Latest news with #ISPOR
Associated Press
15-05-2025
- Health
- Associated Press
Altis Labs Unveils New AI-Powered External Control Arm Product Offering at ISPOR 2025
AI-matched digital twins for MYSTIC trial participants emulated the control arm and overall survival treatment effects. 'These findings highlight the potential for imaging-based digital twins to serve as robust external comparators in oncology clinical trials'— Dr. Omar Khan MONTREAL, QUEBEC, CANADA, May 15, 2025 / / -- Altis Labs, Inc. ('Altis') will present findings at ISPOR 2025 demonstrating how real-world digital twins (rwDTs) can replicate control arm outcomes in AstraZeneca's randomized controlled Phase 3 MYSTIC trial in metastatic non-small cell lung cancer (mNSCLC). These results support the launch of Altis' new product offering that enables clinical development teams to generate external controls with AI applied to comprehensive real-world imaging + clinical + outcomes data. Altis applied MYSTIC's eligibility criteria to its multimodal real-world data to identify historical patients treated with relevant standard-of-care (SOC) treatment. AI models processed the real-world baseline CT scans and quantified thousands of spatial imaging biomarkers representing total tumor burden, body composition, and other prognostic features. Using baseline imaging characteristics of each MYSTIC subject, 'matching' rwDTs were identified to generate an External Control Arms (ECAs). AstraZeneca independently evaluated the survival outcomes of the ECAs and compared them to the MYSTIC trial arms, concluding that the ECAs successfully emulated the actual control arm and yielded consistent treatment effect estimates. 'CT Imaging – a 3D reconstruction of the entire patient anatomy – is the most comprehensive data modality already being used in clinical care and oncology trials,' said Felix Baldauf-Lenschen, CEO of Altis. 'It's no surprise that AI applied to this rich data alone can match patients' baseline characteristics to emulate efficacy readouts.' 'These findings highlight the potential for imaging-based digital twins to serve as robust external comparators in oncology clinical trials,' said the presenting author, Dr. Omar Khan, a Clinical Assistant Professor in the Cumming School of Medicine at the University of Calgary and Medical Oncologist at the Arthur J.E. Child Comprehensive Cancer Centre. 'This approach is particularly relevant to help enhance single-arm trials, where comparative evidence is often limited.' Altis' ECA: A New Tool for Smarter Evidence Generation The newly launched ECA product enables sponsors to generate external controls using their clinical trial imaging data and Altis' real-world imaging data + associated survival outcomes. Sponsors can use these ECAs in various ways: • Benchmarking efficacy signal in single-arm trials • Augmenting a control arm to increase statistical power in RCTs • Real-world external comparators to inform reimbursement strategy Altis' models are trained on a proprietary dataset of over 200,000 cancer patients with longitudinal imaging, demographic, diagnostic, treatment, and survival outcomes data, enabling robust matching. The full results are featured at ISPOR 2025, Poster MSR147: Evaluating Imaging Artificial Intelligence (AI) Matching Real-World Digital Twins (rwDTs) Into an External Control Arm (ECA) for MYSTIC: A Phase 3 Clinical Trial in Metastatic Non-Small Cell Lung Cancer (mNSCLC). About Altis Labs Altis Labs is the computational imaging company accelerating clinical trials with AI. Altis has trained proprietary AI models on the industry's largest multimodal training database spanning over 200 million longitudinal images linked to clinical, molecular, and outcomes data. Top 20 biopharmas use Altis' AI models to more confidently analyze data from phase 1-4 clinical trials so that they can bring the most effective novel treatments to patients sooner. For more information, visit follow @AltisLabs on social media, or email [email protected]. Felix Baldauf-Lenschen Altis Labs, Inc. email us here Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
National Post
14-05-2025
- Health
- National Post
Komodo Health's Real-World Evidence Platform Drives 31 Patient Journey Research Studies at ISPOR 2025
Article content Comprehensive Patient Journey Data Links Clinical Outcomes to Real-World Impact, Addressing Critical Evidence Gaps in Oncology, Neurology, Cardiovascular, Metabolic, and Rare Diseases Article content Article content MONTREAL — Komodo Health today announced that its healthcare intelligence platform enabled 31 research studies being presented at the 2025 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) global conference. These include three studies led by Komodo researchers and 27 collaborative studies with academic institutions, Life Sciences companies, and healthcare organizations. Article content 'The volume and diversity of research powered by our healthcare insights underscore the growing demand for high-quality real-world data combined with advanced analytical capabilities,' said Arif Nathoo, MD, CEO and Co-Founder, Komodo Health. 