In this episode of Certara Talks, Jeff Abolafia, Kristin Kelly, and Julie Ann Hood recap their fantastic presentations from PHUSE US Connect earlier this month.
The team covered inspirational and innovative topics, and Julie Ann and Jeffrey won Best in Stream for their presentations ‘Sowing Seeds of Inspiration: Letters to a Pre-Scientist’ and ‘Future Clinical Data Submission Standards: CDISC, FHIR, OMOP, or Hybrid Model’, respectively.
To learn more about how our Pinnacle 21 Clinical Data Management and Automation Suite is helping pharmaceutical companies halve the time it takes to go from clinical trial protocol to regulatory submission, visit this webpage.
Transcript:
Hello everybody, and welcome to another episode of Certara Talks.
I’m Doctor. Suzanne Minton, and I’m a director of content strategy at Certara. Today, I’m here with my colleagues, Julian Hood, Kristin Kelly, and Jeffrey Abolafia.
Welcome to Certara Talks. Let’s start with some introductions. Julie, could you go first, please?
Hi. I’m Julie Ann. I’m a principal consultant here at, Pinnacle 21 under Suttara.
I’m Kristen Kelly. A senior principal seat as consultant within the P21 team, Certara.
Hello, everybody. I’m Jeff Abolafia and also work within the P21 group. Within Certara as a director of product innovation.
Fantastic. Well, it’s lovely to talk to all three of you. And last week, we were all in Maryland at the Phuse Conference. So I was hoping we could talk about that a little bit. Julie Ann, I missed your poster, unfortunately, but I saw that it won best in stream, which is fantastic. Congratulations. Can you tell us a little bit about what it was about?
Yeah. Thank you so much. So it was really an honor to be able to bring this kind of content to fuse.
So the title of my poster was called, sewing seeds of in operation letters to a pre scientist, and it basically detailed my experience as a pen pal within the letters to a pre scientist program that Certara actually sponsors.
So, basically, what this program does is it matches people in STEMcareers with kids who are school aged and underserved populations, and you exchange four letters throughout the year. So there are different themes for each lever letter, but basically describe your current role and path for how you came to be in this career. And then the kids have letter opening parties at their school where they discuss their pen pals letters with their peers so that they can get different exposure to different types of STEM careers. It really just kind of helps humanize the whole, STEM career pathway.
That’s fantastic, Julie Ann. I love that, and I love that you and Certara were involved in scientific outreach to the community.
Kristin, I know that you and your colleague, Michael Beers, gave a really excellent presentation at Phuse. I was able to catch it. Could you share with us a summary of what you talked about?
Yeah. Sure. So the title of our presentation and paper was Guidance Beyond the SDTM Implementation Guide.
We thought to do this topic because a lot of the work that we do as consultants is we get a lot of questions about how do I map this data? What should I do with this regulatory request and helping, our our clients find information. And so, I focused on all the, assets from CDISC guidance outside of the implementation guide that will help create your SDTAM datasets. We also talked about all the regulatory documents out there, including the technical performance guide, and all of the technical specifications based on therapeutic area.
And then we also talked about the impact of not using these documents, when you’re preparing for a submission.
Thanks so much, Kristin. I hadn’t realized that there’s information that you needed to know that wasn’t in the implementation guide. So that was certainly new to me and and a real learning there.
Jeff, lastly, I know you gave a talk. It was excellent. I I really enjoyed it. Can you share with our audience what your talk was about?
Sure. So my paper, race, looks at what should the future of, standards be for submitting study day of the basic premise being, as a result of changes in the regulatory environment advances and technology, marketing applications have evolved from a of randomized clinical trials. So it is now a maybe it’s still a collection on randomized clinical trials, but also real world data coming from electronic health records, other non interventional design, like observational studies, epidemiological studies, as such. So it begs the question that our current standards, those being CDISC, were developed over twenty years ago.
Could these standards still support multiple study designs that it’s work given the work I’ve been doing on the FDA rural evidence projects. They definitely, pause issues for reviewers while all, data of different designs are submitted using the current standard. So we take a look at what are the options in the future do we stick with CDISC, maybe it’s fire, maybe it’s hung up, maybe it’s some some combination of the above. So In summary, it really is just trying to get the industry to change the conversation from how do we squeeze all this in the CDISC?
So what what should our future be, for submitting study data?
Excellent, Jeff. And I think I forgot to tell our viewers that Jeff’s talk won best in stream for hit for the real world evidence category. So congratulations.
Thank you.
It’s been great to talk to my colleagues, Julianne, Kristin, and Jeff. If you wanna learn more about their work, please visit us at the Certara website. You’ve been watching Certara Talks. I’m Suzanne Minton. We’ll see you next time.
