The Experts below are selected from a list of 14250 Experts worldwide ranked by ideXlab platform
Susan M. Wolf - One of the best experts on this subject based on the ideXlab platform.
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recommendations for oversight of Nanobiotechnology dynamic oversight for complex and convergent technology
Journal of Nanoparticle Research, 2011Co-Authors: Gurumurthy Ramachandran, Jennifer Kuzma, Efrosini Kokkoli, Jordan Paradise, Susan M. Wolf, J Ralph D Hall, J Leili D FatehiAbstract:Federal oversight of Nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between “soft” and “hard” approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of Nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to Nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government.
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Recommendations for oversight of Nanobiotechnology: Dynamic oversight for complex and convergent technology
Journal of Nanoparticle Research, 2011Co-Authors: Gurumurthy Ramachandran, Jennifer Kuzma, Efrosini Kokkoli, Jordan Paradise, Susan M. Wolf, Ralph Hall, Leili FatehiAbstract:Federal oversight of Nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this "stay-the- course" approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between "soft" and "hard" approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of Nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to Nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government. © 2011 Springer Science+Business Media B.V.
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gene therapy oversight lessons for Nanobiotechnology
Journal of Law Medicine & Ethics, 2009Co-Authors: Susan M. Wolf, Rishi Gupta, Peter KohlheppAbstract:Oversight of emerging technology such as Nanobiotechnology raises complex issues at the intersection of institutional design, regulatory theory, and science. Too little of the literature offering recommendations for oversight takes advantage of the rich history of U.S. oversight design efforts in order to harvest the lessons for prospective design. This article systematically analyzes the history of oversight for human gene transfer research (“gene therapy”) to learn the lessons for design of Nanobiotechnology oversight. The human gene therapy oversight experience presents an important model of oversight for science and technology in the research phase with substantial attendant uncertainties. Much of Nanobiotechnology that has application to human health is in research trials or will be in the foreseeable future. The uncertainties about the behavior and toxicity of many materials engineered at the nanoscale (usually defined as 1-100 nanometers) are great, especially more complex and interactive materials (often called “active” as opposed to “passive” nanomaterials). In addition to these similarities between the oversight challenges posed by gene therapy and Nanobiotechnology, gene therapy oversight is already beginning to address nanobio directly, through review of protocols using non-viral nano-vectors to deliver DNA or RNA within the human body. The design of gene therapy oversight, which grew out of oversight for recombinant DNA (rDNA) research in the mid-1980s, exemplifies complex review that combines federal with local institutional oversight and cuts across more than one federal agency. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities (OBA) and its Recombinant DNA Advisory Committee (the RAC) plus federal review at the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) to standard oversight of human subjects research at the researcher's institution by the Institutional Review Board (IRB) and, for some research, the Institutional Biosafety Committee (IBC). This article traces the evolution, successes, and failures of this complex oversight system. The article evaluates the oversight system based on the literature, public opinion data, and a preliminary elicitation of expert views using a survey instrument designed to evaluate oversight systems. The analysis yields a range lessons for oversight of Nanobiotechnology. It sheds light on the relative merits of using preexisting oversight frameworks versus innovating, oversight options to address real but uncertain risks, oversight approaches to deal flexibly with evolving science, trade-offs in assuring public access to information, and challenges in coordinating oversight conducted by more than one federal agency. The article demonstrates the value of rooting oversight design for emerging technology in historical assessment of cognate oversight experiences.
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Gene therapy oversight: Lessons for Nanobiotechnology
Journal of Law Medicine and Ethics, 2009Co-Authors: Susan M. Wolf, Rishi Gupta, Peter KohlheppAbstract:Oversight of human gene transfer research ("gene therapy") presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution (by the Institutional Review Board and, for some research, the Institutional Biosafety Committee) and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing Nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of Nanobiotechnology.
K.k. Jain - One of the best experts on this subject based on the ideXlab platform.
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1.45 – Nanobiotechnology
Comprehensive Biotechnology, 2020Co-Authors: K.k. JainAbstract:Nanotechnology is the creation and utilization of materials, devices, and systems through the control of matter on the nanometer-length scale. Nanobiotechnology is the application of nanotechnology in biotechnology. Applications in molecular diagnostics and pharmaceuticals, which include drug discovery, drug development, and drug delivery, are described. Nanobiotechnology has refined the current molecular diagnostics by extending the limits of detection to single molecules. Nanoparticles play an important role in the delivery of biological therapies, which include cell therapy, gene therapy, vaccines, RNA interference, and antisense therapeutics. Nanomedicine, the application of Nanobiotechnology in medicine, is a broad term applied to all healthcare applications of Nanobiotechnology. Clinical nanomedicine is used in practically all medical specialties and three areas – cancer, neurological disorders, and cardiovascular diseases – are described. Nanotechnology has also refined surgery leading to its further miniaturization as nanosurgery and the use of nanolasers. Nanorobotics is also being developed for therapeutic manipulations. The most promising application of Nanobiotechnology relevant to healthcare is for the development of personalized medicine. The refinement of molecular diagnostics, combination of diagnostics with therapeutics, and targeted drug delivery play important roles in this application. Finally, the safety issues of nanoparticles are discussed including measures to address these. The future prospects of Nanobiotechnology are excellent.
