefan Mühlebach, PhD, Raj Bawa, MS, PhD, Gerrit Borchard, PhD, Yechezkel Barenholz, PhD, Lawrence Tamarkin, PhD, and Neil Desai, MS, PhD Regulation of Combination Products in the United StatesJohn Barlow Weiner, JD, and Thinh X. Nguyen Regulation of Combination Products in the European UnionJanine Jamieson, PhD, and Elizabeth Baker Brief Overview of Current Developments in Nanotechnology EHS Regulation in the U.S.Theodore Voorhees, Jr., JD EPA Targets Nanotechnology: Hi-Ho, Nanosilver, Away?David L. Wallace, JD, and Justin A. Schenck, JD Graphene: Regulatory Considerations for the "Wonder Material"Matthew Kaplan, JD, and Jennifer Woloschyn, JD The Enduring Embrace: The Regulatory Ancien Régime and Governance of Nanomaterials in the U.S.Christopher Bosso, PhD HEALTH, SAFETY, RISK, AND BIOLOGICAL INTERACTIONS Safety of Engineered Nanomaterials and Occupational Health and Safety Issues for Commercial-Scale ProductionPaul F. A. Wright, PhD, and Neale R. C. Jackson, PhD Engineered Nanoparticle Release, Exposure Pathway and Dose, Measures and Measuring Techniques for Nanoparticle Exposure in AirHeinz Fißan, PhD, and Hans-Georg Horn, PhD Managing Environmental and Health Risks in the Nanotechnology IndustryJoseph Luke Huan, LLB (Hons), MPhil Risk Perception and Risk Communication on the Issue of NanotechnologyGaby-Fleur Böl, PhD, Guido Correia Carreira, PhD, Astrid Epp, PhD, Eva Häffner, PhD, and Mark Lohmann, PhD In vitro Risk Assessment of NanoparticlesBirgit K. Gaiser, Julia Susewind, Nadia Ucciferri, Eva-Maria Collnot, Arti Ahluwalia, and Vicki Stone Biological Responses to NanoparticlesReinhard Zellner, PhD, Julia Blechinger, PhD, Cristoph Bräuchle, PhD, I. Hilger, Andreas Janshoff, PhD, Juergen Lademann, PhD, Volker Mailänder, PhD, Martina C. Meinke, PhD, G. U. Nienhaus, PhD, A. Patzelt, MD, F. Rancan, Barbara Rothen-Rutishauser, PhD, Roland H. Stauber, PhD, A. A. Torrano, PhD, Lennart Treuel, PhD, and A. Vogt Cell and Protein Interactions with DiamondRoger J. Narayan, MD, PhD, R. D. Boehm, BS, and Nancy A. Monteiro-Riviere, PhD Intracellular Transport and Unpacking of Polyplex NanoparticlesAndrey A. Rosenkranz, PhD, Yuri V. Khramtsov, PhD, Alexey V. Ulasov, PhD, Nikita Rodichenko, and Alexander S. Sobolev, DSci, PhD Complement Activation: A Capricious Immune Barrier to the Clinical Use of NanomedicinesJános Szebeni, MD, PhD, DSc Nanotoxicology: Focus on NanomedicineHelinor Johnston, PhD, Ali Kermanizadeh, PhD, and Vicki Stone, PhD Toxicity and Genotoxicity of Metal and Metal Oxide Nanomaterials: A General IntroductionMercedes Rey, David Sanz, and Sergio E. Moya Toxicity of Silicon Dioxide Nanoparticles in Mammalian Neural CellsJames C. K. Lai, PhD, Ashvin R. Jaiswal, MS, Maria B. Lai, MS, Sirisha Jandhyam, MS, Solomon W. Leung, PhD, and Alok Bhushan, PhD FUTURE IMPLICATIONS, ETHICS, PERSPECTIVES, AND EDITORIALS Future Concepts in NanomedicineRob Burgess, PhD Is Translational Medicine the Future of Therapy?Christopher-Paul Milne, PhD, and James Mittra, PhD Nanomedical Cognitive Enhancement: Challenges and Future PossibilitiesMelanie Swan, MBA Nanomedicine: Ethical ConsiderationsTodd Kuiken, PhD Clinical Nanobioethical Problems: A Value ApproachJorge Alberto Álvarez-Díaz, MD, PhD Nanomedicine: Shadow and SubstanceZ. Shadi Farhangrazi, PhD, and S. Moein Moghimi, PhD The Tower of Babel: Miscommunication within and about NanomedicineRudolph L. Juliano, PhD Is Nanotechnology Toxic? Was Prince Charles Correct?Pelagie M. Favi, PhD, and Thomas J. Webster, PhD The Audience Is the Message: Nanomedicine as Apotheosis or Damnatio MemoriaeDavid M. Berube, PhD A Sample of Religious Thought on NanotechnologyChris Toumey, PhD Iron Oxide Nanoparticles for Treatment of Anemia of Chronic Kidney Disease: Too Much of a Good Thing?Amy Barton Pai, PharmD Perspectives on Legal Challenges in the Development and Commercialization of NanotechnologyAnnette I. Kahler, JD Nanomedicine and the Fight against HIV/AIDS: Expert PerspectivesAndré Nel, MBChB, PhD, Susan Swindells, MD, Tatiana Bronich, PhD, and Howard E. Gendelman, MD Interdisciplinary Nanomedicine Publications through Interdisciplinary Peer-ReviewAndrew Owen, PhD, Steve P. Rannard, DPhil, Raj Bawa, MS, PhD, and Si-Shen Feng, PhD Nanopharmaceutics Innovations in Gene Therapy: Moving towards Non-Viral and Non-Invasive Delivery MethodsMarianna Foldvari, PhD, DPharmSci Recent Developments in Ocular Nanotherapy: An EditorialKislay Roy, PhD, and Jagat R. Kanwar, MSc, PhD The Promise of Nanoneuromedicine: An EditorialHoward E. Gendelman, MD, R. Lee Mosley, PhD, Michael D. Boska, PhD, and JoEllyn McMillan, PhD Principles of Nanoethics: Theoretical Models and Clinical PracticeMario Ganau, MD, PhD, Lara Prisco, MD, Nikolaos Syrmos, MD, and Laura Ganau The Tree and the Forest: A Need for Dialogue and a Collaborative Approach in the Safety of Nanomedicines Collaborative Approach in the Safety of NanomedicinesHassan A. N. El-Fawal, MSc, PhD The Translational Challenge in Medicine at the NanoscaleRaj Bawa, MS, PhD, S. R. Bawa, MSc, PhD, and Ratnesh N. Mehra, DO Nanotechnology toward Advancing Personalized MedicineJason H. Sakamoto, PhD, Biana Godin, PhD, Ye Hu, PhD, Elvin Blanco, PhD, Anne L. van de Ven, PhD, Adaikkalam Vellaichamy, PhD, Matthew B. Murphy, PhD, Saverio La Francesca, MD, Terry Schuenemeyer, RN, MS, Bruce Given, MD, Anne Meyn, and Mauro Ferrari, PhD Science, Business, and Impact of Nanomedicine: Final ThoughtsMichael Hehenberger, PhD, DrSc




Autore

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 (1995–2001), 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 (2001–2006) 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 (2007–2010), 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 scient










Altre Informazioni

ISBN:

9789814669221

Condizione: Nuovo
Collana: Jenny Stanford Series on Nanomedicine
Dimensioni: 9 x 6 in Ø 4.34 lb
Formato: Copertina rigida
Illustration Notes:36 b/w images and 85 color images
Pagine Arabe: 1502


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