Simulations Plus and Enabling Technologies Consortium Announce Strategic Collaboration to Advance GastroPlus® Enhancements
Simulations Plus (Nasdaq: SLP) has announced a strategic collaboration with the Enabling Technologies Consortium (ETC) to enhance its GastroPlus platform. The funded partnership aims to advance in vitro-in vivo correlation approaches for oral drug delivery by improving the GastroPlus advanced compartmental absorption and transit (ACAT™) model.
The collaboration will focus on developing immediate release oral drug products through enhanced predictive capabilities. Key developments include implementing novel product-particle size distribution methodologies and improved food effect modeling features. These advancements aim to improve drug product development, reduce animal studies, and streamline regulatory submissions.
Throughout the project, Simulations Plus will provide ETC members with beta versions for testing. The final enhanced software will be available to all users, with Simulations Plus retaining intellectual property rights from the partnership.
Simulations Plus (Nasdaq: SLP) ha annunciato una collaborazione strategica con il Consorzio delle Tecnologie Abilitanti (ETC) per migliorare la sua piattaforma GastroPlus. Questa partnership finanziata mira a perfezionare gli approcci di correlazione in vitro-in vivo per la somministrazione orale di farmaci, migliorando il modello di assorbimento e transito compartimentale avanzato (ACAT™) di GastroPlus.
La collaborazione si concentrerà sullo sviluppo di prodotti farmaceutici orali a rilascio immediato attraverso capacità predittive potenziate. I principali sviluppi includono l'implementazione di nuove metodologie di distribuzione delle dimensioni delle particelle del prodotto e miglioramenti nelle caratteristiche di modellazione dell'effetto del cibo. Questi progressi mirano a migliorare lo sviluppo di prodotti farmaceutici, ridurre gli studi sugli animali e semplificare le presentazioni normative.
Durante il progetto, Simulations Plus fornirà ai membri dell'ETC versioni beta per i test. Il software finale potenziato sarà disponibile per tutti gli utenti, con Simulations Plus che mantiene i diritti di proprietà intellettuale derivanti dalla partnership.
Simulations Plus (Nasdaq: SLP) ha anunciado una colaboración estratégica con el Consorcio de Tecnologías Habilitadoras (ETC) para mejorar su plataforma GastroPlus. Esta asociación financiada tiene como objetivo avanzar en enfoques de correlación in vitro-in vivo para la administración oral de medicamentos, mejorando el modelo de absorción y tránsito compartimental avanzado (ACAT™) de GastroPlus.
La colaboración se centrará en desarrollar productos farmacéuticos orales de liberación inmediata mediante capacidades predictivas mejoradas. Los desarrollos clave incluyen la implementación de nuevas metodologías de distribución del tamaño de partículas del producto y características mejoradas en la modelación del efecto de los alimentos. Estos avances tienen como objetivo mejorar el desarrollo de productos farmacéuticos, reducir los estudios en animales y agilizar las presentaciones regulatorias.
A lo largo del proyecto, Simulations Plus proporcionará a los miembros del ETC versiones beta para pruebas. El software mejorado final estará disponible para todos los usuarios, manteniendo Simulations Plus los derechos de propiedad intelectual de la asociación.
Simulations Plus (Nasdaq: SLP)는 기술 지원 컨소시엄 (ETC)과의 전략적 협력을 발표하여 GastroPlus 플랫폼을 개선한다고 밝혔습니다. 이 자금 지원 파트너십은 GastroPlus의 고급 구획 흡수 및 전이(ACAT™) 모델을 개선하여 경구 약물 전달을 위한 인 비트로-인 비보 상관관계 접근 방식을 발전시키는 것을 목표로 합니다.
이번 협력은 개선된 예측 능력을 통해 즉시 방출 경구 약물 제품을 개발하는 데 집중할 것입니다. 주요 개발 내용으로는 새로운 제품 입자 크기 분포 방법론의 도입과 식품 효과 모델링 기능의 개선이 포함됩니다. 이러한 향상은 약물 제품 개발을 개선하고 동물 연구를 줄이며 규제 제출을 간소화하는 것을 목표로 합니다.
