Special Report

Senior Director, Strategic Management Group, Pfizer Global R&D, 50 Pequot Avenue, MS6025-C4171, New London, CT 06320, USA.

Email the corresponding author at devyn.m.smith@pfizer.com

Published Online:15 Jul 2010https://doi.org/10.2217/rme.10.50

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Abstract

Induced pluripotent stem (iPS) cells have generated excitement in the regenerative medicine industry. Products derived from iPS cells could be used in a range of drug discovery and development processes. These nontherapeutic products will continue to be launched over the next 5 years, and provide income and knowledge to drive the therapeutic use of iPS cells forward. While the commercial opportunity for iPS cell-based therapies is potentially large, the looming technical and scientific hurdles must be overcome and, thus, the launch of a therapy based on iPS cells is unlikely to occur until the 2020s. While the launch of a therapeutic is many years away, the business models for commercialization should be well understood and proven based on experience with other non-iPS cell-based therapies (both autologous and allogeneic) that will already be on the market.

Keywords:

Papers of special note have been highlighted as: ▪ of interest ▪▪ of considerable interest

Bibliography

1 Mason C: Regenerative Medicine 2.0. Regen. Med.2(1),11–18 (2007).
Google Scholar
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).▪ An interesting analysis of barriers to commercialization based on interviews performed in the UK. The findings are directly applicable to most other regions of the world.
Google Scholar
3 Mason C, Manzotti E: Induced pluripotent stem cells: an emerging technology platform and the Gartner hype cycle. Regen. Med.4,329–331 (2009).
Google Scholar
4 Takahashi K, Yamanaka S: Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell126,663–676 (2006).▪▪ First paper that documented the creation of induced pluripotent stem (iPS) cells and is a must read in the iPS arena.
Medline CASGoogle Scholar
5 Takahasi K, Tanabe K, Ohnuki M et al.: Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell131,861–872 (2007).
MedlineGoogle Scholar
6 Oikita K, Ichisaka T, Yamanaka S: Generation of germline competent induced pluripotent stem cells. Nature448,313–317 (2007).
MedlineGoogle Scholar
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).
Medline CASGoogle Scholar
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).
Medline CASGoogle Scholar
9 Kiskinis E, Eggan K: Progress toward the clinical application of patient-specific pluripotent stem cells. J. Clin. Invest.120,51–59 (2010).▪▪ Excellent review of the applications of iPS cells as both therapies and as R&D enabling tools.
Medline CASGoogle Scholar
10 Rolletschek A, Wobus AM: Induced human pluripotent stem cells: promises and open questions. Biol. Chem.390,845–849 (2009).
Medline CASGoogle Scholar
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 Cell28(4),704–712 (2010).
MedlineGoogle Scholar
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).
MedlineGoogle Scholar
13 Baker M: Testing time for stem cells. Nature463,719 (2010).
Medline CASGoogle Scholar
14 Ledford H: In search of a viable business model. Nat. Rep. Stem Cells2(3),351–374 (2007).
Google Scholar
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).
CASGoogle Scholar
16 Kettenhofen R, Bohlen H: Preclinical assessment of cardiac toxicity. Drug Discov. Today13,702–707 (2008).
Medline CASGoogle Scholar
17 Gintant G: Pre-clinical cardiac toxicity: testing compounds beyond hERG. Int. Drug Discov.3(5),12–19 (2008).
Google Scholar
18 Lee WM: Drug-induced hepatotoxicity. N. Engl. J. Med.349,474–485 (2003).
Medline CASGoogle Scholar
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).
Medline CASGoogle Scholar
20 Webb S: The gold rush for induced pluripotent stem cells. Nat. Biotechnol.27,977–979 (2009).▪▪ Good review of the state of the iPS field including challenges facing intellectual property.
Medline CASGoogle Scholar
21 McBride R: Stem Cell firms shift from treatments to tools. The Boston Globe, 5 June (2008).
Google Scholar
22 Barthelemy N: Investor presentation. Presented at: Life Technologies Investor Day. Cell Systems, Carlsbad, CA, USA, 2 June 2010.
Google Scholar
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).
Google Scholar
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).
Google Scholar
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).
Google Scholar
101 Cellular Dynamics International www.cellulardynamics.com
Google Scholar
102 Cellartis www.cellartis.com
Google Scholar
103 Vistagen www.vistagen.com
Google Scholar
104 iPierian www.izumibio.com
Google Scholar
105 Fate Therapeutics www.fatetherapeutics.com
Google Scholar
106 Stemgent www.stemgent.com
Google Scholar
107 MHT: Stemgent, Fate Therapeutics launch stem cell platform www.masshightech.com/stories/2009/04/20/daily39-Stemgent-Fate-Therapeutics-launch-stem-cell-platform-.html
Google Scholar
108 ArunA Biomedical, Inc. http://arunabiomedical.com/index.php
Google Scholar
109 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
Google Scholar
110 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
Google Scholar
111 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
Google Scholar
112 Life Technologies www.lifetechnologies.com/about-life-technologies/history.html▪ Invitrogen acquired 15 companies in 3 years as it bought up small companies to bolster its product portfolio
Google Scholar
113 Geron www.geron.com
Google Scholar
114 ADIS Insight www.adisinsight.com
Google Scholar
115 Cytori www.cytoritx.com
Google Scholar
116 Genzyme (see annual report) www.genzyme.com
Google Scholar
117 Viacord www.viacord.com
Google Scholar
118 CHDI Foundation www.highqfoundation.org
Google Scholar
119 Juvenile Diabetes Research Foundation International www.jdrf.org
Google Scholar
120 Advanced Cell Technology www.advancedcell.com
Google Scholar
121 BD www.bd.com
Google Scholar
122 Biotime, Inc. www.biotimeinc.com
Google Scholar
123 GlaxoSmithKline www.gsk.com
Google Scholar
124 International Stem Cell Corporation www.internationalstemcell.com
Google Scholar
125 Pfizer www.pfizer.com
Google Scholar
126 Medtronic www.medtronic.com
Google Scholar
127 Boston Scientific www.bostonscientific.com
Google Scholar
128 Consumer Watchdog www.consumerwatchdog.org/patients/articles//?storyId=13759&bIndex=5
Google Scholar
129 Product Launch PR www.productlaunchpr.com/PRODUCTLAUNCHPR.COM/Pharmaceutical_Consulting_%26_Sales_in_Puerto_Rico.html
Google Scholar
130 PAREXEL www.parexel.com
Google Scholar

Vol. 5, No. 4

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History

Published online 15 July 2010

Published in print July 2010

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Acknowledgements

The author would like to thank his Pfizer colleagues in the Regenerative Medicine Research Unit for useful discussions during the preparation of this manuscript.

Financial & competing interests disclosure

D Smith is a fulltime employee of Pfizer, Inc. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

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Commercialization challenges associated with induced pluripotent stem cell-based products

Abstract

Bibliography