Happy Spring! (for those of us that are North of the Equator)Register now!Simulations Plus continues to thrive and grow with dozens of events planned for 2023 One of our most popular workshops is fast approaching and there are only a few seats remaining. The PBPK modeling FIH, first-in-human workshop is your opportunity to focus on real-world scenarios and gain expertise to apply to your projects. This workshop is scheduled for select dates between April 24th and May 26th.
- Mark your calendars to attend a very exciting workshop on Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives: Universities at Shady Grove (Rockville, MD) Aug. 29th – 31st
The purpose of this workshop is to discuss and establish the best scientific practices for developing the PBBM models for orally administered, systemically active drug products and how these models can be leveraged for streamlining pharmaceutical drug product development and supporting manufacturing changes and controls.Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives (umaryland.edu) Additionally, Simulations Plus is making appearances at several live conferences in the month of April: ConferencesThe workshop is sponsored by the University of Maryland Center for Excellence in Regulatory science and innovation (M-CERSI) and the Food and Drug Administration (FDA).
- CHI’s Drug Discovery Chemistry – April 10th-13th, San Diego, CA
- ARVO 2023 – April 23rd-27th, New Orleans, LA
Presenter: Associate Director, Research and Collaborations, Maxime Le MerdyTitle: Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Besifloxacin Suspension Case Study Date: Tuesday, April 25th Time: 8:45-10:30 am CDT
- AAPS National Biotechnology Conference – April 23rd-26th, Philadelphia, PA
Presenter: Principal Scientist, Jessica SpiresTitle: Validation of PBPK-Based Translation to Predict Monoclonal Antibody Pharmacokinetics in Pediatric Populations Date: Tuesday, April 25th Time: 1:30-2:30 PM EDT Thanks to all that attended the AAPS NERDG meeting at St. John’s University. It was great to see you there and to learn of the great interest in our University + program that provides all of our software platforms to accredited universities at no-charge. The future is bright for the next generation of scientific modelers. My next in-person show will be at the CRS conference in Las Vegas…placing your bet on GastroPlus is a guarantee your research will be a winner!
- CRS Booth #410 – July 24th – 28th, in Las Vegas, NV
Our upcoming workshop schedule is as follows:In-Person Instruction
- PBBM Best Practices for Drug Product Quality: Regulatory and Industry Perspectives Workshop: Sao Paulo, Brazil April 26th-27th
- Population Simulation & Virtual Bioequivalence: PAGE 2023 Pre-conference GastroPlus® Workshop: A Coruña, Spain June 27th
- PBPK Modeling for FIH Predictions: Virtual Workshop April 24th-May 26th
- University+ PBPK Summer Camp June 5th– July 28th
- Complimentary Introduction to GastroPlus® (EU) July 11th
- Transdermal Administration (TCAT™) in GastroPlus
- Injectables (IM, SQ, IA) in GastroPlus Including Biologics and LAIs
As always let me know if we may provide any help or support for you and your research teams.By Dan O’Connor