Handbook of Clinical Nanomedicine, Two-Volume Set

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 PerspectiveChin Wee Shong, PhD, Sow Chorng Haur, PhD, and Andrew T. S. Wee, PhDNanomedicine: Dynamic Integration of Nanotechnology with Biomedical ScienceKi-Bum Lee, PhD, Aniruddh Solanki, PhD, John Dongun Kim, PhD, and Jongjin Jung, PhDA Small Introduction to the World of NanomedicineRutledge Ellis-Behnke, PhDTop Ten Recent Nanomedical Research AdvancesMelanie Swan, MBAThe Coming Era of NanomedicineFritz Allhoff, JD, PhDWhat’s in a Name? Defining "Nano" in the Context of Drug DeliveryRaj Bawa, MS, PhD NANOPARTICLES, NANODEVICES, AND IMAGINGProperties of Nanoparticulate MaterialsTakuya Tsuzuki, PhDSolid Drug Nanoparticles: Methods for Production and Pharmacokinetic BenefitsAndrew Owen, PhD, and Steve P. Rannard, DPhilDesign and Development of Approved Nanopharmaceutical ProductsHeidi M. Mansour, PhD, RPh, Chun-Woong Park, PhD, and Raj Bawa, MS, PhDNanosizing Approaches in Drug DeliverySandip Chavhan, PhD, Kailash Petkar, PhD, and Krutika Sawant, PhDMultilayered Nanoparticles for Personalized Medicine: Translation into Clinical MarketsDania Movia, PhD, Craig Poland, PhD, Lang Tran, PhD, Yuri Volkov, PhD, and Adriele Prina-Mello, PhDNanomaterials for Pharmaceutical ApplicationsBrigitta Loretz, PhD, Ratnesh Jain, PhD, Prajakta Dandekar, PhD, Carolin Thiele, PhD, Yamada Hiroe, PhD, Babak Mostaghaci, PhD, Lian Qiong, MSc, and Claus-Michael Lehr, PhDPolysaccharides as Nanomaterials for TherapeuticsShoshy Mizrahy, MSc, and Dan Peer, PhDThe Story of C60 BuckminsterfullereneHarold W. Kroto, PhDApplications of Nanoparticles in Medical ImagingJason L. J. Dearling, PhD, and Alan B. Packard, PhDNanoimaging for NanomedicineYuri L. Lyubchenko, PhD, DSc, Yuliang Zhang, Alexey V. Krasnoslobodtsev, PhD, and Jean-Christophe Rochet, PhDNanoparticles for Multi-Modality Diagnostic Imaging and Drug DeliveryCatherine M. Lockhart, PharmD, and Rodney J. Y. Ho, PhDMagnetic Nanoparticles for Magnetic Resonance Imaging: A Translational Push toward TheranosticsRyan A. Ortega, Thomas E. Yankeelov, PhD, and Todd D. Giorgio, PhDFirst-in-Human Molecular Targeting and Cancer Imaging Using Ultrasmall Dual-Modality C DotsMichelle S. Bradbury, MD, PhD, and Ulrich Wiesner, PhDAtomic Force Microscopy for NanomedicineShivani Sharma, PhD, and James K. Gimzewski, PhDAtomic Force Microscopy Imaging and Probing of Amyloid NanoaggregatesYuri L. Lyubchenko, PhD, DSc, and Luda S. Shlyakhtenko, PhDImage-Based High-Content Analysis, Stem Cells and Nanomedicines: A Novel Strategy for Drug DiscoveryLeonardo J. Solmesky, PhD, Yonatan Adalist, MSc, and Miguel Weil, PhDViral Nanoparticles: Tools for Materials Science and BiomedicineNicole F. Steinmetz, PhD, and Marianne Manchester, PhDBacterial Secretion Systems: Nanomachines for Infection and Genetic DiversityAgnesa Shala, PhD, Michele Ferraro, MSc, and Gerald F. Audette, PhDThe Vascular Cartographic Scanning NanodeviceFrank J. BoehmAdvancements in Ophthalmic Glucose Nanosensors for Diabetes ManagementAngelika Domschke, PhDTHERAPY AND CLINICAL APPLICATIONSTowards Nanodiagnostics for Bacterial InfectionsGeorgette B. Salieb-Beugelaar, PhD, and Patrick R. Hunziker, MDCopaxone® in the Era of Biosimilars and NanosimilarsJill B. Conner, MS, PhD, Raj Bawa, MS, PhD, J. Michael Nicholas, PhD, and Vera Weinstein, PhDDoxil®: The First FDA-Approved Nanodrug—From an Idea to a Product (January 2015 Update)Yechezkel Barenholz, PhDNanotechnology and the Skin Barrier: Topical and Transdermal Nanocarrier-Based DeliveryHagar I. Labouta, PhD, and Marc Schneider, PhDApplication of Nanotechnology in Non-Invasive Topical Gene TherapyMahmoud Elsabahy, PhD, Maria Jimena Loureiro, MSc, and Marianna Foldvari, PhD, DPharmSciNanocarriers in the Therapy of Inflammatory DiseaseAlf Lamprecht, PhDAdvanced 3D Nano/Microfabrication Techniques for Tissue and Organ RegenerationBenjamin Holmes, MSc, Thomas J. Webster, PhD, and Lijie Grace Zhang, PhDNanomedicine for Acute Lung