In the latest CertaraTalks episode, Krista K. Greenwood, PhD, DABT, Director of Toxicology at Certara, shares key insights from the American College of Toxicology 2023 Annual Meeting. Explore highlights like Project Optimus, the FDA’s groundbreaking dose optimization initiative for oncology products, and updates on the latest safety pharmacology best practices.
Transcript:
Introduction
Welcome. You’re watching Certara Talks. I’m Doctor Suzanne Minton, and I’m a director of content strategy at Certara. Today, I’m talking to my colleague, doctor Krista Greenwood. Krista, welcome to Certara Talks. My name is Krista Greenwood. I’m a director of toxicology here at Certara.
Board certified toxicologist.
Awesome. Well, great to talk to you.
Chapter
The American College of Toxicology Meeting
I hear you just came back from the American College of toxicology meeting. Can you let us know, how it was?
So it was in Orlando, Florida this year. It’s the annual meeting. It is a really great, organization that is a little small. There’s maybe a thousand attendees, but very focused on drug development toxicology, which is a really great fit for myself and my colleagues in the toxicology group. Fantastic. Well, I was hoping we could chat about some of the themes at this year’s meeting. Project Optimists, the FDA’s initiative for dose optimization of oncology products has been a big theme in the industry as a whole, What did folks at ACT have to say about project optimists?
Yeah. So there was actually, a session on project optimists which, I attended and was it was very well attended.
And there was a a lot of talk, It was more on the clinical pharmacology side and, you know, maybe that clinical side, but at least from a non clinical perspective where I’m coming from and talk psychology.
It it helped to understand kind of the end game and and the point of of why we might wanna try to you know, optimize doses in the clinic, and then just give that perspective to us as non clinical toxicologists that are you know, all of our research is occurring far before things get into the clinic, but it’s still nice to have that end in mind. Absolutely.
Chapter
The Three R’s in Drug Development
I’m not a toxicologist, but I certainly from what little I know in the field, I know that the three r’s have been a long standing theme. This is the idea of reduce, replace, and refine the use of of animal testing and drug development What were people at ACT saying about the three r’s this year?
So the three r’s were were a hot topic, ever since COVID, there’s been, short supply of both non human primates and now even dogs, some of the non clinical models that we use and so it is at the front of everyone’s mind to really make sure we’re using animals in a responsible way because they are such a limited resource at this point.
And, you know, there was a lot of discussion about the best way to design studies, opportunities to use historical control data more than what we are using it currently. So I I’m hopeful that in the near future, the regulatory agencies will really support us as toxicologists in making the change and and really reducing those number of animals that we use. Yeah. That would be a great thing to help, get down, reduce the amount of animals required for these programs.
Mhmm.
Chapter
Updates to ICH E14 S7 S7B Best Practices Guide
Lastly, I heard that there were some updates to the ICH E fourteen s seven s seven b best practices guide Can you tell our listeners what that guidance is and what they should know about it?
Right. So, just in general, it’s it’s a mouthful, but it it was an update to the best practices for the, safety pharmacology, specifically the cardiovascular aspect of the safety pharmacology guidance.
From the FDA. The the hope is that we can reduce the need for human thorough QT studies, and so some of new breast best practices came out, and there was a lot of discussion about how to implement these in the non clinical studies that we, perform, things like the HURG, in vitro study, and, the in vivo, cardiovascular study.
Fantastic. Well, Krista, it was a real pleasure talking to you today. If our listeners are interested in learning about more about what Krista and team do. They can always visit us on the Certara website. You’ve been watching Certara Talks. I’m Suzanne Minton. I’ll see you next time.
