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PRINCETON, NJ - Jun 10, 2019 - Certara® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its scientists will participate in 28 sessions at the Population Approach Group in Europe (PAGE) 2019 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 11-14 at the Stockholm Waterfront Congress Centre in Stockholm, Sweden.

“Certara is proud to support PAGE and the important role it plays in educating drug development scientists about the latest advances in model-informed drug development, physiologically-based pharmacokinetics (PBPK), quantitative systems pharmacology and model-based meta-analysis (MBMA),” said Professor Amin Rostami, Chief Scientific Officer and Senior Vice President of Research and Development at Certara. “These approaches, which increase precision and reduce risk by improving decision making throughout the drug development process, have been widely adopted by global sponsors and regulatory agencies alike. As a result, scientists with these skills are in great demand and we are delighted to share our knowledge with them through professional organizations like PAGE, Certara University, our Centers of Excellence, and fellowship, scholarship and new investigator awards programs.”

Furthermore, to help ensure that research progress in these rapidly-evolving fields is not limited by lack of resources, Certara provides 100 academic and not-for-profit organizations with more than 2,000 complimentary licenses for its Simcyp® Simulator, the industry’s most sophisticated PBPK platform.

“We are delighted to see those complimentary academic licenses resulting in so many important research contributions being made to PAGE,” added Professor Rostami.

In addition to providing software licenses and contributing to numerous sessions at PAGE 2019, Certara is continuing its long-standing tradition of helping to fund the PAGE Student Sponsorship. This program enables student presenters, who have no other means of financial support, to attend the conference. Several of this year’s PAGE Scholars share their research focus and aspirations in the latest Certara blog post at https://www.certara.com/2019/06/07/spotlight-on-the-page-student-sponsorship-winners-2019/?UTM_LeadSource=1 .

Furthering its efforts to knowledge share, Certara will be conducting demonstrations of two of its newest products - Integral™ and Trial Simulator v2.3 - in booths 7 and 8 at the conference. Integral is Certara’s cloud-based, 21 CFR Part 11 compliant, next-generation data repository for collecting, managing, and storing multiple types of data sets for analysis, sharing and reporting of clinical pharmacology, pharmacometrics and other relevant clinical data. Trial Simulator v2.3 helps drug developers improve clinical trial design, resulting in greater likelihood of trial success.

Certara will participate in the following sessions at PAGE 2019:

Tuesday, June 11

Workshops

Certara’s Simcyp division is hosting one-day workshops on the following topics:

• Bridging PBPK with POPPK for Pediatrics
• Physiological Modeling of Therapeutic Proteins and Antibody-drug Conjugates

Wednesday, June 12

Presentation

5:25- 5:45 p.m.

• B-18:   A Disease Progression Model for Geographic Atrophy - Mathilde Marchand (contributing author)

Posters

9:50-11:15 a.m.

• I-03: Integrating a Tumor Growth inhibition Model within a Physiologically-based Pharmacokinetic (PBPK) Model to Predict Erlotinib Tumor Concentrations in Mice - Khaled Abduljalil, Rachel H. Rose, Devendra Pade, Siri Kalyan Chirumamilla, Cong Liu, Isha Taneja, Anthonia Afuape, Linzhong Li, Iain Gardner

• I-13: Predicting the Fraction Unbound (fu) and Plasma Drug Clearance Based on Known Changes in Albumin and Alpha1-Acid Glycoprotein Levels at Varying Degrees of Renal Impairment - Amin Rostami

• I-22: PBPK Model to Predict Lung Distribution of Anti-Infective Agents - Piet van der Graaf (contributing author)

• I-35: Application of Model-based Meta-analysis (MBMA) to Evaluate the Relationship Between Early Biomarker to Late-stage Clinical Endpoints for the Development of Anti-asthmatic Drugs - Francesco Bellanti, Eugene Cox (contributing authors)

• I-65: An MBMA of Second-generation Antipsychotics for the Treatment of Schizophrenia - Maria Luisa Sardu, Huub Jan Kleijn, Li Qin, Eugene Cox (contributing authors)

• I-71: Mechanistic Models of Cancer-immune Cycle and Immunotherapies - Viji Chelliah, Georgia Lazarou, Andrzej Kierzek, Piet van der Graaf

