The Implementation of Novel Collaborative Structures for the Identification and Resolution of Barriers to Pluripotent Stem Cell Translation

Abstract

Increased global connectivity has catalyzed technological development in almost all industries, in part through the facilitation of novel collaborative structures. Notably, open innovation and crowd-sourcing-of expertise and/ or funding-has tremendous potential to increase the effi ciency with which biomedical ecosystems interact to deliver safe, effi cacious and affordable therapies to patients. Consequently, such practices offer tremendous potential in advancing development of cellular therapies.In this vein, the CASMI Translational Stem Cell Consortium (CTSCC) was formed to unite global thought-leaders, producing academically rigorous and commercially practicable solutions to a range of challenges in pluripotent stem cell translation. Critically, the CTSCC research agenda is defi ned through continuous consultation with its international funding and research partners.Herein, initial fi ndings for all research focus areas are presented to inform global product development strategies, and to stimulate continued industry interaction around biomanufacturing, strategic partnerships, standards, regulation and intellectual property and clinical adoption.

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

“…20,21 The CTSCC was formed to unify international and multidisciplinary luminaries from major stakeholder groups to break down translational barriers. 1,22 Through disseminating timely and clear findings reflecting contemporary opinions of sector leaders, the aim of this effort will make a practicable contribution to stem cell translation.…”

“…1,23 And in so doing, de-risking and maximizing the overall research and development product of the field ultimately benefits patients suffering with debilitating diseases.…”

“…1 The resulting questionnaire was completed by 20 opinion leaders and senior managers, importantly with balanced representation from industry, academia, and translation center/other (Fig. S1) (Supplementary Data are available at www.liebertonline.com/ rej/).…”

Application of biomaterials to advance induced pluripotent stem cell research and therapy

“…When considering the potential of bringing exogenous iPSC progeny to the clinic, scaling up with batch‐to‐batch consistency becomes a primary concern (Brindley et al , ). For that reason, synthetic peptide‐functionalized substrates may be challenging owing to their high manufacturing costs and extra conjugation steps (Place et al , ).…”

StemBANCC: Governing Access to Material and Data in a Large Stem Cell Research Consortium

“…Although access to materials and data has been identified as especially critical to stem cell science [ 13 ] it has been suggested that the stem cell community has been somewhat slower to respond to the changing frameworks of biomedical innovation and translation. [ 4 ] Unlike genomic and other medical data, which can readily be digitised and shared through Information Communication Technology (ICT) platforms, stem cell research (SCR) involves material biological objects, which can only be shared through physical transportation between locations and partners. SCR therefore at least potentially raises different and unique challenges for sharing material and data amongst large academic industry research consortia.…”