Rod Monroy

Rod Monroy is a senior technology executive with a strong background in managing translational research programs in areas such as cell-based biotherapeutics, immunotherapy, transplantation, and regenerative medicine.

He possesses extensive experience in stem cell research and cellular therapy across various stages from in vitro studies to preclinical models to product development and clinical trials.

Rod has demonstrated proficiency in all phases of biotech development, ranging from start-ups to the completion of phase III studies. He is well-versed in regulatory requirements such as GLP, GMP, GCP, ICH, FDA interactions, and the conduct of clinical trials, particularly in Phase II and III.

Key achievements in his career include serving as a co-investigator utilizing early cytokine (G-CSF) therapy for treating mustard gas casualties, leading product development for a combination biological-device product that obtained CE Mark, co-leading two phase III clinical trials utilizing mesenchymal stem cells for graft versus host disease treatment, resulting in approval from Health Canada, and overseeing the Expanded Access Program for pediatric patient treatment.

Rod Monroy's core strengths lie in strategic and operational management with a focus on start-ups, as well as expertise in clinical cell therapies and engaging with the FDA.

He pursued a PhD in Biochemistry at Case Western Reserve University.

Currently, Rod serves as the Chief Scientific and Product Development Officer at XenoTherapeutics Inc. Previously, he held roles as the Senior Director of North American Clinical Operation at Cytonet LLC, Senior Director of Prochymal at Osiris Therapeutics, Senior Director of Product Development at Biotransplant, Inc, Senior Director at Eligix/Biotransplant, Director of Immunology and Hematology at Biotransplant, Inc, and Research Scientist Director at the U.S. Navy.