프로젝트 전반에 걸쳐 Simulations Plus는 ETC 회원에게 테스트용 베타 버전을 제공할 것입니다. 최종 개선된 소프트웨어는 모든 사용자에게 제공될 예정이며, Simulations Plus는 파트너십에서 발생하는 지적 재산권을 유지합니다.
Simulations Plus (Nasdaq: SLP) a annoncé une collaboration stratégique avec le Consortium des Technologies Facilitantes (ETC) pour améliorer sa plateforme GastroPlus. Ce partenariat financé vise à faire progresser les approches de corrélation in vitro-in vivo pour l'administration orale de médicaments en améliorant le modèle d'absorption et de transit compartimental avancé (ACAT™) de GastroPlus.
La collaboration se concentrera sur le développement de produits pharmaceutiques oraux à libération immédiate grâce à des capacités prédictives améliorées. Les développements clés incluent la mise en œuvre de nouvelles méthodologies de distribution de taille de particules de produits et des fonctionnalités améliorées de modélisation de l'effet alimentaire. Ces avancées visent à améliorer le développement de produits pharmaceutiques, à réduire les études sur les animaux et à simplifier les soumissions réglementaires.
Au cours du projet, Simulations Plus fournira aux membres de l'ETC des versions bêta pour des tests. Le logiciel final amélioré sera disponible pour tous les utilisateurs, tandis que Simulations Plus conservera les droits de propriété intellectuelle issus du partenariat.
Simulations Plus (Nasdaq: SLP) hat eine strategische Zusammenarbeit mit dem Enabling Technologies Consortium (ETC) angekündigt, um seine GastroPlus-Plattform zu verbessern. Das geförderte Partnership hat zum Ziel, in vitro-in vivo-Korrelationsansätze für die orale Arzneimittelabgabe zu fördern, indem das fortgeschrittene compartmental absorption and transit (ACAT™) Modell von GastroPlus optimiert wird.
Der Fokus der Zusammenarbeit liegt auf der Entwicklung von Arzneimitteln zur sofortigen Freisetzung durch verbesserte prädiktive Fähigkeiten. Zu den wichtigsten Entwicklungen gehören die Implementierung neuartiger Produkt-Partikelgrößenverteilungsmethodiken und verbesserte Modelle zur Lebensmitteleinflussmodellierung. Diese Fortschritte zielen darauf ab, die Entwicklung von Arzneimitteln zu verbessern, Tierversuche zu reduzieren und regulatorische Einreichungen zu vereinfachen.
Im Verlauf des Projekts wird Simulations Plus den Mitgliedern des ETC Beta-Versionen zum Testen zur Verfügung stellen. Die endgültige verbesserte Software wird allen Benutzern zur Verfügung stehen, wobei Simulations Plus die Urheberrechte an der Partnerschaft behält.
- Secured funded collaboration with pharmaceutical industry consortium ETC
- Development of enhanced GastroPlus platform features will strengthen market position
- Retention of all intellectual property rights from the collaboration
- Potential for reduced development costs through decreased reliance on animal studies
- None.
Insights
This strategic collaboration marks a pivotal advancement in Simulations Plus's market position within the biosimulation space. The partnership with ETC, which represents major pharmaceutical companies, demonstrates strong industry validation of their GastroPlus platform and creates a significant competitive moat.
The technical enhancements being developed, particularly the novel P-PSD methodologies and enhanced food effect modeling, address critical pain points in drug development. These improvements could potentially accelerate drug development timelines and reduce development costs by minimizing the need for extensive animal studies. For pharmaceutical companies, this translates to faster time-to-market and improved ROI on drug development investments.
