YOUR CONSTANT IN TISSUE-BASED BIOMARKER DISCOVERY
Miguel Angel Garza, CG(ASCP), MBA, MS
Chief Operations Officer & Consultant
Miguel Angel Garza is the Chief Operations Officer at Critical X and is a medical laboratory scientist with 12 years of experience in esoteric clinical and research laboratory organizations. Mr. Garza is experienced in high complexity testing, assay development, operations, and quality systems and has held leadership roles in CRO and CMO environments. In 2009, he joined ApoCell as a Senior Cytogenetics Technologist where he expanded on his expertise in immunofluorescence localization and analysis of rare cells and tissues, cellular imaging, and flow cytometry. He was later promoted through various leadership roles, eventually reaching senior management level. In 2016 Mr. Garza joined Lonza as a Quality Control Supervisor where he led the development and implementation of several quality control cell therapy projects, implementing necessary policies, procedures, and documentation to ensure GxP, USP, ICH, HIPAA and OSHA compliance. His successes led to a Program Manager role where he served as a primary point of contact for various cell therapies and viral drug products while leading high performance teams consisting of Sales, R&D, Manufacturing, QA/QC, Procurement, and Regulatory.
Mr. Garza received his Bachelor of Science in Biology with a specialization in Cytogenetics from The University of Texas, a Master’s in Business Administration from the University of the Incarnate Word, and a Master’s in Environmental Science from the University of Houston – Clear Lake. In addition, Mr. Garza holds clinical testing credentials in Cytogenetics from the American Society for Clinical Pathology and is certified as a Lean Six Sigma Yellow Belt by Lonza.
Timothy McDonnell, MD, PhD
Chief Scientific Officer & Consultant
Dr. McDonnell is Chief Scientific Officer at Critical X and a physician scientist who has been a member of the clinical faculty of the University of Texas MD Anderson Cancer Center for more than 25 years - most recently serving as Deputy Chair of the Department of Hematopathology. Dr. McDonnell has directed a continuously funded research program focusing on the molecular mechanisms of cancer and therapeutic resistance. Dr. McDonnell has devoted considerable effort developing and adapting methodologies that enable complex DNA, RNA, and protein-based biomarker assessments from, often limited, tissue samples. As a member of a multidisciplinary team he has in depth experience in the interrogation of tissue, from study design, to data acquisition, to analytics and data interpretation. His research findings have been reported in over 175 co-authored publications appearing in numerous peer-reviewed scientific and medical journals and have served as the basis for authorship of multiple patents relating to novel cancer therapies.
Dr. McDonnell received his B.S. from the University of California in San Diego, his PhD from the University of North Dakota, and his MD from Washington University in St. Louis. Certified by the American Board of Pathology, he provides accurate and timely diagnostic and prognostic information incorporating morphologic and molecular information from a complex cancer patient population that informs clinical decision making and appropriate patient therapy.
Carlos Genty, BS, HT(ASCP)QIHC, LSSBB
Chief Executive & Technology Officer
Carlos Genty is the Chief Executive and Technology Officer at Critical X and is a laboratory professional with 25 years of experience in clinical and research histotechnology, assay development, operations, and information systems. He has held research and clinical leadership roles in various service laboratories at the MD Anderson Cancer Center and Baylor College of Medicine and commercial laboratories, including large volume, multi-site operations such as Genzyme Genetics. At Genzyme, he served as Anatomic Pathology Process Owner, leading laboratory process and system change management efforts for Anatomic Pathology at a national level. He later joined Clarient, GE Healthcare Company, where he developed and managed integrated process documentation and led the Operational Excellence team charged with deployment of Lean Six Sigma methods across all laboratories. In 2012, Mr. Genty joined ApoCell, a contract research organization focused on biomarker discovery using circulating tumor cells. As Senior Director of Operations, He had care over project managers, scientists, and technologists, ensuring that projects were managed according to contract specifications. In 2014, he founded Critical X in an effort to provide laboratory management, IT, and technical consulting services to clinical and research laboratories and has now expanded the company's service portfolio to include advanced tissue and cell based contract research services, while developing (and leveraging) its proprietary technologies for its customers.
Mr. Genty holds Bachelor of Science from Our Lady of the Lake University and holds clinical testing credentials in histologic technology and immunohistochemistry from the American Society for Clinical Pathology. He also is a certified Lean Six Sigma Black Belt having received his training at the GE Healthcare Institute and the University of Houston.