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Pan Stanford Series on Nanomedicine
Diversity within the broad and evolving arena of nanomedicine and nanopharma is reflected in the expertise of the distinguished contributing authors. The chapters contain key words, figures in full-color and an extensive list of references. As compared to texts on the market, each handbook in the series is comprehensive and intended to be a stand‐alone reference resource, presented in a user-friendly format for easy access. The editors have skillfully curated each chapter to reflect the most relevant and current information possible. The range of topics covered as well as the multidisciplinary approach of the handbooks will attract a global audience. The handbooks are essential reading for both the novice and expert in fields ranging from medicine, biotechnology, pharmaceutical sciences, engineering, FDA law, intellectual property, policy, future studies, ethics, licensing, commercialization, risk analysis, and toxicology.
Handbook of Clinical Nanomedicine. Vol. 1. Nanoparticles, Imaging, Therapy, and Clinical Applications, Raj Bawa, PhD, Gerald F. Audette, PhD, and Israel Rubinstein, MD (Editors)
This handbook (55 chapters) provides a comprehensive roadmap of basic research in nanomedicine as well as clinical applications. However, unlike other texts in nanomedicine, it not only highlights current advances in diagnostics and therapeutics but also explores related issues like nomenclature, historical developments, regulatory aspects, nanosimilars and 3D nanofabrication. While bridging the gap between basic biomedical research, engineering, medicine and law, the handbook provides a thorough understanding of nano’s potential to address (i) medical problems from both the patient and health provider's perspective, and (ii) current applications and their potential in a healthcare setting.
Handbook of Clinical Nanomedicine. Vol. 2. Law, Business, Regulation, Safety, and Risk, Raj Bawa, PhD (Editor), Gerald F. Audette, PhD, and Brian E. Reese, PhD, MBA, JD (Assistant Editors)
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.
Volume 1
GENERAL INTRODUCTION AND BEGINNINGS
Science at the Nanoscale: Introduction and Historical Perspective
Chin Wee Shong, PhD, Sow Chorng Haur, PhD, and Andrew T. S. Wee, PhD
Nanomedicine: Dynamic Integration of Nanotechnology with Biomedical Science
Ki-Bum Lee, PhD, Aniruddh Solanki, PhD, John Dongun Kim, PhD, and Jongjin Jung, PhD
A Small Introduction to the World of Nanomedicine
Rutledge Ellis-Behnke, PhD
Top Ten Recent Nanomedical Research Advances
Melanie Swan, MBA
The Coming Era of Nanomedicine
Fritz Allhoff, JD, PhD
What’s in a Name? Defining "Nano" in the Context of Drug Delivery
Raj Bawa, MS, PhD
NANOPARTICLES, NANODEVICES, AND IMAGING
Properties of Nanoparticulate Materials
Takuya Tsuzuki, PhD
Solid Drug Nanoparticles: Methods for Production and Pharmacokinetic Benefits
Andrew Owen, PhD, and Steve P. Rannard, DPhil
Design and Development of Approved Nanopharmaceutical Products
Heidi M. Mansour, PhD, RPh, Chun-Woong Park, PhD, and Raj Bawa, MS, PhD
