Every now and again, there’s a moment that makes you sit up and think, “Wow… that’s new.”
That’s exactly how I felt watching a recent FDA webcast focused on SEND.
We’ve heard plenty over the years about why SEND exists, how it should be implemented, and how datasets are used to assess safety. What we hear far less often is how the FDA actually uses SEND once it’s received. Even rarer is any candid discussion about what’s working well, what isn’t, and where the agency would genuinely like to see SEND go next.
This webcast delivered all of that… and then dropped a bombshell.
This was a recent CDISC public webcast, where we heard updates from CDISC and PHUSE, but most importantly a presentation from Stephanie Leuenroth‑Quinn, PhD, Associate Director for Pharmacology and Toxicology at FDA’s Office of New Drugs. As always, the disclaimer was given that these views do not represent agency policy – but when someone like Stephanie speaks, we all sit up and listen.
Use of SEND
For as long as SEND has existed, people have asked, “What will the FDA do with my SEND datasets?” We know they’re used to review studies for safety, but is that all? We’ve heard before how reviewers compare studies within a submission, for example, looking at microscopic findings in a 1‑Month versus a 3‑Month study to assess longer exposure effects.
But many have wondered whether the agency goes further than this. Are they building a larger database for data mining? To my knowledge, the FDA had never explicitly confirmed this… until now.
We heard first‑hand that the agency has built a ‘Library’ of SEND datasets for what they described as “Advanced Uses of SEND”, going beyond primary review to include:
- Independent analysis of large datasets
- Querying toxicity profiles within the same pharmacologic class
- Identifying species similarities and differences
- Exploring product‑type toxicity profiles (small molecules, biologics, oligos)
It seems the agency, like much of our industry, has begun to unlock the value of mining large volumes of well‑curated, high‑quality, standardized nonclinical data.
The Future of SEND
Next came a request that was loud and clear: the agency wants SEND expanded to cover a much broader range of data and study types. Specifically, they called out the need to standardize:
- NAMs and in vitro data
- Pharmacology and secondary pharmacology
- Fertility and post‑natal development studies
- Additional genetic toxicology assays, both in vivo and in vitro
At first glance, that’s a daunting list. But personally, I see this as a very positive signal. The message to industry was simple: SEND is valuable, so please give us more!
The Quality Bombshell
It’s rare for FDA to comment on SEND quality beyond the low bar of technical rejection criteria. That’s why the next revelation really stood out.
For the first time (at least to my knowledge), FDA openly acknowledged that they are rejecting some SEND datasets because the quality isn’t good enough. No ambiguity. No “gentle encouragement”. Just a clear statement that quality matters, and that poor SEND has consequences.
Re‑generating and resubmitting SEND causes real delays, so this wasn’t said lightly or casually. I don’t recall hearing this expressed so directly before.
Two sides of the quality coin were highlighted:
- Compliance with the standard – variable lengths, controlled terminology, and similar issues that can prevent datasets loading into tools
- Trustworthiness of the data – SEND must accurately reflect the study report if FDA is going to rely on the data for analysis
They’ve reinforced this message by adding a new section to the FDA Study Data Technical Conformance Guide, explicitly addressing quality and the need to verify SEND packages before submission.
And honestly? I think this is a really positive step forward. Some will view this as an added barrier and worry about delays, but I was genuinely pleased to hear the issue stated so clearly. I was messaging fellow CDISC volunteers during the webcast, and one response simply said, “This is music to my ears.” Those of us who’ve invested a decade or more in SEND are delighted to see FDA stressing conformance and quality with such importance.
Appreciation
Finally, here was expressed genuine appreciation to industry for developing and implementing SEND. It was refreshing to hear just how valuable the standard is and how much it has improved the review process. Everyone involved with SEND should feel encouraged by that message.
So, there you have it – probably the best SEND presentation from an FDA speaker that I’ve seen in a very long time.
’til next time
Marc
When available the presentation will be posted here: https://www.cdisc.org/events/webinars/public
Check out the latest FDA Study Data Technical Conformance Guide here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document
