Author(s): Emily J Culme-Seymour aff1 , James Lawford Davies aff2 , Julian Hitchcock aff3 , Julian Mason aff4 , Melissa K Carpenter aff5 , Chris Mason [*] aff6
cell therapy; regulation; translation
Cell therapy has recently boomed with dramatic increases in investment, clinical efficacy, deals and partnerships, and government support. A requirement to focus on successful translation remains, with numerous groups dedicating research efforts toward novel business models, manufacturing solutions and regulatory strategies. With these latter considerations in mind, the Cell Therapy Regulatory Toolkit has been put together and is now available free of charge to use at [1 ].
The Cell Therapy Regulatory Toolkit was devised by the London Regenerative Medicine Network (LRMN; London, UK), and developed with assistance from Lawford Davies Denoon (London, UK) and Carpenter Group Consulting, Inc. (WA, USA). The toolkit is designed to inform users about licensing, consent and banking requirements associated with different types of cellular products. It also provides details about applicable regulations, product classifications, manufacturing requirements, possible exemptions and available incentives. It is intended to be informative and educational, rather than providing tailored regulatory guidance, and was developed as an online capability in the first instance to ensure ease of access.
Due to the challenges of creating a globally relevant 'generic' tool, there are two different sections to the toolkit: one pertaining to the UK and EU regions, and the other covering the USA. Each section can be accessed from the other, or from the LRMN holding page.
The UK and EU site contains information in five main sections: banking, consent, licensing, therapy and incentives. The fourth section, therapy, incorporates a comprehensive plan for informing those developing cells as therapeutic products, covering the relevant directives, regulations and classifications - all of which is easily navigated to from the home page (Figure 1). Users are taken through a series of questions designed to guide them to useful information relevant to their product, including a number of options to 'see more', where further background and supporting information relating to any complexities of the question...