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American Conference on Pharmacometrics

ACoP12
American Conference on Pharmacometrics

ACoP12 American Conference on Pharmacometrics
Presentations

Poster ID PIB-015 : Implementation of Gamma, Inverse Gaussian, and Weibull Absorption Delay Models

Author: Shuhua Hu, Principle Research Scientist, Certara; Co-authors: Michael Tomashevskiy, Consultant, Certara; Wojciech Krzyzanski, Univ of Buffalo

Poster ID: PIIIA-023 Predicting RSV Efficacy for MK-1654 During Post-COVID-19 Pandemic RSV Seasons with Protracted Transmission Pattern using MBMA and Clinical Trial Simulation Approaches that Account for RSV Force-of-Infection

Author: Nele Plock, Director Pharmacometrics, Certara; Co-authors: Jos Lommerse, Director Modeling & Simulation, Certara; Brian M. Maas, Merck & Co., Inc., Jingxian Chen, Merck & Co., Inc.; Francesco Bellanti, Director of Modeling & Simulation, Certara; Li Qin, Scientist, Certara; Han Witjes, Assoc Director, Certara; Philippe Pierrillas, Associate Director, Certara; Radha A. Railkar, Merck & Co., Inc.; Antonios O. Aliprantis, Merck & Co., Inc.; Kalpit Vora, Merck & Co., Inc.; Wei Gao, Merck & Co., Inc.; Luzelena Caro, Merck & Co., Inc.; S. Y. Amy Cheung, Sr. Director, Certara, Jeffrey R. Sachs, Merck & Co., Inc.

Poster ID: PIB-007 Smallpox: How to define an efficacious dose for an eradicated disease?

Author: Camila de Almedia, Associate Director, Certara; Co-Author: Janet Zhao, Scientist, Certara; Nathan Teuscher, Vice President of Pharmacometric Consulting, Certara; Shamia Faison, Assoc Director, Certara; Tim Tippin, Chimerix, Inc.; John Dunn, Chimerix, Inc.; Tom Brundage, Chimerix, Inc.; Marion Morrison, Chimerix, Inc.; Odin Naderer, Chimerix, Inc.; Virna Schuck, Senior Director, Clinical Pharmacology, Certara

Poster ID: PIIIA-006 Kinetic Monte Carlo Simulation with On-demand Computation and Its Applications to Population Pharmacodynamics

Author: Thanh Vo, Senior Researcher, Certara Co-author: Frederic Y. Bois, Senior Scientific Advisor & Head of Mechanistic Modelling, Certara

Poster ID: PIIIA-024 Children are not small adults, but are preterm neonates just smaller babies? A cautionary tale against off-label use of raltegravir in preterm neonates

Author: Jos Lommerse, Director Modeling & Simulation Co-authors: Diana F Clarke, Boston Medical Ctr; Edward P Acosta, Univ of AL; Hedy Teppler, Merck & Co., Inc.; Anne Chain, Merck & Co., Inc.; Betsy Smith, NIH; Mark Mirochnick, Boston Univ School of Medicine; the IMPAACT P1097 Protocol Team

Poster ID: PIB-027 Development of a PBPK paediatric cancer population model

Author: Ben G. Small, Research Scientist, Certara Co-authors: Farzaneh Salem, Research Scientist, Certara; Shelby Barnett, Newcastle University Centre for Cancer; Gareth J. Veal, Newcastle University Centre for Cancer; Trevor Johnson Principal Scientist, Certara

Symposium Session Speaker | Towards a standardized assessment framework of mechanistically detailed models including QSP and PBPK: Zooming in on model validation

Piet van der Graaf

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SVP Quantitative Science Services

A conversation about current and imminent challenges of simple vs complex models’ validation

Symposium Session Speaker | The Terrific Trio, 3-T’s of Mechanistic Modelling for Vaccines: Targets, Translations, and CTS-based Trial Design

Jos Lommerse

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Director Modeling & Simulation

(Lost in) translation: rodent modeling and validation with MBMA

Tutorial 1: Know a Good Model When You See It, See a Good Model When you Find It: Effective Visualizations for Developing and Qualifying popPK/PKPD, MBMA, and other Pharmacometric Models

Jos Lommerse

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Director Modeling & Simulation

Poster ID: PIA-031 Clinical Quantitative Systems Pharmacology (QSP) Modeling of the Efficacy of a Novel Not-alpha IL-2 as a Mono- and Combination Immunotherapy for Advanced/Metastatic Solid Tumors

Author: Kamau Pierre, Scientist, QSP Modeling, Sanofi Aventis; Co-authors: Tom Snowden, Principal Scientist, QSP/Certara; Md Shahinuzzaman, Research Scientist, QSP/Certara; Tomomi Matsuura, Principal Scientist, QSP/Certara; Rui Wang, Sanofi US Services; Jill M. Mooney, Synthorx; Lina Ma, Synthorx; Filip Janku, The University of Texas MD Anderson Cancer Center; Johanna Bendell ,Sarah Cannon Research Institute/Tennessee Oncology; Gerald Falchook, Sarah Cannon Research Institute at HealthONE; Arun Azad, Peter MacCallum Cancer Centre; Tarek Meniawy, Linear Clinical Research; Neyssa Marina, Synthorx; Giovanni Abbadessa, Sanofi US Services; Spyros K. Stamatelos, Sanofi US Services

