Certara Thought Leaders Contribute to 26 Sessions at the PAGE 2016 Annual Meeting

June 2, 2016

Certara’s contributions include scientific workshops, presentations, and posters

PRINCETON, NJ – June 2, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today detailed the active role it is taking in the Population Approach Group in Europe (PAGE) 2016 Annual Meeting. PAGE is a UK-based, nonprofit organization, which is committed to taking a population approach to data analysis. This year’s conference will be held from June 7-10 at the University of Lisbon in Lisbon, Portugal.

“Our strong presence at the PAGE 2016 Annual Meeting underscores the growing adoption of physiologically-based pharmacokinetic (PBPK) modeling throughout the drug development spectrum from pre-clinical into clinical care,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “Sponsors and global regulatory agencies are increasingly requiring PBPK data to make drug labeling decisions, and clinicians are embracing the discipline’s ability to provide precision dosing for individual patients.”

“Quantitative systems pharmacology (QSP) is also beginning to demonstrate its power to explain the relationships between dose and pharmacological response and the inter-relationship with the disease and its progression,” said Certara’s Simcyp President Steve Toon, BPharm, PhD. “Young drug development scientists know that PBPK and QSP will be integral technologies to their careers and they are keen to learn more about them.”

Certara’s contributions to this year’s meeting include the following:

Monday, June 6 and Tuesday, June 7
Workshops

  • Advanced Level Workshop on Pharmacokinetics
  • Bill and Melinda Gates Workshop and Hackathon

Tuesday, June 7
Workshops

  • Parameter Estimation and Pharmacodynamics (PE/PD) Hands-on Workshop
  • Bridging PBPK with POPPK for Pediatrics
  • Physiological Modeling of Therapeutic Proteins and Antibody-drug conjugates

Wednesday, June 8
Presentations
11:40 a.m. -12:00 p.m.

  • B-07: A Six-stage Workflow for Robust Application of Systems Pharmacology – Kapil Gadkar (Piet van der Graaf, contributing author)

12:00-12:20 p.m.

  • B-08: The Zebrafish as Model for Translational Systems Pharmacology: Expanding the Allometric Scale in Vertebrates with Five Orders of Magnitude – Rob van Wijk (Piet van der Graaf, contributing author)

4:30-5:10 p.m

  • B-15: Characterizing and Forecasting Individual Weight Changes in Term Neonates – Mélanie Wilbaux (Marc Pfister, contributing author)

Posters
10:20-11:40 a.m.

  • I-02: A New Language for Complex ODE Models – Mike Dunlavey
  • I-46: Use of Interim Analysis to Improve Efficiency of Clinical Trial Simulations in Treatment Comparison Trial Design Studies – Shuhua Hu
  • I-53: Time Variation in the Fractional Contribution of an Enzyme to Elimination of a Victim Drug Can Explain Differences in DDI Susceptibility Following Single and Multiple Dosing – Masoud Jamei
  • I-74: An Improved Framework for Shrinkage Computations in NLME Population Models – Robert Leary

3:10-4:30 p.m.

  • II-01: Simcyp Simulator Within the DDMoRe Interoperability Framework – Proof of Concept Cases – Khaled Abduljalil
  • II-40: A Model to Predict Progression-free Survival in Patients with Previously Untreated HER2-positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer Based on Tumor Growth Inhibition Metrics – Pascal Chanu
  • II-48: A Model to Predict Progression-free Survival in Patients with Renal Cell Carcinoma Based on Week 8 Change in Tumor Size – Laurent Claret
  • II-54: Maturation of Glomerular Filtration Throughout the Pediatric Age Range – A Comparison of Different Functions – Cristea Sinziana (Amin Rostami, contributing author)

Thursday, June 9
10:05-11:30 a.m.

  • III-08: A Novel Mechanistic Approach to Predict the Steady State Volume of Distribution (Vss) Using the Fick-Nernst-Planck Equation – Gaohua Lu
  • III-28: Primary Microcephaly: Do All Roads Lead to Rome? – Samer Mouksassi
  • III-37: Combining Population with Physiologically-based Pharmacokinetic (PBPK) Models for Oral Drug Absorption: Predicting the Segmental Bioavailability Differences of R-oxybutynin and its Main Metabolite using a Middle Out Approach – Andrés Olivares-Morales (Amin Rostami, contributing author)
  • III-53: A Mechanistic Maternal-fetal Growth Energy Budget Model – Thomas Peyret
  • III-62: Development of a Novel Multi-compartment Granuloma Model to Predict Local Drug Distribution and its Impact on Pharmacodynamics and Disease Progression in Tuberculosis – Rachel Rose

2:40-4:00 p.m.

  • IV-08: Changes in Liver Volume – A Population-based Approach to Meta-analysis of Pediatric, Adult and Geriatric Populations – Ben Small
  • IV-38: Assessment of DDI Potential of Ruxolitinib (INC424), a Dual Substrate of CYP3A4 and CYP2C9, Using a Verified PBPK Model to Support Submissions to Health Authorities – Umehara Ken-ichi (Kim Crewe and Karen Rowland-Yeo, contributing authors)
  • IV-41: Dose Translation of a Hematopoietic Acute Radiation Syndrome Protection Agent (Recombinant Human Interleukin-12) to Humans – Vladimir Vainstein (Martin Beliveau and Claudia Jomphe, contributing authors)
  • IV-47: The Proof is in the Pee: Population Asparagus Urinary Odor Kinetics – Coen van Hasselt (Piet van der Graaf, contributing author)
  • IV-57: Investigating the Importance of Considering Inter-correlations of Cytochrome P450 Enzyme Abundances in Human Liver When Predicting Drug-Drug Interactions – Janak Wedagedera
  • IV-62: Zika Microcephaly Cutoffs Revisited: A Study of Non-parametric Methods in Fetal Growth – Wilbur Jayson (Samer Mouksassi, contributing author)

In addition, Certara will be conducting Simcyp® Simulator demonstrations throughout the meeting.

For more information about this conference, please visit: http://www.page-meeting.org/default.asp?id=40&keuze=meeting.

About Certara
Certara is a global biosimulation and regulatory writing company, committed to optimizing drug development decisions. Its clients include hundreds of international biopharmaceutical companies, leading academic institutions, and key regulatory agencies. Certara’s solutions, which span drug discovery through patient care, increase the probability of regulatory and commercial success by using the most scientifically-advanced modeling and simulation technologies and regulatory strategies.

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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