Handbook of Clinical Nanomedicine, Two-Volume Set (Hardback) book cover

Handbook of Clinical Nanomedicine, Two-Volume Set

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

© 2014 – Pan Stanford

3,210 pages | 296 Color Illus. | 109 B/W Illus.

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pub: 2016-05-12
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About the Book

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 handbookin 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 handbookswill 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.

Reviews

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

Table of Contents

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

Recent Developments in Ocular Nanotherapy: An Editorial

Kislay Roy, PhD, and Jagat R. Kanwar, MSc, PhD

The Promise of Nanoneuromedicine: An Editorial

Howard E. Gendelman, MD, R. Lee Mosley, PhD, Michael D. Boska, PhD, and JoEllyn McMillan, PhD

Principles of Nanoethics: Theoretical Models and Clinical Practice

Mario Ganau, MD, PhD, Lara Prisco, MD, Nikolaos Syrmos, MD, and Laura Ganau

The Tree and the Forest: A Need for Dialogue and a Collaborative Approach in the Safety of Nanomedicines Collaborative Approach in the Safety of Nanomedicines

Hassan A. N. El-Fawal, MSc, PhD

The Translational Challenge in Medicine at the Nanoscale

Raj Bawa, MS, PhD, S. R. Bawa, MSc, PhD, and Ratnesh N. Mehra, DO

Nanotechnology toward Advancing Personalized Medicine

Jason H. Sakamoto, PhD, Biana Godin, PhD, Ye Hu, PhD, Elvin Blanco, PhD, Anne L. van de Ven, PhD, Adaikkalam Vellaichamy, PhD, Matthew B. Murphy, PhD, Saverio La Francesca, MD, Terry Schuenemeyer, RN, MS, Bruce Given, MD, Anne Meyn, and Mauro Ferrari, PhD

Science, Business, and Impact of Nanomedicine: Final Thoughts

Michael Hehenberger, PhD, DrSc

About the Editors

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.

About the Series

Pan Stanford Series on Nanomedicine

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Subject Categories

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