Latest news with #realworldevidence
Associated Press
23-06-2025
- Health
- Associated Press
3Aware Announces Formation of Scientific Advisory Board
INDIANAPOLIS, INDIANA / ACCESS Newswire / June 23, 2025 / 3Aware, a leading innovator in real-world evidence (RWE) solutions for the medical device industry, today announced the formation of its Scientific Advisory Board. The Board will advise on clinical, regulatory, and scientific strategy to support the company's work in RWE for medical devices. The Board's inaugural members are Dr. Bassil Akra, Dr. Philippe Auclair, and Dr. Trevor Carden. Dr. Akra will serve as Chair of the Scientific Advisory Board. Bassil Akra, PhD, is the CEO of AKRA TEAM GmbH, a medical device consulting firm he founded in 2021. He is a leading expert on European medical device regulations, having helped shape the implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Dr. Akra previously served as Vice President of Strategic Business Development at TÜV SÜD, where he guided regulatory compliance and clinical strategy for medical device approvals. Philippe Auclair, PharmD, PhD, is Former Senior Director of Regulatory Strategy and Advocacy at Abbott. He has over 30 years of experience in the pharmaceutical and medical device industries, with a focus on global regulatory policy and post-market surveillance. Dr. Auclair chairs MedTech Europe's working groups on post-market surveillance and Notified Bodies, and he has been recognized as a Fellow of the Regulatory Affairs Professionals Society (RAPS) for his contributions to regulatory science. Trevor Carden, PhD, is Director of Scientific Affairs at Teleflex, where he leads the scientific and technical strategies for clinical evidence generation across a diverse medical device portfolio. With a PhD in genetics, genomics, and bioinformatics, Dr. Carden focuses on regulatory compliance and optimizing clinical evaluation processes. 'We are thrilled to welcome such esteemed experts to our Scientific Advisory Board,' said Amelia Hufford, PhD, Senior Vice President of Clinical & Regulatory Science at 3Aware. 'Their combined expertise in clinical research and regulatory policy will help ensure our real-world evidence initiatives meet the highest standards of scientific rigor and compliance.' 'This board's formation underscores 3Aware's commitment to delivering best-in-class solutions,' said Kyle Howes, Vice President of Sales at 3Aware. 'By engaging these industry leaders, we ensure our RWE platform continues to deliver exceptional value and instill confidence in our clients.' 'I am honored to join 3Aware's Scientific Advisory Board,' said Dr. Bassil Akra. 'Real-world evidence is increasingly critical for advancing medical device innovation and patient safety. I look forward to working with the 3Aware team to maximize the impact of RWE for device manufacturers.' Contact InformationPhil Stoltzfus VP of Marketing & Public Relations SOURCE: 3Aware press release
National Post
08-05-2025
- Health
- National Post
OM1 to Present Groundbreaking Research on GLP-1 Agonists and Suicidal Ideation at ISPOR 2025
Article content Article content What: OM1, the leader in real-world data and AI-driven insights in mental health for life sciences, announced an upcoming poster presentation hosted by Jessica Probst, OM1's Principal, Real World Evidence. The poster focuses on the linkage between Glucagon-like Peptide 1 Receptor Agonists (GLP-1s) and Suicidal Ideation (SI). Consistent with other findings and despite warnings on the label, there was no significant increase in SI prevalence after GLP-1 initiation. Article content When: The poster session will be held at ISPOR 2025 on Wednesday, May 14, from 4:00 – 7:00 PM, with a discussion period from 6:00 – 7:00 PM. Article content Key Findings: Amid growing scrutiny of GLP-1 receptor agonists (used in diabetes and obesity), OM1's real-world study finds no significant change in suicidal ideation (SI) following treatment initiation across both therapeutic populations. Article content Why It Matters: GLP-1s indicated for obesity feature a package label warning for suicidal ideation, whereas those indicated for diabetes do not. This research adds to the growing body of evidence exploring whether this warning may present an unnecessary obstacle to treatment and a potential barrier to equitable access to healthcare for a long stigmatized population. Article content Suicidal ideation is often undercoded or missing entirely in claims-based datasets. By applying natural language processing (NLP) to unstructured clinician notes, OM1's study captures a richer, more nuanced view of patient mental health. This study reinforces the role of AI and real-world data (RWD) in advancing pharmacovigilance and public health safety. Article content About OM1: OM1 is pioneering cutting-edge healthcare innovation through its insights-driven technology and data. It specializes in personalized medicine, evidence generation, and real-world evidence (RWE) research powered by next-generation AI platforms, deep longitudinal data, and globally recognized thought leadership. OM1 is led by a diverse group of scientists, engineers, researchers, and clinicians with over 30 years of experience in RWE. Article content Article content Article content Article content Article content Contacts Article content Article content
