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Certara to Participate in 40 Pharmacometrics Modeling and Simulation Sessions at ACoP9

Certara thought leaders are contributing to a workshop, presentations, demonstrations and poster sessions this year

PRINCETON, NJ, US - Oct 5, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence solutions, today announced that it is participating in 40 sessions at the ninth American Conference on Pharmacometrics (ACoP9). This annual International Society of Pharmacometrics (ISoP) conference will be held from Oct. 7-9 at the Loews Coronado Bay Resort in San Diego, CA.

 

“ACoP is growing in importance and prominence due to pharmaceutical companies' and global regulators’ broad adoption of physiologically-based pharmacokinetic (PBPK) modeling and simulation and their increasing acceptance of quantitative system pharmacology’s (QSP’s) potential to further inform the drug development process and lead to safer more effective therapies,” said Certara Chief Executive Officer Dr. Edmundo Muniz. “We are proud to support ISoP and actively share our latest advances with our peers at this year’s conference.”

 

Certara will be demonstrating three products at ACoP9. They include its newly-acquired Pirana workbench, which provides modelers with structure, tools and a GUI to facilitate the iterative model and simulation process. CODEx, a user-friendly interactive interface which allows scientists to explore and communicate with data in Certara’s clinical trial outcome databases will also be in action, together with Certara’s enhanced Trial Simulator for computer-assisted trial design.

 

Certara’s contributions to this year’s conference are described below:

 

Saturday, Oct. 6

Pre-meeting Workshop

8:00 a.m. - 5:00 p.m.

  • Bridging Physiologically-based Pharmacokinetics (PBPK) with Population Pharmacokinetics (PopPK) for Pediatrics

 

Monday, Oct. 8

Presentation

2:00 - 3:00 p.m.

  • Quantitative Systems Pharmacology (QSP) for Neuroscience Drug Discovery and Development: Current State, Opportunities and Challenges - Piet van der Graaf

 

Demonstration

4:15 - 4:45 p.m.

  • Trial Simulator - Mark Lovern

 

Posters

7:00 - 9:00 a.m.

  • M-005: A Model-based Meta-analysis (MBMA) to Support Development of Drugs for Treatment of Diabetic Peripheral Neuropathy, Post Herpetic Neuralgia and Fibromyalgia - Richard Franzese, Mark Lovern (contributing authors)

 

  • M-037: PBPK Model Application for Epacadostat to Estimate Starting Doses for Pediatric Clinical Evaluations - Alice Ke (contributing author)

 

  • M-045: Exposure-response Analyses of an MDM2 Inhibitor Milademetan - Tim Bergsma, Mark Lovern (contributing authors)

 

  • M-047: Development of a Pre-clinical QSP Model for E7046, a Novel PGE2 Receptor Type 4 Antagonist for Cancer Immunotherapy - Andrzej Kierzek, Cesar Pichardo, Ben Small, Piet van der Graaf, Neil Benson (contributing authors)

 

  • M-057: Impact of Free Fatty Acids on Prediction of Unbound Fraction of Cefazolin and Diazepam in Plasma of Full-term Neonates - Farzaneh Salem, Khaled Abduljalil, Trevor Johnson

 

  • M-063: An Advanced Approach to Compute the Optimal Dosing Regimen with a Pharmacokinetic/Pharmacodynamic (PK/PD) Model Using Optimal Control Theory - Marc Pfister (contributing author)

 

  • M-065: Sargramostim Modeling and Simulation to Support Dose Recommendation for Hematopoietic Syndrome of Acute Radiation Syndrome in Pediatric Patients from Birth to 17 Years of Age - Eileen Doyle (contributing author)

 

  • M-077: A Time-to-event Analysis of the Exposure-response Relationship for Bezlotoxumab Concentrations and CDI Recurrence - Huub Jan Kleijn

 

  • M-087: Interpretation of Dose-dependent PK of Ruzasvir Using Both PBPK and PopPK Modeling Approaches - Arne van Schanke, Gerly van der Vleuten (contributing authors)

 

3:45 - 4:45 p.m.

  • M-020: A Product-profile-driven Clinical Utility Index Analysis to Balance Benefits and Risks for Dose Selection in Oncology - Bill Poland, Russ Wada

 

  • M-022: PBPK Modeling of Ziprasidone in Pregnant Women - Frederico Martins (contributing author)

 

  • M-088: MBMA of Second-generation Antipsychotics for the Treatment of Schizophrenia - Maria Luisa Sardu, Huub Jan Kleijn, Eugene Cox (contributing authors)

 

  • M-092: Apply Machine Learning Methods to Predict Bilirubin Progression and Need for Phototherapy in Neonates - Marc Pfister (contributing author)

 

Tuesday, Oct. 9

Presentations

9:00 - 10:30 a.m.

  • Modeling Binding Kinetics of Bispecific Antibodies in a Physiological Context - Linzhong Li

 

4:00 - 5:30 p.m.

