Please join us November 9th – 12th, in San Antonio, TX for AAPS PharmSci 360 and discover the latest in pharmaceutical science. Join researchers, industry leaders, and innovators for four days of cutting-edge sessions, networking, and career development across five dynamic scientific tracks. 

Members of our Simulations Plus team will be in attendance, so make sure to connect with them in booth #3635. 

Join us at Rx to Rock: Honky Tonk 
Date: Tuesday, November 11th
Time: 6:00-9:00 PM CST
Location: Lonestar C ballroom at the Grand Hyatt San Antonio

Registration is now open, RSVP today! 

We hope to see you there!

Can’t Miss Presentations! 

Symposium Session: Special Considerations for Patient Populations in Clinical Trials
Moderator – Viera Lukacova, Chief Scientific Officer
Track: Preclinical, Clinical, and Translational Sciences
Date/Time: Tuesday, November 11th |9:00 – 11:00 AM
Location: 225 AB

• Title: Trial Design for Obesity: Right Compound, Right Dose, Right Patient
  Speaker: Maxime Le Merdy, Director, Scientific Product Enablement
  Date/Time: Tuesday, November 11th | 10:00 – 10:30 AM
• Title: Model-Informed Design of Clinical Trial in Patients with Renal Impairment
  Speaker: Viera Lukacova, Chief Scientific Officer
  Date/Time: Tuesday, November 11th | 10:30 – 11:00 AM

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Symposium Session: Accelerating Drug Development Through Digital Innovation 2
Track: Formulation & Delivery
Date/Time: Wednesday, November 12th |9:00 – 11:00 AM
Location: Stars at Night B2/B3

• Title: Derisking Formulation Strategies Using PBBM: Mechanistic Case Studies on Evaluating Food Effects and Guiding Dissolution Specifications
  Speaker: Deanna Mudie, Senior Principal Scientist
  Date/Time: Wednesday, November 12, 2025 | 10:30 – 11:00 AM

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Hot Topic Session: Identifying Gaps and Pushing Boundaries in Mechanistic Dissolution Modeling
Track: Preclinical, Clinical, and Translational Sciences
Date/Time: Wednesday, November 12th |1:30 – 2:30 PM
Location: 220
Moderator/Speaker: Deanna Mudie, Senior Principal Scientist

Dissolution is a key determinant of oral drug product bioavailability and therapeutic effectiveness, making it a common quality attribute of many poorly soluble drug products. A mechanistic understanding of dissolution aids in understanding key performance mechanisms and setting clinically relevant specifications as a function of variable drug product and physiological characteristics. This session will begin with a short overview of key assumptions limiting the effectiveness of classical dissolution models, followed by presentations by two researchers pushing these boundaries.

Additional Speakers: Yanxing Wang, Ph.D., Associate Professor, New Mexico State University and Jozef Al-Gousous, PhD, Lecturer and Adjunct Assistant Professor, Johannes Gutenberg University Mainz; Adjunct Assistant Professor of the University of Michigan

Poster Presentations 

PBPK-Based Prediction of Obesity-Mediated Changes in Small Molecule Pharmacokinetics
Presenter: Maxime Le Merdy, Director, Scientific Product Enablement
Date/Time: Monday, November 10th | 9:30-10:30 AM
Poster #: M0930-05-30

This study aims to demonstrate the use of PBPK models in predicting obesity-induced changes in the PK of small molecules.

From in vitro dissolution testing to in vivo clinical pharmacokinetic prediction using PBPK models for oral cavity drug products
Presenter: Fiona Plait, Senior Principal Scientist
Date/Time: Monday, November 10th | 2:30-3:30 PM
Poster #: M1430-05-30

This project aims to develop a novel in vitro to in vivo extrapolation (IVIVE) method for oral cavity drug products (DP). This IVIVE is informed by data obtained within vitro dissolution measurements of oral cavity DP in artificial saliva.

Population Balance Modeling of Aggregation in Long-Acting Injectable Formulations Integrated with PBPK
Presenter: James Mullin, Scientific Product Specialist
Date/Time: TBD

Modeling Metamorphosis: Advancing Dermal PBPK Modeling – A Metronidazole Case Study
Presenter: Maximo Pettarin, Postdoctoral Fellow
Date/Time: TBD

Physiologically Based Pharmacokinetic Simulations Using Transdermal Compartmental Absorption and Transit Model (TCAT) for RLS-1496 Dermal Preparations
Presenter: Tarang Vora, Senior Scientist II
Date/Time: TBD

Predicting Aflibercept Local Exposure in Humans Using an Ocular PBPK Model
Presenter: Maxime Le Merdy, Director, Scientific Product Enablement
Date/Time: TBD

Simulations Plus Attendees:

• Viera Lukacova – Chief Science Officer
• Grace Fraczkiewicz – Vice President, PBPK Services
• Maxime Le Merdy – Director, Scientific Product Enablement, Product Development
• Fiona Plait – Scientific Product Specialist, Product Development
• Daniela Silva Ryan – Sr. Scientific Product Specialist, Product Development
• James Mullin – Senior Principal Scientist, PBPK R&D  
• Deanna Mudie, Ph.D. – Senior Principal Scientist, PBPK R&D
• Arlene Padron – Senior Director, Business Development
• Dan O’Connor – Senior Director, Business Development
• Andrew Mueller – Director, Business Development
• Tom Sanderson – Director, Business Development  
• Nate Musser – Senior Director, Business Operations, Sales Administration
• Christiina Buchert – Senior Marketing Administrative Assistant, Marketing
• Tarang Vora – Senior Scientist II, Scientific Staff
• Maximo Pettarin – Postdoctoral Fellow, Product Development
• Revathi Chapa – Senior Scientist, Scientific Staff