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Handbook of Clinical Nanomedicine
Law, Business, Regulation, Safety, and Risk
edited by Raj Bawa, Gerald F. Audette and Brian E. Reese
“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, Temple University Beasley School of Law, USA
- Format: Hardcover
- ISBN: 9789814669221
- Series: Jenny Stanford Series on Nanomedicine
- Subject: Nanomedicine
- Published: May 2016
- Pages: 1502
USD $615.00
For Course Instructors: Inspection Copies
Retailers:
This handbook 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.
Key Features:
- Examines the entire "product wheel" from creation of nanomedical products to final market introduction in a stand-alone, easily accessible format
- Serves as an essential reference for the novice and expert alike in fields such as medicine, law, biotechnology, pharmaceutical sciences, engineering, policy, future studies, ethics, licensing, and toxicology
- Addresses critical topics such as personalized medicine, ethics, environmental health, nomenclature, nano-economics, business strategy, licensing, intellectual property, FDA law, EPA law, and governmental policy issues
Chapter 1
An Intellectual Property Primer for Nanomedical Researchers and Engineers
Brian E. Reese, JD, PhD, MBA
Pages: 1
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Add to cartChapter 2
Strategic Intellectual Property Management: Building IP Portfolios
Jeffery P. Langer, PhD, JD
Pages: 43
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Add to cartChapter 3
Extending Patent Term for Nanomedical Inventions: A Nexus between the FDA and the Patent System
Susanne M. Hopkins, JD, and Ari G. Zytcer, JD
Pages: 61
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Add to cartChapter 4
When Patented Technologies Get Put to Experimental Use: Practical Considerations for Nanotech R&D
Victor H. Polk, Jr, JD, and Roman Fayerberg, JD
Pages: 73
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Add to cartChapter 5
Bridging Diagnostics Research, Development and Commercialization
Rosanna W. Peeling, PhD
Pages: 85
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Add to cartChapter 6
What the Supreme Court’s Myriad Decision Means for Nanotechnology Patents
Andrew S. Baluch, JD, Stephen B. Maebius, JD, and Harold C. Wegner, JD
Pages: 103
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Add to cartChapter 7
Managing the Expense of Patent Litigation in Nanotechnology
Todd G. Vare, JD
Pages: 115
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Add to cartChapter 8
Technology Transfer: An Overview
Bruce D. Goldstein, JD, MS
Pages: 123
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Add to cartChapter 9
Licensing Issues in Nanotechnology
Joanna T. Brougher, JD, MPh
Pages: 141
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Add to cartChapter 10
Commercializing Your Intellectual Property: Steps to Take and Pitfalls to Avoid
Inna Dahlin, PhD, JD, and Michael J. Pomianek, PhD, JD
Pages: 167
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Add to cartChapter 11
Overcoming Nanotechnology Commercialisation Challenges: Case Studies of Nanotechnology Ventures
Elicia Maine, PhD
Pages: 187
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Add to cartChapter 12
The Commercialisation of Nanotechnology: The Five Critical Success Factors to a Nanotech-Enabled Whole Product
Craig Belcher, MBA, PhD, Richard Marshall, MBA, Grant Edwards, PhD, and Darren Martin, PhD
Pages: 223
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Add to cartChapter 13
Overcoming the Odds: How to Incubate Fledging Bioscience Companies
Patti Breedlove, MS
Pages: 261
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Add to cartChapter 14
Market Opportunity for Molecular Diagnostics in Personalized Cancer Therapy
Elemer Piros, PhD, Istvan Petak, MD, PhD, Attila Erdos, MD, John Hautman, JD, and Julianna Lisziewicz, PhD
Pages: 273
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Add to cartChapter 15
Nanotechnology Implications for Labor
Noela Invernizzi, PhD, and Guillermo Foladori, PhD
Pages: 303
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Add to cartChapter 16
Insurance Market Perception of Nanotechnology and Nanomaterials Risks
Lijana Baublyte, PhD, Martin Mullins, PhD, Finbarr Murphy, PhD, and Syed A.M. Tofail, PhD
Pages: 323
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Add to cartChapter 17
FDA and Nano: Baby Steps, Regulatory Uncertainty and the Bumpy Road Ahead
Raj Bawa, MS, PhD
Pages: 339
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EU Regulation of Nanobiotechnology
John Quinn, LLM
Pages: 385
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Add to cartChapter 19
Regulating Nanomedicine
Shannon G. Fischer, MS
Pages: 401
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Add to cartChapter 20
Nanomedicines: Addressing the Scientific and Regulatory Gap
Sally 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
Pages: 413
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Add to cartChapter 21
Regulation of Combination Products in the United States
John Barlow Weiner, JD, and Thinh X. Nguyen
Pages: 471
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Regulation of Combination Products in the European Union
Janine Jamieson, PhD, and Elizabeth Baker
Pages: 485
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Add to cartChapter 23
Brief Overview of Current Developments in Nanotechnology EHS Regulation in the U.S.
