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OPEN Health’s response to the FDA’s guidance on long term follow up post gene therapy

Written by Gavin Jones, OPEN Health

The FDA has published their industry guidance on the topic of long term follow up (LTFU) post gene therapy. Please see a link to the full guidance below. In summary, they are stipulating that a good proportion of these therapies will require LTFU of up to fifteen years.

This presents significant challenge to manufacturers given that patients will, in that stretch of time, have multiple changes to their care settings and life circumstances. In addition to this, and if these therapies live up to their promise, treated ‘patients’ will potentially become chronically well and keen to disengage from their previous disease state and their healthcare professionals.

This is a significant challenge but achievable! We have already shared our experienced thinking on this topic and a link to our article is provided below. Our recommendations focus on putting the patient at the centre of a solution and wrapping a, digitally enabled, registry solution around thoughtful patient and healthcare professional engagement.

Please read our full thinking below:

http://edition.pagesuite-professional.co.uk/html5/reader/production/default.aspx?pubname=&edid=5cf08b2f-f3d9-435a-8255-ef07542eb9a3&pnum=31

https://www.fda.gov/media/113768/download

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Get in touch

If you would like to discuss further please contact our director of rare disease: gavinjones@openhealthgroup.com

29th January 2020

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OPEN Health

+44 1628 481112

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