Nanosizing Approaches in Drug Delivery
Sandip Chavhan, PhD, Kailash Petkar, PhD, and Krutika Sawant, PhD
Multilayered Nanoparticles for Personalized Medicine: Translation into Clinical Markets
Dania Movia, PhD, Craig Poland, PhD, Lang Tran, PhD, Yuri Volkov, PhD, and Adriele Prina-Mello, PhD
Nanomaterials for Pharmaceutical Applications
Brigitta Loretz, PhD, Ratnesh Jain, PhD, Prajakta Dandekar, PhD, Carolin Thiele, PhD, Yamada Hiroe, PhD, Babak Mostaghaci, PhD, Lian Qiong, MSc, and Claus-Michael Lehr, PhD
Polysaccharides as Nanomaterials for Therapeutics
Shoshy Mizrahy, MSc, and Dan Peer, PhD
The Story of C60 Buckminsterfullerene
Harold W. Kroto, PhD
Applications of Nanoparticles in Medical Imaging
Jason L. J. Dearling, PhD, and Alan B. Packard, PhD
Nanoimaging for Nanomedicine
Yuri L. Lyubchenko, PhD, DSc, Yuliang Zhang, Alexey V. Krasnoslobodtsev, PhD, and Jean-Christophe Rochet, PhD
Nanoparticles for Multi-Modality Diagnostic Imaging and Drug Delivery
Catherine M. Lockhart, PharmD, and Rodney J. Y. Ho, PhD
Magnetic Nanoparticles for Magnetic Resonance Imaging: A Translational Push toward Theranostics
Ryan A. Ortega, Thomas E. Yankeelov, PhD, and Todd D. Giorgio, PhD
First-in-Human Molecular Targeting and Cancer Imaging Using Ultrasmall Dual-Modality C Dots
Michelle S. Bradbury, MD, PhD, and Ulrich Wiesner, PhD
Atomic Force Microscopy for Nanomedicine
Shivani Sharma, PhD, and James K. Gimzewski, PhD
Atomic Force Microscopy Imaging and Probing of Amyloid Nanoaggregates
Yuri L. Lyubchenko, PhD, DSc, and Luda S. Shlyakhtenko, PhD
Image-Based High-Content Analysis, Stem Cells and Nanomedicines: A Novel Strategy for Drug Discovery
Leonardo J. Solmesky, PhD, Yonatan Adalist, MSc, and Miguel Weil, PhD
Viral Nanoparticles: Tools for Materials Science and Biomedicine
Nicole F. Steinmetz, PhD, and Marianne Manchester, PhD
Bacterial Secretion Systems: Nanomachines for Infection and Genetic Diversity
Agnesa Shala, PhD, Michele Ferraro, MSc, and Gerald F. Audette, PhD
The Vascular Cartographic Scanning Nanodevice
Frank J. Boehm
Advancements in Ophthalmic Glucose Nanosensors for Diabetes Management
Angelika Domschke, PhD
THERAPY AND CLINICAL APPLICATIONS
Towards Nanodiagnostics for Bacterial Infections
Georgette B. Salieb-Beugelaar, PhD, and Patrick R. Hunziker, MD
Copaxone® in the Era of Biosimilars and Nanosimilars
Jill B. Conner, MS, PhD, Raj Bawa, MS, PhD, J. Michael Nicholas, PhD, and Vera Weinstein, PhD
Doxil®: The First FDA-Approved Nanodrug—From an Idea to a Product (January 2015 Update)
Yechezkel Barenholz, PhD
Nanotechnology and the Skin Barrier: Topical and Transdermal Nanocarrier-Based Delivery
Hagar I. Labouta, PhD, and Marc Schneider, PhD
Application of Nanotechnology in Non-Invasive Topical Gene Therapy
Mahmoud Elsabahy, PhD, Maria Jimena Loureiro, MSc, and Marianna Foldvari, PhD,DPharmSci
Nanocarriers in the Therapy of Inflammatory Disease
Alf Lamprecht, PhD
Advanced 3D Nano/Microfabrication Techniques for Tissue and Organ Regeneration
Benjamin Holmes, MSc, Thomas J. Webster, PhD, and Lijie Grace Zhang, PhD
Nanomedicine for Acute Lung Injury/Acute Respiratory Distress Syndrome: A Shifting Paradigm?
