MIDD is Transforming Drug Development

You wanna see somebody actually have access to the drug that needs it. And I’m a very firm believer that this is a very critical piece of the path to get there.

In this world of drug development, what we often face is uncertainty. Certara is helping do the opposite, thinking of ways to bring more certainty to those aspects.

What brought me to work with Certara originally was probably about twenty five years ago.

I was literally asked by the FDA at a meeting to use Simcyp for PVPK modeling and then was introduced to that program as well and what that type of modeling offered. Model informed drug development getting more and more important. Especially for the early stage clinical development, we rely on clinical pharmacologists to answer how the drug behaves in our human and what’s the factor affecting the safety and efficacy. I have an important role to play to bring this new technology, new knowledge back to my team to help to enhance the drug development efficiency and productivity.

Some of the information I’ll take back is just the importance of model informed drug development, strengthening my ability to defend the use of PK and continuing with our story of model informed drug development.

It’s been really informative and also encouraging to see how much QSP, modeling, the acceptance of it by the regulatory authorities, and just the general applicability across all phases of drug development. The QSP modeling work with Sutara really helps shorten our dose escalation phase of our initial clinical trial. The fewer dose levels that we have to assess in the clinic, it really makes a significant impact financially and also helps hopefully speed up the ability to get efficacious doses for patients. Ultimately, it’s really about trying to get our drug to patients as soon as possible.

We are able to develop some of those PBPK models to actually address some of the questions that regulators have asked for about us, and also generate insights, to help us in our clinical development.

One of the biggest wins through the work that Certara has done and and ultimately getting in early with Certara is that I don’t believe we’ve done intensive PK sampling after our phase one. The sparse sampling I think is just helpful. Patients don’t have to hang around for eight hours.

It keeps costs down and it helps with patient retention as well for not having long study visits.

Developing consistent and end to end workflows is the way that we’re looking at approaching our future including implementation of, you know, model informed drug development service offerings. With Certara, basically we’re going to be able to do more with less. The collaboration that we have with Certara really allows us the opportunity to develop those end to end workflows.

We want to bring safe and efficacious medicines to the patients as soon as possible, so we need to optimize the drug development process. That’s where Certara is a partner in that mission.