Certara Scientists to Present Model-informed Drug Development, Systems Pharmacology and MBMA Advances at PAGE 2018

PRINCETON, NJ - May 29, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, health economic outcomes research, market access and real-world evidence services, today announced its participation in 28 sessions at the Population Approach Group in Europe (PAGE) 2018 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 May 29 to June 1 in Montreux, Switzerland.

“As a leader in modeling and simulation, Certara is committed to educating the next generation of pharmacometricians and other quantitative scientists, and PAGE provides an excellent opportunity to share our knowledge with young drug development scientists. To support that goal, we have established Certara University and collaborated with academia to create centers of excellence around the world. We also support fellowships, scholarships and new investigator awards,” said Certara Chief Scientific Officer Professor Amin Rostami-Hodjegan, PharmD, PhD, FCP.

Certara is continuing its multi-year tradition of helping to fund the PAGE Student Sponsorship. This program permits presenters, who have no other means of financial support, to attend the conference. An introduction to this year’s PAGE Student Sponsorship winners can be found on Certara’s blog at https://www.certara.com/2018/05/18/spotlight-on-the-page-student-sponsorship-winners. As Certara believes in working and playing hard, it is also co-sponsoring the PAGE Football Championship 2018.

Certara will participate in the following sessions at PAGE 2018:

Tuesday, May 29
Certara’s Simcyp division is hosting one-day workshops on the following topics:
• Parameter Estimation and Pharmacodynamics (PE/PD) - Hands-on Session
• Bridging Physiologically-based Pharmacokinetics (PBPK) with Population Pharmacokinetics (POPPK) for Pediatrics
• Physiological Modeling of Therapeutic Proteins and Antibody-drug Conjugates

Tuesday, May 29 and Wednesday, May 30
• Certara University is hosted a two-day Phoenix® NLME™ Course

Wednesday, May 30
Posters
10:10-11:40 a.m.
• I-03: Frequency-domain Derived Optimization of Cell Cycle Specific Cancer Treatment - Piet van der Graaf (contributing author)

• I-14: A Comparison of Two Model Reduction Methodologies for a Quantitative Systems Pharmacology (QSP) Bone Biology System with Denosumab Dosing - Tom Snowden, Piet van der Graaf

• I-18: Population-based PBPK Modeling for the Prediction of Bile Salts Disposition within GI
Luminal Fluids-Towards a Mechanistic Bile Salts Model - Konstantinos Stamatopoulos, Shriram M. Pathak, David Turner

• I-42: Systems Pharmacology Modeling of the Alternative Pathway to Study Target Suitability - Piet van der Graaf, Suruchi Bakshi

• I-47: Nanoscale Blood Sampling from Zebrafish Larvae for the Estimation of Distribution Volume and Absolute Clearance - Piet van der Graaf (contributing author)

• I-67: Optimizing Treatment of Cephalosporin-resistant Pneumococcal Meningitis - Piet van der Graaf (contributing author)

3:50-5:20 p.m.
• II-07: Selecting In Vitro Dissolution Tests Using POPPK Modeling to Help Bioequivalence Studies - Kevin Feng, Robert Leary, Michael Dunlavey, Amin Rostami-Hodjegan

• II-44: ShinyMixR: A Project-centric R/Shiny Run Management Tool for nlmixr - Yuan Xiong (contributing author)

• II-54: POPPK Analysis of Tildrakizumab, an Anti-IL-23 Antibody, in Healthy Volunteers and Subjects with Psoriasis - Petra Jauslin, Pooja Kulkarni, Russ Wada, Suresh Vatakuti, Thomas Kerbusch

Thursday, May 31
Posters
9:55-11:30 a.m.
• III-02: Development of PBPK Drug Models to Support Antimalarial Combination Strategy - Lisa Almond, Maurice Dickins, Karen Rowland-Yeo, Zoe Barter, David Wesche (contributing authors)

• III-03: Evaluation of Prediction Performance of In Silico PBPK Models of Oral Drug Absorption - Amin Rostami-Hodjegan (contributing author)

• III-09: Quantitative Modeling of Procalcitonin as a Treatment Response Biomarker in Sepsis - Piet van der Graaf (contributing author)

• III-33: Dose Individualization of CYP3A Substrates in Children: Characterization of Maturation of Intestinal and Hepatic CYP3A Activity in Children to Predict First-pass and Systemic CYP3A-mediated Metabolism - Amin Rostami-Hodjegan (contributing author)

• III-35: Apixaban for Treatment of Venous Thromboembolism (VTEtx): Use of Model-based
Meta-analysis (MBMA) to Support Phase 3 Dose Selection and Beyond - Jaap Mandema (contributing author)

• III-41: Extension of POPPK Analysis of Pembrolizumab to Pediatric Patients with Classical Hodgkin Lymphoma - Aziz Ouerdani, Rik De Greef (contributing authors)

• III-48: Antidepressants, Anxiolytics and Statins: Prediction of Exposure Changes Due to Aging - Manoranjenni Chetty, Felix Stader

• III-59: Characterization of Paracetamol Hepatotoxicity During Pregnancy through PBPK Modeling - Marc Pfister (contributing author)

• III-65: Mechanistic Modeling of In Vitro Bidirectional Permeability Studies and In Vivo Absorption of Metoprolol - Maïlys De Sousa Mendes, Sibylle Neuhoff, Howard Burt

Oral Presentation
11:50 a.m. -12:10 p.m.
• C-08: Exposure-response-based Product-profile-driven Clinical Utility Index to Support Phase 3 Dose Selection in Oncology - Bill Poland, Russ Wada (contributing authors)

Posters
3:10-4:40 p.m.

• IV-05: Automatic Framework for Bioequivalence Studies from In Vitro Test to In Vivo Study Design - Robert Leary, Kevin Feng, Michael Dunlavey, Amin Rostami-Hodjegan

• IV-10: An MBMA to Support Development of Medicines for Treatment of DPN, PHN and Fibromyalgia - Han Witjes, Richard Franzese, Mark Lovern (contributing authors)

• IV-25: Clinical Validation of a QSP Model for Nerve-growth-factor Therapies - Tomomi Matsuura, Mike Walker, Divyanshi Karmani, Neil Benson, Piet van der Graaf

• IV-44: Switching from Immediate Release to Modified Release Can Have an Impact on Intestinal Drug-drug Interactions: A PBPK Simulation Study Using Oxybutynin as a Case Example - Amin Rostami-Hodjegan (contributing author)

• IV-57: QSP Modeling of Neurodegenerative Chronic Diseases and Brain Biomarkers: Adding the Effect of Aging on Brain Volume - Cesar Pichardo-Almarza, Neil Benson

Further information about PAGE 2018 is available at https://www.page-meeting.org/default.asp?id=42&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. For more information, visit www.certara.com.