Stem Cells in Regenerative Medicine

Alain A. Vertès, London Business School, London, UK Nasib Qureshi, United States Department of Agriculture (ARS), National Center for AgriculturalUtilization Research, Illinois, USAArnold I. Caplan, Case Western Reserve University, Ohio, USA Lee Babiss, Pharmaceutical Product Development, North Carolina, USA

• List of contributors viiForeword xiPreface xiiiPart I: The stem cell business1 Therapeutic stem cells answer a strategic breakthrough need of healthcare 3Alain A. Vertès2 Ethical considerations on the research and business of stem cells 27Ljiljana Minwalla3 Projected growth of the world-wide stem cell market 43Ed Field4 Cell therapy manufacturing: identifying and meeting demand 49Jessica Carmen David A. Brindley Natasha L. Davie and David Smith5 The history of stem cell transplantation 69Hillard M. Lazarus and Stanton L. Gerson6 Regulatory and intellectual property considerations for therapeutic human stem cell-based regenerative medicine product development: a US perspective 87Michael Mendicino and Darin Weber7 The regulation of stem cells in the UK and the EU 125Alex Denoon Julian Hitchcock and James Lawford DaviesPart II: Stem cells as research tools8 The business of stem cell research tools 149Erik Miljan9 Stem cell-derived cardiomyocytes and hepatocytes as tools for drug development and screening applications 171Kate Cameron Howard Marriage David Hay and Claire Medine10 Stem cell tools for compound development 193Thomas J. Novak11 Stem cell origin of cancer: prospects for functional therapeutics and regenerative medicine 215Vinagolu K. RajasekharPart III: Stem cells as veterinary medicines12 The market for stem cell medicines for domestic and high value animals 247Robert J. Harman13 Stem cells in veterinary medicine: a conceptual approach 257John Peroni and Lindsey Boone14 Stem cell veterinary medicines: a practical approach 275Robert J. Harman15 Stem cell veterinary medicines as signs pointing towards successful human stem cell therapeutics 289Alain A. VertèsPart IV: Stem cell therapeutics16 Animal models in regenerative medicine 303Andrew N. Bubak John D. Elsworth and John R. Sladek Jr.17 Stem cell characterisation: a guide to stem cell types technologies and future applications 317Justin Lo Re Rezma Shrestha and Leonard Sciorra18 Stem cell value chains 341Judy Muller-Cohn Paul Diaz and Rolf Muller19 Stem cell culture processes 355Ravali Raju Shikha Sharma and Wei-Shou Hu20 Indication transformation maps and the challenge of live cell delivery 375Robert Deans and Lee E. Babiss21 Delivery and targeting of therapeutic cells 387Paul Lin Arnold I. Caplan and Erkki Ruoslahti22 Hematopoietics stem cells 397Stephen D. Wolpe and Lynnet Koh23 MSCs: the new medicine 415Arnold I. Caplan24 Innovation and commercialisation of induced pluripotent stem cells 423Shintaro Sengoku25 Embryonic stem cells 447Rachel Eiges Naomi Zak Benjamin E. Reubinoff and Charles S. Irving26 Allogeneic versus autologous stem cell transplantation in regenerative medicine 487Katarzyna A. Trzaska-Accurso and Pranela RameshwarPart V: Perspectives27 Immunological barriers to regenerative medicine: do they matter? 499Cristina Trento and Francesco Dazzi28 Challenges in the clinical development of stem cells 511John P. Caulfield29 Pricing and reimbursement of regenerative medicines 525Nathan J. Dowden30 The role of patient advocacy in the clinical translation of regenerative medicine 543Bernard Siegel and Alan L. Jakimo31 Financing strategies for regenerative medicine start-ups 615Carol Julie Walton Lee Buckler and Gregory A. Bonfiglio32 Strategic alliances mergers and acquisitions in regenerative medicine 643Nafees N. Malik Timothy E. Allsopp and Devyn M. Smith33 History of monoclonal antibodies and lessons for the development of stem cell therapeutics 665Alain A. Vertès and Nathan J. Dowden34 Deployment of stem cell technologies in industry and healthcare 693Alain A. VertèsIndex 723