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Taking stem cells from bench to business
Despite being a predominantly scientific conference, ISSCR 2014 dedicated several sessions to the business side of stem cell technologies and therapeutics development. As Senior Scientific Advisor of the California Institute for Regenerative Medicine Alan Trounson challenged, stem cell researchers and organizations need to shift from a “cottage industry” mindset and be prepared to gear their efforts up to industrial strength. A lot of interesting work is being done on very small scales, he says, but to have any impact on patients, there will need to be a shift to a manufacturing headspace, which means taking a more integrated approach to development that covers all of the steps from cell transformation to patient access.
Partnerships between academia and industry are going to be vital to this transition, Trounson and several other speakers suggested, but because of the high investment costs involved in transitioning a prospective product from the bench to production facilities, government agencies may need to play a greater role as facilitator.
For example, Cell Therapy Catapult CSO Johan Hyllner described their efforts in the United Kingdom to build manufacturing capabilities for late-stage trials that companies can lease or contract for services. Using government-managed facilities and services, companies and academic centers can mitigate some of the financial risks involved in exploring new therapeutic modalities. The centers can also serve to educate clinicians and regulatory authorities on the new realities presented by stem cells, which are clearly unlike the small molecules or even biologics to which both groups are more accustomed.
When directly asked what was in it for the taxpayer, Hyllner described the UK experience with monoclonal antibodies, which he says were largely developed in the UK but commercialized elsewhere; all investment with little financial reward. As he explained with stem cells, they don’t want to repeat the commercial mistakes of the past.