Simulations Plus Supported Development of Every FDA-Approved Drug in 2024
Simulations Plus (Nasdaq: SLP) announced that its technology and expertise supported the development of 100% of FDA-approved drugs in 2024. The company provides cheminformatics, biosimulation, and medical communications solutions to the biopharma industry.
The company's suite of solutions incorporates artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM), quantitative systems pharmacology/toxicology (QSP/QST), and population PK/PD modeling approaches. These technologies, combined with adaptive learning and medical communications tools, help accelerate drug development processes and support critical advancements in global healthcare.
Simulations Plus (Nasdaq: SLP) ha annunciato che la sua tecnologia e competenza hanno supportato lo sviluppo di il 100% dei farmaci approvati dalla FDA nel 2024. L'azienda fornisce soluzioni di cheminformatica, biosimulazione e comunicazioni mediche all'industria biofarmaceutica.
Il pacchetto di soluzioni dell'azienda incorpora intelligenza artificiale/apprendimento automatico (AI/ML), farmacocinetica/biofarmaceutica basata sulla fisiologia (PBPK/PBBM), farmacologia/toxicologia dei sistemi quantitativi (QSP/QST) e approcci di modellizzazione PK/PD di popolazione. Queste tecnologie, combinate con strumenti di apprendimento adattivo e comunicazioni mediche, aiutano ad accelerare i processi di sviluppo dei farmaci e supportano avanzamenti critici nella sanità globale.
Simulations Plus (Nasdaq: SLP) anunció que su tecnología y experiencia apoyaron el desarrollo de el 100% de los medicamentos aprobados por la FDA en 2024. La empresa proporciona soluciones de quimioinformática, biosimulación y comunicaciones médicas a la industria biofarmacéutica.
El conjunto de soluciones de la empresa incorpora inteligencia artificial/aprendizaje automático (AI/ML), farmacocinética/farmacéutica basada en la fisiología (PBPK/PBBM), farmacología/toxicología de sistemas cuantitativos (QSP/QST) y enfoques de modelado PK/PD poblacional. Estas tecnologías, combinadas con herramientas de aprendizaje adaptativo y de comunicaciones médicas, ayudan a acelerar los procesos de desarrollo de medicamentos y apoyan avances críticos en la atención sanitaria global.
Simulations Plus (Nasdaq: SLP)는 2024년 FDA 승인 약물의 100% 개발을 지원한 기술과 전문성을 발표했습니다. 이 회사는 바이오 제약 산업에 화학 정보학, 생물 시뮬레이션 및 의료 커뮤니케이션 솔루션을 제공합니다.
회사의 솔루션 세트는 인공지능/기계 학습(AI/ML), 생리학 기반 약리학/생물 제약학(PBPK/PBBM), 정량적 시스템 약리학/독성학(QSP/QST) 및 인구 PK/PD 모델링 접근 방식을 포함합니다. 이러한 기술은 적응형 학습 및 의료 커뮤니케이션 도구와 결합되어 약물 개발 프로세스를 가속화하고 글로벌 의료의 중요한 발전을 지원합니다.
Simulations Plus (Nasdaq: SLP) a annoncé que sa technologie et son expertise ont contribué au développement de 100 % des médicaments approuvés par la FDA en 2024. L'entreprise fournit des solutions de chimie informatique, de biosimulation et de communication médicale à l'industrie biopharmaceutique.
Le portefeuille de solutions de l'entreprise intègre intelligence artificielle/apprentissage automatique (AI/ML), pharmacocinétique/biopharmaceutique basée sur la physiologie (PBPK/PBBM), pharmacologie/toxicologie des systèmes quantitatifs (QSP/QST) et approches de modélisation PK/PD populationnelle. Ces technologies, associées à l'apprentissage adaptatif et aux outils de communication médicale, aident à accélérer les processus de développement de médicaments et soutiennent des avancées critiques dans la santé mondiale.
Simulations Plus (Nasdaq: SLP) kündigte an, dass ihre Technologie und Expertise die Entwicklung von 100% der von der FDA im Jahr 2024 genehmigten Medikamente unterstützt hat. Das Unternehmen bietet der biopharmazeutischen Industrie Lösungen in den Bereichen Cheminformatik, Biosimulation und medizinische Kommunikation an.
Das Lösungsspektrum des Unternehmens umfasst künstliche Intelligenz/machine learning (AI/ML), physiologisch basierte Pharmakokinetik/Bio-Pharmazeutik (PBPK/PBBM), quantitative Systempharmakologie/-toxikologie (QSP/QST) sowie PK/PD-Modellierungsansätze in der Bevölkerung. Diese Technologien, kombiniert mit adaptivem Lernen und medizinischen Kommunikationswerkzeugen, helfen, die Arzneimittelentwicklungsprozesse zu beschleunigen und unterstützen kritische Fortschritte im globalen Gesundheitswesen.
- Supported development of 100% of FDA-approved drugs in 2024
- Demonstrates market leadership in pharmaceutical development technology
- Diverse portfolio of advanced technologies including AI/ML integration
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Insights
The revelation that Simulations Plus supported 100% of FDA-approved drugs in 2024 represents a powerful market position indicator. The company's comprehensive involvement in drug development processes through its AI/ML and biosimulation platforms demonstrates its critical role in the
With a modest market cap of
The 100% involvement in FDA approvals reflects an extraordinary level of industry penetration that few technology providers achieve. SLP's comprehensive suite of simulation tools addresses critical bottlenecks in drug development, potentially reducing both time and costs in the approval process. The integration of AI/ML with traditional pharmacokinetic modeling represents a significant competitive advantage in an industry where development costs can exceed
Think of SLP as the "digital wind tunnel" of drug development - just as automotive companies use simulations before building physical prototypes, pharmaceutical companies increasingly rely on SLP's tools to optimize drug candidates before costly clinical trials. This position in the drug development value chain suggests strong defensive characteristics and growth potential as the industry continues to digitalize.
SLP’s technology and expertise accelerates drug development and supports critical advancements in global healthcare
“For more than 25 years, our clients have entrusted us to provide the mission-critical software and services needed to develop therapies that are changing the landscape of healthcare,” said Shawn O’Connor, Chief Executive Officer at Simulations Plus. “We are proud that our advanced modeling and simulation software and consulting services supported the development of every drug approved by the FDA in 2024. This achievement underscores the increasing role that innovative technologies and collaborative expertise plays in accelerating the drug development process. As global health challenges grow, we remain committed to delivering solutions which help advance life-saving therapies that improve patient outcomes worldwide.”
Simulations Plus offers software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. SLP’s suite of solutions leverage artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/physiologically based biopharmaceutics (PBPK/PBBM), quantitative systems pharmacology/quantitative systems toxicology (QSP/QST), and population PK/PD modeling approaches, as well as adaptive learning and medical communications tools.
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
Source: Simulations Plus, Inc.
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