Poster ID: PIIIB-029 Time-Matched, Linear Mixed-Effects Analysis of the Concentration-QT Relationship of Single-Agent Binimetinib in Patients With Cancer and Healthy Volunteers Pooled Across Multiple Studies

Author: Lance Wollenberg, Associate Director Clinical Pharmacology, Pfizer Boulder R&D; Co-authors: Lance Wollenberg, Associate Director Clinical Pharmacology, Pfizer Boulder R&D; Adekemi Taylor, VP CSC/Certara; Kevin Litwiler, Pfizer Boulder R&D

Poster ID: PIA-011 A Physiologically Based Pharmacokinetic Model for the Evaluation of Gepotidacin Drug-Drug Interactions

Author: Aline Barth, Director, Clinical Pharmacology Modeling and Simulation; Co-authors: Alice Ke, Sr. Consultant and Scientific Advisor/Certara; Dung Nguyen; GlaxoSmithKline; Meenakshi Srinivasan; University of Florida, College of Pharmacy; Kunal Taskar; GlaxoSmithKline plc; Rajendra Singh; GlaxoSmithKline plc

Poster ID: PIIA-026 Population Pharmacokinetic Analysis of Encorafenib and Binimetinib in Patients With Unresectable or Metastatic BRAF V600-Mutant Melanoma

Author: Jahidur Rashid, Manager, Pharmacometrics, Pfizer, Inc. Co-authors: Lance Wollenberg; Pfizer Boulder Research and Development; Nathalie H Gosselin, Sr. Director, Certara Strategic Consulting; Laurence Del Frari; Institut de Recherche Pierre Fabre; Eric Didier; Institut de Recherche Pierre Fabre; Kevin Litwiler, Pfizer Boulder Research and Development

Poster ID: PIIB-023 Exposure-Response Analysis of Tremelimumab Monotherapy or in Combination with Durvalumab in Patients with Unresectable Hepatocellular Carcinoma (uHCC)

Author: Xuyang Song, Director, Clinical & Quantitative Pharmacology, AstraZeneca Co-authors: R. Katie Kelley, Univ of CA; Michelle Green, Executive Director/Certara Strategic Consulting; Nathan Standifer, AstraZeneca; KyoungSoo Lim, AstraZeneca; Alejandra Negro, AstraZeneca; Philip He, AstraZeneca; Song Ren, AstraZeneca; Anis Khan, AstraZeneca; Megan Gibbs, AstraZeneca; Ghassan K. Abou-Alfa, Weill Cornell Medical College

Poster ID: PIA-026 Population Pharmacokinetic Analysis of Filgotinib and its Metabolite GS-829845 in Healthy Subjects and Subjects with Rheumatoid Arthritis

Author: Amy Meng, Senior Clinical Pharmacologist, Gilead Sciences Co-Authors: Kacey Anderson, Gilead Sciences; Francesco Bellanti, Director/Certara; Peter Chang, Assoc. Director/Certara; Craig Comisar, Sr. Director/Certara; Kara Nelson, Gilead Sciences

Poster ID: PIA-004 Physiologically Based Pharmacokinetic Modeling of a Novel HER2-Targeted Antibody-Drug Conjugate, Trastuzumab Deruxtecan for Assessment of Pharmacokinetic Drug-Drug Interaction

Author: Akiko Watanabe, Daiichi Sankyo Co-authors: Masakatsu Kotsuma, Daiichi Sankyo; Ming Zheng, Daiichi Sankyo; Iain Gardner, VP, Head of Translational DMPK Sciences/Certara; Mailys De Sousa Mendes, Sr Research Scientist/Certara; Kate Gill, Scientific Advisor/Certara; Emi Kamiyama, Daiichi Sankyo; Takako Shimizu, Diaachi Sankyo; Yoko Magai, Diaachi Sankyo; Masataka Oitate, Daiichi Sankyo; Tushar Garimella, Daiichi Sankyo; Malaz Abutarif, Daiichi Sankyo; Kazutaka Yoshihara, Daiichi Sankyo; Hitoshi Ishuzuka, Daiichi Sankyo

Poster ID: PIIIA-030 A population pharmacokinetic model to inform tacrolimus therapy in heart transplant recipients.

Author: Ranita Kirubakaran, Department of Clinical Pharmacology & Toxicology, St Vincent’s Hospital Co-authors: David W. Uster, Univ of Hamberg; Stefanie Hennig, Director/Certara; Jane E. Carland, Univ of New South Wales; Richard O. Day, Univ of New South Wales; Sebastian G. Wicha, Univ of Hamberg; Sophie l. Stocker, Univ of New South Wales