Latest news with #NAMs
Business Wire
24-07-2025
- Health
- Business Wire
FNIH Program Will Advance Alternative Research Models
NORTH BETHESDA, Md.--(BUSINESS WIRE)--The Foundation for the National Institutes of Health (FNIH) is managing a new program to advance innovative laboratory technologies that model human biology, enabling faster, less expensive testing. 'These innovative approaches ... will support more cost-effective and human-relevant results, compared to traditional models.'— Stacey Adam, PhD Share A public-private partnership launched by the FNIH – in collaboration with the NIH – will accelerate the implementation of this technology. Examples include organ-on-a-chip platforms, AI models, and cell lines. These efforts are expected to reduce the reliance on animals in the laboratory. 'These innovative approaches will advance safety testing, accelerate drug development, and enhance disease modeling,' said Stacey Adam, PhD, FNIH Vice President of Science Partnerships. 'Ultimately, this will support more cost-effective and human-relevant results, compared to traditional models.' To date, more than 40 government, life science, nonprofit, and regulatory organizations have joined the partnership, called the Validation and Qualification Network (VQN). The FNIH continues to recruit partners. (Learn more at The VQN will develop individual projects to help streamline regulatory approvals for therapies and compounds that are eventually tested using these new technologies, which are known collectively as New Approach Methodologies, or NAMs. These projects will include activities such as the establishment of common data elements and standardized results reporting. 'The Validation and Qualification Network will play a key role in advancing the use and broader regulatory acceptance of human-centered research models,' said Nicole Kleinstreuer, PhD, Acting NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives. 'This work will address key challenges in NAMs adoption and implementation.' NAMs have the potential to transform the way scientific research is conducted. These new approaches include computer models that simulate how a substance would act in the body, and cell-based tools that replicate human biology. The VQN is part of the NIH Complement Animal Research in Experimentation (Complement-ARIE) program, which aims to complement, and in some cases replace, traditional animal testing with alternative research methods that model human biology. The Complement-ARIE NAMs VQN is expected to lead to several additional projects to advance the development, standardization, validation, and use of human-based research technologies. Funded by Award No. OT2OD039875 from NIH. Twenty-nine private partners have also provided funding. Learn more at About the Foundation for the National Institutes of Health The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH) with their counterparts in life sciences companies, academia, patient organizations, foundations, and regulatory agencies (including the Food and Drug Administration and European Medicines Agency). Through team science, the FNIH solves complex health challenges and accelerates breakthroughs for patients, regardless of who they are or what health threats they face. The FNIH contributes to the development of new therapies, diagnostics, and potential cures; advances global health; and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit Follow us on social media: LinkedIn, Facebook, Instagram.
Yahoo
03-07-2025
- Business
- Yahoo
Craig-Hallum Trims Simulations (SLP) Price Target, Maintaining a Buy Rating
Simulations Plus, Inc. (NASDAQ:SLP) is one of the top 10 healthcare AI stocks to buy according to hedge funds. Simulations Plus, Inc. (NASDAQ:SLP), a leading provider of modeling and simulation software for pharmaceutical research, saw its price target lowered by Craig-Hallum to $36 from $45 following a cautious Q3 pre-release and a downward revision of its fiscal year 2025 guidance. Despite maintaining a Buy rating, the firm highlighted growing macroeconomic headwinds that are weighing on the company's services segment. Clients have reportedly been slow to initiate new contracts, delay clinical trials, and hold off on major spending decisions—a trend that's been broadly felt across the healthcare landscape. A close-up view of a scientist's hand pressing keys on a laptop as another looks closely at a 3-D model on a large monitor. However, Simulations Plus' core software segment remains resilient. Known for its predictive modeling platforms used in drug discovery and development, the company plays a key role in advancing New Approach Methodologies (NAMs), which aim to modernize and reduce reliance on traditional clinical trials. These technologies, essential in streamlining the drug development process, are gaining broader acceptance across regulators and pharmaceutical companies, solidifying Simulations Plus' role in a rapidly evolving healthcare ecosystem. Craig-Hallum sees long-term potential in this structural shift. While near-term disruptions may cloud visibility, the firm notes that Simulations Plus continues to operate in a growing, innovation-driven market. For investors looking to align with the digital transformation of drug development, the company represents a compelling opportunity rooted in both regulatory trends and scientific advancement. While we acknowledge the potential of SLP to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than SLP and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: 13 Best Biotech Stocks To Invest In Now and 12 Best Healthcare Stocks to Buy Now. Disclosure: None. Sign in to access your portfolio
Newsweek
03-07-2025
- Health
- Newsweek
The Bulletin June 21, 2025