Ruxana T. Sadikot, MD, and Israel Rubinstein, MD
Nanoviricides: Targeted Anti-Viral Nanomaterials
Randall W. Barton, PhD, Jayant G. Tatake, PhD, and Anil R. Diwan, PhD
Nanotechnology in Tissue Engineering for Orthopaedics
Lesley M. Hamming, PhD, JD, and Mark G. Hamming, MD
Applications of Nanomaterials in Dentistry
Karolina Jurczyk, DDS, PhD, and Mieczyslaw Jurczyk, PhD, DSc
Biomimetic Applications in Regenerative Medicine: Scaffolds, Transplantation Modules, Tissue Homing Devices, and Stem Cells
David W. Green, PhD, and Besim Ben-Nissan, PhD
Potential Applications of Nanotechnology in the Nutraceutical Sector
Shu Wang, MD, PhD, and Jia Zhang, MS
Designing Nanocarriers for the Effective Treatment of Cardiovascular Diseases
Bhuvaneshwar Vaidya, MPharm, PhD, and Suresh P. Vyas, MPharm, PhD
Carbon Nanotubes as Substrates for Neuronal Growth
Cécilia Ménard-Moyon, PhD
Polymeric Nanoparticles for Cancer Therapeutics
Mohit S. Verma, Joshua E. Rosen, Ameena Meerasa, Serge Yoffe, MEng, and Frank X. Gu, PhD
Nanotechnology for Radiation Oncology
Srinivas Sridhar, PhD, Ross Berbeco, PhD, Robert A. Cormack, PhD, and G. M. Makrigiorgos, PhD
Gold Nanoparticles against Cancer
Joan Comenge, PhD, Francisco Romero, PhD, Aurora Conill, MS, and Víctor F. Puntes, PhD
Solid Lipid Nanoparticles and Nanostructured Lipid Carriers for Cancer Therapy
Melike Üner, PhD
Nanomedicines Targeted to Aberrant Cancer Signaling and Epigenetics
Archana Retnakumari, MTech, Parwathy Chandran, MTech, Ranjith Ramachandran, MSc, Giridharan L. Malarvizhi, MTech, Shantikumar Nair, PhD, and Manzoor Koyakutty, PhD
Biodegradable Nanoparticle-Based Antiretroviral Therapy across the Blood-Brain Barrier
Supriya D. Mahajan, PhD, Yun Yu, PhD, Ravikumar Aalinkeel, PhD, Jessica L. Reynolds, PhD, Bindukumar B. Nair, PhD, Manoj J. Mammen, MD, Tracey A. Ignatowski, PhD, Chong Cheng, PhD, and Stanley A. Schwartz, PhD, MD
HIV-Specific Immunotherapy with Synthetic Pathogen-Like Nanoparticles
Orsolya Lorincz, PhD, and Julianna Lisziewicz, PhD
Biomedical Engineering and Nanoneurosurgery: From the Laboratory to the Operating Room
Mario Ganau, MD, PhD, Roberto I. Foroni, PhD, Andrea Soddu, PhD, and Rossano Ambu, MD
Nanotechnology-Based Systems for Microbicide Development
Rute Nunes, Carole Sousa, Bruno Sarmento, PhD, and José das Neves, PhD
Nanotechnology-Based Solutions to Combat the Emerging Threat of Superbugs: Current Scenario and Future Prospects
Nisha C. Kalarickal, PhD, and Yashwant R. Mahajan, PhD
Nanolithography and Biochips’ Role in Viral Detection
Inbal Tsarfati-BarAd and Levi A. Gheber, PhD
Lectins as Nano-Tools in Drug Delivery
Anita Gupta, MSc, PhD, and G. S. Gupta, MSc, PhD
Diagnostics of Ebola Hemorrhagic Fever Virus
Ariel Sobarzo, PhD, Robert S. Marks, PhD, and Leslie Lobel, MD, PhD
Nanomedicine as a Strategy to Fight Thrombotic Diseases
Mariana Varna, PhD, Maya Juenet, MSc, Richard Bayles, PhD, Mikael Mazighi, MD, PhD, Cédric Chauvierre, PhD, and Didier Letourneur, PhD
Volume 2
LAW, BUSINESS, AND COMMERCIALIZATION
An Intellectual Property Primer for Nanomedical Researchers and Engineers
Brian E. Reese, JD, PhD, MBA
Strategic Intellectual Property Management: Building IP Portfolios
Jeffery P. Langer, PhD, JD
Extending Patent Term for Nanomedical Inventions: A Nexus between the FDA and the Patent System
Susanne M. Hopkins, JD, and Ari G. Zytcer, JD
When Patented Technologies Get Put to Experimental Use: Practical Considerations for Nanotech R&D
Victor H. Polk, Jr, JD, and Roman Fayerberg, JD
Bridging Diagnostics Research, Development and Commercialization
Rosanna W. Peeling, PhD
What the Supreme Court’s Myriad Decision Means for Nanotechnology Patents
