Simulations Plus and the University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables
Simulations Plus (Nasdaq: SLP) and the University of Connecticut have received a new FDA grant to expand mechanistic modeling for long-acting injectable (LAI) technologies. The collaboration will use GastroPlus® PBPK platform to investigate relationships between LAI formulation and physiological factors at injection sites. The project aims to develop models that could serve as alternatives to in vivo studies for establishing bioequivalence. Dr. Diane Burgess's lab will generate vital data for marketed LAI suspension products, while Simulations Plus will develop PBPK models for validation. The initiative seeks to reduce development time and costs while streamlining regulatory processes for both innovator and generic formulations.
Simulations Plus (Nasdaq: SLP) e l'Università del Connecticut hanno ricevuto un nuovo finanziamento dalla FDA per espandere il modeling meccanicistico delle tecnologie per iniettabili a lunga durata (LAI). La collaborazione utilizzerà la piattaforma GastroPlus® PBPK per indagare le relazioni tra la formulazione del LAI e i fattori fisiologici nei siti di iniezione. Il progetto mira a sviluppare modelli che potrebbero fungere da alternative agli studi in vivo per stabilire la bioequivalenza. Il laboratorio della Dr.ssa Diane Burgess genererà dati vitali per i prodotti di sospensione LAI già commercializzati, mentre Simulations Plus svilupperà modelli PBPK per la convalida. L'iniziativa punta a ridurre i tempi e i costi di sviluppo, semplificando i processi regolatori sia per le formulazioni innovative che per quelle generiche.
Simulations Plus (Nasdaq: SLP) y la Universidad de Connecticut han recibido una nueva subvención de la FDA para ampliar el modelado mecanicista de las tecnologías de inyectables de acción prolongada (LAI). La colaboración utilizará la plataforma GastroPlus® PBPK para investigar las relaciones entre la formulación de LAI y los factores fisiológicos en los sitios de inyección. El proyecto tiene como objetivo desarrollar modelos que puedan servir como alternativas a los estudios in vivo para establecer la bioequivalencia. El laboratorio de la Dra. Diane Burgess generará datos vitales para los productos de suspensión de LAI comercializados, mientras que Simulations Plus desarrollará modelos PBPK para validación. La iniciativa busca reducir el tiempo y los costos de desarrollo, al mismo tiempo que agiliza los procesos regulatorios tanto para las formulaciones innovadoras como para las genéricas.
시뮬레이션 플러스 (Nasdaq: SLP)와 코네티컷 대학교는 지속형 주사제 (LAI) 기술을 위한 기계적 모델링을 확장하기 위해 새로운 FDA 보조금을 받았습니다. 이 협력은 GastroPlus® PBPK 플랫폼을 사용하여 LAI 제형과 주사 부위의 생리적 요인 간의 관계를 조사할 것입니다. 이 프로젝트의 목표는 생물 동등성을 설정하기 위한 생체 내 연구의 대안으로 활용될 수 있는 모델을 개발하는 것입니다. 다이앤 버지스 박사의 연구실은 시판 중인 LAI 현탁액 제품에 대한 중요한 데이터를 생성하고, 시뮬레이션 플러스는 검증을 위한 PBPK 모델을 개발할 것입니다. 이 이니셔티브는 개발 시간과 비용을 줄이고 혁신적인 제형과 일반 제형 모두에 대한 규제 프로세스를 간소화하는 것을 목표로 합니다.
Simulations Plus (Nasdaq: SLP) et l'Université du Connecticut ont reçu une nouvelle subvention de la FDA pour étendre la modélisation mécaniste des technologies d'injections à action prolongée (LAI). La collaboration utilisera la plateforme GastroPlus® PBPK pour étudier les relations entre la formulation LAI et les facteurs physiologiques sur les sites d'injection. Le projet vise à développer des modèles pouvant servir d'alternatives aux études in vivo pour établir la bioéquivalence. Le laboratoire de la Dr Diane Burgess générera des données essentielles pour les produits de suspension LAI commercialisés, tandis que Simulations Plus développera des modèles PBPK pour validation. L'initiative vise à réduire le temps et les coûts de développement tout en rationalisant les processus réglementaires pour les formulations innovantes et génériques.
Simulations Plus (Nasdaq: SLP) und die Universität Connecticut haben einen neuen FDA-Zuschuss erhalten, um das mechanistische Modellieren für langfristig wirkende Injektionen (LAI) Technologien zu erweitern. Die Zusammenarbeit wird die GastroPlus® PBPK-Plattform nutzen, um die Beziehungen zwischen der LAI-Formulierung und physiologischen Faktoren an den Injektionsstellen zu untersuchen. Das Projekt zielt darauf ab, Modelle zu entwickeln, die als Alternativen zu in vivo Studien zur Feststellung der Bioäquivalenz dienen können. Das Labor von Dr. Diane Burgess wird wichtige Daten für marktfähige LAI-Schweissprodukte generieren, während Simulations Plus PBPK-Modelle zur Validierung entwickeln wird. Die Initiative zielt darauf ab, die Entwicklungszeit und -kosten zu reduzieren und gleichzeitig die regulatorischen Prozesse sowohl für innovative als auch für generische Formulierungen zu optimieren.
