Thirteen years of experience in oncology translational science from pre-clinical stage to Phase 2 clinical trials designing & implementing biomarker strategies, translational data generation, preclinical and clinical assay troubleshooting, pharmacokinetic & pharmacodynamic analysis, and in vitro and in vivo models for drug discoverySupports Boudicca Dx. clients with preclinical research, translational research and early clinical biomarker development; review plans, reports, and manage project deliverablesSupports Boudicca Dx. clients with set up of exploratory research laboratories testing human clinical trials that comply with relevant GLP & GCP regulations (Biopharma internal laboratories, IVD developers, & clinical laboratories); provide all compliance documentation. Successfully set up all required compliance infrastructure for Biopharma to bring ADA screening in-house in 30 days!Supports Boudicca Dx. with Research Use Only (RUO) labeling reviews to ensure regulatory compliance & mitigate receiving FDA warning lettersSupports Boudicca Dx. clients with developing early stage patient selection/eligibility assays; successfully supported 4 immunohistochemistry (IHC)-based clinical trial assays & support analysis for cut-off decision (using prevalence & preclinical data)Supports Boudicca Dx. CLIA laboratory clients with Final FDA LDT rule; evaluate analytical validation reports, identify gaps & provide recommendations for alternative FDA-authorized reagents & instruments if availableSupports Boudicca Dx. audits of clinical laboratories & IVD companies; review all technical documentationDeployed to Boudicca Dx. client’s global laboratories to set up new biomarker testing; technical expertise includes: animal-based techniques (long term voting member of Institutional Animal Care & Use Committee (IACUC) committee member), PD & PK assays, molecular biology & cell-based techniques, purified protein-based techniques, and immunohistochemistry

Research Data analysis, CRO coordinating, novel in vivo and in vitro training and test development.

Product Development and optimization, in vivo and in vitro assays

Involved in designing and testing of novel gene therapy methods on research and development projects including high throughput oncology testing, and small animal surgical procedures. Responsible for training of junior colleagues in areas such as in vivo and in vitro based assays.

Clinical Trials - ClinicalDesigning and writing clinical SOP’s for multiple oncology clinical trials. Involved in tissue collection processing and testing as a part of clinical trials frameworks. Next generation sequencing (NGS)- based detection and interpreting results of homologous recombination deficient (HRD) and immunotherapy (PD1) resistant markers.Drug Discovery Project - ResearchOverseeing multiple precision oncology research projects pertaining to melanoma, ovarian, breast, colorectal, lung, and pancreatic cancers from conception to the final result: personally involved in basic science hypothesis design, in vitro and in vivo experiments, and clinical trial concept implementation. Discovering novel drug combinations and drug repurposing through combining the following approaches: high throughput drug screening, in vitro assays, tumor and ctDNA sequencing, as well as in vivo pharmacological studies. Designed and conducted large scale rodent studies to confirm high-throughput drug testing results. Precision Oncology Project - ClinicalDesigning clinical precision oncology initiatives and serving as a key liaison between clinicians and research center. Guiding clinical coordinators to conduct clinical studies, determining collection time points and patient selection (inclusion/exclusion criteria). Presenting results of precision oncology projects to multiple tumor boards. Personally processed samples and created reports for clinicians to aid in precision oncology, as well as trained and supervised personnel in the developed by me workflow.Liquid Biopsy Screening Project - ClinicalInstituted a circulating tumor DNA (ctDNA) monitoring program across multiple medical oncology groups. COVID-19 Screening Project- ClinicalEstablished testing methodology, and conducted and managed the anti-SARS-CoV-2 antibody surveillance program for Sutter Health hospital physicians of high-risk group for COVID-19 exposure. Generating and reporting test results.

Successfully developed and tested novel nanoparticle-based gene therapy systems utilizing in vivo and in vitro assays. Pioneered novel drug delivery systems (packaging) to target various tissues and cancer types.

Conception of original hypotheses, carrying out multiple independent projects, design of experiments, data analysis, presenting data, literature analysis, and preparation of manuscripts for publication. Discovered the role of NEDD9 in protecting AURKA from targeted inhibitors and developed a rational for screening patients for AURKA inhibition susceptibility.

Oversaw in the day to day running of the lab (inventory, ordering, ect.). Organized mouse colony management and assisted in experiments that led to publications. Investigated the role of MTG family of transcription factor proteins and translocation proteins which lead to leukemogenesis.

Student researcher in Elaine Sanders-Bush lab characterizing pharmacological profile of serotonin SNP's. Profiling of serotonin receptor 5HT-2A single nucleotide polymorphisms effect on pharmacodynamics and pharmacokinetics of various compounds.

Student researcher in Ann Richmond's lab identifying critical chemokine and cytokine signaling pathways in melanoma angiogenesis.