Cell and gene therapy represent a transformative advance in drug delivery and outcomes, with implications equally as important to human progress as the digital revolution that began three decades ago.In Vivo speaks with a key player in this evolving field, GE Healthcare’s strategy manager for cell and gene therapy and board member of the Alliance for Regenerative Medicine, Phil Vanek, PhD.
As the pipeline and market for novel cell and gene therapies expands, it is time for drug developers to address other critical aspects in the logistical chain – and for these complex therapies a lot of those issues relate to manufacturing. Looking at specific cases, In Vivo has underlined the main manufacturing challenges facing cell and gene therapy developers, and highlighted methods and approaches being used to generate solutions.
It has become standard practice for manufacturing to get early attention in the cell and gene therapy development, but logistics is often not considered until closer to commercialization, which could be a strategic mistake given the speed with which new treatments are being approved.
Industry and academic representatives shared viewpoints at Biotech Week Boston in September 2018, including what is unique about deal-making in the cell and gene field.
With a well characterized genetic driver, a clear marker to show whether it's working, and available treatments that carry high annual costs, hemophilia may be a good testing ground for commercializing gene therapy, but payers still have to work out how to reimburse the one-time medicines.
Scrip caught up with several companies during the recent Cell and Gene Meeting on the Mesa, sponsored by the Alliance for Regenerative Medicine.
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