Sessions feature physiologically-based pharmacokinetic (PBPK), pharmacokinetic/pharmacodynamic (PK/PD) and quantitative systems pharmacology (QSP) modeling and simulation
Certara®, the global model-informed drug development and decision support leader, today announced that it is participating in 26 sessions at the International Society of Pharmacometrics’ (ISoP’s) annual scientific meeting: the 10th American Conference on Pharmacometrics (ACoP10). This year’s conference will be held from Oct. 20-23 at the Rosen Shingle Creek Hotel in Orlando, FL.
“We welcome this opportunity to discuss and present our latest research with our industry colleagues and regulatory and academic partners. As the leader in model-informed drug development, Certara is committed to knowledge sharing and playing our part in keeping this science advancing. I am particularly excited to be able to report on the progress being made by our Quantitative Systems Pharmacology (QSP) Immunogenicity (IG) and Immuno-oncology Consortia, which includes publication of our first QSP IG Consortium paper, and the development of our new Neurodegeneration QSP Consortium. Our QSP consortia are composed of leading biopharmaceutical companies, who are working together in a pre-competitive environment to develop QSP simulators that can model specific clinical patient populations,” said Certara Senior Vice President QSP Professor Piet van der Graaf.
“We are also delighted to announce ISoP honors bestowed on two of our scientists: Dr. Linzhong Li (co-author of poster M-067) has been selected as an ACoP10 Poster Walk Presenter, and Dr. Shuhua Hu (T-060) has been chosen as a Mathematical and Computational Sciences (MCS) Poster Walk Presenter,” added Professor van der Graaf.
Certara will be providing hands-on demonstrations of several of its products during the conference. They include its Simcyp® Population-based Simulator for PBPK modeling and simulation and its enhanced Trial Simulator for computer-assisted trial design. They will be joined by Certara’s Phoenix WinNonlin™, the industry standard for non-compartmental analysis, PK/PD and toxicokinetic modeling, and its Phoenix Nonlinear Mixed Effects Modeling (NLME™) population PK/PD tool.
Also in action will be Certara’s Pirana workbench, which provides modelers with structure, tools and a GUI to facilitate the iterative model and simulation process; CODEx, its user-friendly interactive interface which allows scientists to explore and communicate with data in Certara’s clinical trial outcome databases; and Certara Integral™, its next-generation data repository for clinical pharmacology and pharmacometrics.
Certara’s contributions to this year’s conference are described below:
Monday, Oct. 21
Presentations
11:00 a.m. - 12:30 p.m.
- Joint Longitudinal and Time-to-event Model for Estimating Risk of Preeclampsia During Pregnancy – Samer Mouksassi
- QSP Consortia Impacting Drug Development: From Open Source to Shared Science Towards Re-purposing of iPSP Models – Piet H. van der Graaf
2:00 p.m. - 3:30 p.m.
- Simcyp ADAM model for Modeling Passive Drug Absorption – David Turner
Posters
- M-003: Relationship Between Transthyretin (TTR) Knockdown and Change in mNIS+7: Findings from the Patisiran Phase 2 Open-Label Extension and Phase 3 APOLLO Studies for Patients with Hereditary Transthyretin-Mediated Amyloidosis – Michael Dodds (contributing author)
- M-009: Population PK/PD Analysis of 2-Way Interaction Between Plazomicin and Changes in Serum Creatinine: A Simultaneous PK/PD Model with a Feedback Loop – Adekemi Taylor, Fran Brown, Nathan Teuscher
- M-014: Exposure-Response Analyses for Efficacy and Safety of Esaxerenone, a Novel Nonsteroidal Mineralocorticoid Receptor Blocker – Kris Jamsen, Helen Kastrissios (contributing authors)
- M-019: Population PK of Eptinezumab for the Preventive Treatment of Migraine – Martin Beliveau, Igor Rubets, My My Trinh (contributing authors)
- M-022: Exposure-Response Analysis for Doravirine Concentrations and Neuropsychiatric AEs and Fasting Lipids – Anetta Claussen, Aziz Ouerdani, Huub Jan Kleijn, Rik de Greef (contributing authors)
- M-067: Mechanistic Modeling of Binding and Cell killing Events of Bispecific Antibodies in both in vitro Cytotoxicity Assay and within a PBPK Framework – Linzhong Li, Dan Liu, Rachel Rose, Iain Gardner, Masoud Jamei
- M-071: PBPK Modeling Prediction of Effect of Renal Impairment on the PK of Olanzapine and Samidorphan When Administered in Combination – Karen Rowland Yeo (contributing author)
Tuesday, Oct. 22
Presentation
3:30 p.m. - 5:00 p.m.
