Immunotherapy with genetically engineered immune cell products is a transformative treatment modality with potential applications in various fields of medicine. A prime example is chimeric antigen receptor (CAR)-modified T cells in hematology and oncology, and the advent of CAR T cell therapies to treat infectious diseases, autoimmune disorders, and cardiovascular diseases. The medical need and demand from patients and caregivers require radical innovations to accelerate and improve pre-clinical development and clinical translation, provision of gene-transfer vectors, and immune cell product manufacturing as well as a critical reflection and discussion on ethical and socioeconomic aspects. The goal of this special issue of Frontiers in Immunology is to provide a comprehensive and multi-faceted view on the current state-of-the-art, imminent and future directions the field is taking in order to accelerate the pre-clinical development, clinical translation, and manufacturing of CAR T cells, increase access and sustainability of CAR T cell therapy for health care systems (in developed and in developing countries). This special issue will focus on the medical and scientific dimension incl. approved and emerging indications, new areas in medicine, advanced gene-transfer and gene-editing technologies, innovations in pre-clinical assessment (efficacy, toxicology, genomic safety), innovations in scalable automated manufacturing (bioprocessing), the implementation of high content data acquisition, machine learning and artificial intelligence, innovations in clinical trial design; and consider the ethical, socioeconomic and societal dimension of CAR T cells in particular and gene-engineered immune cell therapy in general.

This book describes important developments and emerging trends in experimental and clinical cancer gene therapy. It reflects the tremendous advances made over recent years with respect to immunogenes, suicide genes and gene correction therapies, as well as in gene suppression and miRNA therapies. Many of the described strategies focus on the generation of more efficient and specific means of attack at known and novel cellular targets associated with tumor development and progression. The book also details parallel improvements in vector design, vector delivery, and therapeutic efficacy. It offers readers a stimulating, broad overview of advances in the field, linking experimental strategies to their clinical applications.

Immunotherapy is a form of cancer therapy that harnesses the body's immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes. With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

This volume provides comprehensive methods from expert scientists working in the Chimeric Antigen Receptor T Cell (CAR-T Cell) field. Chapters guide readers through the state-of-art of CAR-T cell technology, CAR design and vector production, CAR-T cell generation and manufacturing, CAR-T cell characterization, and quality control. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Chimeric Antigen Receptor T Cells: Development and Production aims to be useful in the production of CAR-T cells, especially for therapeutic purposes.

The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.

These Guidelines are designed both for general users of patent information, as well as for those involved in producing Patent Landscape Reports (PLRs). They provide step-by-step instructions on how to prepare a PLR, as well as background information such as objectives, patent analytics, concepts and frameworks.