Injury/Acute Respiratory Distress Syndrome: A Shifting Paradigm?Ruxana T. Sadikot, MD, and Israel Rubinstein, MDNanoviricides: Targeted Anti-Viral NanomaterialsRandall W. Barton, PhD, Jayant G. Tatake, PhD, and Anil R. Diwan, PhDNanotechnology in Tissue Engineering for OrthopaedicsLesley M. Hamming, PhD, JD, and Mark G. Hamming, MDApplications of Nanomaterials in DentistryKarolina Jurczyk, DDS, PhD, and Mieczyslaw Jurczyk, PhD, DScBiomimetic Applications in Regenerative Medicine: Scaffolds, Transplantation Modules, Tissue Homing Devices, and Stem CellsDavid W. Green, PhD, and Besim Ben-Nissan, PhDPotential Applications of Nanotechnology in the Nutraceutical SectorShu Wang, MD, PhD, and Jia Zhang, MSDesigning Nanocarriers for the Effective Treatment of Cardiovascular DiseasesBhuvaneshwar Vaidya, MPharm, PhD, and Suresh P. Vyas, MPharm, PhDCarbon Nanotubes as Substrates for Neuronal GrowthCécilia Ménard-Moyon, PhDPolymeric Nanoparticles for Cancer TherapeuticsMohit S. Verma, Joshua E. Rosen, Ameena Meerasa, Serge Yoffe, MEng, and Frank X. Gu, PhDNanotechnology for Radiation OncologySrinivas Sridhar, PhD, Ross Berbeco, PhD, Robert A. Cormack, PhD, and G. M. Makrigiorgos, PhDGold Nanoparticles against CancerJoan Comenge, PhD, Francisco Romero, PhD, Aurora Conill, MS, and Víctor F. Puntes, PhDSolid Lipid Nanoparticles and Nanostructured Lipid Carriers for Cancer TherapyMelike Üner, PhDNanomedicines Targeted to Aberrant Cancer Signaling and EpigeneticsArchana Retnakumari, MTech, Parwathy Chandran, MTech, Ranjith Ramachandran, MSc, Giridharan L. Malarvizhi, MTech, Shantikumar Nair, PhD, and Manzoor Koyakutty, PhDBiodegradable Nanoparticle-Based Antiretroviral Therapy across the Blood-Brain BarrierSupriya 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, MDHIV-Specific Immunotherapy with Synthetic Pathogen-Like NanoparticlesOrsolya Lorincz, PhD, and Julianna Lisziewicz, PhDBiomedical Engineering and Nanoneurosurgery: From the Laboratory to the Operating RoomMario Ganau, MD, PhD, Roberto I. Foroni, PhD, Andrea Soddu, PhD, and Rossano Ambu, MDNanotechnology-Based Systems for Microbicide DevelopmentRute Nunes, Carole Sousa, Bruno Sarmento, PhD, and José das Neves, PhDNanotechnology-Based Solutions to Combat the Emerging Threat of Superbugs: Current Scenario and Future ProspectsNisha C. Kalarickal, PhD, and Yashwant R. Mahajan, PhDNanolithography and Biochips’ Role in Viral DetectionInbal Tsarfati-BarAd and Levi A. Gheber, PhDLectins as Nano-Tools in Drug DeliveryAnita Gupta, MSc, PhD, and G. S. Gupta, MSc, PhDDiagnostics of Ebola Hemorrhagic Fever VirusAriel Sobarzo, PhD, Robert S. Marks, PhD, and Leslie Lobel, MD, PhDNanomedicine as a Strategy to Fight Thrombotic DiseasesMariana Varna, PhD, Maya Juenet, MSc, Richard Bayles, PhD, Mikael Mazighi, MD, PhD, Cédric Chauvierre, PhD, and Didier Letourneur, PhD Volume 2 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 Pr

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. Israel Rubinstein, MD, is professor of medicine at the College of Medicine, University of Illinois at Chicago, USA. He is member of the section of pulmonary, critical care, allergy and sleep medicine in the Department of Medicine, University of Illinois at Chicago. He is an attending physician at the University of Illinois Hospital and Health Sciences System and Jesse Brown VA Medical Center in Chicago. Dr. Rubinstein is also the associate chief of staff for research and development at the Jesse Brown Veterans Administration Medical Center. Prior to his appointment at the University of Illinois at Chicago, he was associate professor of medicine at the University of Nebraska Medical Center in Omaha, Nebraska, USA. Dr. Rubinstein received his medical degree from the Hebrew University-Hadassah School of Medicine in Jerusalem, Israel. He was a medical resident in Israel, fellow in respirology at the University of Toronto and a research fellow at the Cardiovascular Research Institute, University of California at San Francisco. Dr. Rubi