Klaus Romero

Drawn to the medical field since his youth, Klaus Romero, MD, MS, FCP commenced his professional journey with a love for the discipline of clinical pharmacology, seeing it as a vector to solve clinical problems for individual patients, as well as broader populations. With a medical degree from the Pontifical Xavierian University, and postgraduate training in clinical pharmacology and epidemiology, from the Colombian National University, and the Colombian School of Medicine, respectively, his career has focused on transforming paradigms to accelerate medical product development.

Early in his career, Dr. Romero adopted a mathematical model used in epidemiology to understand the behavior of infectious diseases to help understand the behavior of adverse reactions to medications. While presenting this method at the 2007 annual meeting of the American College of Clinical Pharmacology, he met the Critical Path Institute’s founder, Dr. Raymond Woosley, who recruited him to join the organization that has become his professional home for the past 14 years. Initially joining as an associate director of the Arizona Center for Education and Research on Therapeutics, he went on to serve as director of clinical research, executive director of clinical pharmacology, and executive director of quantitative medicine through 2019. Since April of 2020, Dr. Romero has excelled as the chief science officer of the Critical Path Institute. In addition, he has been chairman of the board of AZCERT (CredibleMeds, Inc.) and a scientific advisory board member for Pharos Diagnostics between 2017 and 2019.

Dr. Romero is a Fellow of the American College of Clinical Pharmacology, a founding member of the International Society of Pharmacometrics, as well as a member of the American Society for Clinical Pharmacology and Therapeutics, and the International Society of Pharmacoepidemiology. He also serves as an Associate Research Professor at the University of Arizona, as well as Adjunct Professor at the University of Southern California, and Arizona State University.

Finding great success in his career, Dr. Romero was the recipient of the Critical Path Institute “Professional Dedication Award” for “10 Years of Dedicated Service and Outstanding Accomplishments” in 2018. He has also taken home the Coalition Against Major Diseases (CAMD), Alzheimer’s Annual Imaging Biomarkers Award in 2015 and CAMD “Annual Recognition” Award in 2011, among others. He attributes his success to a combination of passion, drive, and discipline. Looking toward the future, Dr. Romero hopes to have the satisfaction of having seen the novel paradigm of collaborative regulatory science take hold across all major therapeutic areas, including rare and orphan diseases. He also sees himself translating this paradigm across medical product classes, from drugs to biologics, to medical devices.