Timothy Stenzel, MD, PhD

Director, OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Device and Radiological Health U.S. Food and Drug Administration

2021 Nathan Kaufman Timely Topics Lecture

Timothy Stenzel, MD, PhD directs the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR) and has an extensive background, spanning more than 20 years, in executive leadership, innovation, companion diagnostics, research and development, FDA regulations, and clinical laboratory operations. He received his MD and PhD in Microbiology and Immunology, focusing on the Molecular Biology of DNA Replication, from Duke University after graduating with Honors in Chemistry from Grinnell College.

Following his residency at Duke University, Tim was recruited to create Duke’s Clinical Molecular Diagnostics Laboratory and served as the Director, Clinical Molecular Diagnostics and Medical Director, Cytogenetics. He also joined the faculty of the Duke University School of Medicine and served as an Assistant Professor of Pathology where his research focused on cancer and genetics, as well as directed the Clinical Cytogenetic and Molecular Diagnostics Laboratories and taught in the School of Medicine. While at Duke, his research laboratory was funded by the NIH/NCI and private agencies to study the molecular genetics and develop novel molecular diagnostics testing for the early detection of breast cancer and the diagnosis and treatment of brain tumors and by the CDC to perform research in the area of performance evaluation and quality assurance for genetic testing. He is board certified in Molecular Genetic Pathology and Anatomic and Clinical Pathology.

In his last position, from 2014 to 2018, Tim served as Chief Operating Officer (COO) at Invivoscribe (San Diego, CA), focusing on Companion Diagnostics and Next Generation Sequencing/Massively Parallel Sequencing in Oncology. During his career prior to joining the FDA, he has played important roles in the development and launch of more than 30 In Vitro Diagnostics (IVD) products, as well as numerous unique laboratory developed test (LDT) services, including the FDA approved companion diagnostic for Novartis’ drug Rydapt and the world’s first clinical microRNA assay (for pancreatic cancer detection). Other experience includes serving as Chief Scientific Officer and founder of the Molecular Diagnostics franchise at Quidel (San Diego, CA), Chief Medical Officer and Vice President of Research and Development at Asuragen (Austin, TX), and Senior Director for Medical, Regulatory and Clinical Affairs at Abbott Molecular (Des Plaines, IL). He served as a Board Director at the ACMG Foundation for Genetic and Genomic Medicine from 2008 to 2013. He has served on the ACMG/CAP Biochemical and Molecular Genetics Resource Committee from 1996 to 2005, the AMP Finance Committee from 2012 to 2018, the AMP Strategic Planning Committee from 2007 to 2009, as the AMP Chair-Elect and Chair of the Solid Tumor Division from 2003 to 2004, the CAP Molecular Oncology Committee from 2013 to 2018, and as a Member of the CAP House of Delegates from 2011 to 2017.

As the OIR Director, Tim advises FDA leadership on all regulatory (pre-market and post-market) for in vitro diagnostics, radiological medical devices, and radiation-emitting product issues that have an impact on Center and Agency level decisions, policy development, nationwide program execution and short and long-range program goals and objectives as well as provide executive leadership and scientific direction to the OIR staff.