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Thomas J. Hwang, MD

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Thomas J. Hwang, MD

Assistant Professor of Medicine, Harvard Medical School

Thomas Hwang is an Assistant Professor at Harvard Medical School and a PORTAL faculty member, where he leads the Cancer Innovation and Regulation Initiative. A physician and health policy researcher, his work focuses on new medicines, medical devices, and digital health interventions in cancer care.

Dr. Hwang has published over 100 peer-reviewed papers, including in the New England Journal of Medicine, JAMA, Science, Lancet, and Lancet Oncology. He serves as the only US-based member of the European Society for Medical Oncology’s Working Group on the Magnitude of Clinical Benefit Scale, and in 2023 he was named one of STAT’s “Wunderkinds” as one of the nation’s leading experts on pharmaceutical regulation.

Previously, Dr. Hwang was a Visiting Expert at the European Medicines Agency and has work experience in venture capital, the World Health Organization, and the White House. He received his undergraduate and medical degrees from Harvard, where he was the 21st recipient of summa cum laude in Harvard Medical School’s history.

Featured Work

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Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine

Hwang TJ, Kesselheim AS, Vokinger KN - JAMA

Commentary & Opinion

| December 2019

Innovation Incentives and Competition
Regulation and Clinical Evidence

AI/ML-based medical devices require a lifecycle regulatory approach rather than the current one-time clearance model. The authors note that many AI/ML products have been cleared through the 510(k) pathway without new clinical testing by claiming substantial equivalence to devices that may be decades old.

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Price Changes and Within-Class Competition of Cancer Drugs in the USA and Europe: A Comparative Analysis

Vokinger KN, Hwang TJ, Carl DL, Laube Y, Ludwig W, Naci H, Kesselheim AS - Lancet Oncology

Research Publications

| April 2022

Innovation Incentives and Competition
Price, Value, and Access

Cancer drug prices in the US increased substantially over time (median 6.07% at 2 years and 15.31% at 4 years after market entry), while prices in Germany and Switzerland with national price negotiation mechanisms generally decreased or remained stable with inflation. The findings suggest that within-class competition did not effectively constrain US cancer drug prices, and the authors recommend that price negotiation mechanisms similar to those used in Germany and Switzerland could help address high cancer drug prices in the US.

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