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PRINCETON, NJ - Nov 1, 2018 - Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence solutions, today announced that its scientists will lead 15 sessions, and also host a Phoenix User Group Meeting, at the American Association of Pharmaceutical Scientists’ (AAPS) Annual Meeting - PharmSci 360. This conference will be held from Nov. 4-7 at the Walter E. Washington Convention Center in Washington, DC.

“As the leader in model-informed drug development (MIDD), we welcome this opportunity to support AAPS and share our latest knowledge with industry colleagues,” said Certara Chief Scientific Officer Professor Amin Rostami. “As global regulators increasingly expect MIDD to be used to inform pivotal drug discovery and development decisions and to play a significant role in new drug and biologic license applications, we consider helping to train scientists on the latest modeling approaches so they can meet those expectations to be one of our primary responsibilities. At PharmSci 360, we will be highlighting our advances in virtual bioequivalence, successful applications of our dermal model, and our progress in quantitative systems pharmacology.”

In fact, two of Certara’s dermal MIDD submissions to this year’s conference received 2018 AAPS Best Abstract Awards. They were “Multi‐phase Multi‐layer Mechanistic Physiologically-based Pharmacokinetic (PBPK) Dermal Absorption Model Verification Including Inter- and Intra-individual Variability Assessment Using Nicotine as Model Drug,” and “Predicting Depth Resolved Concentrations in the Dermis Using PBPK Modeling: Design, Development and Verification of the Model with Five Drugs,” both co-authored by James Clarke, Nikunjkumar Patel and Sebastian Polak. This honor is granted to the top 10% of abstracts highly ranked by AAPS Abstract Screeners.

Certara will participate in the following sessions at this year’s meeting:

Monday, Nov. 5

Presentations

8:30 - 9:00 a.m.

• Physiologically-based Pharmacokinetic (PBPK) Model Applications in Drug Development - Shriram Pathak (moderator)

9:00 - 9:30 a.m.

• Integrating Inter- and Intra-subjects Variability in PBPK Modeling: Considerations and Knowledge Gaps - Masoud Jamei

9:00 - 11:00 a.m.

• PBPK Modeling and Clinical Pharmacology in Regulatory Applications & Decision Making - Chemical - Shriram Pathak (moderator)

User Group Meeting

11:30 a.m. - 12:30 p.m.

• Certara’s Phoenix Lunch & Learn - WinNonlin® Tips and Best Practices (Part 1) - Ana Henry, Venkateswari Muthukrishnan (Keith Nieforth, Master of Ceremonies)

12:30 - 1:30 p.m.

• Certara’s Phoenix Lunch & Learn - Delay Differential Equations; Bioanalysis and PK (Part 2) - Frank Engler (Keith Nieforth, Master of Ceremonies)

Posters

12:30 - 1:30 p.m.

• M1230-05-033: Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin - Ana Henry, Christopher Mehl, Linda Hughes

• M1230-05-036: Multi-phase Multi-layer Mechanistic PBPK Dermal Absorption Model Verification Including Inter- and Intra-individual Variability Assessment Using Nicotine as Model Drug - Nikunjkumar Patel, James Clarke, Sebastian Polak

• M1230-05-037: Development and Verification of Population Level IVIVC Using Mechanistic PBPK Modeling for Trazodone Extended Release Formulations to Support Biowaiver for SUPAC Changes to the Formulation - Nikunjkumar Patel (contributing author)

1:30 - 2:30 p.m.

• M1330-10-074: Phase Behavior and Transformation Kinetics of a Poorly Water Soluble Weakly Basic Drug upon Transit from Low to High pH Conditions - David Turner (contributing author)

Tuesday, Nov. 6

Symposium

10:00 - 10:30 a.m.

• Use of In-vitro and In-silico Models to Predict ‘In Cerebro’ Drug Concentrations - Amin Rostami

User Group Meeting

11:30 a.m. - 12:30 p.m.

• Certara’s Phoenix Lunch & Learn - Model-informed Drug Development: From Academic Nicety to Regulatory Necessity (Part 1) - Ellen Leinfuss (Keith Nieforth, Master of Ceremonies)

12:30 - 1:30 p.m.

• Certara’s Phoenix Lunch & Learn - Trial Simulator Walkthrough and Phoenix Roadmap (Part 2) - Mark Lovern, Shilpa Ramachandra, Kevin Trimm, Michael Eckstut (Keith Nieforth, Master of Ceremonies)

Posters

12:30 - 1:30 p.m.

• T1230-05-033: A Comprehensive and Systematic Review of Gastric pH and Factors Affecting Gastric Fluid Volume Dynamics under Fasted and Fed Conditions in Humans - Krishna Machavaram, Shriram Pathak, Masoud Jamei, David Turner

• T1230-05-037: Predicting Depth Resolved Concentrations in the Dermis Using PBPK Modeling: Design, Development and Verification of the Model with Five Drugs - James Clarke, Nikunjkumar Patel, Sebastian Polak

Wednesday, Nov. 7

Presentations

8:30 - 9:00 a.m.

• Prologue: Overview of the Current Status of Precision Medicine and Practical Limitations - Amin Rostami

• Prologue: Understanding Benefits and Challenges of Interspecies Extrapolations - Masoud Jamei (moderator)

9:00 - 11:00 a.m.

• Pharmacogenetics, Big Data, and Population PK in Personalized Medicine and Special Populations - Chemical - Amin Rostami (moderator)

• Pre-clinical to Clinical Translation - Chemical - Masoud Jamei (moderator)

10:00 - 10:30 a.m.

• Towards Quantitative Systems Pharmacology Models Informed by Individual Genomics Data - Andrzej Kierzek

Additional information about this conference can be found at https://www.aaps.org/pharmsci/annual-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 .