From a market perspective, this collaboration strengthens Simulations Plus's position in several ways:
- Retention of intellectual property rights ensures long-term competitive advantages
- Direct involvement of major pharmaceutical companies provides immediate market validation
- Enhanced platform capabilities could drive increased adoption and user base expansion
- Potential for premium pricing on advanced features
The focus on improving regulatory submission processes is particularly strategic, as it addresses a major industry bottleneck. Success in this area could position Simulations Plus as an essential partner in the drug development process, potentially leading to expanded market share and stronger customer relationships.
Industry partners to provide funding and data to support ACAT™ model improvements
RESEARCH TRIANGLE, N.C.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced that it has entered a new funded collaboration with the Enabling Technologies Consortium (ETC). This partnership is aimed at advancing in vitro-in vivo correlation (IVIVC) approaches for oral drug delivery and expanding the functionality of the GastroPlus platform.
The collaboration focuses on enhancing the predictive capabilities of the GastroPlus advanced compartmental absorption and transit (ACAT™) model to support the development of immediate release (IR) oral drug products. Using data gathered from public sources and members of the ETC, physiologically based pharmacokinetics (PBPK) and biopharmaceutics modeling (PBBM) experts and software engineers at Simulations Plus will look to complete key objectives as defined by the partnership. These advancements, including implementation of novel product-particle size distribution (P-PSD) methodologies and enhanced food effect modeling features, will provide researchers with powerful tools to improve drug product development, reduce reliance on animal studies, and streamline regulatory submissions.
“We are honored to collaborate with ETC, a consortium representing leaders in pharmaceutical innovation who recognize the critical role GastroPlus already plays in drug development,” said Dr. Xavier Pepin, Vice President of PBPK R&D at Simulations Plus and principal investigator for this project. “This partnership reflects the trust and confidence the industry places in our platform and the desire to support its continued evolution. By advancing cutting-edge capabilities, we are not only reaffirming our commitment to innovation but also empowering researchers to solve complex biopharmaceutical challenges with even greater precision and efficiency.”
The collaboration leverages the combined expertise of Simulations Plus and ETC’s Participating Members, which include leading pharmaceutical and biotechnology companies. Throughout the project, Simulations Plus will deliver beta versions of the enhanced GastroPlus platform to ETC members for testing. Upon completion, the updated software will be accessible to the broader user community. Consistent with all collaborations that Simulations Plus enters, the Company will retain ownership of intellectual property developed through this partnership, ensuring that future enhancements to its platform continue to reflect Simulations Plus’ leadership in PBPK/PBBM science.
About the Enabling Technologies Consortium
The Enabling Technologies Consortium (ETC) serves as a dynamic platform for pharmaceutical and biotechnology companies to exchange ideas, share knowledge, and collaborate on pioneering new technologies that enhance drug development and manufacturing processes. With a mission centered on advancing pre-competitive enabling technologies, ETC fosters partnerships between its member companies and external collaborators. Pre-competitive initiatives are defined as joint efforts among multiple pharmaceutical organizations and third parties to develop tools, methodologies, or refinements that drive efficiencies in drug development. These outcomes are made widely accessible through publication, product commercialization, or other dissemination methods.
By uniting industry leaders under a shared vision, ETC is driving progress and empowering pharmaceutical companies to tackle common challenges with innovative, enabling technologies. For more information about ETC and its initiatives, please visit https://www.etconsortium.org/.
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.
Environmental, Social, and Governance (ESG)
We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 2023 ESG update.
Forward-Looking Statements
Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “expect,” and “anticipate” mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to successfully integrate the Pro-ficiency business with our own, as well as expenses we may incur in connection therewith, the efficiency and effectiveness of our internal business restructuring and leadership changes, our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the
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Financial Profiles
Lisa Fortuna
310-622-8251
slp@finprofiles.com
Enabling Technologies Secretariat
James Vergis
202-230-5439
info@etconsortium.org
Source: Simulations Plus, Inc.
FAQ
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