Dr. Tania Rodriguez joined CytoImmune in 2021 and is the Director of Research and Process Development. She has over 17 years of experience in preclinical pharmacology and safety assessments of cell and gene therapies, process and assay development, and clinical biomarker strategies.

Prior to CytoImmune, Dr. Rodriguez was Associate Director and Principal Scientist at Invectys, USA. At Invectys, Dr. Rodriguez led the preclinical IND enabling studies plan of the company’s leading autologous Chimeric Antigen Receptor T cell (CAR-T) product, managed contract research and manufacturing organizations for Chemistry, Manufacturing, and Controls (CMC) activities, and was instrumental in the preparation of the pre-IND briefing package for the company’s first CAR-T product for the treatment of solid tumors (NCT05672459).

Prior to Invectys, Dr. Rodriguez was a lead scientist at Bellicum Pharmaceuticals, where she worked on preclinical assessments of the company’s T cell-based cell products including T-cells genetically modified to express CARs or T-cell receptors (TCRs) for the treatment of solid tumors and hematological malignancies. At Bellicum, she designed and conducted IND enabling vitro and in-vivo pharmacology, pharmacokinetics, and safety assessments leading to IND submission and clearance of the company’s first HER2-targeted dual switch autologous CAR-T product for the treatment of solid tumors (NCT04650451).

Dr. Rodriguez earned a PhD in Immunology & Experimental Therapeutics from the University of Texas Graduate School of Biomedical Sciences, Houston Texas. Her research focused on Major Histocompatibility Complex -I (MHC-I) molecules and dendritic cell-induced T-cell immunity against melanoma. After her PhD, Dr. Rodriguez joined the Cell and Gene Therapy Department at Baylor College of Medicine in Houston, Tx, as a post-doctoral fellow. Her research focused on the development of CAR-T cells for the treatment of glioblastoma.

Dr. Omer Butt joined CytoImmune in 2022 as the Vice President of Regulatory Affairs. He brings over 17 years of experience in the regulatory space, working closely with US FDA, EMA, and PMDA in the Cell Therapy and Biologics space.

Prior to joining CytoImmune Therapeutics, Dr. Butt was the Senior Director of Global Regulatory Affairs at Athersys Inc., where he managed their Investigational Drug, MultiStem®, an allogenic “off the shelf” cell therapy, in a Phase III registration trial globally. He led numerous interactions with the FDA, Country-specific European Regulators, EMA, and PMDA, for the initiation of new INDs and filings of BLA in Japan.

Dr. Butt joined Athersys after spending time at larger companies such as Sanofi, Shire, and Biogen, where he managed multiple portfolios including monoclonal antibodies and enzyme therapy. He is extremely well versed in both Clinical Development of products and life cycle management. Products that he had regulatory oversight on with the above-mentioned companies ranged in therapeutic area from Oncology to Neurology. Before joining the industry, Dr. Butt spent his early career years at the US FDA, as a Staff Fellow, where his responsibilities included the CMC review of INDs, BLA, and all associated life cycle amendments.

Dr. Butt earned a PhD in Biomedical Engineering from The Ohio State University, with a focus on Stem Cell Biomechanics.