Handbook of Clinical Nanomedicine, Two-Volume Set

Edited by Raj Bawa, Gerald F. Audette, Israel Rubinstein

© 2014 – Pan Stanford

800 pages

Purchasing Options:
Hardback: 9789814316170
pub: 2015-08-30
Available for pre-order
US Dollars$849.95
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About the Book

The enormous advances in nanomedicine in the past decade have necessitated a growing need for an authoritative and comprehensive reference source that can be relied upon by scientists, clinicians, students, and industry and policy makers alike. The Handbook of Clinical Nanomedicine: From Bench to Bedside is designed to offer a global perspective on the wonders of nanomedicine.

The handbook aims to provide a broad survey of various interconnected topics pertaining to nanomedicine. It is intended to be a stand-alone, easily accessible volume that examines the entire "product wheel" from creation of nanomedical products to final market introduction, all accomplished in a user-friendly format. Specifically, everything from bio-nanomaterials and nanodevices from the R&D stage to patent protection, clinical regulatory aspects, and eventual commercialization is encompassed in this book. In addition to highlighting cutting-edge technologies, the book addresses critical topics such as ethics, safety and toxicity, environmental health, nanoeconomics, business strategy, licensing, intellectual property, FDA law, EPA law, and governmental policy issues. With contributions from international experts, the diverse team of editors has compiled a book that provides a unified perspective to these varied topics. While many books focus on nanomedicine, nanotechnology, or nanoscience, none provide the medical applications of nanotechnology with both a clinical and business angle. Furthermore, most of the currently available books on the market fail to highlight the truly global nature of nanomedicine.

Table of Contents

Volume 1

Section I – Introduction and Beginnings

Science at the nanoscale: introduction and historical perspective; Shong, Haur, and Wee

Nanomedicine: dynamic integration of nanotechnology with biomedical science; Lee, Solanki, Kim, and Jung

A small introduction to the world of nanomedicine; Ellis-Behnke

Top ten recent nanomedical advances; Swan

The coming era of nanomedicine; Allhoff

What’s in a name? Defining "nano" in the context of drug delivery; Bawa

Section II – Nanoparticles, Nanodevices and Imaging

Properties of nanoparticulate materials; Tsuzuki

Solid drug nanoparticles: methods for production and pharmacokinetic benefits; Owen and Rannard

Design and development of approved nanopharmaceutical products; Mansour, Park, and Bawa

Nanonsizing approaches in drug delivery; Chavhan, Petkar, and Sawant

Multilayered nanoparticles for personalized medicine: translation into clinical markets; Movia, Poland, Tran, Volkov, and Prina-Mello

Nanomaterials for pharmaceutical applications; Loretz, Jain, Dandekar, Thiele, Hiroe, Mostaghaci, Lian, and Lehr

Polysaccharides as nanomaterials for therapeutics; Mizrahy and Peer

Lipid-like delivery materials for efficient siRNA delivery; Dahlman, Langer, and Goldberg

Applications of nanoparticles in medical imaging; Dearling and Packard

Nanoimaging for nanomedicine; Lyubchenko, Zhang, Krasnoslobodtsev, and Rochet

Nanoparticles for multi-modality diagnostic imaging and drug delivery; Lockhart and Ho

Magnetic nanoparticles in magnetic resonance imaging: a translational push toward theranostics; Ortega, Yankeelov, and Giorgio

First-in-human molecular targeting and cancer imaging using ultrasmall dual-modality C-dots; Bradbury and Wiesner

Atomic Force Microscopy for nanomedicine; Sharma and Gimzewski

Atomic Force Microscopy imaging and probing of amyloid nanoaggregates; Lyubchenko and Shlyakhtenko

Image-based high-content analysis, stem cells and nanomedicines: a novel strategy for drug discovery; Solomesky, Adalist, and Weil

Viral nanoparticles: tools for materials science and biomedicine; Steinmetz and Manchester

Bacterial secretion systems: nanomachines for infection and genetic diversity; Shala, Ferarro, and Audette

