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

1472 Pages·2016·34.411 MB·English
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Handbook of Clinical Nanomedicine Vol. 2 Pan Stanford Series on Nanomedicine Series Editor Raj Bawa Titles in the Series Published Forthcoming Vol. 1 Vol. 3 Handbook of Clinical Immune Effects of Nanomedicine: Nanoparticles, Biopharmaceuticals and Imaging, Therapy, and Clinical Nanomedicines Applications Raj Bawa, János Szebeni, Raj Bawa, Gerald F. Audette, and Thomas J. Webster, and Israel Rubinstein, eds. Gerald F. Audette, eds. 2016 2017 978-981-4669-20-7 (Hardcover) 978-981-4669-21-4 (eBook) Vol. 4 Impact of Nanobiotechnology Vol. 2 on the Future of Medicine and Handbook of Clinical Personalized Medicine Nanomedicine: Law, Business, Shaker A. Mousa and Regulation, Safety, and Risk Raj Bawa, eds. Raj Bawa, ed., Gerald F. Audette 2017 and Brian E. Reese, asst. eds. 2016 978-981-4669-22-1 (Hardcover) 978-981-4669-23-8 (eBook) (cid:49)(cid:66)(cid:79)(cid:1)(cid:52)(cid:85)(cid:66)(cid:79)(cid:71)(cid:80)(cid:83)(cid:69)(cid:1)(cid:52)(cid:70)(cid:83)(cid:74)(cid:70)(cid:84)(cid:1)(cid:80)(cid:79)(cid:1)(cid:51)(cid:70)(cid:79)(cid:70)(cid:88)(cid:66)(cid:67)(cid:77)(cid:70)(cid:1)(cid:38)(cid:79)(cid:70)(cid:83)(cid:72)(cid:90)(cid:1)(cid:137)(cid:1)(cid:55)(cid:80)(cid:77)(cid:86)(cid:78)(cid:70)(cid:1)(cid:19) Pan Stanford Series on Nanomedicine Vol. 2 Handbook of Clinical Nanomedicine Law, Business, Regulation, Safety, and Risk Editor Raj Bawa, MS, PhD Patent Agent, Bawa Biotech LLC, Ashburn, Virginia, USA Adjunct Professor, Department of Biological Sciences editors Rensselaer Polytechnic Institute, Troy, New York, USA Preben Maegaard Scientific Advisor, Teva Pharmaceutical Industries, Ltd., Israel Anna Krenz WAsoslifsgtaanntg EPdaitlzors Gerald F. Audette, PhD Associate Professor, Department of Chemistry Acting Director, Centre for Research on Biomolecular Interactions The Rise of Modern Wind Energy York University, Toronto, Canada WBrian Ei. Rneesed, Ph D,P JD, oMBAwer Patent Attorney and Associate Choate, Hall & Stewart LLP Boston, Massachusetts, USA for the World CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2016 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20160419 International Standard Book Number-13: 978-981-4669-23-8 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. Reason- able efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www. copyright.com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organiza- tion that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com This book is dedicated to my wife and parents for their love and support, my students for their inspiration, and my colleagues for their ethical professionalism. This book is dedicated to my family for their— unRfalaj gBgaiwnga support, and to my students who continually inspire me with their curiosity. This book is dedicated to my wife and b—abGye braolyd f oF.r A muadkeitntge my life rich, to my parents for their unending support, and to the nanotech innovators who strive to make the world a better place. —Brian E. Reese TThhiiss ppaaggee iinntteennttiioonnaallllyy lleefftt bbllaannkk About the Editor and Assistant Editors The Editor 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 Nanomedicine on the editorial boards of numerous peer-reviewed journals, Journal of Interdisciplinary including serving as a special associate editor of Nanomedicine (Elsevier) and an editor-in-chief of the (Wiley). Some of Dr. Bawa’s awards include the Innovations Prize from the Institution of Mechanical Engineers, viii About the Editor and Assistant Editors London, UK (2008), the Key Award from Rensselaer’s Office of Alumni Relations (2005) and the Lifetime Achievement Award fTrhome tAhses Aismtearnicta nE dSoitcoiertsy 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 Escherichia coli studied the process of bacterial conjugation (or lateral gene transfer) using the F-plasmid conjugative system of . 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 Journal of Bionanoscience bionanotechnology. Dr. Audette has previously served as co-editor- in-chief of the (2007–2010), and is FACETS currently a subject editor of structural chemistry and crystallography for the journal .

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