Stem Cells in Regenerative Medicine: Science, Regulation and Business Strategies

Stem cells, as therapeutic agents or as research or diagnostics tools, represent an emerging technology with a transformational potential that parallels the paradigm shift operated by the development of monoclonal antibodies in the 1990s, or even the coming of age of genetic engineering technology platforms in the 1980s. Those working with stem cell technologies face a complex matrix of ethical, regulatory, policy, logistics, supply chain, manufacturing, pricing and reimbursement challenges.

This book is a unique guide to emerging stem cell technologies and the opportunities for their commercialisation. It provides in–depth analyses of the science, business, legal, and financing fundamentals of stem cell technologies, offering a holistic assessment of this emerging and dynamic segment of the field of regenerative medicine.

Reviews the very latest advances in the technology and business of stem cells used for therapy, research, and diagnostics
Identifies key challenges to the commercialisation of stem cell technology and avenues to overcome problems in the pipeline
Written by an expert team with extensive experience in the business, basic and applied science of stem cell research

This comprehensive volume is essential reading for researchers in cell biology, biotechnology, regenerative medicine, and tissue engineering, including scientists and professionals, looking to enter commercial biotechnology fields. It is valuable for R&D staff in academia, biotechnology and pharmaceutical companies,
and professionals from consulting firms, regulatory agencies, and patenting offices, also to business and scientific managers, venture capitalists, business development professionals, corporate strategists, policy makers, patient advocates, and healthcare payers. It also constitutes a useful resource as a textbook to support science and
business students looking into courses in the field of regenerative medicine.

Alain A. Vertès, London Business School, London, UK

Nasib Qureshi, United States Department of Agriculture (ARS), National Center for Agricultural
Utilization Research, Illinois, USA

Arnold I. Caplan, Case Western Reserve University, Ohio, USA

Lee Babiss, Pharmaceutical Product Development, North Carolina, USA