The rundown: The issue of animal testing is something most Americans agree on: it needs to change and gradually be stopped. Since President Donald Trump began his second term, his administration has been making moves to transform and reduce animal testing in country. Find out what steps are being taken. Why it matters: In April, the Food and Drug Administration (FDA) said that its animal testing requirement will be "reduced, refined, or potentially replaced" with a range of approaches, including artificial intelligence-based models, known as New Approach Methodologies or NAMs data. The Trump administration's efforts to tackle the issue of animal testing appear to be a step in the right direction, according to experts who spoke with Newsweek. Read more in-depth coverage: Over 300 Animals Removed From US Safari After Decade of Red Flags TL/DR: Millions of animals each year are killed in U.S. laboratories as part of medical training and chemical, food, drug and cosmetic testing. What happens now? A Department of Health and Human Services (HHS) official told Newsweek: "The agency is paving the way for faster, safer, and more cost-effective treatments for American patients.' Deeper reading How Animal Testing in US Could Be Transformed Under Trump
Associated Press
12-06-2025
- Business
- Associated Press
Predictive Oncology Develops Functional 3D Organoid Models Exclusively for Labcorp
PITTSBURGH, June 12, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a leader in AI-driven drug discovery, announced today the company has successfully developed 3D organoid models exclusively for Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services. As part of an ongoing agreement, Predictive Oncology recently developed two distinct and unique 3D liver toxicity models exclusively for Labcorp, including a human and rat model. Both models represent the liver microenvironment and can be used for the evaluation of both drug metabolism and liver toxicity related to drugs. 'The intention of these 3D organoid models is to enable the prediction of in vivo drug clearance, drug transport and hepatotoxicity related to drugs,' said Dr. Arlette Uihlein, Senior Vice President Translational Medicine and Drug Discovery for Predictive Oncology. 'These models provide highly relevant, species-specific data based on their physiologic hepatic microenvironments while also capturing hepatic cellular heterogeneity.' These and other 3D organoid models developed by Predictive Oncology substantially complement its AI-driven 2D platform and 3D spheroids, which utilize human tumor samples to accelerate drug discovery and identify relevant biomarkers across thousands of patients. The platform relies on Predictive Oncology's vast biobank of over 150,000 frozen tumor samples. 'Labcorp is committed to developing and using new approach methodologies (NAMs) in preclinical studies. These models show great promise to enable more rapid evaluation of new potential medicines and help accelerate their availability to patients,' said John Kendrick, Ph.D., NAMs scientific strategy lead at Labcorp. 'With this foundation in place, Labcorp will consider expanding this work into other species to support wider preclinical analyses and translate between animal and human models for these new alternative approaches.' According to Grand View Research, with the growing investment in personalized medicine and biotechnology, organoid-based platforms are key drivers to disrupting healthcare, accelerating drug development, reducing reliance on animal models, and paving the way for next-generation therapeutic solutions. Organoids are transforming disease modeling, drug discovery, and regenerative medicine, offering cost-effective and high-fidelity alternatives to traditional research methods. The functional 3D organoid models developed for Labcorp with specialized matrices and media supplements provide insights into cancer therapeutic behavior in patients. Data sets demonstrating optimal liver morphology and function were generated, including cell junction formation (ZO-1 staining); transferrin staining within hepatocytes; DCFDA staining for hepatotoxicity measurements; canalicular structure visualization; and cell viability confirmation (up to 14 days). About Predictive Oncology Predictive Oncology is on the cutting edge of the rapidly growing use of artificial intelligence and machine learning to expedite early drug discovery and enable drug development for the benefit of cancer patients worldwide. The company's scientifically validated AI platform, PEDAL, is able to predict with 92% accuracy if a tumor sample will respond to a certain drug compound, allowing for a more informed selection of drug/tumor type combinations for subsequent in-vitro testing. Together with the company's vast biobank of more than 150,000 assay-capable heterogenous human tumor samples, Predictive Oncology offers its academic and industry partners one of the industry's broadest AI-based drug discovery solutions, further complimented by its wholly owned CLIA laboratory facility. Predictive Oncology is headquartered in Pittsburgh, PA. Investor Relations Contact: Mike Moyer LifeSci Advisors, LLC [email protected] Forward-Looking Statements Certain statements made in this press release are 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These forward- looking statements reflect Predictive Oncology's current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about Predictive Oncology's operations and the investments Predictive Oncology makes. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, changes in management, plans and objectives of management are forward-looking statements. The words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'would,' 'target' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Predictive Oncology's actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading 'Risk Factors' in Predictive Oncology's filings with the SEC. Except as expressly required by law, Predictive Oncology disclaims any intent or obligation to update these forward-looking statements. Predictive Oncology does not give any assurance that Predictive Oncology will achieve its expectations described in this press release.