The vascular cartographic scanning nanodevice; Boehm

Advancements in ophthalmic glucose nanosensors for diabetes management; Domschke

Section III – Clinical Applications of Nanotherapeutics

Nanoscale therapeutics: introductory overview of key issues; Bawa, Szebeni, Bawa, and Mehra

Copaxone® in the era of biosimilars and nanosimilars; Conner, Bawa, Nicholas, and Weinstein

Doxil®: the first FDA-approved nano-drug; Barenholz

Nanotechnology and the skin barrier: topical and transdermal nanocarrier-based delivery; Labouta and Schneider

Application of nanotechnology in non-invasive topical gene therapy; Elsabahy, Jimena Loureiro, and Foldvari

Nanocarriers in the therapy of inflammatory disease; Lamprecht

Nanoparticles for targeting T cells in allergy and inflammatory airway conditions; Bear, Carpin, Cruz, Drezek, and Fostera

Nanomedicine for acute lung injury/acute respiratory distress syndrome: a shifting paradigm?; Sadikot and Rubinstein

Nanoviricides: targeted anti-viral nanomaterials; Barton, Tatake, and Diwan

Nanotechnology in tissue engineering for orthopaedics; Hamming and Hamming

Applications of nanomaterials in dentistry; Jurczyk and Jurczyk

Biomimetic applications in regenerative medicine: scaffolds, transplantation modules, tissue homing devices, and stem cells; Green and Ben-Nissan

Potential applications of nanotechnology in the nutraceutical sector; Wang and Zhang

Designing nanocarriers for the effective treatment of cardiovascular diseases; Vaidya and Vyas

Carbon nanotubes as substrates for neuronal growth; Ménard-Moyon

Polymeric nanoparticles for cancer therapeutics; Verma, Rosen, Meerasa, Yoffe, and Gu

Nanotechnology for radiation oncology; Sridhar, Berbeco, Cormack, and Makrigiorgos

Gold against cancer; Comenge, Romero, Conill, and Puntes

Solid lipid nanoparticles and nanostructured lipid carriers for cancer therapy; Uner

Nanomedicine targeted to aberrant cancer signalling and epigenetics; Ratnakumari, Chandran, Malarvizhi, Nair, and Koyakutty

Biodegradable nanoparticle-based antiretroviral therapy across the blood brain barrier; Mahajan, Yu, Aalinkeel, Reynolds, Nair, Mammen, Ignatowski, Cheng, and Schwartz

HIV-specific immunotherapy with synthetic pathogen-like nanoparticles; Lorincz and Lisziewicz

Nanotechnology toward advancing personalized medicine; Sakamoto, Godin, Hu, Blanco, van de Ven, Vellaichamy, Murphy, Francesca, Schuenemeyer, Given, Meyn, and Ferrari

Nanotechnology-based systems for microbicide development; Nunes, Sousa, Sarmento, and das Neves

Nanotechnology based solutions to combat the emerging threat of superbugs: current scenario and future prospects; Kalarickal and Mahajan

Nanolithography and biochips’ role in viral detection; Tsarfati-BarAd and Gheber

Volume 2

Section I – Law, Business and Commercialization

An intellectual property primer for nanomedical researchers and engineers; Reese

Strategic intellectual property management: building IP portfolios; Langer

Extending patent term for nanomedical inventions: a nexus between the FDA and the patent system; Hopkins and Zytcer

When patented technologies get put to experimental use: practical considerations for nanotech R&D; Polk and Fayerberg

Critical legal and business strategies for resolving patent disputes over nanoscale drug delivery systems; Harris, Hermann, Bawa, Clevland, and O'Neil

What the Supreme Court’s Myriad decision means for nanotechnology patents; Baluch, Maebius, and Wegner

Managing the expense of patent litigation in nanotechnology; Vare

Technology transfer: an overview; Goldstein

Licensing issues in nanotechnology; Brougher

Commercializing your intellectual property: steps to take and pitfalls to avoid; Dahlin and Pomianek

Overcoming nanotechnology commercialisation challenges: case studies of nanotechnology ventures; Maine

