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Description
(Text)
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 alsobe 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.
(Table of content)
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.
