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An important new collection of clinical and preclinical reports on genetic therapy, this book describes illustrative examples of diseases in which gene-based interventions are presently plausible, and presents case studies of current research using both synthetic oligonucleotides and biological vectors. Combining the insights of over 50 contributors, Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors furnishes a historical overview of genetic therapy highlights official Food and Drug Administration positions on the preparation of oligonucleotides and vectors offers practical models of agent preparation, animal testing, pharmacokinetics, toxicology, and clinical trials discusses both synthetic DNA and biological vector approaches to cancer, viral, and cardiological indications illustrates for new practitioners how each stage of genetic therapy is developed details genetic treatment of leukemia; lymphoma; cancer of the brain, breast, colon, kidney, and lung; melanoma; HIV; and coronary restenosis includes examples of antisense, ribozyme, tumor suppressor, immunostimulation, and gene replacement therapy and addresses questions of preparation, delivery, toxicity, mechanism, and specificity.
Extensively revised and updated, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition reflects the logarithmic progress made in the past four years of oligonucleotide-based therapies, and, in particular, antisense therapeutics and research. Interpreting lessons learned from the clinical trials of first generati
Annotation Dr. Agrawal's newest book is of significant importance since oligonucleotide-based drugs have the advantage of retaining their recognition for the target RNA, and provide the tools needed to modulate the expression of specific genes, making Antisense Therapeutics an essential resource for all antisense researchers.
New Antisense Strategies: Chemical Synthesis of RNA Oligomers, by Junichi Yano und Gerald E. Smyth Development and Modification of Decoy Oligodeoxynucleotides for Clinical Application, by Mariana Kiomy Osako, Hironori Nakagami und Ryuichi Morishita Modulation of Endosomal Toll-Like Receptor-Mediated Immune Responses by Synthetic Oligonucleotides, by Ekambar R. Kandimalla und Sudhir Agrawal Delivery of Nucleic Acid Drugs, by Yan Lee und Kazunori Kataoka Aptamer: Biology to Applications, by Yoshikazu Nakamura Development and Clinical Applications of Nucleic Acid Therapeutics, by Veenu Aishwarya, Anna Kalota und Alan M. Gewirtz
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
This book provides a compelling overall update on current status of RNA interference
This book covers diverse areas in which nanoscience and nanotechnology have led to significant technological advances and practical applications, with special emphasis on novel types of nanomaterials and their applicability into a new generation of nano- and micro-devices. Different nanomaterials are reviewed with a focus on several practical application areas and their commercial utilization. Production technologies of nanomaterials are presented as one of the challenges today. Sectors where nanotechnology has already significantly contributed are presented, along with specific nanotechnology solutions: energy related sectors, NEMS/MEMS, micro power generators, spintronics and healthcare. The basic properties and applications of nanostructured thermoelectric materials, ferroelectric and piezoelectric nanomaterials are reviewed. Examples of several developed thin-film thermogenerators are shown. A review of existing solutions and developing challenges are given regarding sustainable energy production, photovoltaics, solar cells, hydrogen economy and improved classes of batteries as contributions to green products and circular economy. Novel, highly promising areas in nanotechnology, are shown, such as voltage-driven nano-spintronics. Recent advances in friction characterisation at the nano level are described. Several proven nanomaterials have been reviewed pertaining to biomedicine. The use of nanomaterials in ophthalmology and cosmetic industry are reviewed, and the potential for silver nanoparticles and iron-based nanomaterials in biomedicine, also with recognised challenges and possible threats of non-controlled use of nanomaterials. This work is the result of joint efforts of different companies, academic, and research institutions participating in WIMB Tempus project, 543898-TEMPUS-1-2013-1-ES-TEMPUS-JPHES, "Development of Sustainable Interrelations between Education, Research and Innovation at WBC Universities in Nanotechnologies and Advanced Materials where Innovation Means Business", co-funded by the Tempus Programme of the European Union.
In this Handbook of Experimental Pharmacology on “High Density Lipoproteins – from biological understanding to clinical exploitation” contributing authors (members of COST Action BM0904/HDLnet) summarize in more than 20 chapters our current knowledge on the structure, function, metabolism and regulation of HDL in health and several diseases as well as the status of past and ongoing attempts of therapeutic exploitation. The book is of interest to researchers in academia and industry focusing on lipoprotein metabolism, cardiovascular diseases and immunology as well as clinical pharmacologists, cardiologists, diabetologists, nephrologists and other clinicians interested in metabolic or inflammatory diseases.
This report surveys opportunities for future Army applications in biotechnology, including sensors, electronics and computers, materials, logistics, and medical therapeutics, by matching commercial trends and developments with enduring Army requirements. Several biotechnology areas are identified as important for the Army to exploit, either by direct funding of research or by indirect influence of commercial sources, to achieve significant gains in combat effectiveness before 2025.
The processes of discovery, testing and distribution of new medicines have undergone radical change in recent decades, from a focus on small molecule drugs to biomedicine and related technologies. Bruce Rasmussen very effectively draws upon modern theories of the firm, data analysis, and case studies to provide important insights into the consequences of this change. He offers convincing evidence that contradicts the widely-held view that the biopharmaceutical sector has not generated considerable economic value. Frank R. Lichtenberg, Columbia University, US Bio- and pharmaceutical industry discovery is a distressed asset today. Why? Bruce Rasmussen s book is a timely and very informative work, building on rich data sources and extensive economic research, on a subject of concern to us all. Is medicine discovery in permanent decline? Are the biotechnology and traditional pharma groups on a collision course, will the traditional group absorb the new, will integration take place, will a new discovery model emerge? I commend Bruce s book to all who wish to understand what is happening. David W. Anstice, Merck & Co., Inc. This path-breaking book addresses the ongoing implications for traditional pharmaceutical companies and biopharmaceutical start-ups of the realignment of the industry knowledge-base. The theoretical approach draws on the modern theory of the firm and related ideas in order to better define the concept of the business model, which is employed to guide the case studies and empirical analysis in the book. The author shows that while traditional pharmaceutical companies have successfully adjusted their business models to meet the challenges of biotechnology, biopharmaceutical start-ups have experienced more problems. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. However, this has been captured disproportionately by a handful of large, fully-integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical companies. This highly focused book will be a captivating read for innovation and biopharmaceutical industry analysts, as well as advisers formulating policies to support the development of the biopharmaceutical sector. Academics working on innovation and biotechnology, as well as scientists engaged in research in the life sciences, will also find this book of particular interest.