UNIVERSITY OF CALIFORNIA, DAVIS

Hispanic and Latino people make up 20% of the U.S. population but only 6% of physicians. A panel discussion highlighted the need for more Latino physicians, the importance of trust and language concordance in clinical trials, and the diverse backgrounds within the Latino community. Efforts to educate and support Latino clinicians and researchers are crucial for health equity.

Micro-Tracers' SECURtracers, ethyl cellulose-based particles for drug authentication, await FDA approval as a new excipient. The technology, already ISO 9001:2015 and EXCIPACT accredited, has potential applications beyond pharmaceuticals, including animal feeds. Research collaborations and in vivo studies are ongoing to validate safety and efficacy. Micro-Tracers seeks partnerships with pharmaceutical manufacturers for large-scale trials, offering incentives to be the first to adopt SECURtracers, aiming to combat counterfeit drugs and enhance pharmaceutical security.

UC Davis researchers used AAV vectors to deliver CRISPR-Cas9 targeting VEGFA, showing promise in reducing VEGF levels and CNV severity but also causing retinal toxicity at high AAV doses. The study highlights the potential of CRISPR for long-term VEGF suppression but emphasizes the need to optimize AAV delivery to minimize damage.

FDA reasserts authority over regenerative medicine as stem cell clinics boom, despite unproven therapies causing infections, disabilities, and deaths. A 2018 lawsuit against California Stem Cell Treatment Center Inc. for unapproved products was upheld, strengthening FDA oversight. Clinics marketed treatments for various conditions, costing tens of thousands of dollars out of pocket. FDA regulates stem cell therapies as drugs, requiring agency approval before use on patients.

A court ruling allows FDA to regulate stem cell clinics offering unproven treatments, reasserting federal authority over regenerative medicine.

Air pollution, even at safe levels, affects children's brain development, potentially leading to cognitive issues and early Alzheimer's markers. Researchers recommend air filters in homes and schools near pollution sources.

A parallel 2-arm, hybrid type 1 cluster randomized controlled trial compares ESDM and EBI interventions for autism, recruiting 20 CBAs, 20 regional managers, 100 Regional Teams, and 300 child/caregiver dyads. Regions are randomized to ESDM or EBI to prevent contamination, with constrained randomization considering insurance mix and size. ESDM focuses on embedded teaching objectives within play, using developmental and ABA principles, while EBI primarily uses Discrete Trial Teaching. Caregiver involvement is integral, with ESDM providers trained in caregiver coaching strategies. The study aims to assess child social communication and language, adaptive behavior, quality of life, and caregiver competence, with mechanisms including social motivation and caregiver NDBI fidelity. Video data collection and coding ensure observational outcomes are assessed reliably. The trial employs mixed-effects modeling to analyze clustered data, with power analyses indicating sufficient sample size to detect significant improvements in social communication and language.

Erica Ollmann Saphire's $49 million project, America’s SHIELD, aims to develop vaccines for herpesviruses, addressing viral latency and multiple infection mechanisms. The initiative involves a consortium of researchers to tackle the complexity of herpesviruses, focusing on molecular structures, viral genomes, and immune signatures, with potential to significantly impact public health.

Ferring presented Phase 3 data for SI-6603 (condoliase) at NASS 2024, showing significant leg pain improvement vs. sham at Week 13 in U.S. and Japan trials. The pivotal U.S. study results were published in The Spine Journal.

Synedgen appoints Dr. Hal J. Oien to its board of directors, leveraging his extensive entrepreneurial experience and expertise in product development and commercialization.