DMDG 50th Open Meeting
We are excited to be presenting at this conference!
Session 4: Challenges and opportunities in in vitro alternatives with focus on FDA Modernisation Act
Chairs: Amaka Ezuruike, Certara & Beth Williamson, UCB
Although animal models have been integral in our understanding of biology, safety and ADME properties, legislators and the FDA have recognized the issues inherent in animal models and took steps to address it. In December 2022, the FDA Modernization Act 2.0 was adopted as law permitting the utilization of specific alternatives to animal testing, including cell-based assays, such as organs on chips, which can be used to seek FDA exemptions for assessing drug safety and effectiveness during the preclinical phase. This session will focus on the recent advances and opportunities for some of these in vitro alternatives, as well as the challenges faced in utilising them as a surrogate for the 3R’s.
4-1 ADME perspective on the applicability of complex in vitro models in DMPK with focus on FDA Modernisation Act 2.0
Benoit Cox, UCB
4-2 The use of CIVM (complex in vitro models) to understand absorption in drug development
Charlotta Vedin, AstraZeneca
4-3 A primary jejunum and primary hepatocyte multi-organ MPS: a promising tool for more predictive studies of human drug ADME and oral bioavailability
Yassen Abbas, CNBio
4-4 Hepatic biotransformation of anti-neoplastic prodrugs towards different cancer models in a MultiOrgan-Chip test platform
Ricky Bayer, Technische Universität Berlin
Session 5: Decoding Complex DDIs using preclinical, clinical and /or modelling based strategies
Chair: Kunal Taskar, GSK
Drug-drug interactions (DDIs) are mediated when the metabolic enzymes and/or transporters which are relevant for the clearance/disposition of a drug are either inhibited or induced by another perpetrator drug. Usually when a single enzyme or transporter is major determinant of drug clearance then the extrapolation and interpretation of clinical DDIs is comparatively elementary. Frequently, several published case studies have shown that several drugs involve more than one metabolizing enzyme and/or transporters in their clearance pathways. Similarly, more often, several drugs may also inhibit and/or induce more than a few enzymes and/or transporters at the same time. In such scenarios the predictions and evaluation of clinical DDIs becomes a complex task. But with several in vitro, clinical as well as model-based assessments such complex DDIs can be attempted to be decoded and assessed as well as strategies to address such complex DDIs have been or can be established. This session will discuss such complex DDIs and various strategies to address them.
5-1 How can we overcome the challenges posed when conducting complex DDI studies?
Iain Gardner, Certara
5-2 Transporter + Enzyme Complex DDI case study
Justine Badee, Novartis
5-3 Oral Contraceptives and Complex DDIs? Clinical relevance beyond CYP3A4
Gareth Lewis, GSK
Session 7: Tissue Targeted Drug Delivery
Chairs: Jamie Henshall, Vertex Pharmaceuticals & Claire Purdy, Charles River Laboratories