Theodore Voorhees, Jr., JD
Pages: 499
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Add to cartChapter 24
EPA Targets Nanotechnology: Hi-Ho, Nanosilver, Away?
David L. Wallace, JD, and Justin A. Schenck, JD
Pages: 515
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Add to cartChapter 25
Graphene: Regulatory Considerations for the “Wonder Material”
Matthew Kaplan, JD, and Jennifer Woloschyn, JD
Pages: 535
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Add to cartChapter 26
The Enduring Embrace: The Regulatory Ancien Régime and Governance of Nanomaterials in the U.S.
Christopher Bosso, PhD
Pages: 545
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Add to cartChapter 27
Safety of Engineered Nanomaterials and Occupational Health and Safety Issues for Commercial-Scale Production
Paul F. A. Wright, PhD, and Neale R. C. Jackson, PhD
Pages: 569
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Add to cartChapter 28
Engineered Nanoparticle Release, Exposure Pathway and Dose, Measures and Measuring Techniques for Nanoparticle Exposure in Air
Heinz Fißan, PhD, and Hans-Georg Horn, PhD
Pages: 621
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Add to cartChapter 29
Managing Environmental and Health Risks in the Nanotechnology Industry
Joseph Luke Huan, LLB (Hons), MPhil
Pages: 659
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Add to cartChapter 30
Risk Perception and Risk Communication on the Issue of Nanotechnology
Gaby-Fleur Böl, PhD, Guido Correia Carreira, PhD, Astrid Epp, PhD, Eva Häffner, PhD, and Mark Lohmann, PhD
Pages: 683
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Add to cartChapter 31
In vitro Risk Assessment of Nanoparticles
Birgit K. Gaiser, Julia Susewind, Nadia Ucciferri, Eva-Maria Collnot, Arti Ahluwalia, and Vicki Stone
Pages: 719
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Add to cartChapter 32
Biological Responses to Nanoparticles
Reinhard 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, L
Pages: 745
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Add to cartChapter 33
Cell and Protein Interactions with Diamond
Roger J. Narayan, MD, PhD, R. D. Boehm, BS, and Nancy A. Monteiro-Riviere, PhD
Pages: 809
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Add to cartChapter 34
Intracellular Transport and Unpacking of Polyplex Nanoparticles
Andrey A. Rosenkranz, PhD, Yuri V. Khramtsov, PhD, Alexey V. Ulasov, PhD, Nikita Rodichenko, and Alexander S. Sobolev, DSci, PhD
Pages: 823
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Add to cartChapter 35
Complement Activation: A Capricious Immune Barrier to the Clinical Use of Nanomedicines
János Szebeni, MD, PhD, DSc
Pages: 845
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Nanotoxicology: Focus on Nanomedicine
Helinor Johnston, PhD, Ali Kermanizadeh, PhD, and Vicki Stone, PhD
Pages: 873
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Add to cartChapter 37
Toxicity and Genotoxicity of Metal and Metal Oxide Nanomaterials: A General Introduction
Mercedes Rey, David Sanz, and Sergio E. Moya
Pages: 901
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Add to cartChapter 38
Toxicity of Silicon Dioxide Nanoparticles in Mammalian Neural Cells
James C. K. Lai, PhD, Ashvin R. Jaiswal, MS, Maria B. Lai, MS, Sirisha Jandhyam, MS, Solomon W. Leung, PhD, and Alok Bhushan, PhD
Pages: 931
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Add to cartChapter 39
Future Concepts in Nanomedicine
Rob Burgess, PhD
Pages: 961
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Add to cartChapter 40
Is Translational Medicine the Future of Therapy?
Christopher-Paul Milne, PhD, and James Mittra, PhD
Pages: 997
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Add to cartChapter 41
Nanomedical Cognitive Enhancement: Challenges and Future Possibilities
Melanie Swan, MBA
Pages: 1013
USD $34.95
Add to cartChapter 42
Nanomedicine: Ethical Considerations
Todd Kuiken, PhD
Pages: 1031
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Clinical Nanobioethical Problems: A Value Approach
Jorge Alberto Álvarez-Díaz, MD, PhD
Pages: 1057
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Nanomedicine: Shadow and Substance
Z. Shadi Farhangrazi, PhD, and S. Moein Moghimi, PhD
Pages: 1081
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The Tower of Babel: Miscommunication within and about Nanomedicine
Rudolph L. Juliano, PhD
Pages: 1091
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Is Nanotechnology Toxic? Was Prince Charles Correct?
