World Conference on Pharmacometrics (WCoP) 2022

This tailored workshop on in vitro-in vivo extrapolation of metabolism, transport, and biopharmaceutics includes hands-on exercises using the industry standard Simcyp Population-based Simulator for PBPK modeling, formulation development, and DDI predictions. This workshop is intended for scientists working in discovery DMPK, metabolism, transporters, DDI, and formulation development areas of research. To register: https://wcop2022.org/event/intensive-2-day-workshop-on-model-informed-drug-development-using-pbpk-modelling/

Repurposing is an important strategy in general for developing medicines. However in the midst of a health emergency it presents formidable challenges for all stakeholders- manufacturers, medicines regulators, policy recommending agencies, public health officials and procurers. In this presentation examples of the application of translational science, quantitative and clinical pharmacology, adaptive clinical trials, epidemiological modelling and quantitative integration of real world evidence to support decision making in the COVID-19 pandemic will be presented.

This session with mentors Stefanie Hennig (Certara), Holly Kimko (AstraZeneca), Stacey Tannenbaum (Astellas) and Bernd Meibohm (University of Tennessee Health Science Center) will include general career consultation topics which are relevant to supporting professional growth for students and early career scientists in Pharmacometrics, including: communication and soft skill development, leadership advancement, publication guidance, and modeling strategy. The format of this session will be some introductory remarks from each of the mentors and then some Q&A/panel discussions with the participants. Please come prepared with your questions!

The distinction and complementarity of data derived empirical models and system derived mechanistic models are examined with coagulation regulation as the focus. The first mathematical model of the anticoagulation was developed in 1968 by Nagashima. In this work Nagashima also introduced the concept of a turn-over model which later became a foundational building block of mass action for mechanistic models. Systems pharmacology models for coagulation were developed some 30 years later which provided both pharmacological targets and various clotting test outcomes. Later in the 2000s a component of the system pharmacology model was then extracted as the structural basis of a model for analysis of real world data. What followed was a synergy between data and system driven models that was able to describe and predict clinical response in children to anticoagulants.

Good pharmacometrics education is key to foster the further development of the field and allow implementation of model-based approaches with high quality in a way that directly and indirectly affects patients. This symposium aims to provide an overview of different aspects, which aid or hamper this education globally. Furthermore, capitalizing on the variety of approaches, useful strategies to bring out the highest quality in students are investigated and ways forward will be presented. Common factors between successful programs such as program size, industry sponsorship, student level, and future prospects will be identified and their relative impact assessed, ultimately increasing pharmacometric education and collaboration on a national and international level.

Since 2009, a small number of industry and academic pharmacometricians, have collaborated with multiple institutions across Africa to build pharmacometrics capacity. In 2018, we expanded our reach by establishing Pharmacometrics Africa (https://www.pmxafrica.org/), a collaborative platform for open-access quantitative clinical pharmacology educational programs. Our tactics includes virtual trainings (short webinars and longer online courses), workshops (3-5 day hands-on and shorter advocacy events) and gradual incorporation into degree programs. While these investments have helped advance the understanding of dose-exposure-response relationships for several diseases of global health relevance, much remains to be done. This talk will outline progress, challenges and lessons learnt.