- Received new FDA grant funding (Grant #1U01FD008304-01)
- Partnership with prestigious University of Connecticut enhances research capabilities
- Potential to reduce development time and costs for LAI formulations
- Development of alternative methods to expensive in vivo studies
- None.
Insights
This FDA grant represents a significant advancement in drug development efficiency for Long-Acting Injectable (LAI) formulations. The collaboration between Simulations Plus and UConn leverages GastroPlus PBPK platform to potentially revolutionize bioequivalence testing, which could substantially reduce development costs and time-to-market for both innovative and generic LAI drugs.
The project's focus on developing mechanistic in vitro-in vivo correlations (IVIVCs) could establish a new industry standard, potentially eliminating the need for extensive in vivo studies. This would address a critical bottleneck in LAI development, where traditional testing methods are particularly time-consuming and expensive. The involvement of the FDA signals strong regulatory support and potential pathway to faster approvals.
This grant strengthens Simulations Plus's position in the biosimulation market, particularly in the growing LAI segment. The collaboration with both the FDA and a prestigious academic institution enhances the company's credibility and could lead to increased adoption of their GastroPlus platform. The development of new modeling capabilities could create additional revenue streams through expanded licensing and consulting services.
While the immediate financial impact may be modest, the long-term potential is significant as successful validation could make their platform the go-to solution for LAI development, capturing a larger share of the growing drug development market. This aligns with the industry trend toward more efficient, cost-effective drug development processes.
Funded collaboration will leverage current FDA partnership to include additional LAI technologies
This project aims to use the GastroPlus PBPK platform to investigate the intricate relationship between LAI formulation critical quality attributes (CQAs) and physiological factors at the injection site to accurately predict in vivo drug release and absorption. Dr. Diane Burgess, Board of Trustees Distinguished Professor of Pharmaceutics and Pfizer Distinguished Endowed Chair of Pharmaceutical Technology at the University of
“LAI formulations are becoming increasingly important in pharmaceutical pipelines and product portfolios due to their ability to improve patient compliance and deliver extended drug release,” said Dr. Daniela Silva Ryan, Scientist II at Simulations Plus and principal investigator for this grant. “Preclinical and clinical studies to evaluate new formulation designs are lengthy and expensive. With this new grant, we expect our work within GastroPlus to demonstrate how PBPK modeling can reduce development time and costs, while streamlining regulatory processes for both innovator and generic formulations.”
FDA scientific and program staff will actively collaborate with the University of
“It is a privilege to continue combining our expertise with Simulations Plus and the FDA to advance the research on LAI formulation performance even further,” added Dr. Burgess. “The agency’s trust and confidence in this partnership underscores the leadership role both organizations have in our respective spaces. Together, we aim to develop models that bridge the gap between animal and human data and reveal the intricate relationships between formulation properties and injection site physiology, providing insight into virtual BE approaches for this growing drug delivery technology.”
Funding for this collaboration is made possible by the FDA through grant award 1U01FD008304-01. 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 organizations imply endorsement by the United States Government.
About the Burgess laboratory at the University of
The Burgess laboratory in the Department of Pharmaceutical Sciences at the University of Connecticut’s School of Pharmacy has a research focus on formulation science, drug delivery and manufacturing science of complex parenterals. Research efforts cover the basic science of interfacial chemistry, the application of this in preformulation and formulation development, the development of novel drug delivery systems, and the in vitro and in vivo testing of these drug delivery systems including investigation of biopharmaceutics and pharmacodynamics. This research is applied to solving problems with respect to drug and gene delivery and focuses on microsphere, nanoparticle, liposome, emulsion, hydrogel and in situ forming delivery systems. Efforts are also focused on biocompatible coatings to prevent the foreign body reaction that would otherwise result in loss of functionality of parenteral implantable devices.
Major contributions include: development of novel microcapsule dosage forms; development of “real-time” and accelerated performance tests for complex parenteral dosage forms and development of IVIVCs for these complex dosage forms; modeling of the pharmacokinetics of protein therapeutics from microsphere dosage forms; correlation of interfacial properties with emulsion and nanoparticle stability; development of a novel composite coating for implantable devices that has been shown to prevent the foreign body response in animal models in excess of 6 months; development of a method that allows long-term intracellular and intranuclear tracking of gene therapeutics and gene delivery vectors; design of safe, efficient and stable non-viral gene delivery systems; application of quality-by-design principles to nanoparticles and liposomes; and development of novel manufacturing methods for liposomes and emulsions, including the development of continuous manufacturing methods with process analytical technology for complex parenterals such as liposomes, lipid nanoparticles (LNPs)
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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FAQ
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