After a brief hiatus, I’m blogging again and there’s a few important things we need to catch up on.
The end of 2023 came with a surprise in the form of a Federal Register Notice to inform us that the FDA would require SENDIG-Genetox v1.0 for studies starting March 2025. Even for those of us that spend far too much of our time trying to guess the agency’s timelines, this came at least a year earlier than we were expecting, based on past behavior. Don’t get me wrong, I’m welcoming this accelerated adoption. It has focused activity as we all have a clear goal and finish line to get to.
For the vast majority of us, this means racing to be compliant with SENDIG-Genetox. For the uninitiated, this new standard applies to toxicology studies which include in vivo micronucleus and/or comet assay data. As such, the standard itself contains just one new domain: Genetic Toxicology – In Vivo (GV), and SEND 3.1.1 should be used for all of the other domains needed to represent the full study. This new GV domain is relatively simple with no new variables, and bears more than a passing resemblance to LB. At Instem, work is well underway to ensure that both our data collection system, Cyto Study Manager™, and our SEND software suite, submit™ are ready for the new SEND IG and in the hands of customers well in advance of the requirement date.
Aside from implementation of the Genetox IG, the other main activity that is currently advancing is SEND v4.0. We are expecting to see this new version out for public review in the second half of the year. For those who are unaware of its content, let me warn you that this is the most significant update to the standard that I’ve seen in my 10+ years of working in standards development. I thought SENDIG-DART was big, but it’s dwarfed by SEND 4.0. I’m sure that throughout the rest of the year I’ll be posting about the content and getting into detail, but at the highest level, we have 9 new domains to cover new study and data types from nervous system data to immunogenicity studies. At CDISC, the SEND team are busily working away to get the new IG ready for its various review stages. Assuming that all goes as planned we should see version 4.0 published in 2025.
And finally, we have recently seen the European Medicines Agency (EMA) quietly begin a proof-of-concept pilot to evaluate the value of using SEND data in the evaluation of new Marketing Authorisation Applications. If EMA fully adopt SEND, what will this mean for us? Would they have different needs and business rules to FDA? Would the SEND for a study for EMA need to look any different to the SEND for FDA? As the agency has only just published this notice encouraging voluntary SEND submissions, I guess we’ll learn more as the pilot progresses.
What are your thoughts on the SENDIG-Genetox announcement? And how would the EMA adopting SEND impact your work? If you’d like to share your thoughts send me a note to [email protected].
‘til next time
Marc
