Gabriel Nistor

The most valued accomplishment is building my dedicated, highly skilled and versatile team capable of overcoming any given challenge. Created a quality by design environment compliant with modern cGMP, to support the research, development and manufacturing troubleshooting in phase III clinical trial for advanced stage melanoma using autologous tumor initiating cells and autologous dendritic cells. Using patient samples, lead the investigation of the mechanism of action in cancer immune-therapy. Developed final product potency assay and discovered clinical predictive and efficacy biomarkers for dendritic cell based immune-therapy that could complement the current approaches based on checkpoint inhibitors. Using complex investigative methods that included exomic analysis of the purified tumor "stem" cells and mixed lymphocyte reactions elucidated multiple pathways of immune response to strong or weak antigens resulted from cancer associated mutations equally suggestive for immune-escape and tumorigenesis. Investigated feasibility and established methods for manufacturing of purified tumor stem cells as antigen sources for autologous immune-therapy approach in other types of cancer (hepatocellular carcinoma, ovarian cancer, non-small lung cancer, glioblastoma etc). Successful isolated and expanded circulating tumor cells from cancer patients and identified factors that allow survival of the cells in routine blood samples. Developed proprietary reagents and methods that enabled consistent isolation of cancer "stem" cells from bulk tumors and rapid expansion for use as antigenic sources. Filed multiple patent applications and actively involved in developing company's IP portfolio strategy and in the patent prosecution process. Submitted and awarded multiple grants (CIRM, NIH) totaling over $20 millions.

Adopted modern principles of product development based on quality by design: establishing critical quality attributes, process mapping, cause and effect analysis, design of experiments, risk assessment and management. Developed and patented reagent, manufacturing process, in-process control and releasing criteria for stem cell derivates suitable for cell-replacement therapies Coordinating the development of new pipelines of cell products with application in research and clinic. Participated in IND meetings for phase I for SMA stem cell therapy and for phase III Melanoma immunotherapy application Presented R&D pipeline and patent portfolio for investors in various fundraising occasions Developed methods for differentiating human embryonic stem cells in high purity populations of oligodendrocytes, neurons, cardiomyocytes, hepatocytes. Developed a concept and conditions for stemness maintenance, stem cell niche and differentiation mechanism of human embryonic stem cells, used successfully to grow very large quantities of cells with regulatory compliance. Developed in vitro human neuro-muscular system from stem cell derived motor neurons and primary myoblasts differentiated to skeletal muscle. Identified factors that are influencing the stem cell niche aging or renewal, that contribute to the maintenance of healthy organisms with applicability in immune-modulation, aging and cosmetics Transferred proof of concept immune-therapy technology from Hoag Hospital to California Stem Cell Inc manufacturing. Improved manufacturing for purified tumor initiating cells with a new set of reagents and methods designed for high success rate. Developed patenting strategy for the manufacturing and final product applications in various cancers Actively participated with corporate legal office in pre-grant patent prosecution process for initial filings and multiple divisional and international filings.