'By connecting individual patient journeys to large-scale health outcomes, we're enabling researchers to uncover actionable insights that improve clinical practice, healthcare policy, and patient outcomes.' Article content The ISPOR 2025 research presentations demonstrate the value of Komodo's real-world evidence across a wide range of therapeutic areas, including: Article content Oncology: Salix Pharmaceuticals, Analysis Group, and Bausch Health studied the economic burden of opioid-induced constipation among patients with or without cancer; Cardiovascular disease: Veradigm examined the discordance between apolipoprotein B and low-density lipoprotein cholesterol levels in predicting incident hypertension risk and how it correlates to differential hypertension development patterns between diabetic and non-diabetic populations; Metabolic disorders: Novo Nordisk studied non-invasive diagnostic approaches and earlier interventions for metabolic dysfunction-associated steatohepatitis (MASH); Neurology: Jazz Pharmaceuticals analyzed healthcare resource utilization and costs among individuals with narcolepsy or idiopathic hypersomnia (IH) who are considered at higher risk for negative clinical outcomes associated with sodium (due to underlying cardiovascular, cardiometabolic, or renal conditions); and Rare disease: Chiesi analyzed medical claims data to better understand healthcare resource utilization patterns among Fabry disease patients Article content Three poster presentations by Komodo researchers also showcase methodological advances: Article content Komodo provides a multidimensional view of 330+ million patient journeys by linking de-identified claims data with specialty datasets, including lab results, genomics, and demographic information — through its platform to address fundamental challenges in health economics and outcomes research (HEOR). Whereas HEOR teams have traditionally relied on fragmented, incomplete datasets that provide only narrow snapshots of patients' in-network healthcare experiences, Komodo's platform enables researchers to link disparate datasets without the months typically spent on data cleaning and integration. The option to enhance disease understanding at the patient level with lab, EHR, patient insurance, race and ethnicity, and mortality data enables teams to self-serve cohort feasibility and insights. This ability accelerates study planning timelines by weeks and generates more accurate estimates of treatment patterns, healthcare resource utilization, and costs. Article content 'By closing critical data gaps and providing a patient-centric approach to HEOR, our powerful, all-in-one platform brings clean, connected, and compliant real-world data together,' Nathoo added. 'We eliminate the need for messy integrations, manual data wrangling, and coding cohorts from scratch, which enables HEOR teams to generate evidence faster. The inclusion of race, ethnicity, mortality, and other demographic insights at a near-census level also allows researchers to better model the clinical and financial impacts of new therapies across diverse populations, addressing the reality that disease burden is not borne equally across demographic groups.' Article content Article content Article content Article content Article content Contacts Article content Media Contacts: Rowena Kelley 858.255.1651 media@ Article content Article content Article content
National Post
14-05-2025
- Business
- National Post
CapeStart Helps Life Science Teams Scale Faster, Boost Productivity with New Release of MadeAi™, Award-Winning GenAI Platform
Article content MadeAi-LR solution now supports AI-aided Review, AI as Reviewer, Summary- and Arm-Level Extraction, and Built-in Quality Appraisal—cuts literature review time in half and delivers 90% accuracy Article content Article content MONTREAL & CAMBRIDGE, Mass. — At today's ISPOR Montreal 2025 Conference, CapeStart, Inc. announced a major new release of MadeAi™—its award-winning generative AI-based platform that expedites the synthesis of content and data for the life sciences, helping time-strapped teams to scale faster, strengthen regulatory submissions, and advance the pace of scientific research. Article content MadeAi first launched in November of 2024 with MadeAi-LR, a GenAI-enabled software solution leveraging the MadeAi platform to streamline key applications used in new therapy development including systematic literature reviews (SLR), clinical evidence reports (CERs), meta-analysis, targeted literature reviews (TLRs), and other clinical literature assessments. MadeAi-LR cuts literature review time in half while centralizing the process with an end-to-end platform, delivering 90% accuracy, and providing sourcing and attribution along the way for verifiable, traceable, and trustworthy results. Article content MadeAi's new release introduces advanced features for more complex literature review execution and content synthesis, including: Article content Support for AI-aided Review and AI as Reviewer capabilities for both Title & Abstract Screening and Full-text Screening. For the AI-aided Review mode, AI-generated suggestions are shared with two blinded human reviewers to facilitate faster, more informed decisions. For the AI as Reviewer mode, one human reviewer works in parallel with the AI, which serves as the second reviewer—reducing manual workload without compromising review quality. Expanded and customizable Screening model, offering more than a dozen screening criteria including PICOS. In addition, user-defined criteria are also supported to accommodate projects with novel screening needs. More dynamic Extraction, providing a Summary-level Extraction and an Arm-level Extraction. Summary-level Extraction is ideal for internal desk research, offering a consolidated view of key information from each study. For more detailed insights, Arm-level Extraction provides a granular breakdown of outcomes across different study groups, showing the user the origin of the extracted content, making reviewing and editing fast and efficient. AI Agent-Enhanced Extraction, enabling the ability to extract information from text, tables, graphs, and figures. Quality Appraisal built into the MadeAi workflow, allowing users to assess the risk-of-bias for included articles and visualize the results through intuitive tables and charts. Article content Developed with top 15 pharmaceutical companies, MadeAi-LR centralizes the literature review workflow, while bringing full sourcing attribution and transparency into research decision considerations. It frees teams to focus on higher-value work while driving greater productivity, stronger regulatory submissions, sharper internal strategies, and deeper research. With a single review demanding hundreds of onerous hours, MadeAi-LR helps pharma, biotech, and medtech organizations save time, stretch critical resources, and scale research to accelerate innovation. Article content 'MadeAi-LR customers are completing more literature reviews in less time and seeing immediate ROI, and they're eager for us to evolve our platform to address their more complex research needs,' said Gaugarin Oliver, founder and CEO of CapeStart. 