Development Of Gene Therapies PDF Download
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| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 127 |
| Release | : 2020-08-27 |
| Genre | : Medical |
| ISBN | : 0309672988 |
Download Exploring Novel Clinical Trial Designs for Gene-Based Therapies Book in PDF, ePub and Kindle
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.
| Author | : Avery McIntosh |
| Publisher | : Chapman & Hall/CRC Biostatistics Series |
| Total Pages | : 0 |
| Release | : 2024-03-13 |
| Genre | : |
| ISBN | : 9781032136554 |
Download Development of Gene Therapies Book in PDF, ePub and Kindle
Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, statistical, and regulatory aspects of GTx development.
| Author | : Kelly K. Hunt |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 469 |
| Release | : 2007-10-26 |
| Genre | : Medical |
| ISBN | : 159745222X |
Download Gene Therapy for Cancer Book in PDF, ePub and Kindle
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.
| Author | : Stanton L. Gerson |
| Publisher | : Elsevier |
| Total Pages | : 555 |
| Release | : 2002-04-04 |
| Genre | : Science |
| ISBN | : 0080491367 |
Download Gene Therapy of Cancer Book in PDF, ePub and Kindle
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. 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
| Author | : Theodore Friedmann |
| Publisher | : CSHL Press |
| Total Pages | : 748 |
| Release | : 1999 |
| Genre | : Adenoviruses |
| ISBN | : 9780879695286 |
Download The Development of Human Gene Therapy Book in PDF, ePub and Kindle
The idea of human gene therapy was accepted by the medical community and society at large long before believable clinical benefits began to emerge. In this book, some of the fields most distinguished contributors chronicle the evolution of this momentous direction for medicine, illustrating how imaginative concepts shaped the development of technologies and brought the daring new idea to its current position of imminent practical success. This is a book designed to endure as clinical advances accumulate, a clear-eyed work of reference that will anchor the further development of this revolution in therapy. It is an essential addition to libraries of clinical medicine, biotechnology, and public policy, and a resource that no laboratory investigator with an interest in the biology of gene transfer should be without.
| Author | : Maria Cristina Galli |
| Publisher | : Springer Nature |
| Total Pages | : 243 |
| Release | : 2023-08-01 |
| Genre | : Science |
| ISBN | : 3031345673 |
Download Regulatory Aspects of Gene Therapy and Cell Therapy Products Book in PDF, ePub and Kindle
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.
| Author | : Daan J. A. Crommelin |
| Publisher | : CRC Press |
| Total Pages | : 456 |
| Release | : 2002-11-14 |
| Genre | : Medical |
| ISBN | : 9780415285018 |
Download Pharmaceutical Biotechnology Book in PDF, ePub and Kindle
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.
| Author | : P.L. Chang |
| Publisher | : CRC Press |
| Total Pages | : 313 |
| Release | : 2018-01-17 |
| Genre | : Science |
| ISBN | : 1351085212 |
Download Somatic Gene Therapy Book in PDF, ePub and Kindle
As human gene therapy becomes a clinical reality, a new era in medicine dawns. Novel and innovative developments in molecular genetics now provide opportunities to treat the genetic bases of diseases often untreatable before. Somatic Gene Therapy documents these historical clinical trials, reviews current advances in the field, evaluates the use of the many different cell types and organs amenable to gene transfer, and examines the prospects of various exciting strategies for gene therapy.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 78 |
| Release | : 2014-03-27 |
| Genre | : Medical |
| ISBN | : 030929665X |
Download Oversight and Review of Clinical Gene Transfer Protocols Book in PDF, ePub and Kindle
Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.
| Author | : Clévio Nóbrega |
| Publisher | : Springer Nature |
| Total Pages | : 195 |
| Release | : 2020-06-27 |
| Genre | : Medical |
| ISBN | : 3030413330 |
Download A Handbook of Gene and Cell Therapy Book in PDF, ePub and Kindle
This is a reference handbook for young researchers exploring gene and cell therapy. Gene therapy could be defined as a set of strategies modifying gene expression or correcting mutant/defective genes through the administration of DNA (or RNA) to cells, in order to treat disease. Important advances like the discovery of RNA interference, the completion of the Human Genome project or the development of induced pluripotent stem cells (iPSc) and the basics of gene therapy are covered. This is a great book for students, teachers, biomedical researchers delving into gene/cell therapy or researchers borrowing skills from this scientific field.
