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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PHARMACY MARKET
Businesswire | May 29, 2023
Elixir, a pharmacy benefit management company owned by Rite Aid has announced details of the next release of its Laker Software technology platform. The upcoming enhancements include new automated workflows, a customer service tool and modernization of the user interface.
"Already a leader in the industry, Laker Software is going from good to great,” said Jeff Mallad, VP, PBM Technology Sales for Elixir. "Elixir’s technology platform is one of the fastest and most reliable pharmacy claims systems available—and it’s about to become turbo-charged! We’re modernizing the future of pharmacy benefits to support our customers’ business growth, the digital world and cost reduction.”
The upgrade will include a range of advanced functionalities that are designed to help customers better manage their pharmacy claims adjudication data and streamline workflows. The new features will allow users to access and share data more efficiently, collaborate more effectively, and improve productivity.
For more than 20 years, the Laker Software platform has been a leading technology solution and one of only a few that can manage multiple lines of business including
Medicare, Medicaid and Exchange Commercial payers Adjudication and claims processing for 340B pharmacies Prescription savings card programs Workers’ compensation
Built on a resilient, scalable architecture, the Laker Software platform is a 100% virtualized environment. The platform processes millions of paid claims per year and is SOC 1 Type 2 certified. It has multiple levels of data security and redundant backup systems. Laker Software provides a full set of robust capabilities, including
Claims Processing/Adjudication Call Center Plan Set Up Eligibility Accumulator Accounts Payable/Receivable Prior Authorization Reporting
Customers will begin to beta test some of the platform’s newest features shortly, and other enhancements will follow as the next generation of Laker Software evolves. Customers can expect to see improvements in cost reduction due to automation, solutions for improved plan design and channel management, and advanced analytics and statistical analyses. This is in addition to a cloud-based infrastructure and redesigned user interface, allowing for even more flexibility and a better customer experience.
"Elixir is committed to investing in innovative solutions to meet the evolving needs of the pharmacy benefits industry,” said Mallad. “In addition to our Laker platform, customers can rely on our full suite of pharmacy benefit services to custom design their ideal solution. We support your business, enable your growth and help you succeed in every segment of the pharmacy lifecycle."
About Elixir
Elixir, a fully owned subsidiary of Rite Aid Corporation, is a pharmacy services provider that offers pharmacy benefit management services, Medicare-approved prescription drug plans, mail and specialty pharmacy solutions, and prescription discount programs. With the unique ability to optimize the full pharmacy care experience, Elixir is crafting solutions for today’s pharmacy benefits challenges.
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PHARMACY MARKET, PHARMA TECH
Businesswire | April 12, 2023
Shields Health Solutions the premier specialty pharmacy accelerator in the country, announces that it is partnering with Elliot Health System, the largest provider of comprehensive healthcare services in Southern New Hampshire, to launch a new pharmacy program to meet the unique needs of patients with complex, chronic conditions. The program will increase access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health.
The program with Elliot Health System and Shields will initially serve a variety of disease states and clinics including rheumatology, gastroenterology, neurology, pulmonology, oncology, endocrinology and family medicine. Specialty pharmacy liaisons will guide patients and caregivers who fill prescriptions with Elliot Health System and will work with patients on-site. These liaisons can assist patients and families with navigating barriers to care, such as health insurance prior authorizations or securing financial assistance, regardless of the location where they fill their prescription.
“Through our partnership with Shields, we can provide Elliot patients, and patients from other health care systems in our community, with expanded access to critical medications to achieve even greater positive health outcomes, particularly for the patients who require the highest degree of expertise to meet their needs,” said Molly Mortimer, Elliot Health System Director of Pharmacy Services. “We are pleased to join the Shields network to ensure we are doing all that we can to best care for our community.”
Expanded patient support services, combined with access to recently approved and newly available specialty medications, give patients greater availability for onsite treatment options. Shields currently partners with more than 75 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery — often within two days — and improved medication adherence greater than 90 percent on average.
“Through a commitment to outstanding complex patient care and its position as a health care leader in the region, Elliot Health System, and SolutionHealth as a regional system, align well with Shields’ core mission and will make it a highly valued addition to our membership,” said John Lucey, Chief Executive Officer at Shields. “By securing access to 90 percent of the limited distribution drugs that complex patients need and opening the door to restricted payer networks, our partnership will elevate access to affordable care, while improving therapy management and care coordination for Elliot Health System’s patients.”
About Shields Health Solutions
Shields Health Solutions is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system. As the foremost experts in the health system specialty pharmacy industry, Shields has a proven track record of success including access to over 80 percent of all limited distribution drugs (LDDs) and most (health insurance) payers in the nation; and a clinical model proven to lower total cost of care by 13%. In partnership with more than 70 health systems across the country through national-scale collaboration, Shields has a vested interest in delivering measurable clinical and financial results for health systems.
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