Concurrent Session: ATMP - New Modality Processing Approaches|Innovative ATMP treatments for patients have come a long way since the first insertion gene therapy clinical trial in 1990. Since then over 3,000 clinical trials have been initiated with a growing number of therapeutics, addressing many complex and unmet needs, approved by regulators around the world. The technology platform is coming of age and this session shares some of the opportunities and challenges of bringing such processing to the next level. From the challenges of developing and designing facilities and processes for personalised, single patient treatments to the development of uniquely agile quality management systems the presentations in this session will focus on how the industry is responding while remaining aligned with the emerging regulatory guidance on such processing.
Director, Manufacturing Science and Technology,