Commercialization challenges associated with induced pluripotent stem cell-based products

Regenerative Medicine

Volumn 5, Issue 4, 2010, Pages 593-603

  Smith, Devyn ^a  

^a PFIZER INC   (United States)

Author keywords

allogeneic; autologous; business models; induced pluripotent stem cells; research tools; therapeutic products

Indexed keywords

ALLOGENEIC STEM CELL TRANSPLANTATION; CARCINOGENESIS; CELL DIFFERENTIATION; CELL POPULATION; CELL THERAPY; COMMERCIAL PHENOMENA; DRUG INDUSTRY; EMBRYONIC STEM CELL; FIBROBLAST; HEART MUSCLE CELL; HIGH THROUGHPUT SCREENING; HUMAN; IN VITRO STUDY; MOLECULAR DYNAMICS; NONHUMAN; PLURIPOTENT STEM CELL; PRIORITY JOURNAL; REGENERATIVE MEDICINE; REVIEW;

HUMANS; INDUCED PLURIPOTENT STEM CELLS; MARKETING OF HEALTH SERVICES; REGENERATIVE MEDICINE;

EID: 77954805151     PISSN: 17460751     EISSN: None     Source Type: Journal    
DOI: 10.2217/rme.10.50     Document Type: Review

References (55)

1. Mason C: Regenerative Medicine 2.0. Regen. Med. 2(1), 11-18 (2007).
2. Plagnol AD, Rowley E, Martin P, Livesey F: Industry perceptions of barriers to commercialization of regenerative medicine products in the UK. Regen. Med. 4, 549-559 (2009).
3. Mason C, Manzotti E: Induced pluripotent stem cells: an emerging technology platform and the Gartner hype cycle. Regen. Med. 4, 329-331 (2009).
4. Takahashi K, Yamanaka S: Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 126, 663-676 (2006).
5. Takahasi K, Tanabe K, Ohnuki M, et al.: Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell 131, 861-872 (2007).
6. Oikita K, Ichisaka T, Yamanaka S: Generation of germline competent induced pluripotent stem cells. Nature 448, 313-317 (2007).
7. Gunaseeli I, Doss MX, Antzelevitch C, Hescheler J, Sachinidis A: Induced pluripotent stem cells as a model for accelerated patient- and disease-specific drug discovery. Curr. Med. Chem. 17(8), 759-766 (2010).
8. Shi Y: Induced pluripotent stem cells, new tools for drug discovery and new hope for stem cell therapies. Curr. Mol. Pharmacol. 2, 15-18 (2009).
9. Kiskinis E, Eggan K: Progress toward the clinical application of patient-specific pluripotent stem cells. J. Clin. Invest. 120, 51-59 (2010).
10. Rolletschek A, Wobus AM: Induced human pluripotent stem cells: promises and open questions. Biol. Chem. 390, 845-849 (2009).
11. Feng Q, Lu S-J, Klimanskaya I, et al.: Hemangioblastic derivatives from human induced pluripotent stem cells exhibit limited expansion and early senescence. Stem Cell 28(4), 704-712 (2010).
12. Das AK, Pal R: Induced pluripotent stem cells (iPSCs): the emergence of a new champion in stem cell technology-driven biomedical application. J. Tissue Eng. Regen. Med. doi:10.1002/term.258 (2010) (Epub ahead of print).
13. Baker M: Testing time for stem cells. Nature 463, 719 (2010).
14. Ledford H: In search of a viable business model. Nat. Rep. Stem Cells 2(3), 351-374 (2007).
15. Rowntree RK, McNeish JD: Induced pluripotent stem cells: opportunities as research and development tools in 21st century drug discovery. Reg. Med. 5(4), 557-568 (2010).
16. Kettenhofen R, Bohlen H: Preclinical assessment of cardiac toxicity. Drug Discov. Today 13, 702-707 (2008).
17. Gintant G: Pre-clinical cardiac toxicity: testing compounds beyond hERG. Int. Drug Discov. 3(5), 12-19 (2008).
18. Lee WM: Drug-induced hepatotoxicity. N. Engl. J. Med. 349, 474-485 (2003).
19. Cornwell PD, Ulricht PD: Investigating the mechanistic basis for hepatic toxicity induced by an experimental chemokine receptor 5 (CCR5) antagonist using a compendium of gene expression profiles. Toxicol. Pathol. 35, 576-588 (2007).
20. Webb S: The gold rush for induced pluripotent stem cells. Nat. Biotechnol. 27, 977-979 (2009).
21. McBride R: Stem Cell firms shift from treatments to tools. The Boston Globe, 5 June (2008).
22. Barthelemy N: Investor presentation. Presented at: Life Technologies Investor Day. Cell Systems, Carlsbad, CA, USA, 2 June 2010.
23. Smith D: Creating partnerships with large pharma? getting ready for the big day. In: The World Stem Cell Report 2009. Siegal B (Ed.). Genetics Policy Institute, FL, USA 131-137 (2009).
24. Smith D: Successful business models for cell-based therapies. In: The World Stem Cell Report 2008. Siegal B (Ed.). Genetics Policy Institute, FL, USA 158-162 (2008).
25. Martin P, Brown N, Turner A: Capitalizing hope: the commercial development of umbilical cord blood stem cell banking. New Genet. Soc. 27, 127-143 (2008).
26. Cellular Dynamics International www.cellulardynamics.com
27. Cellartis www.cellartis.com
28. Vistagen www.vistagen.com
29. iPierian www.izumibio.com
30. Fate Therapeutics www.fatetherapeutics.com
31. Stemgent www.stemgent.com
32. MHT: Stemgent, Fate Therapeutics launch stem cell platform www.masshightech.com/stories/2009/04/20/ daily39-Stemgent-Fate-Therapeutics- launch-stem-cell-platform-.html
33. ArunA Biomedical, Inc. http://arunabiomedical.com/index.php
34. Drug Discovery News. Cellular Dynamics International reprograms blood cells into stem cells using a small volume of human blood www.drugdiscoverynews. com/index. php?newsarticle=3129
35. Free Press Release. The market size of stem cell research products is expanding through double digit growth www.free-press-release.com/ news/200902/1235794980.html
36. Ubiquigent: Stemgent invests $4.5 million, announces formation of ubiquigent, a new UK-listed biotechnology company based in Dundee, Scotland www.ubiquigent.com/stemgent-ubiquigent- release.php
37. Life Technologies www.lifetechnologies.com/about-life-technologies/ history.html
38. Geron www.geron.com
39. ADIS Insight www.adisinsight.com
40. Cytori www.cytoritx.com
41. Genzyme (see annual report) www.genzyme.com
42. Viacord www.viacord.com
43. CHDI Foundation www.highqfoundation.org
44. Juvenile Diabetes Research Foundation International www.jdrf.org
45. Advanced Cell Technology www.advancedcell.com
46. BD www.bd.com
47. Biotime, Inc. www.biotimeinc.com
48. GlaxoSmithKline www.gsk.com
49. International Stem Cell Corporation www.internationalstemcell.com
50. Pfizer www.pfizer.com
51. Medtronic www.medtronic.com
52. Boston Scientific www.bostonscientific.com
53. Consumer Watchdog www.consumerwatchdog.org/patients/articles//?storyId= 13759&bIndex=5
54. Product Launch PR www.productlaunchpr.com/ PRODUCTLAUNCHPR.COM/ Pharmaceutical-Consulting-%26-Sales-in- Puerto-Rico.html
55. PAREXEL www.parexel.com