Mark your calendars to attend this workshop on FDA/M-CERSI Physiologically Based Biopharmaceutics Modeling, PBBM Best Scientific
Practices to Drive Drug Product Quality: Latest Regulatory and Industry Perspectives. The 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).

Join Simulations Plus Vice President of Regulatory Affairs Sandra Suarez-Sharp and Associate Vice President of Regulatory Affairs Xavier Pepin for this industry-regulator collaborative event to advance the use of PBBM and identify best practices through case study evaluations.

A detailed agenda for this three-day workshop will be available at a later date.

Can’t miss presentations:

Title: Introduction to Breakout Sessions A-E: Day 1: Considerations for in vitro data inputs to PBBM
Presented by: Simulations Plus Vice President, Regulatory Affairs Sandra Suarez-Sharp
Date/Time: Tuesday, August 29th, 1:00-1:15 pm EDT

Title: Hot topic C: Methods for integrating dissolution in PBBM 
Presented by: Simulations Plus Associate Vice President, Regulatory Affairs Xavier Pepin
Date/Time: Tuesday, August 29th, 1:15-1:45 pm EDT

Title: Hot topic H: Considerations for model application: VBE trials vs. single representative modeling, dealing with within and between subjects’ variability and parameter uncertainty
Presented by: Simulations Plus Chief Science Officer Viera Lukacova & Amin Rostami, University of Manchester
Date/Time: Wednesday, August 30th, 1:15-1:45 pm EDT

Title: Hot topic I: Considerations for model application: Establishing safe space and failure edges, non-BE batches and alternative IVIVR/C 
Presented by: Simulations Plus Associate Vice President, Regulatory Affairs Xavier Pepin, Konstantinos Stamatopoulos, GSK and Siri Kalyan Chirumamilla, Certara
Date/Time: Wednesday, August 30th, 1:15-1:45 pm EDT

Title: Hot topic M: Introduction & case study on safe space & extrapolation
Presented by: Simulations Plus Vice President, Regulatory Affairs Sandra Suarez-Sharp,
Date/Time: Thursday, August 31st, 1:30-2:00 pm EDT

Title: Breakout session M: Safe space & extrapolation 
Moderated by: Simulations Plus Vice President, Regulatory Affairs Sandra Suarez-Sharp, and Kimberly Raines, FDA
Date/Time: Thursday, August 31st, 2:00-3:45 pm EDT

About the Event

Pharmaceutical researchers, regulatory and materials scientists, and manufacturing colleagues from industry, academia, and regulatory agencies are invited to attend an in-person workshop on Physiologically Based Biopharmaceutics Models (PBBM) on August 29-31, 2023, from 8:30 a.m. to 4:30 p.m. (ET). The event will be held in-person at The Universities at Shady Grove campus.

PBBM is an evolving tool which can be used throughout drug product development, regulatory approval, and life cycle management. PBBM focuses on providing mechanistic understanding of how drug product quality attributes interact with physiology influencing the in vivo drug performance. The application of PBBM is not only important in the development of drug products, but can also be a key component for regulatory approval of clinically relevant specifications and continued quality assurance throughout the product life cycle.

To further advance the science of PBBM and establish best practices, PBBM case studies for oral drug products submitted as part of global marketing applications were reviewed by FDA, EMA, Health Canada, ANVISA, MHRA and PMDA. 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.

This workshop provides a forum for experts from regulatory agencies, innovator and generic drug industry, consultants, academia and commercial software providers and others in the field of modeling and simulation, to discuss the opportunities and best practices for incorporating drug product quality attributes within PBBM models to support development programs and regulatory submissions. The workshop also aims to identify bottlenecks/gaps which hinder the development and efficient utilization of PBBM models to support drug product quality.

The workshop will include morning presentations of PBBM case studies by global regulatory agencies. Afternoon breakout sessions will provide the opportunity to deep dive into challenges highlighted by the case study presentations and delineate best practices.

Topics

1. Regulatory strategy and applications of PBBM during clinical development, marketing application, and post approval change
2. Discussions around a framework for reporting PBBM models
3. Challenges and considerations in the development of biorelevant/biopredictive inputs such as solubility, dissolution, permeability, etc. for the PBBM model development
4. Scientific considerations for establishing verification and validation strategies for PBBM models for their intended purpose of application

Who Should Attend

Regulatory agencies, regulatory professionals, members of innovator and generic drug industry, consultants, academia and commercial software providers and others in the field of modeling and simulation.

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $5,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.