ASCPT 2025 Annual Meeting

• PBPK-led assessment of antimalarial drug concentrations in breastmilk: A strategy for optimal use of prediction methods to guide decision making in an understudied population (Top Poster Ribbon) – Lisa Almond
• PBPK model reproducibility: Learning from the development of a PBPK model repository for global health – Mackenzie Kolev
• Building an OATP1B1-matrix: Performance verification of IVIVE-PBPK models in the prediction of OATP1B1/183 mediated drug-drug interactions (Top Poster Ribbon) – Jean Dinh, Oliver Hatley, Liam Curry, Charlotte Cross, Udoamaka Ezuruike, Matthew Harwood, Kim Crewe, Sibylle Neuhoff
• Building an OAT-matrix: Performance verification of IVIVE-PBPK models in the prediction of OAT1/OAT3 mediated drug-drug interactions – Oliver Hatley, Jean Dinh, Celine Brochot, Udoamaka Ezuruike, Sibylle Neuhoff
• Analyzing and integrating postpartum physiological changes in lactating women – Neel Deferm
• Translation of rat to human brain concentrations using PBPK modeling confirms high brain penetration of the TYK2/JAK1 inhibitor BHV-8000 – R. Bertz¹, L. Shireman², H. Jones², D. Heller³, R. Bhardwaj³, E. Thompson¹, E. Dierks¹, P. Ackerman¹, N. Kozauer¹, I. Qureshi1, V. Coric¹; ¹Biohaven, New Haven, CT, United States, ²Certara UK, Sheffield, United Kingdom, ³Certara USA, Radnor, PA, United States.
• Incorporating hepatic impairment transporter zonation into physiologically based pharmacokinetic (PBPK) models: Implications for pravastatin disposition in white and Chinese populations considering OATP1B1 phenotypes – Mattie Hartauer¹, William A Murphy¹, Kim LR Brouwer¹, Sibylle Neuhoff²; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA¹, Certara UK Ltd., Certara Predictive Technology, Simcyp Division, Sheffield, United Kingdom²

Speakers:

• Tong Zhu, PhD, FCP, Vice President, Global Head, Clinical Pharmacology & Translational Medicine, Certara Drug Development Solutions
• Fei Hua, PhD, Executive Director, Quantitative Systems Pharmacology, Certara
• Hannah Jones, PhD, Senior Vice President of PBPK Consultancy Services, Certara

Co-chaired by Karen Rowland Yeo

Join our Certara experts as they present a poster on the use of PBPK predictions combined with real-world data to evaluate antidepressant systemic exposure across all three trimesters of pregnancy. The findings suggest that prior knowledge of a patient’s CYP2D6 genotype may help identify pregnant women at greater risk of discontinuing antidepressant treatment due to lack of efficacy. PBPK modeling could support dose adjustment strategies during pregnancy based on CYP2D6 genotype to improve treatment outcomes.

Presenters:

• Eva Berglund, PhD, Senior Director, Clinical Pharmacology & Regulatory Strategy, Certara Drug Development Solutions
• Karen Rowland, Yeo, PhD, Senior Vice President, Client & Regulatory Strategy, Certara
• Paola Coppola, MSc, Director, Clinical Pharmacology and Translational Medicine, Certara Drug Development Solutions

• Applications and limitations of 4beta-hydroxycholesterol as a sensitive endogenous biomarker – Aneesh Karkhanis, Matthew Harwood, Felix Strader, Frederic Bois, Sibylle Neuhoff
• Mechanistic insights into cytokine antagonist -drug interactions: A physiologically-based pharmacokinetic modeling approach with toclizumab as a case study (Top Poster Ribbon) – Xian Pan, Felix Stader, Cong Liu, Abdallah Derbalah, Masoud Jamei, Iain Gardner
• Relative impact of CYP2D6 genotype phenotype on exposure of SSRIs during pregnancy: Extrapolation approach using RWD and PBPK modelling – Karen Rowland Yeo
• Predicting the exposure of irinotecan and its active metabolite (SN-38) in cancer patients using physiologically-based pharmacokinetic modeling – Abeer M. Rababa’h¹, Kristina Z. Denic¹,², Joel M. Reid¹, Sibylle Neuhoff³ ;Division of Oncology Research, Mayo Clinic, Rochester, Minnesota 55905, USA¹ Travere Therapeutics, San Diego, CA 92130, USA² ,Certara UK Limited, Certara Predictive Technologies, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK³

Presenters:

• Eva Berglund, PhD, Senior Director, Clinical Pharmacology & Regulatory Strategy, Certara Drug Development Solutions
• Karen Rowland, Yeo, PhD, Senior Vice President, Client & Regulatory Strategy, Certara
• Paola Coppola, MSc, Director, Clinical Pharmacology and Translational Medicine, Certara Drug Development Solutions

Featured speaker: Xian Pan