LANCASTER, Calif.--(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 been awarded a newly funded grant from the U.S.

加利福尼亚州兰开斯特市——（商业新闻短讯）——Simulations Plus，Inc.（纳斯达克：SLP）（“Simulations Plus”）是生物模拟、模拟性能和智能解决方案以及生物制药行业医疗通信的领先提供商，今天宣布已获得美国新资助。

Food and Drug Administration (FDA) to use physiologically based pharmacokinetic (PBPK) approaches in GastroPlus® to build and validate mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) technologies through a joint proposal with the University of Connecticut’s School of Pharmacy, Department of Pharmaceutical Sciences..

美国食品和药物管理局（FDA）将在GastroPlus®中使用基于生理学的药代动力学（PBPK）方法，通过与康涅狄格大学药学院制药科学系的联合提案，建立和验证长效注射（LAI）技术的机制性体外-体内相关性（IVIVC）。。

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 Connecticut and her lab will generate in vitro and in vivo data for marketed LAI suspension products using novel discriminatory systems.

该项目旨在使用GastroPlus PBPK平台来研究LAI制剂关键质量属性（CQA）与注射部位生理因素之间的复杂关系，以准确预测体内药物释放和吸收。康涅狄格大学董事会杰出药剂学教授和辉瑞杰出捐赠制药技术主席Diane Burgess博士及其实验室将使用新型歧视系统为市售LAI悬浮产品生成体外和体内数据。

The scientific team at Simulations Plus will use this data, along with additional inputs from research collaborators, to develop PBPK models and apply them to validate mechanistic IVIVCs. This effort is expected to lay the groundwork for a practical alternative to in vivo studies in establishing bioequivalence (BE) for additional LAI product technologies..

Simulations Plus的科学团队将使用这些数据以及研究合作者的额外输入来开发PBPK模型，并将其应用于验证机械IVIVC。预计这项努力将为建立其他LAI产品技术的生物等效性（BE）的体内研究的实用替代方案奠定基础。。

“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.

Simulations Plus的科学家兼该基金的首席研究员Daniela Silva Ryan博士说：“LAI制剂在制药管道和产品组合中变得越来越重要，因为它们能够提高患者的依从性并延长药物释放时间。”。“评估新配方设计的临床前和临床研究既冗长又昂贵。

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.”.

有了这项新的拨款，我们希望我们在GastroPlus内的工作能够证明PBPK建模如何减少开发时间和成本，同时简化创新者和通用配方的监管流程。”。

FDA scientific and program staff will actively collaborate with the University of Connecticut, Simulations Plus, and select industry partners. Dr. Silva Ryan, with assistance from scientists at Simulations Plus, will coordinate the contract’s modeling and simulation activities.

FDA的科学和项目工作人员将积极与康涅狄格大学、Simulations Plus和选定的行业合作伙伴合作。Silva Ryan博士将在Simulations Plus科学家的协助下，协调合同的建模和仿真活动。

“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.

伯吉斯博士补充道：“很荣幸能够继续将我们的专业知识与Simulations Plus和FDA相结合，进一步推进LAI配方性能的研究。”。“原子能机构对这一伙伴关系的信任和信心突显了两个组织在我们各自领域的领导作用。

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.”.

总之，我们的目标是开发模型，弥合动物和人类数据之间的差距，揭示配方特性和注射部位生理学之间的复杂关系，为这种不断增长的药物输送技术提供虚拟BE方法的见解。”。

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..

FDA通过赠款1U01FD008304-01为这项合作提供资金。本新闻稿中表达的观点不一定反映卫生与公众服务部的官方政策；提及商品名称、商业惯例或组织也不意味着美国政府的认可。。

About the Burgess laboratory at the University of Connecticut

关于康涅狄格大学伯吉斯实验室

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.

康涅狄格大学药学院药物科学系的伯吉斯实验室的研究重点是复杂肠胃外制剂的配方科学，药物输送和制造科学。研究工作包括界面化学的基础科学，其在预成型和制剂开发中的应用，新型药物递送系统的开发以及这些药物递送系统的体外和体内测试，包括生物药剂学和药效学的研究。

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..

这项研究用于解决药物和基因递送方面的问题，重点是微球，纳米粒子，脂质体，乳液，水凝胶和原位形成递送系统。努力还集中在生物相容性涂层上，以防止异物反应，否则会导致肠胃外植入式装置的功能丧失。。

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).

主要贡献包括：开发新型微胶囊剂型；开发复杂肠胃外剂型的“实时”和加速性能测试，并开发这些复杂剂型的IVIVC；从微球剂型模拟蛋白质治疗剂的药代动力学；界面性质与乳液和纳米粒子稳定性的相关性；开发一种用于植入式装置的新型复合涂层，已被证明可以防止动物模型中超过6个月的异物反应；开发一种方法，可以对基因治疗剂和基因传递载体进行长期的细胞内和核内追踪；；质量设计原则在纳米粒子和脂质体中的应用；并开发脂质体和乳剂的新型制造方法，包括开发用于复杂肠胃外药物（如脂质体，脂质纳米颗粒（LNPs））的连续制造方法和过程分析技术。

About Simulations Plus, Inc.

关于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.

Simulations Plus拥有超过25年的全球客户服务经验，是生物制药领域的领先供应商，提供先进的软件和咨询服务，可增强药物发现、开发、研究、临床试验操作、监管提交和商业化。

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.

我们全面的生物模拟解决方案集成了人工智能/机器学习（AI/ML），基于生理的药代动力学，基于生理的生物制药，定量系统药理学/毒理学和群体PK/PD建模方法。我们还提供支持模拟的性能和智能解决方案，以及用于临床和商业药物开发的医疗通信支持。

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..

我们的尖端技术已获得全球领先的制药、生物技术和监管机构的许可和使用。有关更多信息，请访问我们的网站www.simulations-plus.com。在LinkedIn | X | YouTube上关注我们。。

Environmental, Social, and Governance (ESG)

环境、社会和治理（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.

我们将环境、社会和治理（ESG）的工作重点放在能够产生最积极影响的地方。要了解更多有关我们最新举措和优先事项的信息，请访问我们的网站阅读2023年ESG更新。

Forward-Looking Statements

前瞻性声明

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.

。像“相信”、“期望”和“期望”这样的词意味着这些是我们在撰写本文时的最佳估计，但不能保证预期或预期的结果或事件会实际发生，因此我们未来的实际结果可能与这些陈述有很大差异。

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 U.S. Securities and Exchange Commission..

有关我们风险因素的更多信息，请参阅我们的季度和年度报告，并提交给美国证券交易委员会。。