Rosemary Cesario

HUYA Bioscience works on a virtual biotech platform; my responsibilities focus on contributing to the design, execution and support of immune-oncology related preclinical pharmacology studies, nonclinical development, and translational studies, as well as activities supporting the advancement of lead clinical candidates in the field of oncology. • Design experiments, oversee execution, review and approve data and reports generated at CROs • Develop operational plans including MSA, proposals, quotes, timelines, and project tracking • Facilitate delivery and manage inventory of API for CRO studies • Develop and troubleshoot cell based efficacy assays including stem cell differentiation and ELISAs for proof of concept studies for clinical candidate compounds, including qualification and validation studies at CROs • Using my extensive knowledge in NanoString technology I head up multiple data analysis projects analyzing both in vivo efficacy and patient samples, leading to multiple patent applications • Design and implement studies to investigate biomarker discovery in clinical samples • Wrote clinical sample collection sections of the IND Phase 1b/2 for the use of an HDACi in combination with Nivolumab • Manage collection, shipping, and tracking of clinical samples sent to CROs for analysis • Design clinical sample collection kits including patient submission forms and facilitate delivery to clinical sites by tracking patient enrollment • Work directly with clinical team, both in house and contracted, to train clinical site personnel (CRAs) in collection, tracking and purpose of clinical samples for biomarker discovery

Team member responsible for developing human embryonic stem (hES) cell-derived therapies for diabetes treatment. Key contributor to development of in-house manufacturing and release of cell therapy product for human transplantation in Phase I/II clinical trials with GMP team. • NanoString Technologies nCounter Assay • Lead Scientist for RNA quantitation in R&D and GLP settings • CodeSet design, ordering and quality control • Data analysis using Genedata Inc. Expressionist, analyses included PCA, linear modeling, ANOVA, gene ontology, and hierarchical clustering • Development of NanoString nCounter GLP assay including methods, standards, and generation of qualification protocols and reports • Developed and performed assays for cell product release • Identified and corrected issues with qPCR assay development, and established optimized operating protocol • Supported transition of company R&D activities to GMP activities • Prepared Study protocols and reports; Qualification protocols and reports; and SOPs for methods, instrument maintenance, and laboratory compliance • Internal auditor for GMP activities: ISO13485, 21CFR820 and 21CFR Part 211 • Developed and performed viability assay for release of manufactured final product • Set-up and maintenance of a GLP laboratory including protocols and instrumentation • Developed protocols for the culture of hES cells in feeder free culture both in monolayer and aggregate suspensions • Optimized differentiation of hES cell lines to pancreatic endoderm • Cultured human embryonic stem cell lines on mouse feeders and feeder free cultures • Prepared cells for Flow Cytometry (FACS) analysis • Proficient in several software applications, including Excel, Word, PowerPoint, QCBD, Genedata Expressionist, and multiple instrumentation programs

2000-2005 Scientist 1996-2000 Associate Scientist 1993-1996 Assistant Scientist Research focused on development of oncology and metabolic disease in vitro studies. Developed several cell-based assays utilizing multiple molecular and cellular techniques through investigation and characterization of RXR, RAR and PPAR nuclear receptors. • Oncology and Metabolic disease assay development utilizing multiple techniques: soft agar and invasion assays, growth and cell death assays, differentiation assays, co-transfection, cell staining, immunohistochemistry • Protein isolation and characterization using immunoprecipitation, immunoblotting, Western blot, phosphorylation studies, FACS and ELISA, antibody labeling • RNA isolation, quantitation via RT-PCR, qPCR, ABI770 primer design • Mammalian tissue culture of transformed and primary cells • Analysis and presentation of data and key findings • In Vivo study design, animal handling, blood collection, and dosing • Project Management and Supervisory Experience: o Managed a nuclear receptor program pilot project o Directed, trained and mentored associate scientists o Supervised research associates performing in vivo and in vitro experiments