Gene Based Therapies For Cancer

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Gene Therapy of Cancer

Author : Stanton L. Gerson
Publisher : Elsevier
ISBN 13 : 9780080491363
Total Pages : 534 pages
Book Rating : 4.4/5 (913 download)

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Book Synopsis Gene Therapy of Cancer by : Stanton L. Gerson

Download or read book Gene Therapy of Cancer written by Stanton L. Gerson and published by Elsevier. This book was released on 2002-04-04 with total page 534 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Second Edition of Gene Therapy of Cancer provides crucial updates on the basic science and ongoing research in this field, examining the state of the art technology in gene therapy and its therapeutic applications to the treatment of cancer. The clinical chapters are improved to include new areas of research and more successful trials. Chapters emphasize the scientific basis of gene therapy using immune, oncogene, antisense, pro-drug activating, and drug resistance gene targets, while other chapters discuss therapeutic approaches and clinical applications. This book is a valuable reference for anyone needing to stay abreast of the latest advances in gene therapy treatment for cancer. Key Features * Provides in-depth description of targeted systems and treatment strategies * Explains the underlying cancer biology necessary for understanding a given therapeutic approach * Extensively covers immune therapeutics of vaccines, cytokines, and peptide-induced responses * Presents translational focus with emphasis on requirements for clinical implementation * Incorporates detailed illustrations of vectors and therapeutic approaches ideal for classroom presentations and general reference

Gene-Based Therapies for Cancer

Author : Jack A. Roth
Publisher : Springer Science & Business Media
ISBN 13 : 144196102X
Total Pages : 282 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Gene-Based Therapies for Cancer by : Jack A. Roth

Download or read book Gene-Based Therapies for Cancer written by Jack A. Roth and published by Springer Science & Business Media. This book was released on 2010-07-28 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer gene therapy is a novel therapy that targets the underlying genetic defects in the cancer cell. Progress in this field has been rapid and gene therapy promises to further extend personalized cancer treatment. In this volume leading experts have contributed their experience in developing gene therapies for a variety of cancers. Translational gene therapy approaches are emphasized. Chapters include discussions of specific gene delivery technologies as well as their application to various cancers with extensive discussions of ongoing clinical trials. This information should be useful to both students, fellows, and experienced scientists with an interest in this rapidly developing area.

Gene Therapy for Cancer

Author : Kelly K. Hunt
Publisher : Springer Science & Business Media
ISBN 13 : 159745222X
Total Pages : 469 pages
Book Rating : 4.5/5 (974 download)

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Book Synopsis Gene Therapy for Cancer by : Kelly K. Hunt

Download or read book Gene Therapy for Cancer written by Kelly K. Hunt and published by Springer Science & Business Media. This book was released on 2007-10-26 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: The three sections of this volume present currently available cancer gene therapy techniques. Part I describes the various aspects of gene delivery. In Part II, the contributors discuss strategies and targets for the treatment of cancer. Finally, in Part III, experts discuss the difficulties inherent in bringing gene therapy treatment for cancer to the clinic. This book will prove valuable as the volume of preclinical and clinical data continues to increase.

Exploring Novel Clinical Trial Designs for Gene-Based Therapies

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309672988
Total Pages : 127 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Exploring Novel Clinical Trial Designs for Gene-Based Therapies by : National Academies of Sciences, Engineering, and Medicine

Download or read book Exploring Novel Clinical Trial Designs for Gene-Based Therapies written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-08-27 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.

Cancer Gene Therapy

Author : David T. Curiel
Publisher : Springer Science & Business Media
ISBN 13 : 1592597858
Total Pages : 490 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis Cancer Gene Therapy by : David T. Curiel

Download or read book Cancer Gene Therapy written by David T. Curiel and published by Springer Science & Business Media. This book was released on 2007-11-03 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete introduction and guide to the latest developments in cancer gene therapy-from bench to bedside. The authors comprehensively review the anticancer genes and gene delivery methods currently available for cancer gene therapy, including the transfer of genetic material into the cancer cells, stimulation of the immune system to recognize and eliminate cancer cells, and the targeting of the nonmalignant stromal cells that support their growth. They also thoroughly examine the advantages and limitations of the different therapies and detail strategies to overcome obstacles to their clinical implementation. Topics of special interest include vector-targeting techniques, the lessons learned to date from clinical trials of cancer gene therapy, and the regulatory guidelines for future trials. Noninvasive techniques to monitor the extent of gene transfer and disease regression during the course of treatment are also discussed.

