Certara Pharmacometricians to Highlight Modeling and Simulation Advances at PAGE 2017

Certara will contribute to 31 sessions, including workshops, presentations and a tutorial

PRINCETON, NJ – June 5, 2017 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that its scientists are playing leading roles in more than 30 sessions at the Population Approach Group in Europe (PAGE) 2017 Annual Meeting. PAGE is a UK-based, nonprofit organization, which is committed to taking a population approach to data analysis. This year’s meeting is being held in Budapest, Hungary from June 6-9.

“Modeling and simulation (M&S) has evolved from a scientific nicety into a regulatory necessity. It has been widely adopted by global biopharmaceutical companies and is used by the US Food and Drug Administration (FDA), European Medicines Agency, Chinese FDA, and Japanese Pharmaceuticals and Medical Devices Agency to evaluate regulatory submissions,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD.

“As a leader in M&S, Certara is committed to educating the next generation of pharmacometricians and PAGE provides an excellent opportunity to share our knowledge with young drug development scientists. This year, we will be discussing advances in physiologically-based pharmacokinetics (PBPK), model-based meta-analysis, and quantitative systems pharmacology. Together, they can help to determine drug doses for individual patients, improve pre-clinical and clinical data analyses, and reduce attrition between clinical phases by investigating how the relationship between drug dose and pharmacological response relates to the disease and its progression,” said Dr. Muniz.

As part of its commitment to pharmacometrics education, Certara helps to fund the PAGE Student Sponsorship which permits presenters, who have no other means of financial support, to attend the conference. This year’s PAGE Student Sponsorship winners are featured on Certara’s blog at https://www.certara.com/blog.

Certara will participate in the following sessions at PAGE 2017:

Monday, June 5 and Tuesday, June 6

Two-day Workshop Hosted by Certara’s Software Division

  • Advanced Pharmacometrics Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling Course using Phoenix NLME

Tuesday, June 6

One-day Workshops Hosted by Certara’s Simcyp Division

  • Parameter Estimation and Pharmacodynamics Hands-on Workshop
  • Bridging PBPK with Population PK (PopPK) for Pediatrics
  • Physiological Modeling of Therapeutic Proteins and Antibody-drug Conjugates

Wednesday, June 7

Presentations

10:30 – 12:30

  • I-03: Application of Global Sensitivity Analysis Methods to Determine the most Influential Parameters of a Minimal PBPK Model of Quinidine – Dan Liu, Linzhong Li and Masoud Jamei 
  • I-52: PBPK Model for Halofantrine Cardiac Effect Prediction – Proof-of-concept Study Towards the System for the Antimalarial Drugs Cardiac Safety Assessment – Sebastian Polak
  • I-56: PharmTeX: A LaTeX-based Open-Source Platform for Automated Reporting Workflow – Christian Hove Rasmussen
  • I-61: Predicting Diclofenac Systemic and Synovial Fluid Concentrations After Dermal Application Using the Multi-Phase Multi-Layer MechDermA PBPK model – Amin Rostami, Sebastian Polak, Nikunjkumar Patel, Frederico Martins, Farzaneh Salem and Masoud Jamei

15:10 – 16:40

  • II-03: nlmixr: An Open-Source Package for Pharmacometric Modeling In R – Yuan Xiong (contributing author)
  • II-05: Frequency-domain Response Analysis for Quantitative Systems Pharmacology Models– Piet van der Graaf (contributing author)
  • II-35: Simulation of PK of Amitriptyline and Nortriptyline and Their Common Effect on Human Cardiac Electrophysiology in Healthy Population – Sebastian Polak (contributing author)
  • II-39: A Comprehensive Model-Based Meta-Analysis of Diabetes Studies in Type 2 Diabetes Mellitus Patients to Quantify the Relationship between HbA1c and Fasting Plasma Glucose – Mark Lovern, Jaap Mandema, Leon Bax, and Thomas Kerbusch (contributing authors)
  • II-42: Quantifying the Growth Hormone (GH) Lowering Effect of BIM23B065 after a GH Stimulation Test – Piet van der Graaf (contributing author)
  • II-45: A Parent-metabolite Pharmacokinetic Model of Paracetamol in Zebrafish – Rob van Wijk and Piet van der Graaf
  • II-52: Statistical Power Analysis to Detect Drug-Drug Interaction (DDI) between Lorezapam and Probenecid in Healthy and Renal-impaired Populations Using PBPK Modeling and the Simcyp R Package – Janak Wedagedera, Theresa Cain and Masoud Jamei

Thursday, June 8

Presentations

09:50-11:20

  • III-05: Study and Application of Nonparametric and Parametric Population Modeling for Automatic Subpopulation Classification to CYP2D6 Phenotype Compounds and Pediatric Age Groups – Kevin Feng, Robert H. Leary, Michael Dunlavey and Amin Rostami
  • III-11: A Whole Body PBPK Model for Antibody Drug Conjugates – Model Development and Validation in Rat – Iain Gardner, Linzhong Li, Felix Stader, Rachel Rose, Indranil Rao and Masoud Jamei
  • III-26: PopPK of L-DOPA and its Main Metabolites: Use of the Phoenix-based QRPEM Algorithm – Nathan Teuscher (contributing author)
  • III-32: Sensitivity Analysis of P-glycoprotein Ki Values in Dynamic DDI Predictions – Eleanor Howgate, Sibylle Neuhoff and Karen Rowland-Yeo
  • III-37: Virtual Bioequivalence Assessment of Two Tramadol Formulations Using the Advanced Dissolution Absorption and Metabolism Model via Simcyp R Package – Masoud Jamei, Janak Wedagedera, Theresa Cain and Shriram Pathak
  • III-45: Herceptin in HER2-positive Gastric Cancer: Evaluation of Exposure-response with Two Dose Levels – Mathilde Marchand (contributing author)

Tutorial

11:20-12:00

  • An Overview of Non-Parametric Estimation Methods Used in Population Analysis – Robert H. Leary

Presentations

14:45-16:15

  • IV-01: Application of PBPK Model to Predict Tramadol Concentration in Human Milk – Khaled Abduljalil, Trevor N. Johnson and Masoud Jamei
  • IV-03: Operating Characteristics of Stepwise Covariate Selection in Pharmacometric Modeling – Anna Largajolli, Paul M Diderichsen, Rik de Greef, Thomas Kerbusch and Han Witjes
  • IV-11: Systems Pharmacology Modeling of Alternative Pathway of Complement Activation – Piet H. van der Graaf (contributing author)
  • IV-32: Accuracy of Plasma Clearance Scaling from Adults to Children Using Pathway-specific Covariate Models: A Systematic Investigation Using a PBPK Workflow – Amin Rostami, Piet Van Der Graaf and Trevor N. Johnson
  • IV-36: An Extrapolation Approach to Aprepitant Pediatric Drug Development – Leila Kheibarshekan and Nathalie H Gosselin (contributing authors)
  • IV-41: Prediction of the PK of Renally-Excreted Anti-retrovirals in Older Patients, Using PBPK Modeling – Manoranjenni Chetty, Mailys De Sousa Mendes and Karen Rowland-Yeo
  • IV-49: The Impact of Renal Transporters on Pediatric Renal Clearance – Amin Rostami (contributing author)
  • IV-54: Predicting Human Fetal Exposure Using PBPK Models – Mailys De Sousa Mendes
  • IV-66: Use of Distributed Delay in PML – Mike Dunlavey and Shuhua Hu

For additional information about PAGE 2017, please visit https://www.page-meeting.org/default.asp?id=41&keuze=meeting.

About Certara
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

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