'Our latest release offers enhancements that allow the GenAI to support more dynamic aspects of literature review research—including AI as Reviewer, Arm-level Extraction, and Quality Appraisals, among other improvements—so teams can scale faster and focus on what matters most: advancing science.' Article content Since MadeAi's launch in 2024, the platform has been recognized for AI excellence in life sciences several times over. It received a Stevie® award in the 21st Annual International Business Awards® program, where it was recognized as an innovative Artificial Intelligence/Machine Learning Solution in Healthcare within the Business Technology category. The platform was also named a PM360 2024 Innovator in the Generative AI Category. And most recently, MadeAi was named a winner of the 2025 Artificial Intelligence Excellence Awards, presented by the Business Intelligence Group. Article content Article content Article content Article content Article content Contacts Article content Media Contacts: Meghan Oates-Zalesky Chief Marketing Officer for CapeStart 617-435-2470 Article content Article content
National Post
13-05-2025
- Health
- National Post
Tempus Announces Six Posters Accepted for Presentation at ISPOR 2025
Article content CHICAGO — Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, has announced the presentation of six posters, including one oral presentation, at the 2025 annual meeting of the Professional Society for Health Economics and Outcomes Research (ISPOR), taking place May 13-16 in Montreal, Canada. Tempus researchers are showcasing scientific and clinical studies highlighting the impact of AI and real-world data on health economics and outcomes research. Article content Article content 'The research we're presenting at ISPOR 2025 underscores the powerful potential of integrating clinical, molecular, and claims data to unlock actionable insights that drive more personalized and effective cancer care,' said Emilie Scherrer, Senior Director and Head of Outcomes Research, at Tempus. 'At Tempus, we share ISPOR's deep focus on empowering providers and health systems with the real-world data they need to optimize treatment strategies and improve outcomes for their patients.' Article content Research highlights include: Article content Poster Presentation: Impact of Adverse Event Definitions on Real-World Detection of Immune-Related Adverse Events Date/Time: Thursday, May 15; 10:30 AM – 1:30 PM ET Location: Exhibit Hall 220B-E, Poster #6044 Overview: Researchers investigated the impact of varying definitions on the identification of immune-related adverse events (irAEs) in real-world data (RWD) from non-small cell lung cancer (NSCLC) patients treated with immune checkpoint blockade (ICB). The research utilized Tempus clinico-genomic data linked to Komodo Health's claims to analyze irAEs within one year of ICB treatment in patients with stage 3C+ NSCLC. Three peer-reviewed irAE definitions—differing in included irAEs, ICD-10 codes, and pre-treatment washout periods—were applied to the cohort of 4,831 patients. The overall prevalence of irAEs varied significantly across definitions: 41.0% (n=1,981) for Study A (9 irAEs), 75.4% (n=3,849) for Study B (10 irAEs), and 5.4% (n=264) for Study C (3 irAEs). This study demonstrates that irAE identification in RWD varies based on the definitions used, which can affect post-market surveillance, clinical practice guidelines, and patient care. The authors emphasize the need for researchers to accurately communicate the definitions used and conduct sensitivity analyses. Article content Poster Presentation: Comparison of Demographics and Clinical Characteristics using Real World Data from Tempus Multimodal Database and SEER Cancer Registry Across 17 Solid Cancer Cohorts Date/Time: Thursday, May 15; 4:00 PM – 7:00 PM ET Location: Exhibit Hall 220B-E, Poster #6019 Overview: This study benchmarked the Tempus multimodal database — a real-world data source with clinical and biomarker data from cancer patients — against the SEER cancer registry. Analyzing data from 63,520 patients with solid tumors diagnosed between 2016 and 2021, researchers compared baseline demographic, clinical, and treatment characteristics against the SEER database. The proportion of cancer types of new cancer cases were similar among the two databases. The Tempus database showed a larger representation of patients from the Midwest, whereas the SEER database had a heavy representation from the West. Tempus patients were younger on average but had more advanced cancer staging. Additionally, the Tempus database had more racial diversity based on self-reported race and more complete treatment data. In conclusion, the Tempus and SEER databases show general comparability in demographics and clinical characteristics, but the Tempus database provides greater treatment data granularity and captures more late-stage disease, attributable to sequencing patterns in clinical care. Article content Poster Presentation: Assessing the Completeness of Oncology Treatment Data from Administrative Claims: A Benchmarking Study Against Abstracted EHRs Using Patient-Level