Gene and Cellular Immunotherapy for Cancer

Author : Armin Ghobadi
Publisher : Springer Nature
ISBN 13 : 303087849X
Total Pages : 371 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Gene and Cellular Immunotherapy for Cancer by : Armin Ghobadi

Download or read book Gene and Cellular Immunotherapy for Cancer written by Armin Ghobadi and published by Springer Nature. This book was released on 2022-01-01 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical and preclinical exploration of gene and cellular immunotherapy have seen rapid growth and interest with the development and approval of five Chimeric Antigen Receptor T-cell (CAR-T) products for lymphoma and myeloma and one Bispecific T-Cell Engager (BiTE) for acute lymphoblastic leukemia (ALL). These advances have dramatically improved the management of patients with relapsed refractory lymphoma, myeloma and leukemia. Gene and Cellular Immunotherapy for Cancer offers readers a comprehensive review of current cellular and gene-based immunotherapies. Divided into eighteen cohesive chapters, this book provides an in-depth and detailed look into cellular-based immunotherapies including CAR-T, TCR-T, TIL, Viral CTLs, NK cells in addition to T/NK cell engagers, focusing on their historical perspectives, biology, development and manufacturing, toxicities and more. Edited by two leading experts on gene and cellular immunotherapy, the book will feature chapters written by a diverse collection of recognized and up-and-coming experts and researchers in the field, providing oncologists, immunologists, researchers and clinical and basic science trainees with a bench to bedside view of the latest developments in the field.

Handbook of Research on Advancements in Cancer Therapeutics

Author : Kumar, Sumit
Publisher : IGI Global
ISBN 13 : 1799865312
Total Pages : 913 pages
Book Rating : 4.7/5 (998 download)

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Book Synopsis Handbook of Research on Advancements in Cancer Therapeutics by : Kumar, Sumit

Download or read book Handbook of Research on Advancements in Cancer Therapeutics written by Kumar, Sumit and published by IGI Global. This book was released on 2020-11-27 with total page 913 pages. Available in PDF, EPUB and Kindle. Book excerpt: The complexity of cancer demands an integrated approach from both a cancer biology standpoint and a pharmaceutical basis to understand the different anticancer modalities. Current research has been focused on conventional and newer anticancer modalities, recent discoveries in cancer research, and also the advancements in cancer treatment. There is a current need for more research on the advances in cancer therapeutics that bridge the gap between basic research (pharmaceutical drug development processes, regulatory issues, and translational experimentation) and clinical application. Recent promising discoveries such as immunotherapies, promising therapies undergoing clinical trials, synthetic lethality, carbon beam radiation, and other exciting targeted therapies are being studied to improve and advance the studies of modern cancer treatment. The Handbook of Research on Advancements in Cancer Therapeutics serves as a comprehensive guide in modern cancer treatment by combining and merging the knowledge from both cancer biology and the pharmacology of anticancer modalities. The chapters come from multi-disciplinary backgrounds, including scientists and clinicians from both academia and various industries, to discuss nascent personalized therapies and big data-driven cancer treatment. While highlighting topic areas that include cancer prevention, cancer therapeutics, and cancer treatments through the lenses of technology, medicine/drugs, and alternate therapies, this book is ideally intended for oncologists, radiation oncologists, surgical oncologists, and cancer biologists, along with practitioners, stakeholders, researchers, academicians, and students who are interested in understanding the most fundamental aspects of cancer and the available therapeutic opportunities.

