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EPNextS Group and Frontage Laboratories, Inc. Announce Collaboration in Early Phase Clinical Trials in the United States to Improve "Drug Lag" and "Drug Loss" Issues in Japan

EPNextS Group and Frontage Laboratories, Inc. Announce Collaboration in Early Phase Clinical Trials in the United States to Improve "Drug Lag" and "Drug Loss" Issues in Japan

EPnexts 集团和方达实验室公司宣布在美国合作开展早期临床试验,以改善日本的 “药物滞后” 和 “药物流失” 问题
PR Newswire ·  03/26 08:00

EXTON, Pa., March 26, 2024 /PRNewswire/ -- EPNextS Group, a Japanese based leading provider of clinical trial solutions, and Frontage Laboratories, Inc., a US based full-service contract research organization (CRO), have announced a collaboration aimed at addressing the challenges of "Drug Lag" and "Drug Loss" in Japan.

宾夕法尼亚州埃克斯顿,2024年3月26日 /PRNewswire/ — 总部位于日本的领先临床试验解决方案提供商EPnexts集团和总部位于美国的全方位服务合同研究组织(CRO)Frontage Laboratories, Inc. 宣布了一项旨在应对日本 “药物滞后” 和 “药物流失” 挑战的合作。

Japan's pharmaceutical market faces significant hurdles related to the lag in the introduction of new drugs compared to other developed countries, often resulting in delays in patient access to life-saving medications. Additionally, stringent regulatory requirements and complex clinical trial procedures contribute to drug loss, where promising therapies fail to reach the market due to inefficiencies in the development process.

与其他发达国家相比,日本的药品市场面临着与新药推出滞后相关的重大障碍,这通常会导致患者延迟获得救生药物。此外,严格的监管要求和复杂的临床试验程序会导致药物流失,在这种情况下,由于开发过程效率低下,有前途的疗法无法进入市场。

EPNextS Group and Frontage intend to leverage EPNextS Group's expertise in clinical trial solutions and Frontage's extensive experience in early-phase drug development and clinical research services, to overcome these challenges and drive positive change in the pharmaceutical landscape.

EPNEXTS Group和Frontage打算利用EPNEXTS集团在临床试验解决方案方面的专业知识以及方达在早期药物开发和临床研究服务方面的丰富经验,来克服这些挑战,推动制药领域的积极变革。

"We are excited to join forces with Frontage to address the critical issues of drug lag and drug loss in Japan," said Tatsuma Nagaoka, Representative Director and President of EPNextS. "Our collaboration with Frontage underscores our commitment to advancing clinical research and improving patient access to innovative therapies. By combining our strengths, we aim to streamline the drug development process and bring novel treatments to market more efficiently."

epnexts代表董事兼总裁Tatsuma Nagaoka表示:“我们很高兴与Frontage联手解决日本的药物滞后和药品流失等关键问题。”“我们与Frontage的合作凸显了我们对推进临床研究和改善患者获得创新疗法机会的承诺。通过结合我们的优势,我们的目标是简化药物开发流程,更有效地将新疗法推向市场。”

EPS Corporation, led by Takehisa Yamada, Representative Director and President, is a wholly owned subsidiary of EPNextS. EPS and Frontage intend to conduct collaborative business development activities in Japan and the United States to expand market reach and conduct early phase clinical trials in Japanese and non-Japanese populations in the United States. EPS expects to provide Project Management services in this arrangement for Japanese Clients. In the future, another wholly owned subsidiary of EPNextS, EP-SOGO Co., Ltd., led by Representative Director and President, Kenichi Yamamoto, may explore opportunities to develop overseas training programs with Frontage.

由代表董事兼总裁山田武久领导的EPS公司是EPNEXTS的全资子公司。EPS和Frontage打算在日本和美国开展合作业务开发活动,以扩大市场覆盖范围,并在美国对日本和非日本人群进行早期临床试验。EPS希望通过这种安排为日本客户提供项目管理服务。未来,由代表董事兼总裁山本健一领导的EPNEXTS的另一家全资子公司EP-SOGO有限公司可能会探索与Frontage一起开发海外培训计划的机会。

Frontage brings a wealth of experience in early-phase clinical research, including bioanalytical services, clinical pharmacology, and clinical operations. Frontage services are expected to include clinical trial execution, data management, biostatistical programming, pharmacokinetic analyses, and medical writing.

