Stem Cells Live: Pathways to Market Begin to Clear for Regenerative Medicine Products

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The world stem cell and regenerative medicine congress began today with a series of captivating keynote interviews conducted by regenerative medicine stalwart, Chris Mason.

First to join Prof. Mason was the Cell Therapy Catapult’s (CTC) CEO, Keith Thomspon. The CTC was set up approximately 2 years ago in order to help translate promising clinical research in the regenerative medicine arena to commercial products manufactured via robust bioprocesses. Lauding the role of the government in promoting and supporting the UK’s regenerative medicine sector both financially and legislatively, Mr Thompson described how the path towards commercialisation was beginning to clear for those involved in translational research in this area. Indeed, he added that more and more figures in the cell therapy sector now “understood the bet”, suggesting that it is becoming easier to balance risk and reward in commercialisation of research in this field. The delegate from the CTC also revealed plans for a £55m (~$80m), 5,000m2 large scale bioprocess facility that will more than triple the current clean room capacity in the UK aimed at kick-starting commercial scale production of cell therapy products in Britain.

The focus of the interviews then shifted to new trends in the regulation of advanced therapies. Prof. Mason spoke with the Vice Chair of the EMA’s Committee for Advanced Therapies (CAT), Dr Paula Salmikangas and subsequently, Dr Masakazu Hirata from Japan’s Pharmaceutical and Medical Devices Agency (PMDA). Both interviewees focused on the new pathways being forged by regulatory bodies to ameliorate commercialisation of advanced therapies. Dr Salmikangas outlined the EMA’s plan to introduce adaptive licensing to its member states. Classification of eligible products for this scheme – which would authorise advanced therapies for restricted populations based on early clinical trials, before using data gained from this initial licensing to gain market approval for broader population spectrums – is still ongoing. Dr Salmikangas concluded by inviting organisations to sign up to the CATs Interested Parties scheme that allows its readers first access to breaking information and opportunities to help discuss future regulatory guidelines.

Dr. Hirota, from Japan’s PMDA, chose to focus upon new laws adopted in Japan based on the need to update regulation of regenerative medicine technologies in Japan. Two new acts were described by Dr Hirota, which are aimed at creating a new framework designed to encourage and secure the provision of regenerative medicine products in the timely mannered required by the Japanese public. Updates to current regulations include a provision for “conditional licensing” of cell therapy products, which is not dissimilar to the adaptive licensing scheme currently being introduced by the EMA. When asked about the future of cell therapies, Dr Hirota commented that he hoped Japan’s new laws would see an increase in the number of cell therapies gaining market approval through the new conditional licensing programme.

In an upbeat start to the conference, all three interviewees gave optimistic forecasts for the regenerative medicine sector in the coming year.

Michael Jenkins for Terrapinn at WSCRM Congress, London

Twitter: @MJ_Jenks

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