Associated Press
12-06-2025
- Business
- Associated Press
Infinimmune Launches GLIMPSE-1 AI Model Trained Exclusively on Human Antibody Sequences for Advanced Therapeutic Engineering
ALAMEDA, Calif.--(BUSINESS WIRE)--Jun 12, 2025-- Infinimmune, a biotechnology company pioneering human-first antibody discovery and design, today announced the launch of GLIMPSE-1, a protein language model trained solely on native human antibody sequences. Developed using millions of paired heavy and light chains from human memory B cells, GLIMPSE-1 represents a new paradigm for therapeutic antibody engineering that applies the design principles of the human adaptive immune system. Infinimmune published results in a new bioRxiv preprint, demonstrating that GLIMPSE-1 can humanize clinical antibodies, engineer for affinity and developability parameters, and generate highly divergent functional variants, all through in silico design guided by the biology of the human adaptive immune system. 'Fully human antibodies carry the evolutionary fingerprints of the human immune system, optimized over millions of years,' said Wyatt McDonnell, Ph.D., Co-Founder and CEO, Infinimmune. 'With GLIMPSE-1, we can decode and encode that logic directly from immune repertoires to discover and design better, safer biologics from day one. This approach complements the FDA's recent focus on assessing human-relevant methods for therapeutic development, which could ultimately benefit patients through more comprehensive safety assessment. We believe models like GLIMPSE-1 will remain essential in the discovery and development of modern antibody medicines.' GLIMPSE-1 was developed as a core component of Infinimmune's therapeutic development capabilities, strengthening the company's pipeline of antibody drug candidates. The model was trained using a large, diverse dataset with proprietary sequences from Infinimmune's Complete Human® and Anthrobody® technologies, which source antibodies directly from native human repertoires, allowing it to learn the biological and functional constraints of human immunity. Key results from the preprint include: GLIMPSE-1 operates entirely in human antibody sequence space, predicting viable antibody variants without 3D structure modeling, energy calculations, or experimental screening beforehand. The resulting antibodies maintain essential functional properties and characteristics consistent with clinically approved monoclonal antibodies, all guided by patterns learned from human immune systems. The development of GLIMPSE-1 aligns with recent FDA initiatives exploring human-relevant methodologies for therapeutic development. The FDA's roadmap for integrating New Approach Methodologies (NAMs) identifies monoclonal antibodies as an initial focus area, creating an environment where human-first models like GLIMPSE-1 may provide valuable complementary insights. Infinimmune has successfully integrated GLIMPSE-1 into its therapeutic antibody development pipeline, where the model has significantly contributed to the engineering and optimization of the company's lead programs. The company is currently exploring strategic partnerships with pharmaceutical and biotechnology companies to apply GLIMPSE-1's capabilities to partner's therapeutic programs. About Infinimmune Infinimmune is a biotechnology company pioneering a novel approach to antibody drug discovery and development. Founded by a world-class, multidisciplinary team of scientists and technologists, Infinimmune is reinventing antibody discovery with an end-to-end platform to deliver antibody drugs derived directly from the human immune system. These truly human antibodies are designed to drug new and existing targets with improved safety and efficacy. Infinimmune is building its own pipeline of drug candidates and partnering with pharmaceutical companies to advance their antibody programs, fill their pipelines, and reach new patients and new indications. To learn more, visit and follow us on LinkedIn and @infinimmune. View source version on CONTACT: Media Kimberly Ha KKH Advisors 917-291-5744 [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: RESEARCH TECHNOLOGY GENETICS SOFTWARE BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ARTIFICIAL INTELLIGENCE OTHER SCIENCE SOURCE: Infinimmune Copyright Business Wire 2025. PUB: 06/12/2025 08:07 AM/DISC: 06/12/2025 08:05 AM
