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Certara will host two Phoenix WinNonlin™ Lunch and Learns and also lead 18 workshop, presentation and poster sessions on model-informed drug development

PRINCETON, NJ – Nov. 4, 2019 – Certara®, the global model-informed drug development and decision support leader, today announced that its scientists will lead 20 sessions at the American Association of Pharmaceutical Scientists’ (AAPS’) Annual Meeting – 2019 AAPS PharmSci 360. This year’s conference will be held from Nov. 3-6 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

“This is such an exciting time to be working in model-informed drug development,” said Certara Chief Scientific Officer Professor Amin Rostami. “More than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) are supported by Certara software or services. Our physiologically-based pharmacokinetic (PBPK) Simcyp Simulator has been used to inform drug label claims – removing the need for specific clinical investigation – for more than 50 new drugs approved by FDA and applications for the technology continue to grow. For example, earlier this year, the Simcyp Simulator was used to demonstrate bioequivalence for the FDA approval of a complex generic drug on its abbreviated new drug application pathway. We are looking forward to sharing both our latest research and great enthusiasm for this rapidly-evolving field with fellow scientists at PharmSci 360.”

AAPS is also introducing a new event – Special Poster Collections – at this year’s conference. AAPS leaders reviewed the top poster abstracts submitted for PharmSci 360 and chose those that they were most excited to see for inclusion in the high-profile collections. Nathalie Rioux’s poster (M1430-09-58) was selected for that honor. 

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

Sunday, Nov. 3

Workshop

12:45 - 1:15 p.m.

• PBPK: Introduction and State-of-the-Art – Amin Rostami

   

  Monday, Nov. 4

  Workshop

  12:00 - 2:00 p.m.

  Certara's Phoenix WinNonlin Lunch and Learn Day 1 – Ana Henry

   

  Presentation

  3:15 - 3:30 p.m.

• Biopharmaceutic In-Vitro In-Vivo Extrapolation (IVIVE-) Informed PBPK Model of Ritonavir Absorption – Sumit Arora

   

  Posters

  10:30 - 11:00 a.m.

• M1030-09-61: Predicting Human Oral Bioavailability: Comparison of In Vivo Animal (Rat, Dog, and Monkey) Studies versus Mechanistic IVIVE-based Predictions – Nikunjkumar Patel, Mian Zhang, Masoud Jamei

   

  2:30 - 3:30 p.m.

• M1430-09-58: New Insights in the Distribution, Metabolism, and Excretion of H3B-6545, a Novel Selective ERα Covalent Antagonist (SERCA), in Sprague Dawley and Long Evans Rats – Nathalie Rioux

   

  Tuesday, Nov. 5

  Workshop

  12:00 - 2:00 p.m.

• Certara's Phoenix WinNonlin Lunch and Learn Day Two – Ana Henry

   

  Presentations

  8:30 - 9:00 a.m.

• Prologue: Applications of Non-linear Mixed Effect (NLME) Models to Define Systems: Shifting Focus Away from Single Drug – Chemical – Amin Rostami

   

  9:30 - 10:00 a.m.

• Reverse Translation for UGTs: Leveraging clinical data to obtain UGT-mediated intrinsic clearances for IVIVE-PBPK – Matthew Harwood

   

  3:45 - 4:00 p.m.

• PBPK Modeling of Transdermal Selegiline Disposition Discrepancy in Special Populations –  Santosh Kumar Puttrevu

   

  4:45 - 5:00 p.m.

• Mechanistic Dermal Absorption PBPK Modeling Supports Bioequivalence of Complex Topicals – Tariq Abdulla

   

  Posters

  1:30 - 2:30 p.m.

• T1330-13-84: Development and Verification of a PBPK - Pharmacodynamic (PBPK-PD) Canine Model for Propofol in Greyhounds and Beagles – Tariq Abdulla, Devendra Pade, Sibylle Neuhoff, Masoud Jamei

   

• T1330-13-87: Development of a PBPK Model for the Prediction of Amiodarone Pharmacokinetics in Fed and Fasted State Using the Advanced Dissolution, Absorption and Metabolism (ADAM) Model – Peter Kilford, Xian Pan, Sumit Arora, Iain Gardner

   

  2:30 - 3:30 p.m.

  • T1430-13-88: Evaluation of Methamphetamine and Amphetamine Disposition Discrepancy upon Selegiline Transdermal Patch Administration in Healthy Volunteers Versus Special Populations Using PBPK Modeling – Santosh Kumar Puttrevu, Sumit Arora, Sebastian Polak, Nikunjkumar Patel

     

    Wednesday, Nov. 6

    Presentations

    8:30 - 9:00 a.m.

• Prologue: The Regulatory Impact of PBPK Modeling and How We Got There – Chemical – Masoud Jamei (Moderator)

   

  9:30 - 10:00 a.m.

• Regulatory Interactions on PBPK Modeling: A Case of PPIs not DDIs – Karen Rowland Yeo

   

  9:00 - 11:00 a.m.

• Symposium: Lessons Learned from Regulatory Interactions in Clinical Pharmacology for Innovative New Chemical Entities, Complex Generics, and Biosimilars – Chemical – Masoud Jamei (Moderator)

   

  10:30 - 11:00 a.m.

• Towards Bridging Translational Gap in Cardiotoxicity Prediction: Progressive Cardiac Risk Assessment Strategy for Moxifloxacin – Nikunjkumar Patel

   

  4:00 - 5:00 p.m.

• Panel Discussion: Clinical Pharmacology – Karen Rowland Yeo

   

  Posters

  9:30 - 10:30 a.m.

• W0930-13-88: Biopharmaceutic IVIVE-informed PBPK Model of Ritonavir Norvir® Tablet Absorption in Humans Under Fasted and Fed State Conditions – Sumit Arora, Amita Pansari, Masoud Jamei, Iain Gardner, David B. Turner

   

  12:30 - 1:30 p.m.

• W1230-10-66: Development and Verification of a PBPK-PD Dog model for Irbesartan following Oral Dose Administration –  Devendra Pade, Sibylle Neuhoff, Khaled Abduljalil, Masoud Jamei

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

About Certara

Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, 90+% of all novel drugs approved by the US FDA in the past four years were supported by Certara software or services. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.