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