This book focuses on the current developments and future perspectives on cell therapies. It includes chapters on new scientific developments, non-scientific challenges, standards development and brief summaries of the state of regulation in certain areas. Taken with its companion volume Advanced Cell Therapies: Experiences on the pathway, these two volumes provide perspectives from other professionals focused on supporting successful delivery of safe and effective cell therapy products including regulators, standards organisations and suppliers of raw materials and consulting services. It will draw authors from both North America, Europe and Asia and International organisations to provide a balance of approaches from different jurisdictions. The financial and legal realities of delivering such products will also be addressed by expert authors in the field. The ethical challenges in different parts of the world and for international translation of particular products will also be explored, with specifics provided. Cell Therapy: Current Developments and Future Directions and its companion volume are essential reading for researchers moving into translational science, industry and legal personnel wishing to understand cell therapies, regulators and policy makers developing regulation and guidelines, and advanced students researching this field.
The development of gene edited cell therapies: challenges and solutions
.- Combined advanced therapies: challenges and solutions.- Developing
advanced therapies in a challenging patent and legal environment:
perspectives on current and future cell therapies .- Developing Ethical
perspectives on advanced therapies and future challenges .- Modelling
adequate reimbursement for cell therapies .- Facilitating international
coordination of manufacturers and regulators .- The future of reference
materials for cell therapies .- Experiences Development of ISO standards for
cell therapies .- NIST activities in development of standards for cell
therapies .- FIRM and Japanese standardization initiative for regenerative
medicine .- The industry perspective: ARM SBC and ASTM .- Development of
cell therapy regulation: the Japanese experience.- MFDS and Korean regulation
.- Australian approaches to regulation .- EU regulatory processes for cell
therapy applications .- Canadian cell therapyregs .- Development of cell
therapy regulation: the US perspective.
Glyn Stacey has a background in microbiology and cancer research and has worked on the development of cell substrates for manufacture of biological medicines for over fifteen years. He is currently at the National Institute for Biological Standards and Control which is a part of the Medicines and Healthcare Products Regulatory Agency. He is Head of Division of Cell Biology and Imaging and Director for the UK Stem Cell Bank (UKSCB). The work of his group covers safety and quality issues in cell therapy, cells used for manufacturing purposes, development of novel cell-based assays and the development of reference materials for tissue typing and diagnosis of genetic disorders. This work includes the need for scale up of preservation techniques and long term storage of DNA and cell lines of various types including human stem cell lines and cells used in bioassays and vaccine production.
Tongbiao Zhao is a principal investigator at the Institute of Zoology, Chinese Academy of Sciences, where he leads the Laboratory of Stem Cell and Immunology. He also serves as Joint Deputy Dean of the Beijing Institute for Stem Cells and Regenerative Medicine and Joint Professor at the University of the Chinese Academy of Sciences. His research primarily focuses on stem cell immunology and translational stem cell research. His team has pioneered stem cell immunology; their seminal discovery of induced pluripotent stem cell immunogenicity has reshaped clinical strategies for stem cell translation, highlighting the need to induce immune tolerance. Additionally, his team has identified oxidative phosphorylation and heightened autophagic flux as intrinsic metabolic features critical for maintaining pluripotent stem cell identity. Serving as the Director of the Standard Working Committee of the Chinese Society for Cell Biology and as a member of TC276 of the International Organization for Standardization and the International Society for Stem Cell Research, he has coordinated interdisciplinary experts to develop standards supporting stem cell applications and achieved groundbreaking advancements, including the establishment of a series of seminal national and international stem cell standards.