Andrew 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 Overview
Bruce D. Goldstein, JD, MS
Licensing Issues in Nanotechnology
Joanna T. Brougher, JD, MPh
Commercializing Your Intellectual Property: Steps to Take and Pitfalls to Avoid
Inna Dahlin, PhD, JD, and Michael J. Pomianek, PhD, JD
Overcoming Nanotechnology Commercialisation Challenges: Case Studies of Nanotechnology Ventures
Elicia Maine, PhD
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
Overcoming the Odds: How to Incubate Fledging Bioscience Companies
Patti Breedlove, MS
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, Ph
Nanotechnology Implications for Labor
Noela Invernizzi, PhD, and Guillermo Foladori, PhD
Insurance Market Perception of Nanotechnology and Nanomaterials Risks
Lijana Baublyte, PhD, Martin Mullins, PhD, Finbarr Murphy, PhD, and Syed A.M. Tofail, PhD
REGULATORY ISSUES AND NANOGOVERNANCE
FDA and Nano: Baby Steps, Regulatory Uncertainty and the Bumpy Road Ahead|
Raj Bawa, MS, PhD
EU Regulation of Nanobiotechnology
John Quinn, LLM
Regulating Nanomedicine
Shannon G. Fischer, MS
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
Regulation of Combination Products in the United States
John Barlow Weiner, JD, and Thinh X. Nguyen
Regulation of Combination Products in the European Union
Janine 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 Production
Paul 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 Air
Heinz Fißan, PhD, and Hans-Georg Horn, PhD
Managing Environmental and Health Risks in the Nanotechnology Industry
Joseph Luke Huan, LLB (Hons), MPhil
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
In vitro Risk Assessment of Nanoparticles
Birgit K. Gaiser, Julia Susewind, Nadia Ucciferri, Eva-Maria Collnot, Arti Ahluwalia, and Vicki Stone
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, Lennart Treuel, PhD, and A. Vogt
Cell and Protein Interactions with Diamond
Roger J. Narayan, MD, PhD, R. D. Boehm, BS, and Nancy A. Monteiro-Riviere, PhD
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
Complement Activation: A Capricious Immune Barrier to the Clinical Use of Nanomedicines
János Szebeni, MD, PhD, DSc
Nanotoxicology: Focus on Nanomedicine
Helinor Johnston, PhD, Ali Kermanizadeh, PhD, and Vicki Stone, PhD
Toxicity and Genotoxicity of Metal and Metal Oxide Nanomaterials: A General Introduction
Mercedes Rey, David Sanz, and Sergio E. Moya
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
FUTURE IMPLICATIONS, ETHICS, PERSPECTIVES, AND EDITORIALS
Future Concepts in Nanomedicine
Rob Burgess, PhD
Is Translational Medicine the Future of Therapy?
Christopher-Paul Milne, PhD, and James Mittra, PhD
Nanomedical Cognitive Enhancement: Challenges and Future Possibilities
Melanie Swan, MBA
Nanomedicine: Ethical Considerations
Todd Kuiken, PhD
Clinical Nanobioethical Problems: A Value Approach
Jorge Alberto Álvarez-Díaz, MD, PhD
Nanomedicine: Shadow and Substance
Z. Shadi Farhangrazi, PhD, and S. Moein Moghimi, PhD
The Tower of Babel: Miscommunication within and about Nanomedicine
Rudolph 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 Memoriae
David M. Berube, PhD
A Sample of Religious Thought on Nanotechnology
Chris 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 Nanotechnology
Annette I. Kahler, JD
Nanomedicine and the Fight against HIV/AIDS: Expert Perspectives
André Nel, MBChB, PhD, Susan Swindells, MD, Tatiana Bronich, PhD, and Howard E. Gendelman, MD
Interdisciplinary Nanomedicine Publications through Interdisciplinary Peer-Review
Andrew 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 Methods
Marianna Foldvari, PhD, DPharmSci
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