Linkages Date/Time: Thursday, May 15; 4:00 PM – 7:00 PM ET Location: Exhibit Hall 220B-E, Poster #6041 Overview: This study benchmarked oncology treatment data from administrative claims against abstracted electronic health records (EHR) for 6,487 stage 4 lung adenocarcinoma patients diagnosed between 2020 and 2023. Claims data (open and closed) were linked using de-identified patient tokens, with EHR data considered the ground truth. Sensitivities and positive predictive values (PPVs) were calculated for 13 infusional and 3 oral medications. Closed claims showed greater sensitivities (50.0-95.3%) than open claims (14.3-54.8%), with infusions having higher sensitivities than orals. PPVs were high for both infusions (closed: 79.1-98.3%; open: 61.5-99.1%) and orals (closed: 84.5-94.2%; open: 91.8-96.8%). Exact matches for abstracted infusion start dates in claims ranged from 45.5-82.5% for closed claims, while 27.6-65.9% of oral start dates matched within 7 days. The team concludes that while EHR remains the gold standard, individual claims may be sufficient for identifying patients receiving specific treatments, and closed claims may be suitable for constructing comprehensive treatment journeys. Article content Poster Presentation: Integrating Next Generation Sequencing, EHR, and Claims Data to Extend Follow-Up in a Real-World Advanced Lung Adenocarcinoma Biomarker-Treatment Landscape Date/Time: Friday, May 16; 9:00 AM – 11:30 AM ET Location: Exhibit Hall 220B-E, Poster #6046 Overview: The research team explored the use of closed claims data to enhance electronic health record (EHR)-derived treatment histories for stage 4 lung adenocarcinoma patients with comprehensive genomic profiling (CGP) and a diagnosis between 2020 and 2023. By linking closed claims data to EHRs, researchers extended abstracted lines of therapy (LOTs), defining new LOTs based on treatment gaps, persistent treatments, and follow-up duration. Integrating claims data increased the number of patients in LOT1, LOT2, and LOT3 and extended LOTs previously lost to follow-up. The integrated LOTs reflected NCCN guidelines, with EGFR inhibitors frequently used in EGFR-mutated patients and immunotherapy and KRAS inhibitors used in KRAS p.G12C patients. The study concludes that using closed claims to extend EHR-abstracted treatment data is valuable for real-world treatment pattern and outcome analyses. Article content Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world's largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit Article content This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the 'Securities Act'), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus' industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the quality of Tempus' research and publications; the contributions of Tempus' research and findings to the larger scientific community and the use of Tempus' products and services to advance clinical care for patients. In some cases, you can identify forward-looking statements because they contain words such as 'anticipate,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'going to,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' or 'would' or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release. Article content You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus' business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: the intended use of Tempus' products and services; Tempus' financial performance; the ability to attract and retain customers and partners; managing Tempus' growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus' intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled 'Risk Factors' in Tempus' Quarterly Report on Form 10-Q for the fiscal quarter ending February 24, 2025 filed with the Securities and Exchange Commission ('SEC') as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. Article content Article content Article content Article content Article content Article content
National Post
13-05-2025
- Business
- National Post
Nuvation Bio to Present Matching-adjusted Indirect Comparison Data for Taletrectinib vs. Entrectinib at ISPOR 2025
Article content NEW YORK — Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus entrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented in a poster session at ISPOR 2025, the Professional Society for Health Economics and Outcomes Research's annual conference, taking place May 13-16, 2025 in Montreal, QC, Canada. Article content Article content Presentation Overview: Article content Title: Taletrectinib vs Entrectinib in ROS1-Positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC): A Matching-Adjusted Indirect Comparison (MAIC) Presenter: Misako Nagasaka, M.D., Ph.D., Associate Professor – Division of Hematology and Oncology, UCI School of Medicine Date: Wednesday, May 14 Session Time: 10:30 a.m. – 1:30 p.m. ET Session: Poster Session 1 Presentation Number: CO151 Article content The materials will be made available in the Publications section of Nuvation Bio's website after the presentation. Article content About Taletrectinib Article content Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study. Article content Based on results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted and granted Priority Review to Nuvation Bio's NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China's NMPA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Article content About Nuvation Bio Article content Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib, a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor for glioma; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Article content Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). Article content Article content Article content Contacts Article content Article content
