Simulations Plus and Partners Awarded New FDA Grant to Validate In Vitro-In Vivo Extrapolation Methods for Complex Formulations
Simulations Plus (Nasdaq: SLP) has secured a new FDA grant in partnership with the University of Strathclyde and InnoGI Technologies. The collaboration aims to improve understanding of amorphous solid dispersion (ASD) formulations and predict food and pH-dependent drug-drug interactions through in vitro testing and simulation. The project will utilize GastroPlus® platform for physiologically based pharmacokinetic modeling to link in vitro dissolution with in vivo data. The research is expected to accelerate formulation adjustments, reduce costs, and speed up time-to-market for both innovator and generic ASD products.
Simulations Plus (Nasdaq: SLP) ha ottenuto una nuova sovvenzione dalla FDA in collaborazione con l'Università di Strathclyde e InnoGI Technologies. La collaborazione mira a migliorare la comprensione delle formulazioni di dispersione solida amorfa (ASD) e a prevedere le interazioni farmaco-farmaco dipendenti dal cibo e dal pH attraverso test in vitro e simulazioni. Il progetto utilizzerà la piattaforma GastroPlus® per la modellizzazione farmacocinetica basata sulla fisiologia, al fine di collegare la dissoluzione in vitro con i dati in vivo. La ricerca si prevede accelererà gli aggiustamenti delle formulazioni, ridurrà i costi e velocizzerà il tempo di commercializzazione sia per i prodotti ASD innovativi che generici.
Simulations Plus (Nasdaq: SLP) ha asegurado una nueva subvención de la FDA en asociación con la Universidad de Strathclyde y InnoGI Technologies. La colaboración tiene como objetivo mejorar la comprensión de las formulaciones de dispersión sólida amorfa (ASD) y predecir interacciones entre fármacos dependientes de alimentos y pH a través de pruebas in vitro y simulación. El proyecto utilizará la plataforma GastroPlus® para el modelado farmacocinético basado en la fisiología, vinculando la disolución in vitro con los datos in vivo. Se espera que la investigación acelere los ajustes en las formulaciones, reduzca costos y agilice el tiempo de comercialización tanto para productos ASD innovadores como genéricos.
Simulations Plus (Nasdaq: SLP)는 Strathclyde 대학교 및 InnoGI Technologies와 협력하여 새로운 FDA 보조금을 확보했습니다. 이 협업의 목적은 비정질 고형 분산 (ASD) 제형에 대한 이해를 높이고, 음식 및 pH 의존적인 약물 간 상호작용을 in vitro 테스트 및 시뮬레이션을 통해 예측하는 것입니다. 이 프로젝트는 생리학 기반 약리 동역학 모델링을 위한 GastroPlus® 플랫폼을 활용하여 in vitro 용해와 in vivo 데이터를 연결합니다. 이 연구는 제형 조정을 가속화하고 비용을 절감하며 혁신 및 일반 ASD 제품의 시장 출시 시간을 단축할 것으로 예상됩니다.
Simulations Plus (Nasdaq: SLP) a obtenu une nouvelle subvention de la FDA en partenariat avec l'Université de Strathclyde et InnoGI Technologies. Cette collaboration vise à améliorer la compréhension des formulations de dispersion solide amorphe (ASD) et à prédire les interactions médicamenteuses dépendantes des aliments et du pH grâce à des tests in vitro et à des simulations. Le projet utilisera la plateforme GastroPlus® pour la modélisation pharmacocinétique basée sur la physiologie, afin de relier la dissolution in vitro aux données in vivo. Cette recherche devrait accélérer les ajustements de formulation, réduire les coûts et accélérer le délai de mise sur le marché des produits ASD, qu'ils soient innovants ou génériques.
Simulations Plus (Nasdaq: SLP) hat einen neuen FDA-Zuschuss in Partnerschaft mit der Universität Strathclyde und InnoGI Technologies gesichert. Die Zusammenarbeit zielt darauf ab, das Verständnis von amorphen Feststoffdispersions (ASD)-Formulierungen zu verbessern und essens- und pH-abhängige Arzneimittelwechselwirkungen durch In-vitro-Tests und Simulationen vorherzusagen. Das Projekt wird die GastroPlus®-Plattform für physiologisch basierte pharmakokinetische Modellierung nutzen, um die In-vitro-Löslichkeit mit In-vivo-Daten zu verknüpfen. Es wird erwartet, dass die Forschung die Anpassungen von Formulierungen beschleunigt, Kosten senkt und die Markteinführungszeit sowohl für innovative als auch für generische ASD-Produkte verkürzt.
