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May 1, 2011 (Vol. 31, No. 9)

Cell Therapy Building on Momentum

Success of Dendreon's Provenge Illuminates Possibilities in this Fast-Growing Field

  • Where Next?

    As well as demonstrating the efficacy of many cell therapies, several key barriers to cell therapies becoming widely adopted in the U.K. were discussed. Funding and affordability were cited as problems. “Altrika has already been bankrupt once, but we were fortunate enough to be purchased by Ilika, so now we have the funding to continue our work in the U.K.,” Haddow stated. Dr. Mason added, “There needs to be an urgent step to change the way we calculate reimbursement. Cell therapies are aimed at cure and not conventional symptom control and disease management, therefore a combination of healthcare, employment, and social consequences need to be taken into consideration. “For example, the success of Provenge, Dendreon’s autologous cell therapy for the treatment of advanced prostate cancer, is helping investors to see that an autologous stem cell product that sells for $93,000 is a viable proposition because of its unique ability to significantly extend a patient’s life.” The complexity of the U.K.’s regulatory system was also seen as a potential barrier to success. “We have not suffered because of the science; we have safe cells that have been extensively preclinically tested,” stated Hunt. “They are straightforward to scale and bank, but it is the regulatory process that has slowed down our progress at times.

  • Analysis & Insight: A Clearer Regulatory Pathway for Cell Therapy May Help Improve Investment

    It isn’t just the U.K. that suffers from complicated guidelines for developing these types of treatments. The U.S. sector too is fraught with uncertainty, which has naturally kept most investors away from this field. Government and disease foundations have thus come to act as important funding providers for cell therapy R&D. To get all the details on regulatory and financing activities on both sides of the pond, read our story here.

  • “We have interacted with 12 licensing and regulatory bodies during the seven-year preclinical development of ReN001,” he continued. “Perhaps our licensing and regulatory bodies need to work more closely together or be consolidated to some extent to ensure that the regulation of cell therapy candidates in the U.K. is as efficient as possible.” Despite these problems, speakers at IBIZ were upbeat about the future of cell therapies in the U.K. As Dr. Habib summarized, “The U.K. is in a prime position, with companies such as Cell Medica showing us how you can use hospital and university centers to produce and distribute more affordable autologous cell therapies. There is also a great resilience seen with companies like Altrika and ReNeuron.

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