BUSINESS INSIGHTS, PHARMA TECH
businesswire | April 19, 2023
Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced that the U.S. FDA has renewed its licenses to the DILIsym® software platform, the flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI). The one-year renewal provides continued access to DILIsym software for authorized FDA employees across all FDA divisions.
Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, commented, “The FDA’s renewal of these licenses endorses the value of DILIsym software in both predicting liver safety liabilities and defining the underlying mechanisms, which are critical to evaluating risk. The recent signing of the FDA Modernization Act 2.0 by President Biden, which encourages the FDA to limit animal use in drug development, should be a positive catalyst for greater utilization of DILIsym software in drug development. In my role as Chair of the SAB, I am very excited about the direction of the public-private partnership that is guiding further development of the DILIsym platform that will benefit many key stakeholders.”
Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus, added, “Given the effect of rising costs on providing vital healthcare, the use of novel simulation technologies to improve the efficiency of drug development is more critical than ever. An important first step is ensuring that regulatory agencies have the most advanced technology tools to fulfill their essential mission. We are delighted the FDA has opted to renew once again and will continue using DILIsym and other Simulations Plus tools to enable reviews and enhance regulatory science.”
DILIsym software results support crucial drug development decisions by predicting potential DILI risk of new drug candidates. The modeling also identifies the biochemical events that lead to DILI caused by a drug and can thereby predict certain subgroups of patients at increased risk for DILI from that drug. The information from DILIsym modeling serves to help guide go/no-go decisions on major drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that DILI will not be an insurmountable obstacle to regulatory approval. For the past 13 years, DILIsym Services, a division of Simulations Plus, has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym software package. DILIsym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim Initiative consortium and/or commercial licenses. The DILIsym Services division also routinely uses DILIsym for comprehensive consulting services on safety-related issues.
Companies interested in a free trial version of the DILIsym software can request it here.
About Simulations Plus
Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.
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BUSINESS INSIGHTS, PHARMACY MARKET
prnewswire | April 21, 2023
ArisGlobal, the leading provider of life sciences software designed to automate core drug development functions with its end-to-end technology platform LifeSphere®, today announces the completion of its acquisition of Amplexor Life Sciences. This deal will deliver the most intelligent, connected, and comprehensive regulatory platform available, bringing increased efficiency for life sciences organizations as they bring new therapies to market.
A key development is the introduction of LifeSphere Quality Management, marking ArisGlobal's entry into the continuous quality improvement and risk management aspects of drug development.
LifeSphere Quality represents an expansion of ArisGlobal's interconnected drug development platform that spans the pharmaceutical product lifecycle including Clinical, Regulatory, Medical Affairs and Safety. Robust quality management system (QMS) capabilities, including automated workflows and analytics, are now available to support customers' global regulatory compliance needs.
The acquisition also rounds out the end-to-end LifeSphere Regulatory platform with the addition of a labeling management solution and accelerates the Regulatory product roadmap through the integration of enhanced global submission publishing capabilities.
ArisGlobal's intent to purchase was previously announced in late February 2023, and brings two new office locations in Croatia and Slovenia into ArisGlobal's geographic footprint.
About ArisGlobal
ArisGlobal is the creator of LifeSphere, a market leader in drug development technology solutions worldwide that is transforming the way today's most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States.
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BUSINESS INSIGHTS, PHARMACY MARKET
PRNewswire | May 03, 2023
ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems, and MEPHARMA, a strategic regulatory consulting services company, have partnered to provide a range of regulatory intelligence, compliance, and validation and automation solutions for companies in the United Arab Emirates (UAE) and the Middle East and North Africa (MENA).
MEPHARMA provides high-quality regulatory consulting services in addition to a host of other specialized services, including pharmacovigilance, GxP, due diligence and auditing for pharmaceutical, biotechnology and contract research organizations (CRO).
ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world's leading life sciences companies enforce compliance and enable standardization with 100% digital, risk-based validation software.
Combining their extensive experience, MEPHARMA and ValGenesis are poised to expand next-generation digital validation and compliance solutions into countries in the MENA region.
"We are excited to partner with MEPHARMA and empower companies in this region with cutting-edge digital transformation tools that advance them on their Pharma 4.0 journey," says Bo Olsen, ValGenesis' SVP of Partners. "Together we provide well-defined, robust validation lifecycle management strategies and solutions that enable companies adhere to the most stringent global regulatory requirements."
"We are thrilled to collaborate with ValGenesis, the enterprise Validation Lifecycle Management Systems leader, to bring comprehensive regulatory intelligence, compliance, and validation solutions to local manufacturing companies in the UAE and MENA region," says Dr. Ayman Mahmoud, Managing Director at MEPHARMA. "Our partnership with ValGenesis will empower regional life sciences companies to streamline their validation processes and achieve maximum compliance with the highest GMP regional and global standards. Together, we are committed to delivering exceptional value to our clients and supporting their digital transformation journey towards Pharma 4.0."
ABOUT VALGENESIS
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.
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