A New joint Initiative to Advance Women’s Health and Tuberculosis Therapies in Regions with Constrained Healthcare Resources
ESQlabs GmbH, is pleased to announce a pioneering open-source model-informed drug development (MIDD) project focused on enhancing treatments for Women’s Health and Tuberculosis (TB) in regions with constrained healthcare resources. This project, supported by funding from the Bill & Melinda Gates Foundation (Award Announcement), centers on creating accessible, advanced modeling tools that streamline the development of crucial treatments, particularly for communities that have historically faced barriers to healthcare.
Through this initiative, ESQlabs will translate and optimize proprietary physiologically-based pharmacokinetic (PBPK) model resources, transforming them as open-source industrialized tools with optimized MIDD utility for researchers, healthcare providers, and regulatory agencies worldwide. This project aims to enhance global health research by accelerating the transition of key disease and female reproductive tract MIDD solutions to open-source formats, and providing the models and training free to the public to promote global health by enabling broader access to critical modeling tools, thereby driving innovation in drug development for diseases that disproportionately affect low-income populations.
Advancing Women’s Health with Tailored PBPK Modeling
With a strong focus on Women’s Health, this initiative will develop and refine PBPK models tailored to the female reproductive system. Historically, drug development has often overlooked female-specific physiology, leaving critical gaps in treatments that meet women’s unique healthcare needs. By providing openly accessible models that predict drug distribution in female-specific tissues, this project offers researchers and healthcare professionals a valuable resource for optimizing dosing strategies, supporting improved drug safety and efficacy in Women’s Health.
Enhancing TB Therapy in Regions with Constrained Healthcare Resources
The project will also accelerate TB therapy by focusing on a streamlined selection of essential TB compounds trough an industrialized MIDD framework which integrates PBPK with modeling solutions to predict therapeutic- and adverse effect of novel TB drugs. Targeting key drugs such as rifampicin, rifapentine, isoniazid, and moxifloxacin, the initiative aims to create predictive PBPK models to support the creation of a TB MIDD platform for high-throughput screening and development of promising, safer and more effective personalized TB treatment options, particularly in communities most impacted by the disease.
To provide an integrated view of drug action, ESQlabs will combine PBPK models with TB disease models and pharmacodynamic (PD) data. This PBPK-PD integration allows researchers to simulate and predict the impact of TB therapies on pathogen replication and disease progression, providing insights that can optimize treatment regimens and enhance therapeutic efficacy. An innovative addition to the project is the development of Quantitative Systems Toxicology (QST) modeling to predict QTc prolongation, a critical risk factor associated with TB drugs like bedaquiline and moxifloxacin. This approach enables researchers to better understand and mitigate potential cardiac risks, improving patient safety in TB therapy.
Another unique feature of this initiative is the application of high-throughput PBPK (HT-PBPK) models for early-stage drug discovery, using quantitative structure-activity relationship (QSAR)-based predictions to streamline and support the identification of new TB therapies.
Open-Source for Global Impact: Fostering Collaboration and Accessibility
Embracing an open-source framework, ESQlabs aims to reduce technological barriers, making advanced pharmacological models accessible to a global audience. All models, codes, and outputs will be published on the www.Open-Systems-Pharmacology.org (OSP) GitHub platform, enabling collaboration across academic, regulatory, and public health sectors. “Our goal is to provide researchers worldwide with accessible, high-quality tools that address pressing issues in Women’s Health and TB,” said Marco Siccardi, project and science lead. “By focusing on open-source resources, we aim to accelerate global collaboration and make impactful therapies achievable for all.”