Gene Therapy of Cancer

Author : Edmund C. Lattime
Publisher : Academic Press
ISBN 13 : 0123946328
Total Pages : 554 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Gene Therapy of Cancer by : Edmund C. Lattime

Download or read book Gene Therapy of Cancer written by Edmund C. Lattime and published by Academic Press. This book was released on 2013-08-28 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gene therapy as a treatment for cancer is at a critical point in its evolution. Exciting new developments in gene targeting and vector technology, coupled with results from the first generation of preclinical and clinical studies have led to the design and testing of new therapeutic approaches. The Third Edition of Gene Therapy of Cancer provides crucial updates on the basic and applied sciences of gene therapy. It offers a comprehensive assessment of the field including the areas of suicide gene therapy, oncogene and suppressor gene targeting, immunotherapy, drug resistance gene therapy, and the genetic modification of stem cells. Researchers at all levels of development, from basic laboratory investigators to clinical practitioners, will find this book to be instructive. Cancer gene therapy, like cancer therapy in general, is evolving rapidly, testing new concepts, targets and pathways, evoking new technologies, and passing new regulatory hurdles. Its essence, however, has not changed: the hope and challenges of returning altered genes to normal, using targeted gene expression to alter the function of both tumor and microenvironment, and in some cases normal cells, and delivering functionally important genes to specific cell types to increase sensitivity to killing or to protect normal cells from cancer therapies. In some instances, gene therapy for cancer forms a continuum from gene repair through the use of molecularly modified cells; the use of viral and non-viral vector based gene delivery to both tumor and tumor microenvironment; the use of viral and gene based vaccines; and development of new gene-based therapeutics. The unique mechanistically chosen vector platforms are at the heart of this technology because they allow for direct and selective cell death and transient to sustained delivery of vaccine molecules or molecules that affect the microenvironment, vasculature, or the immune response. Explains the underlying cancer biology necessary for understanding proposed therapeutic approaches Presents in-depth description of targeting systems and treatment strategies Covers the breadth of gene therapy approaches including immunotherapeutic, drug resistance,oncolytic viruses, as well as regulatory perspectives from both the NCI and FDA

Adenoviral Vectors for Gene Therapy

Author : David T. Curiel
Publisher : Academic Press
ISBN 13 : 0128005106
Total Pages : 868 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Adenoviral Vectors for Gene Therapy by : David T. Curiel

Download or read book Adenoviral Vectors for Gene Therapy written by David T. Curiel and published by Academic Press. This book was released on 2016-03-10 with total page 868 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adenoviral Vectors for Gene Therapy, Second Edition provides detailed, comprehensive coverage of the gene delivery vehicles that are based on the adenovirus that is emerging as an important tool in gene therapy. These exciting new therapeutic agents have great potential for the treatment of disease, making gene therapy a fast-growing field for research. This book presents topics ranging from the basic biology of adenoviruses, through the construction and purification of adenoviral vectors, cutting-edge vectorology, and the use of adenoviral vectors in preclinical animal models, with final consideration of the regulatory issues surrounding human clinical gene therapy trials. This broad scope of information provides a solid overview of the field, allowing the reader to gain a complete understanding of the development and use of adenoviral vectors. Provides complete coverage of the basic biology of adenoviruses, as well as their construction, propagation, and purification of adenoviral vectors Introduces common strategies for the development of adenoviral vectors, along with cutting-edge methods for their improvement Demonstrates noninvasive imaging of adenovirus-mediated gene transfer Discusses utility of adenoviral vectors in animal disease models Considers Federal Drug Administration regulations for human clinical trials

Gene-Based Therapies for Pediatric Blood Diseases, An Issue of Hematology/Oncology Clinics of North America, E-Book

Author : Nirali N. Shah
Publisher : Elsevier Health Sciences
ISBN 13 : 0323987761
Total Pages : 273 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Gene-Based Therapies for Pediatric Blood Diseases, An Issue of Hematology/Oncology Clinics of North America, E-Book by : Nirali N. Shah

Download or read book Gene-Based Therapies for Pediatric Blood Diseases, An Issue of Hematology/Oncology Clinics of North America, E-Book written by Nirali N. Shah and published by Elsevier Health Sciences. This book was released on 2022-07-19 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this issue of Hematology/Oncology Clinics, guest editors Drs. Sung-Yun Pai and Nirali N. Shah bring their considerable expertise to the topic of Gene-Based Therapies for Pediatric Blood Diseases. Top experts in the field cover key topics such as CAR T-cell therapy: current status; engineered T cells; NK-cell therapy; hemoglobinopathies: beta-thalassemia, sickle cell disease; hemophilia A/B; primary immunodeficiencies; and more. Contains 14 relevant, practice-oriented topics including the evolution of gene therapy; viral vectors in hematopoietic stem cell gene therapy; gene editing in hematopoietic stem cells; nonintegrating vectors and engineered capsids; regulatory aspects of gene therapy; and more. Provides in-depth clinical reviews on gene-based therapies for pediatric blood diseases, offering actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews.