  • Application of PBPK Modeling for Rationalizing Dose Selection in Pediatric Rare Diseases - Karen Rowland Yeo

 

Demonstrations

8:15-8:45 a.m.

  • CODEx - Leon Bax

 

1:00 - 1:30 p.m.

  • Pirana workbench - Ron Keizer

 

Posters

8:00 - 9:00 a.m.

  • T-017: Visualization of Complex Trial Data in Non-linear Mixed-effect Analyses with Covariates - Jos Lommerse, Michelle Green (contributing authors)

 

  • T-019: PK/PD Analysis of Lanadelumab in Patients with Hereditary Angioedema - JF Marier, Colin Chang, Elliot Offman

 

  • T-035: Clinical Trial Simulation for a New Rapidly-absorbed Paracetamol Formulation Development from the Conventional Paracetamol Tablet - Kairui (Kevin) Feng, Robert Leary, Michael Dunlavey, Amin Rostami-Hodjegan

 

  • T-051: Development of a PopPK Model for Binimetinib with Subsequent Exposure-response Analyses in NRAS Mutant Melanoma - Mathilde Marchand, Henri Merdjan (contributing authors)

 

  • T-067: Application of Feto-maternal PBPK Model to Predict Emtricitabine Concentration During Pregnancy - Masoud Jamei, Khaled Abduljalil, Trevor Johnson

 

1:00 - 2:00 p.m.

  • T-018: Potential PD Drug Interaction Between Lanadelumab and Drugs Commonly Used in Patients with Hereditary Angioedema - JF Marier, Claudia Jomphe, Nathalie Gosselin

 

  • T-036: Modeling Double Peak Phenomenon and In Vitro-In Vivo Correlation in PK for Clinical Trial Simulation of Virtual Bioequivalence Studies - Kairui (Kevin) Feng, Robert Leary, Michael Dunlavey, Amin Rostami-Hodjegan

 

  • T-038: PopPK Analysis of Solriamfetol (JZP-110), a Selective Dopamine and Norepinephrine Reuptake Inhibitor - Nastya Kassir, Leila Kheibarshekan (contributing authors)

 

  • T-052: PBPK Modeling Prediction of Systemic Exposure of Olanzapine and Samidorphan when Administered in Combination as ALKS 3831 in Pediatric Subjects - Zoe Barter, Karen Rowland Yeo (contributing authors)

 

  • T-094: Tedizolid Phosphate Dose Selection for Pediatric Patients from 28 Days to Less Than 12 Years of Age Based on Simulations Using a PopPK Model for the Active Moiety Tedizolid - Vincent Duval, Rik De Greef (contributing authors)

 

Wednesday, Oct. 10

Presentations

3:15 - 4:45 p.m.

  • QSP Modeling Approach for Alzheimer’s Disease - Cesar Pichardo, Neil Benson (contributing authors)

 

  • Development of a Pre-clinical QSP Model for E7046, a Novel PGE2 Receptor Type 4 Antagonist for Cancer Immunotherapy - Andrzej Kierzek, Mike Walker, Cesar Pichardo, Ben Small, Piet van der Graaf, Neil Benson (contributing authors)

 

Posters

8:00 - 9:00 a.m.

  • W-013: Development of a PBPK Model for Docetaxel as a CYP3A Substrate and Accounting for Binding to Multiple Plasma Proteins - Rachel Rose, Ciaran Fisher, Iain Gardner

 

  • W-029: Combining Machine Learning and Mechanistic Modeling Approaches to Solve Real Life Problems and Assessment of the Local Tissue Binding and Its Influence on the Systemic Exposure after Topical Application of Drugs - Sebastian Polak, Nikunjkumar Patel

 

  • W-041: Performance Verification of Mechanistic Dermal Physiological Based Pharmacokinetic (PBPK) Model for Enhanced Understanding of Dermal Absorption: Prediction of Local Tissue Exposure after Topical Application of Acitretin - Sumit Arora, Nikunjkumar Patel, Sebastian Polak

 

2:00 - 3:00 p.m.

  • W-002: PopPK Analysis of Lanadelumab in Patients with Hereditary Angioedema - JF Marier, Colin Chang, Elliot Offman

 

  • W-034: Extension of the Distributed Delay Approach to Model Delayed Outcomes Involving Loss Mechanism During the Delay Process - Shuhua Hu

 

  • W-056: Development of Virtual Population Database from Real World Data - Gerly van der Vleuten, Li Qin (contributing authors)

 

  • W-058: Solving Sensitivity Equations by Inductive Linearization and Its Applications in PopPK and PD Models via FOCEi - Yuan Xiong (contributing author)

 

  • W-086: PopPK Analysis of Sargramostim to Support Dose Recommendation for Hematopoietic Syndrome of Acute Radiation Syndrome in Adults - Eileen Doyle (contributing author)

 

Further information about ACoP9 is available at http://www.go-acop.org .

 

About Certara

Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence solutions and knowledge integration. As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit  www.certara.com .