Early Feasibility Assessment (EFA) with Certara IQ™

Introducing Certara IQ, an AI enabled modeling platform for scaling and democratizing QFP modeling. Certara IQ offers a range of model libraries licensed separately, spanning numerous pharmacologies and therapeutic areas.

In this video, we are joined by Sarah DeBartolo, a Certara quantitative biologist and expert in early feasibility assessments. Hi, Sarah.

Thanks for having me.

So I wanna talk first about early feasibility assessment. Can you explain to us what early feasibility assessment or EFA is?

Yeah. So at the earliest stages of drug discovery, often before any lead molecules are even generated or any data has been produced, we can already use mechanistic modeling to predict which drug concepts are likely to work as intended in vivo.

For example, does the drug get into the intended side tissue side of action? Does it achieve a high enough concentration to bind to its target?

Is that binding sustained throughout the dosing interval, or is it affected by processes like target mediated degradation?

So this type of modeling is what we refer to as early feasibility assessment, or EFA.

And applying modeling at this early stage has a really great return on investment because we can use these relatively simple, pre built pharmacology models to prioritize resources towards concepts that are de risked pharmacologically and importantly to kill programs early that would likely fail years down the line. So the earlier the better when it comes to bringing mechanistic modeling into decision making.

Thank you. That’s great. The next question, of course, I want to ask is what kinds of questions can, EFA answer the users?

Some questions at this stage might be like, we have six different drug targets we’re considering, but we only have resources to move forward with one or maybe two. How do we prioritize between those? Or we know our target, but which drug modality should we use to hit that target, like antibody or ADC or degrader, etcetera?

Or to help guide drug design, how can we optimize drug properties like binding affinity, half life, etcetera, to maximize a therapeutic window?

Or competitor analysis, differentiation.

How well is this concept differentiated from other competition in the market?

So we can ask these kinds of questions for one concept at a time, or we can apply them at scale across a portfolio, which allows us to prioritize between different concepts and kind of rank order which ones are worth pursuing based on their pharmacological risk.

Okay. Finally, what does a typical efa workflow look like?

Yeah. Because at this stage decisions are usually happening very quickly, we can take advantage of our library of pre built pharmacology models in Certara IQ, which cover a wide range of different drug modalities.

And with these models, you just plug in a set of parameters for your drug and your target and your disease, which at this stage are typically informed either by literature or possibly some early in vitro data.

And then these models can output predictions of, like, for example, drug PK and binding and inhibition of the target in the relevant tissue site of action.

So these pre built models can be licensed directly through Certara IQ or clients can choose to work with us and our team of experts in parameterizing and running these models to deliver results and recommendations.

Thank you, Sarah.

Thanks, Jessica.

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