Physiologically Based Biopharmaceutics Modelling Conference 2024

Physiologically based biopharmaceutics models (PBBMs) are evolving tools which can be used throughout drug product development and post approval. PBBM focusses on the generation of mechanistic understanding of how drug product quality attributes interact with physiology to influence 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.

In 2021, a virtual webinar series entitled “Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug products” was organised by the Academy of Pharmaceutical Sciences (APS) Biopharmaceutics Science focus group with speakers including Industry, Academia and Regulatory colleagues. The webinars reviewed the current state of scientific progress in the field, emerging trends and identified areas where Industry and Regulators can engage to further harmonise and enable the future development of CRDS. A summary of the webinar series was published in MDPI Pharmaceutics and can be accessed here.

The dialogue between industrial, regulatory and academic biopharmaceutics scientists has continued to progress the thinking on the positioning of PBBM for regulatory applications with the most recent meeting held at University of Maryland’s M-CERSI facility in August 2023 (https://www.pharmacy.umaryland.edu/centers/cersievents/PBBM2023/). This two-day workshop at the MHRA offices in London is intended to follow on from the M-CERSI meeting and provide further opportunity to review and discuss scientific practices for defining formulation performance in a PBBM and to share progress since the M-CERSI meeting with development of a common template for PBBM regulatory submission. There will also be a session on further exploring the utilisation of PBBM to define product safe space with facilitated breakouts to assess the challenges and opportunities. This workshop will be of interest to regulatory agencies, innovator and generic drug companies, consultants, academia, commercial software providers and others in the field of oral drug product modelling and simulation. Workshop attendees will have the opportunity to learn more around the implementation of PBBM for product development, contribute to the discussions on hot topics for PBBM and influence the future pathway for regulatory use.

Hotels and Accommodation near the MHRA

• Novotel London Canary Wharf (0.2 mi away)
• Britannia International Hotel (0.2 mi away)
• Cove - Landmark Pinnacle, Canary Wharf (0.2 mi away)
• Point A London, Canary Wharf (0.2 mi away)
• Hilton London Canary Wharf (0.3 mi away)
• Canary Riverside Plaza Hotel (0.3 mi away)
• Premier Inn London Canary Wharf (Westferry) Hotel (0.4 mi away)