Meet the Experts at Instem—SEND Edition!
Welcome to “Meet the Experts,” a new series of articles focused on shining a spotlight on the brightest minds at Instem.
This week’s topic is SEND, and the obvious choice for our expert is the esteemed Marc Ellison!
Marc is our Director of SEND Solutions and has been a CDISC volunteer for 12 years, since long before SEND became an FDA requirement. He has 27 years of experience creating nonclinical software and working with researchers on how to best collect and organize their data.
We recently caught up with Marc and asked him a few questions about SEND:
Hey Marc, what key issues should SEND teams be focused on in 2025?
“Oh, there are several things, but I’ll pick two. First in timing and importance is that the FDA is requiring SENDIG-Genetox v1.0 for studies starting March 2025. This announcement in early 2024 came at least a year earlier than we were expecting, based on past behavior. At Instem, we welcome this accelerated adoption, and we are diligently striving to ensure that our customers are compliant.
This new standard applies to toxicology studies that include in vivo micronucleus and/or comet assay data. 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 in time for the requirement date. More information on this topic to come!
Secondly, teams should plan to be ready to review the new version of SEND, SEND v4.0, when it comes out for public review sometime in 2025. As I recently stated during a live talk at the ACT 2024 conference, this is the most significant update to the standard that I’ve seen in my 12 years of working in standards development. At the highest level, we have 9 new domains to cover new study and data types, from nervous system data to immunogenicity studies. Throughout 2025 I’ll be posting to the Instem.com blog about this topic and will be getting into the finer details.”
Thanks Marc. Beyond SEND-readiness, what are the potential future uses of SEND datasets that you think people need to start considering?
“Ah this is an exciting area! We often refer to this as using SEND data “beyond submission”, since the proliferation of standardized nonclinical data has paved the way for us to explore new ways to reuse and repurpose existing study data. There are several opportunities to leverage your SEND data, including:
- Virtual Control Groups – VCGs reuse control subjects from past studies for a current study in order to reduce the number of subjects needed to run the study. SEND could have a useful role in referencing data from these past studies.
- Remote Study Monitoring and Easy Data Sharing – I’m increasingly hearing about the need for sponsors to have access to data as studies are being conducted and of course, SEND is the perfect exchange mechanism.
- S1B – a.k.a. ICH S1B (R1), this guideline aims to remove unnecessary animal testing. Without diving too deep on this, organizations can re-use their SEND data for part of this process. We have more information on this topic coming soon!”
Thank you for all this insightful information about SEND Marc! Do you have any final thoughts?
“SEND is truly my passion, and I welcome any questions or thoughts you may have. Please reach out anytime on this page I will get in touch. Lastly make sure to continue to read our blog! It is the best way to stay up to date on these topics and we will try to keep you entertained along the way.”
Thank you for your time, Marc and thank you for reading! To learn more about our SEND offerings at Instem, check out our Regulatory Submission Solutions page.
We will be back soon with more experts and insights for your team!
