Ashlyn Buzzelli, Ph.D. Email and Phone Number

• Assists in the development of clinical study design and authoring of study protocols.• Interacts with sponsor to determine the format, design, and direction of clinical/statistical reports.• Leads clinical feasibility efforts, including scientific development of protocol synopsis in collaboration with key opinion leaders from the sponsor as well as key investigators.• Summarizes animal and clinical studies and drew conclusions as to the potential safety of the drug under study.• Writes and edits documents to support regulatory submissions including, but not limited to, clinical trial authorizations (INDs, CTAs) and marketing authorization applications (NDAs, BLAs).• Leads document review coordination for regulatory submissions, including a 505(b)(1) submission, monitoring timelines and availability of expert and quality control reviewers.• Interacts with the product sponsor and designated authors to determine the content and direction of scientific publications.• Ensures compliance with the SOPs for publication development.• Maintains a current working knowledge of the guidelines and requirements of regulatory activities and ICH Guideline for reference in the development of required documents.

Research: (1) Planning and execution of experiments to elucidate the role of the histone demethylase ubiquitously transcribed tetratricopeptide repeat (UTX) during persistent antigen stimulation. (2) Utilizing novel murine strains to identify how CD4+ T cell intrinsic expression of UTX is critical to drive peripheral neuropathy. • Techniques utilized: PCR, infection with acute and chronic lymphocytic choriomeningitis virus (LCMV) strains, monitoring and assessing mice high blood sugar and peripheral neuropathy, Flow Cytometry, plaque assays, and mouse colony maintenance. • Murine work included: Tamoxifen-inducible deletion systems, adoptive cell transfer and, immune checkpoint blockade during chronic infection. Administration and analysis of melanoma tumors, and isolation and analysis of blood, spleen, liver, lung, kidney, and sciatic nerve. Downstream analyses included assessment of CD4+ and CD8+ T cell populations via Flow Cytometry and quantification of viral burden.

Research: (1) Completed a variety of in vitro, in vivo, and genomic experiments to understand how STAT4 influenced Th17 pathogenicity. (2) Investigated how a sialic acid contributed to CD4+ stem-like properties during intestinal autoimmunity. • Techniques utilized: Western blot, PCR and qPCR, tissue culture, cell purification, CD4+ T cell differentiation, ELISA, Flow Cytometry, bulk and single-cell RNA sequencing, Nanostring, cell purification, and mouse colony maintenance. • Murine work included: A variety of cytokine reporter mice for adoptive cell transfer and analyses, induced Experimental Autoimmune Encephalomyelitis and Colitis. Downstream analyses included preparing samples for histology or sequencing and assessing phenotype and function of CD4+ T cells in different mouse tissues including the brain, spinal cord, and colon. • Mentored and trained undergraduate students in the laboratory in a variety of techniques such as Flow Cytometry, mouse colony maintenance, western blot, and tissue culture.

Research: Planned and executed in vitro experiments to provide insights into the process of CD4 effector subset differentiation.• Techniques included: PCR, promoter-reporter, and coding sequencing cloning, point mutagenesis, western blot analysis, and gene-reporter luciferase assay.