Cancer Gene Therapy by Viral and Non-viral Vectors

Author : Malcolm Brenner
Publisher : John Wiley & Sons
ISBN 13 : 1118501659
Total Pages : 176 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Cancer Gene Therapy by Viral and Non-viral Vectors by : Malcolm Brenner

Download or read book Cancer Gene Therapy by Viral and Non-viral Vectors written by Malcolm Brenner and published by John Wiley & Sons. This book was released on 2014-02-25 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides expert, state-of-the-art insight into the currentprogress of viral and non-viral gene therapy Translational medicine has opened the gateway to the era ofpersonalized or precision medicine. No longer a one-size-fits-allapproach, the treatment of cancer is now based on an understandingof underlying biologic mechanisms and is increasingly beingtailored to the molecular specificity of a tumor. This book provides a comprehensive overview of the pertinentmolecular discoveries in the cancer field and explains how theseare being used for gene-based cancer therapies. Designed as avolume in the Translational Oncology book series, Cancer GeneTherapy by Viral and Non-viral Vectors deals with the practiceof gene-therapy, with reference to vectors for gene expression andgene transfer, as well as viral therapy. It covers the history andcurrent and future applications of gene transfer in cancer, andprovides expert insight on the progress of viral and non-viral genetherapy with regard to delivery system, vector design, potentialtherapeutic genes, and principles and regulations for cancer genetherapy. Presented in three parts, Cancer Gene Therapy by Viral andNon-viral Vectors covers: Delivery Systems • Translational Cancer Research: Gene Therapy by Viraland Non-viral Vectors • Retroviruses for Cancer Therapy • DNA Plasmids for Non-viral Gene Therapy ofCancer • Cancer Therapy with RNAi delivered by Non-viralMembrane/Core Nanoparticles Targeted Expression • Cancer Gene Therapy by Tissue-specific andCancer-targeting Promptors • MicroRNAs as Drugs and Drug Targets in Cancer Principles of Clinical Trials in Gene Therapy • Regulatory issues for Manufacturers of Viral Vectorsand Vector-transduced Cells for Phase I/II Trials • US Regulations Governing Clinical Trials in GeneTherapy • Remaining Obstacles to the Success of Cancer GeneTherapy Focusing on speeding the process in clinical cancer care bybringing therapies as quickly as possible from bench to bedside,Cancer Gene Therapy by Viral and Non-viral Vectors is anabsolutely vital book for physicians, clinicians, researchers, andstudents involved in this area of medicine.

Nucleic Acids as Gene Anticancer Drug Delivery Therapy

Author : Loutfy H. Madkour
Publisher : Academic Press
ISBN 13 : 0128197781
Total Pages : 650 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Nucleic Acids as Gene Anticancer Drug Delivery Therapy by : Loutfy H. Madkour

Download or read book Nucleic Acids as Gene Anticancer Drug Delivery Therapy written by Loutfy H. Madkour and published by Academic Press. This book was released on 2019-08-27 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nucleic Acids as Gene Anticancer Drug Delivery Therapy highlights the most recent developments in cancer treatment using nucleic acids, nanoparticles and polymer nanoparticles for genomic nanocarriers as drug delivery, including promising opportunities for targeted and combination therapy. The development of a wide spectrum of nanoscale technologies is beginning to change the scientific landscape in terms of disease diagnosis, treatment, and prevention. This book presents the use of nanotechnology for medical applications, focusing on its use for anticancer drug delivery. Various intelligent drug delivery systems such as inorganic nanoparticles and polymer-based drug delivery are discussed. The use of smart drug delivery systems seems to be a promising approach for developing intelligent therapeutic systems for cancer immunotherapies and is discussed in detail along with nucleic acid-targeted drug delivery combination therapy for cancer. Nucleic Acids as Gene Anticancer Drug Delivery Therapy will be a useful reference for pharmaceutical scientists, pharmacologiests, and those involved in nanotechnology and cancer research. Discusses intelligent drug delivery systems such as inorganic nanoparticles and polymer-based drug delivery Contains a comprehensive comparison of various delivery systems, listing their advantages and limitations Presents combination therapy as a new hope for enhancing current gene-based treatment efficacy

