NATIONAL INSTITUTES OF HEALTH

UCSD researchers developed nanopillars breaching cell nuclei without harming outer membranes, potentially revolutionizing gene therapy and drug delivery.

Rhenium (186Re) Obisbemeda delivered via CED shows safety, response, and potential efficacy in treating recurrent glioblastoma. Mean Phase 2 absorbed dose was 300 Gy, with 89% of patients exceeding the 100 Gy threshold. The ReSPECT-GBM Phase 1/2 trial has expanded to two new U.S. sites.

Oregon State University researchers, funded by a $1.2 million NIH grant, aim to develop a personalized medicine device for epilepsy patients using saliva analysis and AI to optimize anti-seizure drug dosing.

Abridge launches research collaborative with Epic, Stanford to study AI's impact on clinician experience, patient experience, healthcare costs, outcomes, and health equity. Epic faces antitrust lawsuit from Particle Health over data market dominance. Micky Tripathi, federal health IT official, oversees HHS's AI strategy and data standards. Stanford's James Zou discusses limited reimbursement for FDA-authorized AI medical devices. MedStar's Raj Ratwani proposes a certification process for AI systems with local testing support. Pitchbook report indicates generative AI's limited impact in clinical trials due to regulatory hurdles. Senate Dems introduce Health Infrastructure Security and Accountability Act to set minimum cyber standards for healthcare entities.

The All of Us Research Program aims to gather data from over 1 million diverse participants to create a database considering individual differences in genes, environment, and lifestyle. The program prioritizes underrepresented communities and seeks to accelerate precision medical treatments. With over 832,000 participants, 87% from underrepresented groups, the program emphasizes collaboration and engagement with participants as research partners.

Black patients' distrust in clinical research, influenced by spiritual beliefs and historical mistreatment, contributes to underrepresentation in cancer trials. Researchers suggest addressing these factors to improve recruitment and ensure trials reflect diverse populations.

The NRG-HN005 phase II/III trial failed to meet non-inferiority criteria for p16+ oropharyngeal cancer patients, affirming traditional chemoradiation's effectiveness. The study compared standard IMRT and cisplatin to lower dose IMRT with cisplatin or nivolumab, but interim futility analysis showed the control arm's 2-year PFS rate of 98.1% was too high for experimental arms to be deemed non-inferior.

Tonix Pharmaceuticals CEO, Dr. Seth Lederman, participated in the 'RECOVER Treating Long COVID (TLC) - Navigating the Pathway Forward' workshop, discussing clinical trial endpoints for Long COVID therapeutics. Lederman highlighted the potential of Patient Global Impression of Change (PGIC) as a primary endpoint for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID, drawing parallels to Progression-Free Survival (PFS) in cancer drug development.