- Secured new FDA grant funding through award 1U01FD008388-01
- Partnership with University of Strathclyde and InnoGI Technologies strengthens research capabilities
- Project aims to reduce development costs and accelerate time-to-market for ASD products
- None.
Insights
This FDA grant represents a significant advancement in drug development methodology. The collaboration aims to develop and validate new approaches for predicting how amorphous solid dispersion (ASD) formulations perform under various conditions, which could substantially reduce development costs and time-to-market for both innovative and generic drugs.
The project combines three critical elements: advanced in vitro testing using SurroGUT™ Platform, PBPK modeling through GastroPlus® and clinical validation through virtual bioequivalence trials. This comprehensive approach could revolutionize how drug formulations are tested and optimized, potentially eliminating the need for some costly clinical trials.
The partnership between Simulations Plus, University of Strathclyde and InnoGI Technologies, backed by FDA funding, validates the scientific merit and potential impact of this research. While immediate financial impact may be , successful outcomes could significantly enhance SLP's GastroPlus® platform's value proposition and market position in the long term.
Collaboration goal to develop alternative methods to assess clinical performance of product variants under different conditions
For this award, Professor Hannah Batchelor, through her lab at the University of Strathclyde, will analyze ASD drug products and their respective formulation variants. InnoGI Technologies will then test the different ASD formulations under fasted, fed, and higher gastric pH conditions utilizing the tiny-TIMsg, part of the SurroGUT™ Platform, in vitro system. Next, physiologically based pharmacokinetic (PBPK) models will be developed in the GastroPlus® platform to link in vitro dissolution with in vivo pharmacokinetic data and develop in vitro-in vivo extrapolations (IVIVEs). Finally, virtual bioequivalence (VBE) trial simulations will be conducted in GastroPlus to assess the clinical performance of ASD formulation variants to validate the approaches. The resulting outcomes are anticipated to help speed up formulation adjustments, reduce costs, and accelerate time-to-market for both innovator and generic ASD products.
“We are delighted to be at the forefront of this important research, which has the potential to significantly advance PBPK science and revolutionize how we predict drug product performance,” said Dr. Maxime Le Merdy, Director of PBPK Collaborations at Simulations Plus and principal investigator for this grant. “Developing a novel IVIVE methodology for ASD drug products will play a crucial role in optimizing formulation development, fine-tuning process parameters, and supporting bioequivalence assessments by offering key insights into the factors that impact in vivo performance.”
FDA scientific and program staff will actively collaborate with the University of Strathclyde, InnoGI Technologies, and Simulations Plus. Dr. Le Merdy, with assistance from scientists at Simulations Plus, will coordinate the modeling and simulation activities of the contract.
“By leveraging the power of this industry-academia-regulatory collaboration, we will push the boundaries of innovation and accelerate the development of safer, more effective therapies,” said Prof. Batchelor. “This unique partnership allows us to combine InnoGI’s cutting-edge in vitro technologies, GastroPlus’s mechanistic modeling, and real-world clinical insights, driving greater efficiency and confidence in drug development decisions.”
“As oral formulation development grows increasingly complex, evaluating drug product performance while studying luminal events in real time demands the integration of advanced technologies to bridge in vitro and in vivo testing gaps, thus reducing development risks for more efficient drug development,” said Susann Bellmann, CTO of InnoGI Technologies.
Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD008388-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
About the Batchelor laboratory at the University of Strathclyde
Hannah Batchelor, a professor of Pharmaceutics within the Strathclyde Institute of Pharmacy and Biomedical Sciences at the University of Strathclyde, and her team have broad research interests which focus on the development of age-appropriate medicines for children. Specific research areas include pediatric biopharmaceutics and development of appropriate in vitro testing strategies to predict in vivo performance, along with the application of in silico modeling in pediatric populations to optimize pharmacokinetic study design and evaluate the impact of drug-food interactions. She is currently the director of the GIBio facility at Strathclyde (https://cmac.ac.uk/gibio) and her work, supported by federal and industrial funding, has led to many peer-reviewed publications and invited presentations in these areas.
About InnoGI Technologies
InnoGI Technologies, formerly known as The TIM Company, is a global leader in the development of advanced in vitro gastrointestinal models and expert services, building on decades of expertise in oral drug testing. Based in Delft,
About Simulations Plus, Inc.
With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube
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