• I-74: Application of PBPK Model to Mechanistically Predict Increased Tumor Uptake of Paclitaxel in Cancer Patients - Siri Kalyan Chirumamilla, Rachel Rose, Khaled Abduljalil, Devendra Pade, Cong Liu, Isha Taneja, Anthonia Afuape, Linzhong Li, Iain Gardner

• I-82: Transporter Inhibition: Modeling In-vitro Transwell Assays - Mailys De Sousa Mendes, Matthew Harwood, Howard Burt, Sibylle Neuhoff

• I-85: Population Modeling and Simulations of Binimetinib PK in Subjects with Hepatic Impairment to Explore Optimal Dosing Regimen Using Total and Unbound Binimetinib Exposures - Nathalie Gosselin, Claudia Jomphe, JF Marier (contributing authors)

3:10 - 4:40 p.m.

• II-08: Population PK of Piperacillin-tazobactam Extended Infusions in Pediatric Population - Jean Lavigne, Nastya Kassir (contributing authors)

• II-20: Investigating Impacts of Model Parameter Correlations in Global Sensitivity Analysis: Determining the Most Influential Parameters of a Minimal PBPK Model of Midazolam - Dan Liu, Linzhong Li, Amin Rostami, Masoud Jamei (contributing authors)

• II-21: Modeling Inflammatory Biomarker Dynamics During Clinical Challenge Studies with Lipopolysaccharide - Piet van der Graaf (contributing author)

• II-74: Pharmacodynamics (PD) of Rituximab on B cells in Pediatric Post-HSCT patients with EBV - SY Amy Cheung (contributing author)

• II-75: Development of a Quantitative Systems Pharmacology (QSP) Model to Support Dosing of rhPTH(1-84), a Recombinant Human Parathyroid Hormone, in Adult Patients with Hypoparathyroidism - Thomas Peyret, Benjamin Rich, JF Marier (contributing authors)

Thursday, June 13

Posters

9:55-11:20 a.m.

• III-12: Modeling Decline in Cognition to Decline in Function in Alzheimer’s Disease - Luyuan Qi (contributing author)

• III-14: Performance of the FOCEI Algorithm in the Open-source Non-linear Mixed Effect Modeling Tool nlmixr - Yuan Xiong (contributing author)

• III-37: The Dynamics of Pharmacological Effects Aimed at Gut Wall: A Framework for a Nested-target-within-enterocyte (NTWE) Model that Accounts for Turnover of Target and Cell - Amin Rostami (contributing author)

• III-57: Methadone Dosing Strategies in Preterm Neonates Can Be Simplified - Marc Pfister (contributing author)

• III-58: Nanoscale PK and PD of Isoniazid Treatment of Tuberculosis in Zebrafish Larvae - Piet van der Graaf (contributing author)

• III-85: Explaining Inter-species Differences to Anti-PDL1 Cancer Immunotherapy Using a Translational QSP Approach - Mike Walker, Andrzej M. Kierzek, Piet van der Graaf (contributing authors)

3:25 - 4:50 p.m.

• IV-05: A Continuous-time Markov Model (CTMM) for Investigator’s Global Assessment (IGA) Score in Moderate-to-severe Atopic Dermatitis Treated With Subcutaneous Nemolizumab - Vincent Duval, Emilie Schindler, Anna Largajolli, Petra Jauslin (contributing authors)

• IV-13: Development and Performance Verification of a Semi-PBPK Model for Topical Ocular Delivery of Pilocarpine and Timolol to Rabbit Eyes - Anam Fayyaz, Iain Gardner, Masoud Jamei (contributing authors)

• IV-19: Hemodynamic Systems Model to Characterize Cardiovascular Drug Effects - Piet van der Graaf (contributing author)

• IV-22: Population PK Modeling of Esaxerenone: A Novel Nonsteroidal Mineralocorticoid Receptor Blocker - Kris Jamsen, Helen Kastrissios (contributing authors)

• IV-62: Modeling Bounded Scales for Evaluation of Treatment Response to Subcutaneous Nemolizumab in Moderate to Severe Atopic Dermatitis - Petra Jauslin, Anna Largajolli, Emilie Schindler, Vincent Duval (contributing authors)

Further information about PAGE 2019 is available at https://www.page-meeting.org/default.asp?id=43&keuze=meeting .

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 .