UNIVERSITY OF CALIFORNIA, DAVIS

In spring 2024, UNC acquired Veeva SiteVault and eConsent as a long-term solution for eConsent and e-signatures, retiring DocuSign for human subjects research and Part 11 consenting. Veeva is the recommended system for HSR and Part 11 e-signatures, offering better user experience, oversight, and compliance. Important transition dates include January 1, 2025, for new studies, April 1, 2025, for existing studies, and June 30, 2025, for moving documents from DocuSign. Training sessions for Veeva are scheduled for December 2024 and January-March 2025.

The Sean M. Healey & AMG Center for ALS at MGH awarded the sixth annual Sean M. Healey International Prize for Innovation in ALS to Leigh Hochberg, M.D., Ph.D., and the BrainGate Consortium team for their groundbreaking Brain Computer Interfaces (BCIs) aimed at restoring communication, mobility, and independence in neurological diseases including ALS.

Meghan Rosen, a staff writer for Science News, holds a Ph.D. in biochemistry and molecular biology from UC Davis and completed a science communication program at UC Santa Cruz.

Platelets, crucial for blood clotting, face classification debates but remain lifesavers. Current platelet function assessment methods are inadequate, prompting new technologies focusing on force measurement. Innovations like Stasys Medical Corporation's platform and Mechano-Cas12a Assisted Tension Sensor (MCATS) aim to provide more precise, less invasive diagnostics, potentially revolutionizing trauma and surgical care.

A girl with Rett syndrome died after receiving Neurogene’s high-dose gene therapy, prompting the company to halt tests of that dose but continue with a lower dose. The FDA allowed the trial to proceed with the lower dose after reviewing safety data. Neurogene plans to remove the high-dose from the trial protocol and does not plan to enroll further participants in that group. The therapy aims to deliver the MECP2 gene via AAV9 vector to address Rett syndrome’s symptoms.

Agricultural science integrates technology, biotechnology, and sustainability to address global challenges like food security and climate change. Top universities for agricultural science include UC Davis, Cornell, Texas A&M, Wageningen, Florida, Purdue, and Guelph, offering diverse programs, research opportunities, and industry connections. Aspiring students should consider faculty expertise, hands-on learning, and career support when choosing a university.

Early access to investigational therapies can transform cancer treatment, offering new hope and improving outcomes. IQVIA experts discuss early development advantages, including enhanced drug effect assessments and easier comparisons to standard care, within the FDA’s Project FrontRunner. Learn about designing robust randomized controlled trials and accelerating development and patient access through innovative strategies.

UC Davis scientists identified new cell clusters in the amygdala with distinct gene expression patterns in humans and non-human primates, potentially leading to more targeted treatments for anxiety and other disorders.

Selena Ahmed, global director of the Periodic Table of Food Initiative, discusses her journey from ethnobotany to foodomics, aiming to quantify food quality and link agricultural practices to food biochemistries. She envisions a future where food systems are managed with food quality as a central parameter, benefiting both people and the planet.

Capricor Therapeutics announced positive three-year results from its HOPE-2 study for deramiocel, a treatment for Duchenne muscular dystrophy (DMD), showing sustained efficacy and safety, particularly in stabilizing cardiac and skeletal muscle function. The company plans to submit a Biologics License Application to the FDA by the end of 2024, aiming for fast-track approval. Deramiocel has received Orphan Drug Designation and is supported by the Regenerative Medicine Advanced Therapy Designation.