President and CEO, Critical Path Institute
Chair of the Board of Directors, Regulatory Affairs Professional Society
Former Senior VP Worldwide Regulatory Affairs and Quality Assurance, Pfizer
Dr. Martha Brumfield is President and Chief Executive Officer of the Critical Path Institute, an Arizona-based non-profit (501(c)(3)). In this role, Brumfield leads the institute in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science, which is accomplished by leading teams that share data, knowledge, and expertise resulting in sound, consensus-based science. Brumfield assumes the role of CEO after most recently serving as Critical Path Institute’s Director of International and Regulatory Programs. In that position, she helped guide international program development and provided regulatory expertise to consortia. She is also a Professor at College of Pharmacy, The University of Arizona.
She also has her own consulting practice (Martha A. Brumfield LLC) focusing on concordance in global regulatory initiatives and regulatory science qualification programs. Other areas of focus in her practice include excellence in clinical trial conduct and pharmacovigilance, facilitation of scientific consortia, and programs supporting patient access to medicines.
Brumfield brings 20 years of experience from Pfizer Inc., most recently, as senior vice president of worldwide regulatory affairs and quality assurance. There, she led a global team that supported lifecycle pharmaceutical research, development, and commercialization through creation and implementation of regulatory strategies and quality assurance oversight. Brumfield also played a key role in managing the broader company relationships with global regulators, trade associations, academics, and others on regulatory policy issues. She served on corporate governance initiatives including the planning and implementation of mergers and acquisitions, and led her departments through these periods of significant change.
She is Chair of the Board of Directors for the Regulatory Affairs Professional Society, and chaired the Global Curriculum Coordinating Committee with FDA’s Office of International Policy, which oversaw the development of a competency framework for regulators in developing countries. She is also active with global nonprofits, including the Regulatory Harmonization Institute and GlobalMD, where she delivers educational workshops on regulatory and clinical trial topics in Asia. She has served on and contributed to the Institute of Medicine consensus committees, which were commissioned by U.S. FDA focusing on global regulatory systems and on falsified and substandard drugs. She also serves on the Steering Committee of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard.
Brumfield earned a Bachelor of Science degree and a Master of Science degree in Chemistry from Virginia Commonwealth University, a Ph.D. in Organic Chemistry from the University of Maryland, and served as a post-doctoral fellow at The Rockefeller University.