Citations 2
Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study
Davies, Benjamin M. , Rikabi, Sarah , French, Anna , Pinedo‐Villanueva, Rafael , Wartolowska, Karolina , Judge, Andrew , MacLaren, Robert E. , Mathur, Anthony , Williams, David , Wall, Ivan , Birchall, Martin , Reeve, Brock , Barker, Richard , Cui, Zhanfeng , Bure, Kim, Snyder, Evan Y., Carr, Andrew , Morrey, Mark E. , Atala, Anthony , Furniss, Dominic , Karp, Jeffrey M. , Price, Andrew James , Brindley, David A.
Journal of Tissue Engineering | September 23, 2014 | Volume: 5 | Issue: No issue available | Pages: No page available
There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.
The Implementation of Novel Collaborative Structures for the Identification and Resolution of Barriers to Pluripotent Stem Cell Translation
French, Anna , Suh, Jane, Roberts, Mackenna, Davies, Benjamin M. , Pinedo‐Villanueva, Rafael , Wartolowska, Karolina , Rooke, Kelly, Kramm, Anneke, Judge, Andrew , Chandra, Amit , Hurley, Hannah, Grover, Liam M. , Bingham, Ian, Siegel, Bernard, Rattley, Matt S., Buckler, R. Lee, McKeon, David, Krumholz, Katie, Hook, Lilian , Rikabi, Sarah , Pigott, Rosie, Morys-Carter, Megan M. , Sabokbar, Afsie, Titus, Emily, Laâbi, Yacine, Zahkia, Raymond, Sipp, Douglas , Horne, Robert , Bravery, Christopher A., Williams, David , Wall, Ivan , Snyder, Evan Y., Barker, Richard , Bure, Kim, Reeve, Brock , Brindley, David A. , Morrey, Mark E. , May, Michael E , Lemaı̂tre, Gilles , Karp, Jeffrey M. , Carr, Andrew Jonathan , Horne, Rob
Stem Cells and Development | December 4, 2013 | Volume: 22 | Issue: 1_suppl | Pages: 63-72
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 efficiency with which biomedical ecosystems interact to deliver safe, efficacious 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 defined through continuous consultation with its international funding and research partners. Herein, initial findings 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.