Northwestern University Human Resources

Survey of 64 FDA device panel members reveals 46% find pivotal trials well-designed, 89% suggest preemptive consultation on trial design, and 87% recommend an executive session for more honest deliberations. These findings indicate potential improvements in the FDA premarket approval process by increasing panelist involvement.

Shower heads and toothbrushes harbor diverse, previously unseen viruses, mostly bacteriophage targeting bacteria, potentially useful against antibiotic-resistant germs. Each sample is unique, highlighting viral diversity. Mycobacteriophage, infecting dangerous mycobacteria, show promise for pathogen control. Regular cleaning and toothbrush replacement advised, avoiding antimicrobial products to prevent resistance.

Amphix Bio receives FDA Breakthrough Device designation for a bone regeneration product to treat degenerative disc disease with TLIF procedures, offering advantages over current TLIF products.

ARPA-H awarded $34.9 million to Rice University for developing ROGUE, a bioelectronic implant to improve type 2 diabetes treatment adherence. ROGUE, named Rx On-site Generation Using Electronics, will house cells producing T2D and obesity therapies based on patient needs. The device aims to transform biologics delivery and is designed for weekly recharging via a wearable.

Rice University leads a multiuniversity team awarded $34.9 million by ARPA-H to develop ROGUE, a bioelectronic implant for obesity and type 2 diabetes treatment, aiming to reduce costs and improve adherence. ROGUE functions as a 'living pharmacy,' producing biologics on demand, and is rechargeable via a wearable device, designed for outpatient deployment. The project, backed by over $100 million from ARPA-H and DARPA, includes collaborations with Carnegie Mellon, Northwestern, and other institutions, focusing on clinical translation and commercialization.

Dr. Lu Tian, ScD '02, to receive the 2024 Lagakos Distinguished Alumni Award for contributions in biostatistics, precision medicine, and teaching at Stanford.

Scientists have made breakthroughs in regrowing damaged neural connections, leading to promising clinical trials for spinal cord injury patients. However, recent tax law and patent regulation changes threaten to derail these treatments, potentially stifling medical innovation. A bipartisan bill aims to repeal harmful Section 174 changes, emphasizing the need for policies that support innovation.

Calidi Biotherapeutics' CLD-101, an allogeneic immunotherapy using neural stem cells to deliver engineered oncolytic adenoviruses, received FDA clearance for a Phase 1b/2 trial in newly diagnosed high-grade glioma patients. The trial, expected to start in late 2024, aims to assess safety and feasibility of multiple doses. Previous Phase 1 results showed feasibility and safety, with median progression-free survival of 9.05 months and overall survival of 18.4 months.