The commercialisation of nanotechnology: the five critical success factors to a nanotech-enabled whole product; Belcher, Marshall, Edwards, and Martina

Overcoming the odds: how to incubate fledging bioscience companies; Breedlove

Market opportunity for molecular diagnostics in personalized cancer therapy; Piros, Petak, Erdos, Hautman, and Lisziewicz

Nanotechnology implications for labor; Invernizzi and Foladori

Insurance market perception of nanotechnology and nanomaterials risks; Baublyte, Mullins, Murphy, and Tofail

Section II – Regulatory Issues and Nanogovernance

FDA and nanotech: baby steps lead to regulatory uncertainty; Bawa

EU regulation of nanobiotechnology; Quinn

Regulating nanomedicine; Fischer

Nanomedicines: addressing the scientific and regulatory gap; Tinkle, McNeil, Muhlebach, Bawa, Borchard, Barenholz, Tamarkin, and Desai

Regulation of combination products in the United States; Weiner and Nguyen

Regulation of combination products in the European Union; Jamieson and Baker

Brief overview of current developments in nanotechnology EHS regulation in the U.S; Voorhees

EPA targets nanotechnology: hi-ho, nanosilver, away?; Wallace and Schenck

Graphene: regulatory considerations for the "wonder material"; Kaplan and Woloschyn

The enduring embrace: the regulatory ancien régime and governance of nanomaterials in the U.S.; Bosso

Section III – Health, Safety, Risk and Biological Interactions

Safety of engineered nanomaterials and occupational health and safety issues for commercial-scale production; Wright and Jackson

Engineered nanoparticle release, exposure pathway and dose, measures and measuring techniques for nanoparticle exposure in air; Fissan and Horn

Managing environmental and health risks in the nanotechnology industry; Huan

Risk perception and risk communication on the issue of nanotechnology; Böl, Carreira, Epp, Häffner, and Lohmann

In vitro risk assessment of nanoparticles; Gaiser, Susewind, Ucciferri, Collnot, Ahluwalia, and Stone

Biological responses to nanoparticles; Zellner, Blechinger, Bräuchle, Hilger, Janshoff, Lademann, Mailänder, Meinke, Nienhaus, Patzelt, Rancan, Rothen-Rutishauser, Stauber, Torrano, Treuel, and Vogt

Cell and protein interactions with small-scale diamond materials; Narayan, Boehm, and Monteiro-Riviere

Intracellular transport and unpacking of polyplex nanoparticles; Rosenkranz, Khramtsov, Ulasov, Rodichenko, and Sobolev

Complement activation: a capricious immune barrier to nanomedicine clinical application; Szebeni

Nanotoxicology: Focus on nanomedicine; Johnston, Kermanizadeh, and Stone

Toxicity and genotoxicity of metal and metal oxide nanomaterials: a general introduction; Rey, Sanz, and Moya

Toxicity of silicon dioxide nanoparticles in mammalian neural cells; Lai, Jaiswal, Lai, Jandhyam, Leung, and Bhushan

Section IV – Future Implications, Ethics and Perspectives

Future concepts in nanomedicine; Burgess

Is translational medicine the future of therapy?; Milne and Mittra

Nanomedical cognitive enhancement: challenges and future possibilities; Swan

Nanomedicine: Ethical considerations; Kuiken

Clinical nanobioethical problems: a value approach; Álvarez-Díaz

Nanomedicine: shadow and substance; Farhangrazi and Moghimi

The Tower of Babel: miscommunication within and about nanomedicine; Juliano

Is nanotechnology toxic? Was Prince Charles correct?; Favi and Webster

The audience is the message: nanomedicine as apotheosis or damnatio memoriae; Berube