Frontage在早期临床研究方面拥有丰富的经验,包括生物分析服务、临床药理学和临床运营。Frontage服务预计将包括临床试验执行、数据管理、生物统计编程、药代动力学分析和医学写作。

"We are pleased announce this collaboration with EPNextS Group to address the pressing challenges facing the Japanese pharmaceutical industry," said Abdul Mutlib, CEO of Frontage. "Together, we will leverage our collective expertise to accelerate the development and commercialization of new therapies, ultimately benefiting patients in Japan and beyond."

方达首席执行官阿卜杜勒·穆特利布表示:“我们很高兴地宣布与epnexts集团合作,以应对日本制药行业面临的紧迫挑战。”“我们将共同利用我们的集体专业知识来加速新疗法的开发和商业化,最终使日本及其他地区的患者受益。”

The collaboration between EPNextS Group and Frontage represents a significant step forward in addressing the complexities of drug development and regulatory processes in Japan, with the potential to improve patient outcomes and drive innovation in healthcare.

epnexts Group与Frontage之间的合作是在解决日本药物研发和监管程序的复杂性方面向前迈出的重要一步,有可能改善患者预后并推动医疗保健创新。

About EPS

关于 EPS

[About EPNextS Group] EPNextS Group is a leading provider of comprehensive clinical trial solutions, offering a range of services to support pharmaceutical and biotechnology companies in accelerating drug development. With a focus on innovation and efficiency, EPNextS Group is committed to advancing clinical research and improving patient access to life-saving therapies.

[关于epnexts集团] epnexts集团是综合临床试验解决方案的领先提供商,提供一系列服务,以支持制药和生物技术公司加速药物开发。epnexts集团专注于创新和效率,致力于推进临床研究,改善患者获得救生疗法的机会。

[About EPS Corporation] EPS launched its business in 1991 as a Top Tier CRO to comprehensively support clinical studies with a focus on clinical trials and post marketing surveillance. The company proposes new models to satisfy customers' needs by leveraging its data science expertise and digital technology, cultivated through its extensive track record. These service offerings are anchored in its Trial GATE concept, which acts as the gateway for all clinical trial functions.

[关于EPS Corporation] EPS于1991年作为顶级合同研究组织启动了业务,旨在全面支持临床研究,重点是临床试验和上市后监测。该公司利用其丰富的往绩记录积累的数据科学专业知识和数字技术,提出新模式以满足客户的需求。这些服务以其Trial GATE概念为基础,该概念是所有临床试验功能的门户。

[About EP-SOGO Co., Ltd.] EP-SOGO started its SMO business in 1999, and currently has contracts with approximately 7,000 Investigators' sites (medical institutions) and handles clinical trial operations at these sites so clinical trials can be conducted in accordance with ICH-GCP and relevant regulations. Celebrating its 25th anniversary this year as a milestone for a new beginning, the company will change its name to "EPLink Co., Ltd." on April 1, 2024. With a renewed commitment, EPLink aims to continuously create new values that contribute to the further improvement of the clinical trial environment and propose the best solutions.

[关于株式会社EP-SOGO]EP-SOGO于1999年开始其SMO业务,目前与大约7,000个研究机构(医疗机构)签订了合同,并在这些地点处理临床试验业务,因此可以根据ICH-GCP和相关法规进行临床试验。庆祝成立 25第四 今年的周年纪念作为新起点的里程碑,公司将于2024年4月1日更名为 “epLink有限公司”。通过新的承诺,epLink旨在不断创造新的价值,为进一步改善临床试验环境做出贡献,并提出最佳解决方案。

About Frontage ()

关于 Frontage ()

Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions. For more details visit:

方达控股公司(1521.HK)及其全资子公司方达实验室是一家全球合同研究组织(CRO),提供从药物发现到后期临床过程的综合性、科学驱动的产品开发服务,使生物制药公司能够实现其发展目标。综合服务包括药物代谢和药代动力学、分析测试和配方开发、临床前和临床试验材料制造、生物分析、临床前安全和毒理学评估以及早期临床研究。Frontage使许多不同规模的生物技术公司和领先的制药公司能够通过开发推进大量新分子的开发,并成功提交全球监管申报。欲了解更多详情,请访问:

Contact: Debra Santolini, (908) 872-8092, [email protected]

联系人:黛布拉·桑托利尼,(908) 872-8092,[email protected]

SOURCE Frontage Laboratories, Inc.

来源 Frontage 实验室有限公司

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