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DMDG 50th Open Meeting

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

Drugs need to reach their site of action to exert pharmacological effect. In many cases, the site of action is a specific organ of the body determined by the disease or expression of the target. It is often desirable to maximise the free drug concentration in the target organ relative to the rest of the body to minimize any systemic toxicity or DDI liability, and reduce the required dose. This diverse session will explore developments in targeting drugs to the site of action, such as the delivery of mAbs to restricted organs, in vitro 3D models of the BBB, nanoparticle drug delivery, tumour targeting, and cell and gene therapy vector tropism.
7-1 Targeted Delivery – Getting the Elephant into the Room
Steve Hood, Non-clinical Science, GSK (DMDG Fellow)
7-2 Building on the success of Osimertinib. Targeting brain exposure in oncology drug discovery
Nicola Colclough, AstraZeneca
7-3 The limits and constraints of tissue-targeted delivery of biologics
Armin Sepp and Iain Gardner, Certara UK Ltd, Simcyp Division
7-4 Human blood-brain barrier in vitro models to investigate transport of biologics to the brain
Shane Clerkin, Roche Pharma Research and Early Development, Basel, Switzerland
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