Pelagie M. Favi, PhD, and Thomas J. Webster, PhD
Pages: 1101
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The Audience Is the Message: Nanomedicine as Apotheosis or Damnatio Memoriae
David M. Berube, PhD
Pages: 1117
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A Sample of Religious Thought on Nanotechnology
Chris Toumey, PhD
Pages: 1141
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Add to cartChapter 49
Iron Oxide Nanoparticles for Treatment of Anemia of Chronic Kidney Disease: Too Much of a Good Thing?
Amy Barton Pai, PharmD
Pages: 1163
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Add to cartChapter 50
Perspectives on Legal Challenges in the Development and Commercialization of Nanotechnology
Annette I. Kahler, JD
Pages: 1175
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Add to cartChapter 51
Nanomedicine and the Fight against HIV/AIDS: Expert Perspectives
André Nel, MBChB, PhD, Susan Swindells, MD, Tatiana Bronich, PhD, and Howard E. Gendelman, MD
Pages: 1191
USD $34.95
Add to cartChapter 52
Interdisciplinary Nanomedicine Publications through Interdisciplinary Peer-Review
Andrew Owen, PhD, Steve P. Rannard, DPhil, Raj Bawa, MS, PhD, and Si-Shen Feng, PhD
Pages: 1223
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Add to cartChapter 53
Nanopharmaceutics Innovations in Gene Therapy: Moving towards Non-Viral and Non-Invasive Delivery Methods
Marianna Foldvari, PhD, DPharmSci
Pages: 1239
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Add to cartChapter 54
Recent Developments in Ocular Nanotherapy: An Editorial
Kislay Roy, PhD, and Jagat R. Kanwar, MSc, PhD
Pages: 1245
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Add to cartChapter 55
The Promise of Nanoneuromedicine: An Editorial
Howard E. Gendelman, MD, R. Lee Mosley, PhD, Michael D. Boska, PhD, and JoEllyn McMillan, PhD
Pages: 1253
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Add to cartChapter 56
Principles of Nanoethics: Theoretical Models and Clinical Practice
Mario Ganau, MD, PhD, Lara Prisco, MD, Nikolaos Syrmos, MD, and Laura Ganau
Pages: 1269
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Add to cartChapter 57
The Tree and the Forest: A Need for Dialogue and a Collaborative Approach in the Safety of Nanomedicines
Hassan A. N. El-Fawal, MSc, PhD
Pages: 1281
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Add to cartChapter 58
The Translational Challenge in Medicine at the Nanoscale
Raj Bawa, MS, PhD, S. R. Bawa, MSc, PhD, and Ratnesh N. Mehra, DO
Pages: 1291
USD $34.95
Add to cartChapter 59
Nanotechnology toward Advancing Personalized Medicine
Jason 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
Pages: 1347
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Add to cartChapter 60
Science, Business, and Impact of Nanomedicine: Final Thoughts
Michael Hehenberger, PhD, DrSc
Pages: 1413
USD $34.95
Add to cartRaj Bawa, PhD, MD, is president of Bawa Biotech LLC (founded 2002), a biotech/pharma consultancy and patent law firm based in Ashburn, Virginia. Trained as a microbiologist and biochemist, he is an inventor, author, entrepreneur, professor, and registered patent agent (since 2002) licensed to practice before the US Patent & Trademark Office. He is currently scientific advisor to Teva Pharmaceutical Industries, Israel (since 2010); visiting research scholar at Pharmaceutical Research Institute of Albany Pharmacy, Albany, New York; and full professor (adjunct) at NOVA in Annandale, Virginia (since 2004). He is VP/chief IP officer at Guanine, Inc., in Rensselaer, New York (since 2017), a company focused on rapid, accurate detection of infective pathogens. Dr. Bawa has served as a principal investigator of various NCI research grants, and most recently as a principal investigator of a CDC grant to develop an assay for carbapenemase resistant bacteria. Previously, he was an adjunct professor at Rensselaer Polytechnic Institute, Troy, New York, from 1998 to 2018. He held various positions at the US Patent Office, including primary examiner from 1996 to 2002. He earned a BSc (Honors School) in microbiology, MS in cancer biology, PhD in biophysics/biochemistry, and MD. Currently, he is a life member of Sigma Xi, cochair of the nanotech and precision medicine committees of the American Bar Association and founding director of the American Society for Nanomedicine (established 2008). He has authored over 100 publications, edited 10 texts, and serves on the editorial boards of numerous peer-reviewed journals, including serving as an associate editor of Nanomedicine (Elsevier).
Gerald F. Audette, PhD, has been a faculty member at York University in Toronto, Canada, in the Department of Chemistry since 2006. Currently he is associate professor in the department and a member of the Centre for Research on Biomolecular Interactions at York University. Dr. Audette is the co-editor of volumes 1-4 of the Pan Stanford Series on Nanomedicine and is a subject editor of structural chemistry and crystallography for the journal FACETS.
“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, 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, 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, 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, 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, Hebrew University-Hadassah Medical School, Israel