Certara IQ™: Model-Informed First-In-Human (FIH) Dose Selection

Introducing Certara IQ, an AI enabled modeling platform for scaling and democratizing QSP modeling. Certara IQ offers various workflows to help jump start model building to answer key questions.

In this video, we are joined by David Flowers, Certara’s modeling scientist who has supported many programs in the first in human space using QSP modeling. Hi, David.

Hi, Jessica.

David, before we talk about Certara IQ’s first in human work flow, maybe you can tell us what some of the challenges are in using QSP modeling to support first in human dose selection.

Yeah. So when we talk about the work that you have to do in order to use QSP modeling, Often the focus is on developing the what I would call the structure of the model, which is really the equations behind it and relating that to key pieces of biology that you expect to play into the pharmacology that’s relevant for first in human dose projections.

But really a substantial fraction of the effort involved is, not just in putting the equations together, but in building and configuring and debugging all the code that’s required to take those equations and solve them and in various configurations.

So for different dose regimens or different solutions that you need. And then visualize the results in some meaningful way that can be interpreted.

So these parts of the project that are actually generating the results are very often created from scratch or done very manually.

And, this could be a very lengthy and perhaps most importantly error prone process for us. So, it’s it’s definitely a space that, could use some some kind of solution to help regularize a breach of structure to it.

So this is, of course, where Certara IQ’s first in human workflow comes in. Can you tell us about it? What is the first in human workflow and how does it address some of these challenges you just mentioned?

So the first in human workflow is a code template, that’s, provides a prewritten structure for implementing first in human QSP modeling projects. So, the, the template captures many of our learnings that we have gathered, over executing many projects in the space, around the most efficient and productive ways of putting together the code, how to organize it, what kinds of parameterization strategies make sense, and, what what how the how the code needs to be executed and in what order in order to get the results that you need.

So at the end of the day, using this template allows the modeling scientists and their team to spend a substantially smaller amount of time writing what I would call boilerplate code and, helps the modeler to avoid the need to figure out an efficient organization for the code and the files and everything else involved in, simulating the model and generating the results. Additionally, by using a template such as this, different QSP modeling projects that implemented using the same template will look similar to one another, which has a massive benefit for sharing the results. Scientists looking at the code will, see code that’s very similar to what they would have written themselves in other projects, which makes it easier to read it, makes it easier to understand what’s going on, and, makes reuse far simpler.

So as a result, projects executed in the space can be done faster. And, thanks to the speed and regularity and readability, you can expect fewer mistakes, to to come out as part of this process.

So you mentioned a lot of really useful features of the workflow. To summarize, how does this help distinguish Certara IQ from other QSB modeling products?

So the first in human workflow is what I would call an end to end solution, meaning it takes as inputs the raw data that were collected from preclinical studies and based on those, outputs figures and tables in a report template notebook, to ease interpretation. So with regenerate the results of the report.

And this is fast because the model simulations are run using optimized solvers. Solvers. They’ve been tested and refined on many QSP models, and they’re automatically parallelized and cached so that the results must have generated once can be reused again. So together, the performance and the features makes it possible to iterate on the entire project in a short amount of time. You can, evaluate evaluate how various changes to how you would calibrate the model or other pieces of the the work would impact the end results in just minutes, with the report automatically updating with any kind of changes you make. So this makes it very easy to reduce mistakes and increase efficiency and reproducibility and reuseability.

Thank you, David.

Thanks, Jessica. Thanks for the opportunity to talk about this.

With intuitive and scalable QSP model building, Certara IQ helps transform your drug development. To learn more, visit our website.