Shanni Yamaki

Led preclinical and translational development of a CNS-targeted immunotherapeutic, advancing a lead asset toward pre-IND/IND submission while evaluating neuropsychiatric and neurodegenerative indication expansion opportunities, including bipolar disorder, schizophrenia, major depressive disorder, Alzheimer’s disease, dementia, and Parkinson’s disease. Developed and validated FDA-aligned ELISA biomarker assays for clinical diagnostic deployment, establishing decision thresholds that enabled quantitative resolution beyond existing reference methods. Transitioned assays to an external diagnostic development partner to support CAP/CLIA certification for patient stratification and indication expansion. Established and scaled disease pathology and mechanism-of-action assays, including receptor internalization flow cytometry and calcium fluorimetry, directly driving lead candidate advancement. Deployed assays in high-throughput formats, implementing automated 384-well ELISA workflows alongside 96-well cell-based platforms to accelerate candidate evaluation and translational decision-making. Built and led an in vitro translational assay development and screening team (three direct reports), aligning scientific priorities with evolving program timelines to deliver data-driven decisions supporting indication expansion. Evaluated BBB-penetrant drug candidates using cell-based efficacy assays and supported in vivo BBB PK/PD studies through external CROs. Served as primary scientific liaison for CROs, vendors, and consultants, defining scopes of work, reviewing protocols, managing test articles, and resolving execution and logistical challenges across discovery, translational, and IND-enabling activities. Authored study reports and contributed to regulatory documentation (pre-IND/IND), intellectual property filings, abstracts, and peer-reviewed publications.

Arialys is a clinical stage CNS company focused on how the immune system impacts CNS health, disease and treatment. New data confirm that the CNS is not immune privileged and that B-cells, T-cells and antibodies are all present with significant activity which can at times lead to disease. Our challenge is to characterize the nature and prevalence of pathogenic auto-antibody activity in the CNS and pioneer novel methods of inhibition. Armed with the very latest insights from the burgeoning field of autoimmune neurology, we look forward to advancing breakthrough therapies for a variety of CNS disorders which have plagued mankind for millennia. Founding scientist responsible for establishing preclinical discovery and translational research capabilities for a CNS-targeted immunotherapeutic program. Led the scientific transfer of lead asset ART5803 from Astellas Pharma, integrating transferred materials, datasets, and methodologies while adapting external learnings into internal discovery and translational workflows. Built and operationalized a discovery laboratory from the ground up, including infrastructure setup, equipment selection and qualification, assay readiness, and implementation of standardized laboratory practices to support early-stage drug discovery and translational research. Developed and optimized foundational disease pathology and mechanism-of-action cell-based assays, including receptor internalization flow cytometry and calcium fluorimetry, establishing the experimental backbone used to advance the lead drug candidate. Implemented initial high-throughput screening capabilities, deploying 96-well cell-based and 384-well ELISA workflows to enable early candidate evaluation and prioritization. Supported early biomarker discovery efforts and assisted with assay development activities that informed downstream translational strategy. Contributed to internal study reports, scientific documentation, and early regulatory-supporting materials.

Scientific lead for the transfer of ART5803 (anti-NMDAR encephalitis therapeutic) from Astellas Pharma to Arialys Therapeutics. Acted as the primary liaison to guarantee uninterrupted research continuity, equipping Arialys with essential materials, critical methodologies, and program knowledge needed to progress the program. Contributed to early biomarker identification efforts in immune mediated CNS disorders.

My research focused on the molecular mechanisms of somatosensation, the process by which external sensory information is interpreted differentially as painful or non painful by the body. Understanding the role of these somatosensory ion channels involved in peripheral sensitization under injury or disease states (ex. inflammation, diabetes, chemotherapy induced neuropathy) will lead to better development of drugs to alleviate these pain symptoms in a multitude of medical conditions. -Developed an invivo study to distinguish the role of TRPA1 in promoting neurogenic inflammation induced cold pain (Yamaki et al., PAIN, 2021 and Yang et al., Journal of Neuroscience, 2023). -Utilized single cell RNA-seq databases to identify genes involved in cold pain pathways. -Conducted biopanning and cellular assays to identify TRPM8, NaV 1.7, and Artemin antibody candidates. Tested antibody candidate invivo efficacy inhibiting inflammatory cold allodynia in collaboration with Dr. Myron Goodman at the University of Southern California (Jeong et al., Nucleic Acids Research, 2022). -Investigated the role of gut microbiota in chemotherapy induced peripheral neuropathy (CIPN)(Ramakrishna, et al., Scientific Reports, 2019).

Teaching assistant for BISC 407: Cellular and Molecular Neuroscience. Designed and taught discussion course materials.

Assisted Genetics Lab students in understanding lab procedures and techniques.

Tutored students in general biology and genetics class material.

Assisted Lab Coordinator in preparing lab materials, lab set up, maintaining lab equipment and supplies.

Under Dr. Frank Percival conducted research on characterizing the microbial communities (bacterial and fungal) on Carpinteria salt marsh plants through next generation sequencing and environmental chemical analysis.