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. 2014 Feb;17(1):84-8.
doi: 10.1089/rej.2014.1545.

CASMI TSCC launch event, Paris, France, July 2013: an assessment of the key barriers to the commercialization and clinical adoption of pluripotent stem cell therapies

Anna French  1 , Kim Bure, David A Brindley
Affiliations

CASMI TSCC launch event, Paris, France, July 2013: an assessment of the key barriers to the commercialization and clinical adoption of pluripotent stem cell therapies

Anna French et al. Rejuvenation Res. 2014 Feb.

Abstract

The high incidence of unmet medical needs in combination with the rising burden of chronic diseases, linked to an increasingly aging population, necessitates new approaches to therapeutic intervention. One potential class of health care innovation that may offer an alternative approach to addressing current shortfalls is stem cell therapies. The CASMI Translational Stem Cell Consortium (CTSCC) was formed to elucidate the key hurdles to the commercialization and clinical adoption of stem cell technologies, with a particular focus on pluripotent stem cell (PSC) technologies. As a global pre-competitive academic-industry consortium, the CTSCC unites thought leaders from a range of sectors and technical specialties in defining and discovering solutions to roadblocks that will impede the field. Targeted toward stakeholder requirements at the delivery end of the translational spectrum, the CTSCC aims to provide mechanisms for multidirectional dialogue and to produce academically rigorous and commercially practicable research outputs to accelerate industry progress. On the 30th and 31st of July, 2013, the CASMI Translational Stem Cell Consortium (CTSCC) held a launch event at the Saint James Club, Paris, France.

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Figures

<b>FIG. 1.</b>
FIG. 1.
Prioritization of key challenges within focus areas: “Score” was assigned based on distance of the cumulative count for a question group component from the mean cumulative count within the question group. (A) Standards, (B) Regulation, (C) Intellectual Property (IP), (D) Biomanufacturing, (E) Strategic Partnerships (HSCI, Harvard Stem Cell Institute, US; CCRM, Centre for Commercialization of Regenerative Medicine, Canada; I-Stem, France; Cell Therapy Catapult, UK), and (F) Clinical Adoption. FDA, Food and Drug Administration; MHRA, Medicines and Healthcare Products Regulatory Agency; EMA, European Medicines Agency; PMDA, Pharmaceutical and Medical Devices Agency; iPS, induced pluripotent stem cells; IP, intellectual property; PSC, pluripotent stem cells; cGMP, current Good Manufacturing Practices; CMO, Contract Manufacturing Organization; COGs, Cost of Good; QbD, Quality by Design; DOE, design of experiments; CTs, cell therapies.
See this image and copyright information in PMC

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