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.
Table of Contents
Volume 1. Section I – Introduction and Beginnings. Section II – Nanoparticles, Nanodevices and Imaging. Section III – Clinical Applications of Nanotherapeutics. Volume 2. Section I – Law, Business and Commercialization. Section II – Regulatory Issues and Nanogovernance. Section III – Health, Safety, Risk and Biological Interactions. Section IV – Future Implications, Ethics and Perspectives.
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. 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 a 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.
Brian E. Reese, PhD, JD, MBA, is an associate at the law firm of Choate, Hall, and Stewart in Boston, Massachusetts since 2012. Dr. Reese has extensive experience in intellectual property law, particularly patenting and trademark issues in the life sciences, and brings a practical knowledge of business strategy to his practice. As a former stock analyst, Dr. Reese has a strong appreciation for the business realities his clients face and how intellectual property can help them achieve their objectives. Dr. Reese graduated with a BS in cellular biochemistry from the State University of New York at Plattsburgh, where he received the Chancellor’s Award for academic excellence. He subsequently obtained his PhD from Pennsylvania State University for his research in the areas of neuroscience, molecular biology and toxicology. He also completed his MBA at Pennsylvania State University. Dr. Reese attended Albany Law School in Albany, NY, where he graduated magna cum laude. As a trained neuroscientist, Dr. Reese has authored several scientific and legal research papers in peer- reviewed journals. Each year, he moderates the American Bar Association’s panel on science and technology law at the Current Issues in Medicine and Pharma conference held at Rensselaer Polytechnic Institute in Troy, NY. Dr. Reese is active in providing pro bono services in intellectual property for several entities in the Boston area and currently serves as co-chair of the Nanotech Committee of the American Bar Association.
Reviews for Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications (Volume 1)
"Dr. Bawa and his team have meticulously gathered the distilled experience of world-class researchers, clinicians and business leaders addressing the most salient issues confronted in product concept development and translation. Knowledge is power, particularly in nanomedicine translation, and this handbook is an essential guide that illustrates and clarifies our way to commercial success."
—Gregory Lanza, MD, PhD, Professor of Medicine and Oliver M. Langenberg Distinguished Professor, Washington University Medical School, USA
"This is an outstanding, comprehensive volume that crosscuts disciplines and topics fitting individuals from a variety of fields looking to become knowledgeable in medical nanotech research and its translation from the bench to the bedside."
—Shaker A. Mousa, PhD, MBA, Vice Provost and Professor of Pharmacology, Albany College of Pharmacy and Health Sciences, USA
"Masterful! This handbook will have a welcome place in the hands of students, educators, clinicians and experienced scientists alike. In a rapidly evolving arena, the authors have harnessed the field and its future by highlighting both current and future needs in diagnosis and therapies. Bravo!"
—Howard E. Gendelman, MD, Margaret R. Larson Professor and Chair, University of Nebraska Medical Center, USA
"It is refreshing to see a handbook that does not merely focus on preclinical aspects or exaggerated projections of nanomedicine. Unlike other books, this handbook not only highlights current advances in diagnostics and therapies but also addresses critical issues like terminology, regulatory aspects and personalized medicine."
—Gert Storm, PhD, Professor of Pharmaceutics, Utrecht University, The Netherlands
Reviews for Handbook of Clinical Nanomedicine: Law, Business, Regulation, Safety, and Risk (Volume 2)
"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, Peter J. Liacouras Professor of Law and Associate Dean, 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, Vice Provost and Professor of Pharmacology, 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, Professor of Medicine and Oliver M. Langenberg Distinguished Professor, 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, Chief Patent Officer, 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, Professor Emeritus of Biochemistry and Daniel Miller Professor of Cancer Research, Hebrew University-Hadassah Medical School, Israel