Book Description
Dr. Yves Bayon is a Senior Principal Scientist at Medtronic and Dr. Alain Vertes is affiliated with NxR Biotechnologies GmbH. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
Author : Tracy Tong Li Yu
Publisher : Frontiers Media SA
Page : 175 pages
File Size : 25,18 MB
Release : 2021-01-21
Category : Science
ISBN : 2889664147
Dr. Yves Bayon is a Senior Principal Scientist at Medtronic and Dr. Alain Vertes is affiliated with NxR Biotechnologies GmbH. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
Author : Tingting Qiu
Publisher :
Page : 0 pages
File Size : 37,41 MB
Release : 2023
Category :
ISBN : 9781003366676
"A comprehensive review of the challenges that exist in patient accessibility to advanced therapy medicinal products (ATMPs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialisation. Specfically, we investigated how COVID-19 has impacted the RMs industry by elaborating on the disruptions it caused but also the new opportunities it brought. The ultimate goal of this work is to make strategic recommendations for manufacturers and decisions-markers on effective strategies to address the above obstacles and facilitate patient access to promising regenerative medicines"--
Author : Maria Cristina Galli
Publisher :
Page : 0 pages
File Size : 31,48 MB
Release : 2023
Category :
ISBN : 9783031345685
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 : Nicolaus Kröger
Publisher : Springer Nature
Page : 221 pages
File Size : 26,30 MB
Release : 2022-02-07
Category : Medical
ISBN : 3030943534
This first open access European CAR-T Handbook, co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues. This book, written by leading experts in the field to enhance readers’ knowledge and practice skills, provides an unparalleled overview of the CAR-T cell technology and its application in clinical care, to enhance readers’ knowledge and practice skills.
Author : Maria Cristina Galli
Publisher : Springer
Page : 235 pages
File Size : 40,3 MB
Release : 2015-09-15
Category : Medical
ISBN : 3319186183
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.
Author : Annetine C. Gelijns
Publisher : National Academies
Page : 78 pages
File Size : 45,76 MB
Release : 1989
Category : Clinical medicine
ISBN :
Author : Miguel-Angel Perales
Publisher : Springer
Page : 288 pages
File Size : 12,76 MB
Release : 2018-11-27
Category : Medical
ISBN : 3319543687
In this book, experts in the field express their well-reasoned opinions on a range of complex, clinically relevant issues across the full spectrum of cell and gene therapies with the aim of providing trainee and practicing hematologists, including hematopoietic transplant physicians, with information that is relevant to clinical practice and ongoing research. Each chapter focuses on a particular topic, and the concise text is supported by numerous working tables, algorithms, and figures. Whenever appropriate, guidance is provided regarding the availability of potentially high-impact clinical trials. The rapid evolution of cell and gene therapies is giving rise to numerous controversies that need to be carefully addressed. In meeting this challenge, this book will appeal to all residents, fellows, and faculty members responsible for the care of hematopoietic cell transplant patients. It will also offer a robust, engaging tool to aid vital activities in the daily work of every hematology and oncology trainee.
Author : Sumantra Ray
Publisher : Oxford University Press
Page : 603 pages
File Size : 20,3 MB
Release : 2016
Category : Medical
ISBN : 0199608474
This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.
Author : Institute of Medicine
Publisher : National Academies Press
Page : 442 pages
File Size : 27,40 MB
Release : 2011-04-03
Category : Medical
ISBN : 0309158060
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author :
Publisher : Academic Press
Page : 1436 pages
File Size : 22,37 MB
Release : 2019-06-03
Category : Science
ISBN : 0128137002
Encyclopedia of Tissue Engineering and Regenerative Medicine, Three Volume Set provides a comprehensive collection of personal overviews on the latest developments and likely future directions in the field. By providing concise expositions on a broad range of topics, this encyclopedia is an excellent resource. Tissue engineering and regenerative medicine are relatively new fields still in their early stages of development, yet they already show great promise. This encyclopedia brings together foundational content and hot topics in both disciplines into a comprehensive resource, allowing deeper interdisciplinary research and conclusions to be drawn from two increasingly connected areas of biomedicine. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the fields of tissue engineering and regenerative medicine Contains multimedia features, including hyperlinked references and further readings, cross-references and diagrams/images Represents the most comprehensive and exhaustive product on the market on the topic