A Sample of Religious Thought on Nanotechnology; Toumey

About the Editors

Raj Bawa, MS., PhD, is president of Bawa Biotech LLC, a biotech/pharma consultancy and patent law firm he founded in 2002 and is currently based in Ashburn, VA (USA). He is an inventor, entrepreneur, professor, and registered patent agent licensed to practice before the U.S. Patent & Trademark Office. Trained as a biochemist and microbiologist, he has been an active researcher for the past two decades. He has extensive expertise in pharmaceutical sciences, biotechnology, nanomedicine, drug delivery, and biodefense-related scientific, FDA regulatory, and patent law issues. He has served as an advisor, consultant, or expert to numerous global corporations, US government (NIH, NSF), law firms, universities, nonprofits, and NGOs. Since 1999, he has held faculty appointments at Rensselaer Polytechnic Institute (Troy, NY) where he is currently an adjunct professor of biological sciences. Since 2004, he has been an adjunct associate professor of natural and applied sciences at NVCC (Annandale, VA). Since 2012, he has been a scientific advisor to Teva Pharmaceutical Industries, Ltd. (Israel). He previously served as patent legal advisor at Sequoia Pharmaceuticals (Gaithersburg, MD) and as senior scientist at SynerGene Therapeutics, Inc. (Potomac, MD). He recently served as principle investigator for two US National Cancer Institute/SBIR contracts titled "Targeted nanocomplexed iron oxide for early detection with concurrent hyperthermia treatment of cancer" and "A targeted nanocomplex for early detection of lung cancer. In the 1990s, Dr. Bawa held various positions at the US Patent & Trademark Office, including primary examiner (6 years) and instructor at the US Patent Academy. He is a life member of Sigma Xi, founding director of the American Society for Nanomedicine, and co-chair of the Nanotech Committee of the American Bar Association. He has authored over 100 publications, co-edited two books, and presented or chaired at over 200 conferences worldwide. He serves on the editorial boards of 16 peer-reviewed journals, including Pharmaceutical Patent Analyst, International Journal of Nanomedicine, Cancer Nanotechnology, Applied Scientific Reports, Recent Patents on Biomedical Engineering, Nanotechnology Law and Business, Recent Patents on Nanotechnology, Journal of Epidemiology and Preventive Medicine, WIRE’s Nanomedicine and Nanobiotechnology, JSM Biotechnology & Biomedical Engineering, Nanomedicine: NBM. Some of Dr. Bawa’s awards include the Innovations Prize from the Institution of Mechanical Engineers, London, UK (2008); Appreciation Award from the US Undersecretary of Commerce, Washington, DC (2001); a Research Fellowship from Rensselaer (1989–1990); the Key Award from Rensselaer’s Office of Alumni Relations (2005); and 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) in the Department of Chemistry since 2006. Currently he is an associate professor in the department, and is a member of the Centre for Research on Biomolecular Interactions at York University. He received his doctorate in the Department of Biochemistry at the University of Saskatchewan in Saskatoon, Canada in 2002. 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 the 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 the 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).

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, department of medicine, University of Illinois at Chicago, and attending physician at the University of Illinois Hospital & Health Sciences System and Jesse Brown VA Medical Center in Chicago. Dr. Rubinstein is the associate chief of staff for research and development at the Jesse Brown VA 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. Rubinstein holds 18 issued and pending patents and has authored close to 200 peer-reviewed papers in scientific journals. Dr. Rubinstein’s funded research endeavors center around nanomedicine and targeted drug delivery with specific focus on lipid-based products and repurposing. Currently, he serves as editor-in-chief of Nanotechnology, Science and Applications; associate editor of the International Journal of Nanomedicine and editorial board member of several scientific journals. Dr. Rubinstein is member of the scientific advisory board of the International Academy of Cardiology. He is a fellow of the American Heart Association as well as the American College of Physicians and the American College of Chest Physicians. In addition, he is member of the American Thoracic Society, American Physiological Society, American Society for Pharmacology and Experimental Therapeutics, and American Microbiology Society. Dr. Rubinstein is a board member and director of Advanced Life Sciences, a publicly traded biopharmaceutical company based in Woodridge, Illinois (USA). He is a co-founder of ResQ Pharma, an emerging clinical stage pharmaceutical company focusing on repurposing FDA-approved drugs for cardiopulmonary resuscitation and drug overdoses.

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
SCI010000
SCIENCE / Biotechnology
TEC021000
TECHNOLOGY & ENGINEERING / Material Science