BUSINESS INSIGHTS, PHARMA TECH
Businesswire | March 29, 2023
Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it established a strategic research collaboration with the Sino-American Cancer Foundation (SACF). This collaboration will leverage Simulations Plus’ staff and Artificial Intelligence-driven Drug Design technology in the ADMET Predictor® software platform to support the discovery and design of novel inhibitors of methylenetetrahydrofolate dehydrogenase 2 (MTHFD2), an emerging cancer target.
Per the terms of the collaboration, Simulations Plus will develop quantitative structure-activity relationship (QSAR) models for efficacy against MTHFD2, using information from SACF as well as academic and patent literature. The biologists, computational and medicinal chemists in the Early Drug Discovery Services team at Simulations Plus will work with the researchers at SACF to define the multi-objective parameters against which the lead molecule(s) will be optimized. The new AIDD Module in ADMET Predictor® will then be employed to generate libraries of virtual compounds that are optimized for potency and other chosen parameters. The teams will select promising candidates for synthesis and testing, and ensuing rounds of QSAR model building and AIDD optimization will be performed until the milestone criteria in the collaboration agreement are achieved.
“We value the trust and confidence SACF has in our team and AI technology to complement and accelerate conventional drug design and lead optimization processes,” said Dr. Jeremy Jones, Principal Scientist at Simulations Plus and project lead. “By combining their drug discovery expertise with our algorithmic and data science know-how, we are confident we will successfully support their hit-to-lead target development activities.”
As part of this agreement, SACF will provide upfront funding to Simulations Plus to design a set number of compounds for efficacy against MTHFD2 which will be exclusive to SACF. Subsequent milestone payments will be made as key research and development goals are met.
“SACF has had an active interest in AI for de novo design for some time, and we have found a trusted partner in Simulations Plus to help us integrate this into our research,” added Dr. Frank Luh, CEO of SACF. “Scientists from the two organizations will work side-by-side to combine SACF’s data with all that Simulations Plus offers to identify the next generation of compounds that could help in the treatment of cancer.”
John DiBella, SLP Division President, said, “The Early Drug Discovery Services offering at Simulations Plus is tailor made for this type of partnership, where our team of experts, including computational, medicinal, and cheminformatics specialists, provide end-to-end AI-driven drug discovery and optimization support to complement the SACF team. Simulations Plus continues to invite future collaborations which benefit organizations and, most importantly, the global communities we serve.”
About Simulations Plus, Inc.
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 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.
BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | April 06, 2023
Societal CDMO, Inc. a contract development and manufacturing organization announced that it has been selected by Longboard Pharmaceuticals, Inc. to provide CDMO services. The agreement spans a range of Societal CDMO’s offerings including technology transfer and analytical method validation activities to support Longboard’s lead asset, LP352, a 5-HT2C receptor superagonist. LP352 is currently being evaluated in the PACIFIC Study, a Phase 1b/2a basket trial, in participants with developmental and epileptic encephalopathies or DEEs, such as Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, CDKL5 deficiency disorder, SCN2A-related disorders, among others.
“This agreement with Longboard offers an excellent illustration of the strides that Societal CDMO continues to make in establishing itself as a preferred CDMO partner for biopharmaceutical companies developing innovative therapeutic candidates. The scope of work for this project highlights the broad range of services we offer to support drug developers as they advance their innovative candidates through clinical development, spanning tech transfer through to cGMP manufacturing,” said David Enloe, chief executive officer of Societal CDMO. “We are grateful for the trust that Longboard has placed in our team to make a contribution to the development of an important therapeutic that has the potential to meaningfully impact the lives of patients in need. At the end of the day, that is the mission that drives all members of the Societal CDMO team.”
About Societal CDMO
Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
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.