Industry news round-up: updates from January 2024
Discover the latest industry developments in real-world data (RWD) and real-world evidence (RWE) research from January 2024 in our regular monthly column.
FDA unveils new guidance on use of digital health technologies for remote data acquisition in clinical trials
US FDA released a new guidance document, ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’, outlining how developers and researchers can leverage DHTs to collect data remotely from participants in clinical trials.
FDA issues final guidance on data standards for drug and biological product submissions containing real-world data
New US FDA final guidance for industry on ‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data’ covers challenges and resources for applying currently supported data standards to real-world data sources.
Learn more about the various FDA resources and guidance for industry on the use of RWD and RWE to support regulatory decision-making in this infographic.
Caris Life Sciences and Flatiron Health team up to advance cancer research and care with real-world data initiative
Leveraging Caris’ genomic, transcriptomic, and imaging database with Flatiron’s patient data, they aim to accelerate personalized therapeutic interventions.
FDA finalizes guidance on using registries to generate real-world data for regulatory decision-making
The US FDA has released its finalized guidance for industry titled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products”, providing insights for sponsors proposing to design or use a registry to inform decisions about a drug’s effectiveness or safety.
Alliance for Genomic Discovery welcomes three new members, boosting real-world data-driven drug development
Illumina, Inc., a global provider of DNA sequencing and array-based technologies, and Nashville Biosciences, LLC (NashBio) have welcomed three prominent pharmaceutical companies – Bristol Myers Squibb, GSK and Novo Nordisk – to the Alliance for Genomic Discovery. This collaboration seeks to expedite drug development through extensive genomics research.
Duke-Margolis Center for Health Policy releases International Harmonization of Real-World Evidence Standards Dashboard
Duke-Margolis Center addresses the growing importance of RWE in medical product regulation with the International Harmonization of Real World Evidence Standards Dashboard. It offers a centralized, navigable tool for stakeholders to access the latest guidance from global regulatory agencies.
ConcertAI and NeoGenomics join forces to advance hematologic research through integration of real-world data and AI technologies
ConcertAI partners with NeoGenomics to advance large-scale hematologic research solutions, combining expertise in oncology RWD, RWE, and AI technology to address challenges in hematologic malignancy research.
Target RWE announces biorepository Precision Medicine Platform to advance real-world evidence in liver disease and immune-mediated inflammatory conditions in dermatology and gastroenterology
Target RWE introduces Precision Medicine Platform biorepository with 150,000+ samples from over 10,000 patients, complementing clinical registries for RWE insights into liver disease and immune-mediated inflammatory conditions in dermatology and gastroenterology.
SOPHiA GENETICS and Exactis Innovation form collaboration to progress cancer research and patient care through real-world data
SOPHiA GENETICS collaborates with Exactis Innovation, a Canadian hospital network, to advance cancer research using SOPHiA’s multimodal RWD. The partnership aims to enhance data-driven decision-making in medicine.
New Atropos–Arcadia partnership to drive value-based personalized clinical decision-making by democratizing access to bespoke real-world evidence
New Atropos–Arcadia collaboration to add Atropos on-demand personalized RWE generation to Arcadia data platform and to expand Atropos Evidence Network with Arcadia RWD.
Lynx.MD and Allied Digestive Health collaborate to advance gastroenterology research and patient care with real-world data library
Lynx.MD has expanded its gastroenterology RWD repository through a new partnership with Allied Digestive Health, a company of Assured Healthcare Partners.
ISPOR announces report of top 10 HEOR trends for 2024 with real-world evidence in pole position
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has published its much anticipated Top 10 Health Economics and Outcomes Research (HEOR) Trends Report, which provides a comprehensive overview of pivotal trends influencing global healthcare decision-making.
Komodo Health collaborates with the Robert Wood Johnson Foundation and Mathematica to propel nationwide diet-related health research with a focus on real-world evidence
Komodo Health’s new grant program, in collaboration with Robert Wood Johnson Foundation and Mathematica, will offer eight researchers access to RWD for a US-wide investigation of diet-related diseases.
The Innovative Health Initiative announces a funding call to advance evidence-based practical guidance for real-world data and real-world evidence
The Innovative Health Initiative has announced a new funding call for proposals, IHI 6, focused on RWD and RWE, which aims to address a spectrum of challenges in health research and innovation.
Atropos Health and Every Cure partner to advance the discovery and development of therapies for underserved populations leveraging real-world data
New collaboration will see Every Cure leverage Atropos Health’s RWE generation suite to confirm drug repurposing opportunities and speed their clinical development with real-world data trial emulation.
FDA announces submission deadlines for meeting opportunities within the Advancing Real-World Evidence Program
The FDA has set the first deadline of March 31, 2024 for any sponsors looking to discuss the use of RWE in medical product development under the Advancing Real-World Evidence Program.
New study raises concerns about impact of IRA drug pricing negotiations on US biopharmaceutical landscape
The study from Vital Transformation warns that expanding the drug pricing provisions of the Inflation Reduction Act (IRA) could jeopardize patient health, innovative treatments and US biopharma jobs.
WHO releases guidelines on AI ethics and governance for large multi-modal models
The World Health Organization (WHO) has introduced new guidance addressing the ethical considerations and governance of large multi-modal models (LMMs), a rapidly advancing category of generative AI being applied to a wide range of healthcare domains.
Alira Health and Sancare announce real-world data partnership to drive healthcare innovation
Alira Health and Sancare partner to create a French RWD platform integrating electronic medical records and claims with AI.
Big Data Steering Group’s 2023 report unveils eleven recommendations for real-world evidence integration
The BDSG 2023 report provides an overview of the key activities and achievements of the BDSG in 2023 and outlines 11 priority recommendations to advance the integration of RWE and big data into regulatory decision-making.
Blair Institute proposes NHS Data Trust for biotech and AI advancements in health care
The Tony Blair Institute for Global Change’s proposal for the NHS Data Trust aims to leverage anonymized NHS data for biotech and AI advancements.
FinOMOP consortium uses OMOP CDM for real-world data studies milestone
In 2020, FinOMOP began integrating Finnish medical terms into the OMOP CDM, generating interest across universities. Enhanced collaboration led to nationwide mappings, and a recent acceptance into the Darwin EU network marked a milestone for RWD studies.
New report explores real-world data trends in GLP-1 RA medications
Truveta Research’s real-world data-driven GLP-1 RA monitoring report shows consistent prescribing patterns, highlighting early tirzepatide adoption for obesity amid access challenges and increasing medication popularity.
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NICE conditionally approves wearable devices for remote Parkinson’s disease monitoring
The National Institute for Health and Care Excellence (NICE) has conditionally approved five wearable devices for remote monitoring of Parkinson’s disease, enabling the collection of RWD by the NHS.
Atropos Health and Google Cloud collaborate to optimize healthcare innovation with GENEVA™ OS integration for real-world evidence
Atropos Health integrates GENEVA™ OS with Google Cloud’s healthcare solutions, including the Healthcare Data Engine and BigQuery, streamlining raw data conversion into valuable insights.
