In this video, Dr. Mark Sullivan, Managing Director of Medicines Development for Global Health, explains how Certara’s model-informed drug development expertise was used to support developing moxidectin as a treatment for onchocerciasis “river blindness.”
Transcript
The role that Certara has played has really been a as an as a integral part of our drug development team. So falling out of the project team, indeed being part of our governance structure, really bringing that global drug development expertise into our group. So we’re located in Australia, which is a little bit isolated from some of the core aspects of, pharmaceutical development. And so we really needed that that expertise that Sutaro brings, the strengths of the group more broadly than just, the people who are located in your particular region.
We bought that to bear on our programs. So Certara;s role was as a as an integral part of our program.
They fulfilled the the clinical pharmacology function, but also then brought in a number of other, really regulatory expertise, aspects to the program right across the board from clinical clinical pharmacology even into our CMC program. And in fact, you know, Satara sat alongside of me, at FDA meetings and, and really gave me a great deal of confidence about, our approach, the the strength of our data, and the information that we were, sharing and how to share that, was was really, a critical part of that particular story. Moxidactine is a as a treatment will be used in adults and children.
And, in particular, some of the indications such as solar transmitted helmets, which affects one and a half half billion people, most of whom, children. So we, have really focused on delivering a pediatric formulation and, and Certara being a a core part of that, process of developing a pediatric formulation, but also modeling out, you know, the the information that we would need to select the dose appropriately to, to help us in in making very good decisions about how we go forward in pediatric use. But also, you know, in global health, drugs are used very broadly in the field often in menstrual administration programs.
So it’s incredibly helpful to have really well modeled data in populations such as, pregnant women, and in breastfeeding, you know, the the type of real world use, where it’s very difficult to get data. The modeling data helps us to understand a lot more about about that use. So that that’s been an important part. So some of these things all fit together, the pediatric formulation and pediatric development, dose selection, risk, and risk associated with, populations such as pregnant and and breastfeeding women.
And, and, and, and, we honestly, how else can you do this? You you you need a a a real engine of clinical pharmacology and the modeling built into your program.
This was a such an important role for us to fulfill and to, start us on that beautiful course.