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<p>List of contributors vii</p> <p>Foreword xi</p> <p>Preface xiii</p> <p><b>Part I: The stem cell business</b></p> <p>1 Therapeutic stem cells answer a strategic breakthrough need of healthcare 3<br /><i>Alain A. Vertès</i></p> <p>2 Ethical considerations on the research and business of stem cells 27<br /><i>Ljiljana Minwalla</i></p> <p>3 Projected growth of the world-wide stem cell market 43<br /><i>Ed Field</i></p> <p>4 Cell therapy manufacturing: identifying and meeting demand 49<br /><i>Jessica Carmen David A. Brindley Natasha L. Davie and David Smith</i></p> <p>5 The history of stem cell transplantation 69<br /><i>Hillard M. Lazarus and Stanton L. Gerson</i></p> <p>6 Regulatory and intellectual property considerations for therapeutic human stem cell-based regenerative medicine product development: a US perspective 87<br /><i>Michael Mendicino and Darin Weber</i></p> <p>7 The regulation of stem cells in the UK and the EU 125<br /><i>Alex Denoon Julian Hitchcock and James Lawford Davies</i></p> <p><b>Part II: Stem cells as research tools</b></p> <p>8 The business of stem cell research tools 149<br /><i>Erik Miljan</i></p> <p>9 Stem cell-derived cardiomyocytes and hepatocytes as tools for drug development and screening applications 171<br /><i>Kate Cameron Howard Marriage David Hay and Claire Medine</i></p> <p>10 Stem cell tools for compound development 193<br /><i>Thomas J. Novak</i></p> <p>11 Stem cell origin of cancer: prospects for functional therapeutics and regenerative medicine 215<br /><i>Vinagolu K. Rajasekhar</i></p> <p><b>Part III: Stem cells as veterinary medicines</b></p> <p>12 The market for stem cell medicines for domestic and high value animals 247<br /><i>Robert J. Harman</i></p> <p>13 Stem cells in veterinary medicine: a conceptual approach 257<br /><i>John Peroni and Lindsey Boone</i></p> <p>14 Stem cell veterinary medicines: a practical approach 275<br /><i>Robert J. Harman</i></p> <p>15 Stem cell veterinary medicines as signs pointing towards successful human stem cell therapeutics 289<br /><i>Alain A. Vertès</i></p> <p><b>Part IV: Stem cell therapeutics</b></p> <p>16 Animal models in regenerative medicine 303<br /><i>Andrew N. Bubak John D. Elsworth and John R. Sladek Jr.</i></p> <p>17 Stem cell characterisation: a guide to stem cell types technologies and future applications 317<br /><i>Justin Lo Re Rezma Shrestha and Leonard Sciorra</i></p> <p>18 Stem cell value chains 341<br /><i>Judy Muller-Cohn Paul Diaz and Rolf Muller</i></p> <p>19 Stem cell culture processes 355<br /><i>Ravali Raju Shikha Sharma and Wei-Shou Hu</i></p> <p>20 Indication transformation maps and the challenge of live cell delivery 375<br /><i>Robert Deans and Lee E. Babiss</i></p> <p>21 Delivery and targeting of therapeutic cells 387<br /><i>Paul Lin Arnold I. Caplan and Erkki Ruoslahti</i></p> <p>22 Hematopoietics stem cells 397<br /><i>Stephen D. Wolpe and Lynnet Koh</i></p> <p>23 MSCs: the new medicine 415<br /><i>Arnold I. Caplan</i></p> <p>24 Innovation and commercialisation of induced pluripotent stem cells 423<br /><i>Shintaro Sengoku</i></p> <p>25 Embryonic stem cells 447<br /><i>Rachel Eiges Naomi Zak Benjamin E. Reubinoff and Charles S. Irving</i></p> <p>26 Allogeneic versus autologous stem cell transplantation in regenerative medicine 487<br /><i>Katarzyna A. Trzaska-Accurso and Pranela Rameshwar</i></p> <p><b>Part V: Perspectives</b></p> <p>27 Immunological barriers to regenerative medicine: do they matter? 499<br /><i>Cristina Trento and Francesco Dazzi</i></p> <p>28 Challenges in the clinical development of stem cells 511<br /><i>John P. Caulfield</i></p> <p>29 Pricing and reimbursement of regenerative medicines 525<br /><i>Nathan J. Dowden</i></p> <p>30 The role of patient advocacy in the clinical translation of regenerative medicine 543<br /><i>Bernard Siegel and Alan L. Jakimo</i></p> <p>31 Financing strategies for regenerative medicine start-ups 615<br /><i>Carol Julie Walton Lee Buckler and Gregory A. Bonfiglio</i></p> <p>32 Strategic alliances mergers and acquisitions in regenerative medicine 643<br /><i>Nafees N. Malik Timothy E. Allsopp and Devyn M. Smith</i></p> <p>33 History of monoclonal antibodies and lessons for the development of stem cell therapeutics 665<br /><i>Alain A. Vertès and Nathan J. Dowden</i></p> <p>34 Deployment of stem cell technologies in industry and healthcare 693<br /><i>Alain A. Vertès</i></p> <p>Index 723</p>

<p><b>Alain A. Vertès,</b> <b><i>London Business School, London, UK</i></b><br /> <br /> <b>Nasib Qureshi, <i>United States Department of Agriculture (ARS), National Center for Agricultural</i><br /> <i>Utilization Research, Illinois, USA</i></b></p> <p><b>Arnold I. Caplan,</b> <b><i>Case Western Reserve University, Ohio, USA</i></b><br /> <b><br /> Lee Babiss,</b> <b><i>Pharmaceutical Product Development, North Carolina, USA</i></b></p>

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

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