Longtime quantitative medicine and regulatory science expert to spearhead C-Path’s collaborative efforts in accelerating drug development
TUCSON, Ariz., January 9, 2024 — Critical Path Institute (C-Path) today announced that Klaus Romero, M.D., M.S., FCP, has been named its new Chief Executive Officer. Romero, a seasoned clinician scientist, has been vital in positioning C-Path as an essential partner in accelerating drug development worldwide, significantly shaping scientific and regulatory pathways to expedite the delivery of therapies for people in urgent need.
With an impressive tenure of over 16 years at C-Path, Romero has held key positions within the organization including Chief Science Officer and Executive Director of both Clinical Pharmacology and the Quantitative Medicine Program. His pivotal role in establishing and leading the Quantitative Medicine Program underscores his significant contributions to C-Path’s critical initiatives in drug development over the years.
M. Wainwright Fishburn, Jr., Chairman of C-Path’s Board, commented on the appointment: “Dr. Romero’s outstanding expertise and leadership have been instrumental in our journey to create and implement groundbreaking scientific and regulatory pathways. His strategic vision aligns perfectly with C-Path’s mission of accelerating the development of novel therapies. We are confident in his capacity to propel the organization forward in its next phase of global impact and pioneering innovation.”
“Assuming the position of CEO at C-Path represents a profound honor, coupled with a tremendous sense of responsibility,” said Romero. “My commitment is to continue C-Path’s tradition of excellence and innovation to transform drug development for the benefit of those in need. This is a commitment deeply rooted in my early days at C-Path, inspired by the visionary mentorship and guidance of C-Path’s founder, Dr. Raymond Woosley. Our collaborative efforts will persist in transforming drug development paradigms, for the benefit of those in need.”
Kristen Swingle, President and Chief Operating Officer of C-Path, also expressed enthusiastic support for Dr. Romero: “Klaus’ visionary leadership and profound commitment to our core values have been vital in our journey towards becoming a leader in fostering medical development on a global scale. His ascension to CEO is a significant milestone in our mission to bring transformative therapies to patients who desperately need them.”
Dr. Romero’s background includes extensive experience in leading initiatives across a spectrum of medical product development areas. He has been instrumental in developing actionable drug development tools in Alzheimer’s disease, contributing to a paradigm shift in the drug development process for this condition. In tuberculosis, his leadership facilitated the generation of a drug development infrastructure that contributed to the approval of the first new individual drug and regimen for the disease in over half a century. Moreover, his influence extends to diverse areas such as polycystic kidney disease, Parkinson’s and Huntington’s diseases, type 1 diabetes prevention, kidney transplantation, Duchenne muscular dystrophy, and several other rare and orphan indications.
As a trained clinical pharmacologist and epidemiologist, 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 holds academic positions as an Associate Research Professor at the University of Arizona and as an Adjunct Professor at the University of Southern California and Arizona State University.
Romero succeeds Daniel M. Jorgensen, M.D., MPH, MBA, who served as CEO since October 2022. Romero will continue to serve a dual role as CEO and CSO until the CSO position is filled.
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 54% funded by the FDA/HHS, totaling $19,436,549, and 46% funded by non-government source(s), totaling $16,373,368. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
Roxan Triolo Olivas