Immunopharmacology

Author : Manzoor M. Khan
Publisher : Springer Science & Business Media
ISBN 13 : 0387779760
Total Pages : 275 pages
Book Rating : 4.3/5 (877 download)

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Book Synopsis Immunopharmacology by : Manzoor M. Khan

Download or read book Immunopharmacology written by Manzoor M. Khan and published by Springer Science & Business Media. This book was released on 2008-12-19 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decades, with the introduction of the recombinant DNA, hybridoma and transgenic technologies there has been an exponential evolution in understanding the pathogenesis, diagnosis and treatment of a large number of human diseases. The technologies are evident with the development of cytokines and monoclonal antibodies as therapeutic agents and the techniques used in gene therapy. Immunopharmacology is that area of biomedical sciences where immunology, pharmacology and pathology overlap. It concerns the pharmacological approach to the immune response in physiological as well as pathological events. This goals and objectives of this textbook are to emphasize the developments in immunology and pharmacology as they relate to the modulation of immune response. The information includes the pharmacology of cytokines, monoclonal antibodies, mechanism of action of immune-suppressive agents and their relevance in tissue transplantation, therapeutic strategies for the treatment of AIDS and the techniques employed in gene therapy. The book is intended for health care professional students and graduate students in pharmacology and immunology.

Exploring Novel Clinical Trial Designs for Gene-Based Therapies

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309673011
Total Pages : 127 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Exploring Novel Clinical Trial Designs for Gene-Based Therapies by : National Academies of Sciences, Engineering, and Medicine

Download or read book Exploring Novel Clinical Trial Designs for Gene-Based Therapies written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-07-27 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.

Pharmaceutical Biotechnology

Author : Daan J. A. Crommelin
Publisher : CRC Press
ISBN 13 : 9780415285018
Total Pages : 456 pages
Book Rating : 4.2/5 (85 download)

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Book Synopsis Pharmaceutical Biotechnology by : Daan J. A. Crommelin

Download or read book Pharmaceutical Biotechnology written by Daan J. A. Crommelin and published by CRC Press. This book was released on 2002-11-14 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well.

Emerging Trends in Cell and Gene Therapy

Author : Michael K. Danquah
Publisher : Springer Science & Business Media
ISBN 13 : 162703417X
Total Pages : 705 pages
Book Rating : 4.6/5 (27 download)

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Book Synopsis Emerging Trends in Cell and Gene Therapy by : Michael K. Danquah

Download or read book Emerging Trends in Cell and Gene Therapy written by Michael K. Danquah and published by Springer Science & Business Media. This book was released on 2013-06-14 with total page 705 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examples from various organs and diseases illustrate the potential benefit obtained when both therapeutic approaches are combined with delivery strategies. Representing the combined effort of several leading international research and clinical experts, this book, Emerging Trends in Cell and Gene Therapy, provides a complete account on and brings into sharp focus current trends and state-of-the-art in important areas at the interface of cell- and gene-based therapies. This book addresses the current fragmented understanding regarding these two research areas and fills the vast unmet educational need and interest of both students and researchers in academia and industry. Main features of the book: · Biological aspects of stem cell sources, differentiation and engineering. · Application of microfluidics to study stem cell dynamics · Potential clinical application of stem cells and gene therapy to specific human disease. · Utilization of biomaterials and stem cells in regenerative medicine with particular emphasis on spinal cord repair, ligament and bone tissue engineering. · Biomimetic multiscale topography for cell alignment.

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Author : Maria Cristina Galli
Publisher : Springer Nature
ISBN 13 : 3031345673
Total Pages : 243 pages
Book Rating : 4.0/5 (313 download)

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Book Synopsis Regulatory Aspects of Gene Therapy and Cell Therapy Products by : Maria Cristina Galli

Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer Nature. This book was released on 2023-08-01 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. 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 and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, 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 & 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.