- Population PKPD Analysis of 2-Way Interaction between Plazomicin and Changes in Serum Creatinine: A Simultaneous PK/PD Model with a Feedback Loop – Adekemi Taylor
Posters
Tuesday, Oct. 22
- T-002: A Tumor Growth Inhibition-Overall Survival Model for Atezolizumab in First-line Non-small Cell Lung Cancer Based on IMpower150 Study – Mathilde Marchand (contributing author)
- T-006: Population PK and Exposure Efficacy Analyses of Deutetrabenazine in Patients with Moderate to Severe Tardive Dyskinesia – Nathalie H. Gosselin (contributing author)
- T-016: An MBMA to Study the Effect of Glucagon-like Peptide (GLP-1) Receptor Agonists on Body Weight in Obese and Type 2 Diabetic Populations – Li Qin, Nele Mueller-Plock, Eugene Cox, John Maringwa (contributing authors)
- T-021: Population PK Modeling and Simulations of rhPTH(1-84), a Recombinant Human Parathyroid Hormone, to Determine Dosing in Pediatric Patients with Chronic Hypoparathyroidism – Olivier Barriere, Nathalie H. Gosselin, Leng Hong Pheng, Jean-Francois Marier (contributing authors)
- T-028: Development of a Translational Population PK/PD Model of mRNA-1944 Encoding Antibody Against Chikungunya Virus in Rats and Non-human Primates – Frank Engler (contributing author)
- T-034: Population PK Modeling and Exposure-Response Analysis of Probuphine Implants in Opioid Use Disorder Subjects – Olivier Barriere, Nathalie H. Gosselin, Nada Farhat (contributing authors)
- T-055: Exposure-Response Model of Subcutaneous C1-Inhibitor Concentrate to Estimate the Risk of Attacks in Patients with Hereditary Angioedema Using Data from the COMPACT Phase III and Open-label Extension Studies – Emilie Schindler (contributing author)
- T-060: Incorporation of a Time-dependent Loss Mechanism into the Delay Process – Shuhua Hu
- T-098: vpcstats: A New, Flexible, Powerful and Efficient R package to Compute VPC Percentiles and Prediction Intervals – Olivier Barriere, Samer Mouksassi, Benjamin Rich (contributing authors)
Wednesday, Oct. 23
Presentation
2:30 p.m. - 3:30 p.m.
- Roller Coaster Session 1b – Craig Comisar (Chair)
Posters
- W-019: Population PK and Exposure Safety Analyses of Deutetrabenazine in Patients with Moderate to Severe Tardive Dyskinesia— Nathalie H. Gosselin (contributing author)
- W026: Relationship Between Urinary Aminolevulinic Acid (ALA) Levels and Porphyria Attacks in Acute Hepatic Porphyria Patients in Clinical Trials with Givosiran – Michael Dodds (contributing author)
- W-027: Population PK of Brincidofovir and Cidofovir in Adults and Pediatric Subjects With Viral Infection – Mark Lovern, Virna Schuck, Adekemi Taylor, Tim Bergsma, Yuan Xiong (contributing authors)
- W-047: Concentration-Response Modeling of ECG data from Early-phase Clinical Studies to assess QT Prolongation Risk of Contezolid (MRX-I), an Oxazolidinone Antibacterial Agent – Kun Wang (contributing author)
- W-052: Population PK of Cabotegravir in Adult Healthy Subjects and HIV-1 Infected Patients Following Administration of Oral Tablet and Long-acting Intramuscular Injection – Mark Lovern, Prokash Paul, Yuan Xiong (contributing authors)
Additional information about ACoP10 can be found at https://www.go-acop.org.
About Certara
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, 90+% of all novel drugs approved by the US FDA in the past four years were supported by Certara software or services. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.