Fabio Triolo, DdR, MPhil, PhD
Director, cGMP Facilities
Program in Regenerative Medicine
Fabio Triolo, D.d.R., M.Phil., Ph.D. is an expert in clinical cell therapy manufacturing, has a broad background in aseptic methods of harvesting, purification, processing, culture, storage and characterization of human cells, and extensive experience in compliance with current Good Manufacturing Practices (cGMP). He graduated summa cum laude in Biological Sciences from the University of Palermo, Italy, where he also completed a Research Doctorate (D.d.R.) in Chemical Sciences in 1999 and obtained the Italian Biological Board License in 2001. From 1996 to 2001 he was a Fulbright Fellow at Mount Sinai School of Medicine of New York University, where he was conferred a Master of Philosophy (M.Phil.) and a Doctor of Philosophy (Ph.D.) in Biomedical Sciences in 2000 and 2002, respectively.
In 2003, Dr. Triolo joined the Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT) of the University of Pittsburgh Medical Center, in Palermo, Italy where he served as Director of the Experimental Cell Therapy and Cell Transplantation Laboratory until 2011. During his tenure, he established and directed ISMETT’s Office of Research, Health and Biomedical Sciences and designed a state-of-the-art Human Cell Processing cGMP Facility, which was awarded over 6 million euros by the Italian Ministry of Innovation and Technologies in 2005. In 2006 he made the facility operational and was the first person in the Region of Sicily to ever be authorized by the Italian Drug Agency and the Italian Ministry of Education, University and Research, to act as Qualified Person (according to European directive 2001/83/EC) of cGMP facilities authorized to produce cell therapy products.
In 2007, he founded ISMETT’s Regenerative Medicine and Cell Therapy Unit, which he co-directed throughout 2010. Within the unit, he led the human fetal precursor cell isolation and bioreactor group. He also served as Adjunct Assistant Professor of Surgery (2005-2008) and as Affiliate Faculty Member of the McGowan Institute for Regenerative Medicine (2009-2011) of the University of Pittsburgh.
In 2008, he became a member of the National Reference Pole for the Coordination of Biological Resource Centers and Biobanks, nominated by the National Committee for Biosafety, Biotechnology and Life Sciences of the Italian Presidency of the Council of Ministers. He actively participated to the drafting and review of several national guidelines, including the Italian Presidency of the Council of Ministers guidelines for biological banks for infectious diseases, the Italian Presidency of the Council of Ministers guidelines for biobanks and biological resource centers for storage of human samples for research purposes, the Italian Ministry of Health guidelines for procurement, processing, storage and distribution of cells and tissues for clinical use, and the National Transplant Center guidelines for procurement, processing, preservation, storage and distribution of pancreatic islets and hepatocytes. He also served on the task force for Advanced Therapy Medicinal Products (somatic cell therapy, gene therapy and tissue engineering products) of the European Advanced Translational Research InfraStructure in Medicine (EATRIS), aimed at creating a distributed pan-European infrastructure consisting of a network of well-renowned biomedical translation research centers across Europe. Dr. Triolo is a strong advocate of the importance of regulatory requirements and actively contributes to their implementation. For example, he was the first to publish specific risk analysis approaches and procedures applicable to cell therapy manufacturing and to provide a specific model for guidance of cell transplantation centers and cell processing facilities, especially if approaching risk management for the first time.
In 2011, he joined the University of Texas Health Science Center at Houston (UTHealth) as Assistant Professor in the Department of Pediatric Surgery, Assistant Professor of Clinical and Translational Sciences and Director of the Human Cell Processing cGMP Facilities in the Program of Regenerative Medicine. At UTHealth, he made operational the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, an FDA-registered cGMP Facility, and the Judith R. Hoffberger Cellular Therapeutics Translational Laboratory, both of which he directs. He leads the translation, scale-up and validation of promising new therapeutic technologies developed by scientists at a preclinical level, into clinical-grade processes that can be used to manufacture cell-based and/or tissue engineered products for clinical applications. His most recent research interests are focused on the development of innovative fetal tissue engineering therapeutic approaches and cell-based therapies aimed at neurological injury.