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Nanobiotechnology and personalized medicine.
Progress in molecular biology and translational science, 2020Co-Authors: K.k. JainAbstract:This chapter will start with a definition and scope of personalized medicine and describe how various nanobiotechnologies will contribute to its development. Nanodiagnostics and its combination with therapeutics as well as nanoparticle-based drug delivery will play an important role. The most important applications of Nanobiotechnology will be personalized management of cancer, neurological disorders, and cardiovascular diseases.
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role of Nanobiotechnology in the development of personalized medicine
Nanomedicine: Nanotechnology Biology and Medicine, 2009Co-Authors: K.k. JainAbstract:Personalized medicine simply means the prescription of specific treatments and therapeutics best suited for an individual taking into consideration both genetic and environmental factors that influence response to therapy [1,2]. Besides pharmacogenomics and pharmacogenetics, other -omics such as pharmacoproteomics and pharmacometabonomics are also contributing to the development of personalized medicine. Personalized medicine is the best way to integrate new biotechnologies into medicine for improving the understanding of pathomechanism of diseases, molecular diagnosis and integration with therapeutics. Nanomedicine is defined as the application of Nanobiotechnology to medicine [3]. Nanobiotechnology is also making important contributions to personalized medicine through refinement of various technologies used for diagnostics and therapeutics as well as interactions among these (Figure 1).
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role of Nanobiotechnology in developing personalized medicine for cancer
Technology in Cancer Research & Treatment, 2005Co-Authors: K.k. JainAbstract:Personalized medicine simply means the prescription of specific therapeutics best suited for an individual. Personalization of cancer therapies is based on a better understanding of the disease at the molecular level. Nanotechnology will play an important role in this area. Nanobiotechnology is being used to refine discovery of biomarkers, molecular diagnostics, drug discovery and drug delivery, which are important basic components of personalized medicine and are applicable to management of cancer as well. Examples are given of the application of quantum dots, gold nanoparticles, and molecular imaging in diagnostics and combination with therapeutics - another important feature of personalized medicine. Personalized medicine is beginning to be recognized and is expected to become a part of medical practice within the next decade. Personalized management of cancer, facilitated by Nanobiotechnology, is expected to enable early detection of cancer, more effective and less toxic treatment increasing the chanc...
Gurumurthy Ramachandran - One of the best experts on this subject based on the ideXlab platform.
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recommendations for oversight of Nanobiotechnology dynamic oversight for complex and convergent technology
Journal of Nanoparticle Research, 2011Co-Authors: Gurumurthy Ramachandran, Jennifer Kuzma, Efrosini Kokkoli, Jordan Paradise, Susan M. Wolf, J Ralph D Hall, J Leili D FatehiAbstract:Federal oversight of Nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between “soft” and “hard” approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of Nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to Nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government.
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Recommendations for oversight of Nanobiotechnology: Dynamic oversight for complex and convergent technology
Journal of Nanoparticle Research, 2011Co-Authors: Gurumurthy Ramachandran, Jennifer Kuzma, Efrosini Kokkoli, Jordan Paradise, Susan M. Wolf, Ralph Hall, Leili FatehiAbstract:Federal oversight of Nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this "stay-the- course" approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between "soft" and "hard" approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of Nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to Nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government. © 2011 Springer Science+Business Media B.V.
Ulrich Wiesner - One of the best experts on this subject based on the ideXlab platform.
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fluorescent core shell silica nanoparticles towards lab on a particle architectures for Nanobiotechnology
Chemical Society Reviews, 2006Co-Authors: Andrew Burns, Hooisweng Ow, Ulrich WiesnerAbstract:Novel nanoscale fluorescent materials are integral to the progress of emergent fields such as Nanobiotechnology and facilitate new research in a variety of contexts. Sol–gel derived silica is an excellent host material for creating fluorescent nanoparticles by the inclusion of covalently-bound organic dyes. Significant enhancements in the brightness and stability of organic dye emission can be achieved for silica-based core–shell nanoparticle architectures at length scales down to tens of nanometers with narrow size distributions. This tutorial review will highlight these findings and describe the evolution of the fluorescent core–shell silica nanoparticle concept towards integration of multiple functionalities including mesoporosity, metal nanoshells and quantitative chemical sensing. These developments point towards the development of “lab on a particle” architectures with promising prospects for Nanobiotechnology, drug development and beyond.
