Dr. Mathew T. Thomas retired from the U.S. Food and Drug Administration (FDA) in June 2023, after serving almost 34 years in regulatory, management, and leadership positions, primarily within FDA’s Center for Drug Evaluation and Research (CDER). He currently serves as the President, MTT Consulting LLC., which offers independent consulting services for entities engaged in medical product development, basic and clinical research, institutional review board activities, development of products to treat rare diseases, GCP regulatory issues, ICH guidance, and data integrity audits.

His FDA career included service as a medical reviewer for new drugs, a scientific reviewer for a wide variety of bioresearch monitoring inspections, a health science administrator for orphan product development, Chair of FDA’s institutional review board (RIHSC), Director for CDER’s Enforcement and Post-market Safety, Country Director of the U.S. FDA India Office in New Delhi, U.S. Health Attaché to India, acting Deputy Director for the DHHS Office of Global Affairs, acting Associate Director for Global Affairs of Generic Drugs, and senior policy advisor for CDER’s Office of Scientific Investigations (OSI).

His experience in rare diseases includes:

• Work as a Health Science Administrator in U.S. FDA’s Office of Orphan Products Development (OOPD) for about 4.5 years, reviewing “orphan” drug designation requests, and grant applications.
• Conducting numerous site visits for OOPD grantees and offering protocol assistance for enhancing study enrollment and data quality.
• Organizing and conducting orphan drug workshops in the US and in India.

The attached link is for an eight part presentation on OOPD’s website that Dr. Thomas and an FDA colleague recorded in June 2023 (prior to his retirement from FDA) on the topic Sponsor-Investigator Responsibilities for Orphan Drug Grantees, https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/orphan-products-grants-program-information-applicants-and-grantees#:~:text=Overview%20of%20Sponsor,External%20Link%20Disclaimer

David Pearce is President of Innovation, Research, & World Clinic for Sanford Health. He completed his undergraduate Bachelor of Science Degree with honors in biological sciences at Wolverhampton Polytechnic in 1986. He gained his PhD in 1990 at the University of Bath, UK, and did postdoctoral training at the University of Rochester, U.S., and Oxford University, UK.

Dr. Pearce has published over 100 research papers on Batten disease. He also oversees a national registry for rare diseases known as the Coordination of Rare Diseases at Sanford (CoRDS). He has served on numerous NIH review committees, has organized rare disease workshops for the National Institute for Neurological Disorders and Stroke (NINDS) arm of the National Institutes of Health (NIH) and is currently the chair of the consortium assembly for the International Rare Diseases Research Consortium (IRDiRC).

As President of Innovation, Research, & World Clinic at Sanford, he oversees the development of research programs, including more than 450 researchers, eight research centers and more than 300 ongoing clinical trials.