University Of Massachusetts Medical School

The Institutional Biosafety Committee (IBC) meeting focused on reviewing past incidents, administratively reviewing several protocols, and discussing a set of protocols requiring full committee discussion. Past incidents reported included a BSL-3 PAPR incident and several needlestick incidents in BSL-3 settings, one involving a researcher working with HIV infected cells, and another involving potential TB exposure. Administratively reviewed protocols included updates to studies involving renal biobanking, inflammation in metabolic and neuronal disease, autoimmune uveitis, and bacterial DNA extraction for sequencing. Protocols discussed included amendments for lentiviral vector use in murine melanoma cell lines (with broader cell line approval sought), renewal of a protocol for expressing recombinant monoclonal antibodies, renewal of a genome-wide evaluation of allelic effects using various human cell lines and viruses, an amendment to a hind limb ischemia study involving AAV vectors, a new protocol for an AAV-mediated gene therapy for myotonic dystrophy type 1, a renewal for studying the role of Rip1 in TNF transduction and leukemogenesis using engineered mouse models and gene editing, a new protocol establishing capability for Plasmid DNA manufacturing, and a previously tabled protocol on the development of RNAi-based therapeutics which was tabled again due to collaboration clarity issues. Additionally, updates were given on BSL-3 facility decommissioning and design planning, and general biosafety matters such as training requirements and facility inspection results.

The committee reviewed reports on incidents/accidents from Employee Health Services, noting 19 total events for the year, an improvement from the previous year. Administrative reviews were conducted for protocols concerning large-scale production of Recombinant Adeno-Associated Viral Vector, the clinical trial Alexion IGAN-320 evaluating ravulizumab for IgA nephropathy, and research on immune regulation in intestinal physiology. Protocols discussed included renewals for projects on Epigenetic Plasticity and Tumor Initiation and Progression, Toll Receptors in Health and Disease, Multiple Sclerosis Center Research Specimen Processing Lab operations, pharmacokinetics of therapies for retinal degeneration, complement activation in relation to mucosal pathogens (combining two protocols), the role of Transposable Elements in physiological processes, and the neurobiology of stress reward interactions (amendment for adding canine adenoviral vectors). Several protocols were approved contingent upon completion of action items.

The UMass Center for Clinical and Translational Science (UMCCTS) presents its vision and overarching goals aimed at improving health and healthcare delivery. Key strategic pillars include advancing the science of translation, catalyzing high-quality research across the translational spectrum, and building a robust translational workforce. The plan focuses on speeding the development of new products and approaches to advance patient care and community health, and training the next generation of leaders in clinical and translational research, supported by extensive collaboration, funding, research efficiency services, workforce development, and core resources.

The UMass Center for Clinical and Translational Science (UMCCTS) outlines its strategic direction to improve health and healthcare delivery. Its vision focuses on advancing the science of translation, catalyzing high-quality research, and building a robust translational workforce. Overarching goals include speeding the development of new products for patient care and community health, and training the next generation of leaders in clinical and translational research. The plan emphasizes collaboration, community engagement, funding, research quality and efficiency, workforce development, and core resources.

The meeting addressed completed action items and submissions under review. Discussions included the DURC/PEPP policy go-live, IBC Minutes public posting go-live, and reports on incidents from Employee Health Services. The committee reviewed and discussed several protocols, including studies on neural markers of infant social engagement, modeling of cerebral emboli, diabetic foot ulcers, cell cycle control, microbiota modulation, and muscular dystrophy. Additional topics covered disorders of white blood cell, regulation of yeast DNA replication, tumor suppressor proteins, immune response of B and T Cells, and immune responses to viral infections. The committee also discussed issues involving BSL-3 & ABSL-3 Facilities.