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Fluorescent core–shell silica nanoparticles: towards “Lab on a Particle” architectures for Nanobiotechnology
Chemical Society Reviews, 2006Co-Authors: Andrew Burns, Hooisweng Ow, Ulrich WiesnerAbstract:Novel nanoscale fluorescent materials are integral to the progress of emergent fields such as Nanobiotechnology and facilitate new research in a variety of contexts. Sol–gel derived silica is an excellent host material for creating fluorescent nanoparticles by the inclusion of covalently-bound organic dyes. Significant enhancements in the brightness and stability of organic dye emission can be achieved for silica-based core–shell nanoparticle architectures at length scales down to tens of nanometers with narrow size distributions. This tutorial review will highlight these findings and describe the evolution of the fluorescent core–shell silica nanoparticle concept towards integration of multiple functionalities including mesoporosity, metal nanoshells and quantitative chemical sensing. These developments point towards the development of “lab on a particle” architectures with promising prospects for Nanobiotechnology, drug development and beyond.
Kewal K. Jain - One of the best experts on this subject based on the ideXlab platform.
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Role of Nanobiotechnology in Drug Delivery
Drug Delivery Systems, 2020Co-Authors: Kewal K. JainAbstract:This chapter is a brief overview of use of Nanobiotechnology in drug delivery. Several types of nanoparticles are available. Nanoparticulate formulations of normally used drugs have increased efficacy due to improved absorption and require lower dosage with less side effects than standard formulations. Nanobiotechnology also facilitates targeted drug delivery of anticancer drugs, which is important for the management of cancer. Nanoparticles also facilitate crossing of biological barriers in the human body for drug delivery to targeted organs, for example, crossing the blood–brain barrier to reach the brain. Nanobiotechnology applications in delivery of biological therapies are expanding in areas such as cell and gene therapies, siRNAs, and monoclonal antibodies. Some nanoparticles can carry more than one therapeutic molecule enabling multimodal therapy and combination with physical modalities such as radiotherapy in cancer. Nanorobotics is developing with applications in drug delivery, particularly for cancer. Other anticipated developments in this area include use of nanotechnology for creating intelligent drug release devices.
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Nanobiotechnology based strategies for crossing the blood brain barrier
Nanomedicine: Nanotechnology Biology and Medicine, 2012Co-Authors: Kewal K. JainAbstract:The blood–brain barrier (BBB) is meant to protect the brain from noxious agents; however, it also significantly hinders the delivery of therapeutics to the brain. Several strategies have been employed to deliver drugs across this barrier and some of these may do structural damage to the BBB by forcibly opening it to allow the uncontrolled passage of drugs. The ideal method for transporting drugs across the BBB should be controlled and should not damage the barrier. Among the various approaches that are available, Nanobiotechnology-based delivery methods provide the best prospects for achieving this ideal. This review describes various nanoparticle (NP)-based methods used for drug delivery to the brain and the known underlying mechanisms. Some strategies require multifunctional NPs combining controlled passage across the BBB with targeted delivery of the therapeutic cargo to the intended site of action in the brain. An important application of Nanobiotechnology is to facilitate the delivery of drugs and bi...
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Miscellaneous Healthcare Applications of Nanobiotechnology
The Handbook of Nanomedicine, 2012Co-Authors: Kewal K. JainAbstract:Nanobiotechnology impacts nearly all aspects of healthcare. Separate chapters were devoted to major therapeutic areas. Other areas which are not well defined or specialties where the use of Nanobiotechnology is still limited are all included in this chapter.
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Nanobiotechnology and personalized medicine.
Progress in Molecular Biology and Translational Science, 2012Co-Authors: Kewal K. JainAbstract:Personalized medicine simply means the prescription of specific therapeutics best suited for an individual. It is usually based on pharmacogenetic, pharmacogenomic, transcriptomic, pharmacoproteomic, and pharmacometabolomic information. Other individual variations in patients and environmental factors are also taken into consideration (Jain 2009). Personalized medicine means improving healthcare by incorporating early detection of disease, preventive medicine, rational drug discovery and development, and monitoring of therapy. Concept of personalized medicine as systems medicine is the best way of integrating new technologies and translating them into clinical application for improving healthcare. Application of Nanobiotechnology is described for personalized management of cancer and cardiovascular disorders. Advances in Nanobiotechnology will facilitate the development of personalized medicine by the following:
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Nanobiotechnology in Cardiovascular Disorders
Applications of Biotechnology in Cardiovascular Therapeutics, 2011Co-Authors: Kewal K. JainAbstract:Nanotechnology (Greek word nano means dwarf) is the creation and utilization of materials, devices, and systems through the control of matter on the nanometerlength scale, that is, at the level of atoms, molecules, and supramolecular structures. Nanotechnology, as defined by the National Nanotechnology Initiative (http://www. nano.gov/), is the understanding and control of matter at dimensions of roughly 1–100 nm, where unique phenomena enable novel applications (Jain 2011). Encompassing nanoscale science, engineering and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale. It is the popular term for the construction and utilization of functional structures with at least one characteristic dimension measured in nanometers − a nanometer is one billionth of a meter (10–9 m). Given the inherent nanoscale functional components of living cells, it was inevitable that nanotechnology will be applied in biotechnology giving rise to the term Nanobiotechnology. Nanomedicine is defined as the application of Nanobiotechnology to medicine, and some of these applications are shown in Table 6.1 (Jain 2008).
