SILVER SPRING, MD, March 13, 2026 /24-7PressRelease/ -- Edwin John Matthews, PhD, has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.

First, Dr. Matthews considers his employment at the U.S. Food and Drug Administration (FDA) to have been a privilege and honor, and he is grateful for all the opportunities he had while working there.

Dr. Matthews has established a distinguished career in computational toxicology, most notably through his longstanding tenure at the FDA beginning in 1991. Early in his tenure, computational toxicology and associated machine learning software (now known as artificial intelligence AI) were regarded as non-traditional scientific disciplines. They were considered by management to be unreliable and inappropriate for regulatory use and decision-making. In contrast, Dr. Matthews was convinced these disciplines could become extraordinarily valuable tools for FDA regulatory decisions because AI software models could capture the collective toxicologic data within FDA archives and publicly available sources and the AI results could provide prompt and cost-free answers to scientific questions. Furthermore, properly constructed and configured AI software models would yield statistically significant results, mechanistic insights, early in the regulatory decision-making process, and thereby effectively direct needed traditional studies.

His major accomplishments at the FDA during his tenure were to develop, promote, and implement the use and acceptance of AI software to provide the Agency with timely decision support information. He carefully published the methods he developed, the source material he used, the strengths and weaknesses of the AI models, and suggestions for their application in a regulatory environment. He set up collaborative agreements with a dozen AI software companies through FDA cooperative research and development agreements (CRADAs) and material transfer agreements (MTAs) which thereby promoted the acceptance and use of this technology. As the Agency Expert in this field, he functioned as a consultant to other government agencies and pharmaceutical industry on their use of this technology. He gave nearly 100 presentations at scientific meetings internally, nationally and internationally to explain and encourage this technology.

During his tenure at the FDA Dr. Matthews was given numerous opportunities to serve the Agency. For example, as a pharmacologist and Agency expert in computational toxicology, he was instrumental in advancing digital resources used by pharmaceutical industry. Notably, Dr. Matthews recognized the limitations of the outdated microfiche-based systems for storing Center for Drug Evaluation and Research (CDER) historical documents. He set up a meeting that resulted in a collaborative agreement between CDER and Elsevier in which microfiche data were digitally transformed and resulted in the creation of PharmaPendium software. This comprehensive digital platform integrates critical drug information, including chemical structures and adverse effects, and has become an essential tool for nearly every pharmaceutical company worldwide.

As the FDA representative on the United States Environmental Protection Agency (EPA) Interagency Testing Committee (ITC), Dr. Matthews played a pivotal role in obtaining for the FDA proprietary health effects data from manufactures of siloxanes and silicones. Siloxanes that had been used in breast implants which failed and caused serious health effects in women. ITC has the authority under TSCA legislation to designate chemicals to the Commissioner of the EPA and issue test rules to force industry to either release relevant health effects data or to perform bioassays to obtain necessary information.

A passion for continuous learning prompted Dr. Matthews to pursue academic excellence. He completed a Bachelor of Science in biology from Rensselaer Polytechnic Institute (RPI), after which he began graduate studies. His education at RPI included advanced courses in chemistry and mathematics that were foundational in his computational toxicology career decades later. He now holds a Doctor of Philosophy in microbiology from Duke University in 1969, where he studied viruses causing cancer in chickens. His education at Duke included advanced courses in immunology and biochemistry that were instrumental in his first career in industry. From 1969 to 1971, Dr. Matthews was recognized as a postdoctoral fellow at the National Cancer Institute (NCI) at the National Institutes of Health (NIH) where he studied viruses responsible for tumors in rodents.

In 1971, Dr. Matthews began his professional career as an instructor at the University of Virginia School of Medicine, where he shared his knowledge of microbiology and virology with future medical professionals. Shortly thereafter he joined private industry and served as a senior scientist at Litten Bionetics and Hazelton Laboratories from 1972 to 1990, now known as Fortrea. He was Principal Investigator on an NCI Contract that studied stage II melanoma patients being treated at the NIH, and his laboratory provided two support services. Dr. Matthews supervised: a) the production and quality control of a tissue culture, tumor cell vaccine used to treat melanoma, and b) monitoring of patient humoral and cellular immunocompetence during therapy using cultured melanoma cells and patient blood samples. Dr. Matthews was also Principal Investigator on contracts with the National Institute of Environmental Health Science (NIEHS), National Toxicology Program (NTP). NTP investigated dozens of alternative tests in their ability to predict results of costly 2-year rodent carcinogenicity bioassays. Dr. Matthews was awarded one of the alternative tests, and he published his extensive investigations with the BALB/c-3T3 tissue culture assay.

Dr. Matthews attributes his success to collaborations with exceptionally intelligent and innovative scientists throughout his career in academia, the NIH, the FDA, and industry. Drs Gilles Klopman and Herbert Rosenkranz were his first instructors and mentors for developing a career in computational toxicology. Dr. Matthews further acknowledges his supervisor and collaborator at CDER, Dr Joseph Contrera, whose support made it possible for him to pursue a career in computational toxicology.

Dr. Matthews values family life alongside his professional pursuits. He is married to an accomplished expert in electron microscopy and pathology who has made significant contributions to medical research through her work at the University of Maryland Medical School and Frederick Cancer Research Center. Dr. Matthews and his wife have one daughter, who is dedicated to environmentalism and naturalism with a passion for animal welfare and environmental protection.

To achieve balance, Dr. Matthews enjoys researching genealogy and conducting ancestry work. He is still engaged with scientific advancements by following progress in AI applications within science and finds it rewarding that the FDA now has approved over 80 AI software programs for medical purposes. Looking toward the future, Dr. Matthews will continue his work while reflecting on his career and his enduring commitment to scientific innovation and public health advancement through both research excellence and regulatory leadership.

About Marquis Who's Who®:
Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America®, Marquis Who's Who® has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Who's Who in America® remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. The suite of Marquis® publications can be viewed at the official Marquis Who's Who® website, www.marquiswhoswho.com.

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