As a GLG Network Member, I bring 10 years’ of experience in the biotech industry to help clients solve some of their toughest business challenges around product development and preclinical research.GLG is the world’s insight network. It connects decision makers to the right experts so they can act with the confidence that comes from true clarity and have what it takes to get ahead. Its network of experts is the world’s largest and most varied source of first-hand expertise.

I was responsible for delivering assistance in the development of clinical operations quality systems, including SOPs, document management, clinical operations personnel training, and quality control process to maintain seamless flow work. My job was to direct cGMP manufacturing process of the Company’s dendric cells-based therapy in accordance with SOP and FDA regulatory guidelines. My task was to prepare and share clinical studies progress reports with executive-level management. Conducted training sessions to enhance understanding of site personnel regarding handling and administration of anti-tumor dendritic cell vaccine. Followed all protocol specifications, FDA regulations, and chain of custody documentation while managing delivery of product to patients.

My task was to support Company’s R&D activities to accomplish clinical product development in fast and cost effective manner. I performed in vitro, ex vivo, and in vivo validation of new cancer immunological targets by devising new experimental methodologies. I was responsible for acquiring partial funding for the development of single-step manufacturing process while working in close collaboration with MD Anderson Cancer Center, as Principal Investigator and Kiromic’s leader. Involved in discovery and validation of new tumor-specific targets for anti-CD19 CAR T cell-resistant B-ALL, DLBCL, ovarian cancer, and mesothelioma by developing a novel bioinformatic prediction and wet-lab validation process. Assisted in the production of dendritic cells for cancer immunotherapy by developing and executing cGMP protocol. Ensured 50% cost and time reduction by improving dendritic cell manufacturing protocol.  Utilized a cost-effective single-step manufacturing process to make an orally delivered, M-cell targeting microparticle vaccine. Played an important role in identifying a new adeno-associated virus vector to deliver anti-inflammatory gene therapy and treat arteriosclerosis. Wrote five patents covering all aspects of the new technologies and methodologies in collaboration with the Company’s IP lawyers to expand company IP portfolio.

My job was to coordinate with Chief Scientific Officer to lead R&D department in accordance with the Company's objectives. I was responsible for contributing to developing new cellular immunology and molecular immunology techniques. I provided assistance to the Medical Officer in the successful implementation of standard operating procedures for the manufacturing of clinical-grade products.

I was involved in authorizing new Cancer/Testis Antigens in NSCLC as vaccine targets as well as a novel panel of Cancer/Testis Antigens in Triple-Negative Breast Cancer. My job was to study non-invasive imaging of ovarian cancer by designing new SP17-targeted, near-infrared and quantum dot-based system. Performed research on new ovarian cancer oral vaccine efficacy in murine models. Conducted study on ovarian cancer detection by executing and new serological test.

My research project is focused on unrevealing the molecular mechanisms of Notch-mediated signals affecting the response to chemokines in hematological malignancies, namely acute leukemias and multiple myeloma. We have shown that Notch-1 is required for T-cell acute leukemia survival and metastatic spread, both in cell lines and in patients’ primary tumor cells as well. The research on multiple myeloma has been performed in collaboration with Dr M. Chiriva-Internati (Director of the Translational Research Project, Division of Hematology and Oncology, Texas Tech University Health Sciences Center, Lubbock, Texas, U.S.A.). In vitro and in vivo experiments based on xenograft murine models of the disease clearly indicated that inhibition of Notch receptors significantly reduced plasma cell survival, bone marrow infiltration and bone disruption by affecting the expression of the chemokine receptor CXCR4 and of its ligand SDF-1.We have shown that the Notch-CXCR4-SDF1 axis is a novel and very promising druggable target to treat advanced multiple myeloma, reducing the risk of resistance to chemotherapy and the infiltration of the bone marrow by plasma cells. Results were published in Leukemia (Mirandola L et al., 2013).

Teaching activity/board of examiners in the course “Neoplastic Cell”.

Teaching activity in the degree course “Laboratory Practice”.

Teaching activity in the course “General Pathology”.