A neutral third party created to support the FDA's Critical Path Initiative
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C-Path Leadership Team
Martha Brumfield, PhD
President and CEO
Martha Brumfield, Ph.D., was recently named the interim president and chief executive officer of the Critical Path Institute. In this role, Brumfield will lead the institute in its mission to foster development of new evaluation tools, which accelerate medical product approval. Brumfield assumes the role of CEO after most recently serving as Critical Path Institute's director of International & Regulatory Programs. In that position, she helped guide international program development and provided regulatory expertise to consortia.
She also leads 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 participates in an advisory capacity to the Harvard Global Health Institute's Multi-Regional Clinical Trial Center in developing a curriculum for potential Data and Safety Monitoring Board candidates from 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 International Office of Medicine consensus committees, which were commissioned by U.S. FDA focusing on global regulatory systems.
Brumfield earned a B.S. and an M.S. 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.
Steve Broadbent, MBA
Chief Operating Officer
Steve Broadbent is responsible for the daily operations of the organization as well as developing and implementing C-Path's strategy and goals. He manages the organization's finances, human resources, facilities, information technology, and personnel. In addition, he also oversees C-Path's consortia efforts to ensure successful qualification of safety and efficacy biomarkers, disease progression models, patient-reported outcome instruments, and other drug development tools.
Before joining C-Path, Steve was an IBM executive with nearly 31 years of experience in storage product development. He managed over 400 engineers in four countries with responsibility for architecting, developing, testing, and supporting IBM's largest and most complex disk storage systems — those used by top businesses and government agencies to store their most important data.
He earned a Bachelor of Science degree in electrical engineering from the University of Idaho, and a Master's of Business Administration from the Eller College of Management at The University of Arizona. He is also a certified Project Manager.
Chief Technology Officer
Enrique Avilés joined Critical Path Institute (C-Path) in 2010 as its Chief Technology Officer and Director of Data Standards, Management, and Technology. Mr. Avilés has over 30 years of experience in information technology product development, data storage, and program management, and has led numerous projects to support large IT clients with a special focus on healthcare and banking IT systems. Since 2001, Mr. Avilés served as an executive at IBM in roles such as data storage product program management, storage product development, client technical support, and marketing. His executive experience also includes a two-year assignment working as the IBM technical advocate for a major healthcare provider in the United States in support of their electronic health records (EHR) system, one of the largest deployments of an EHR system. In this role, his responsibility was to ensure that IBM hardware, software, and services used for the client's EHR system operated reliably on a 24/7 basis. Additionally, Mr. Avilés was the IBM executive data storage advocate for one of the largest banks in Japan, traveling there multiple times each year to review product quality and new product development status with senior bank executives. Mr. Avilés received his Bachelor of Science degree in Mechanical Engineering from the Georgia Institute of Technology. He also received graduate certificates from the University of Arizona for an executive MBA program and from George Washington University for Project Management.
Stephen Joel Coons, PhD
Executive Director, Patient-Reported Outcomes (PRO) Consortium
For over two decades, the primary focus of Stephen's research has been the measurement of patient-reported outcomes. Prior to joining C-Path, Stephen was a professor in the College of Pharmacy and the Mel & Enid Zuckerman College of Public Health at The University of Arizona (UA). In addition, he served as co-director of the Arizona Cancer Center's Behavioral Measurements Shared Service.
After receiving a BS in pharmacy from the University of Connecticut, he then completed a hospital pharmacy residency at the VA Medical Center in Phoenix and earned an MS in pharmacy, an MEd in higher education, and a PhD in pharmacy (administrative and behavioral sciences) at UA. His post-doctoral training in health outcomes research was completed at the University of California, San Diego. Previous academic appointments have been in the colleges of pharmacy, medicine, and allied health professions at the University of Kentucky, and in the Division of Health Care Sciences at the UCSD School of Medicine. Stephen is an emeritus professor at UA and a fellow in the American Association of Pharmaceutical Scientists.
Debra Hanna, PhD
Executive Director, Critical Path to TB Drug Regimens Regulatory Science Consortium
Dr. Debra Hanna joined Critical Path Institute as Associate Director for the Critical Path to TB Drug Regimens Consortium, beginning June 1, 2011. Prior to joining C-Path, Dr. Hanna was a laboratory head and project team leader for 10 years within the Antibacterials Research Unit at Pfizer Worldwide Research and Development. During her time at Pfizer, Dr. Hanna led a dynamic research team focused on understanding pre-clinical pharmacodynamic and pharmacokinetic (PK/PD) relationships for novel antibacterial agents, spanning early discovery to Phase 2 development. She championed the use of in silico PK/PD modeling to drive the optimal compound and dose selection for new antibacterial agents. Dr. Hanna's passion for tuberculosis research began during her postdoctoral fellowship at the University of California, San Diego, where she studied the impact of virulence genes for survival of Mycobacterium tuberculosis in the host lung. She received her PhD in Microbiology from North Carolina State University, and her BS in Microbiology and Immunology from Colorado State University.
Lynn D. Hudson, PhD
Chief Science Officer
Dr. Lynn Hudson serves as the Chief Science Officer for Critical Path Institute. She received a BS in Biochemistry at the University of Wisconsin, a PhD in Genetics and Cell Biology at the University of Minnesota, and post-doctoral training at Harvard Medical School and Brown University. For most of her career, Dr. Hudson has been a bench neuroscientist at the National Institutes of Health (NIH), where she directed the Office of Science Policy Analysis from 2006-2011. As a major source for policy analysis within NIH's Office of the Director, her office covered a wide spectrum of sensitive and emerging issues and oversaw a number of programs, including the AAAS/NIH Science Policy Fellowship program, NIHâ€™s contract with the National Academy of Sciences, and the Public-Private Partnership Program. Her policy team's awards cite contributions to NIH's Congressional Justification, Biennial Report, implementation of the NIH Reform Act, Stem Cell Guidelines, and Comparative Effectiveness Research. Dr. Hudson conducted research in the National Institute of Neurological Disorders and Stroke (NINDS) intramural program, where she was Chief of the Section of Developmental Genetics for 16 years. Dr. Hudson received the NIH Merit Award for her discovery of the causative mutations in the neurologic disorder Pelizaeus-Merzbacher disease (PMD), and an NINDS Award for educational outreach efforts. Dr. Hudson's research focused on defining the network of genes involved in the development of glial cells, with the goal of designing strategies to overcome glial dysfunction in inherited or acquired neurological diseases. She served as an officer for the American Society for Neurochemistry, an officer on the scientific advisory board of the PMD Foundation, and as an advisor for a number of granting agencies and disease foundations, including the National Multiple Sclerosis Society.
J. Jason Lundy, PhD
Director, Electronic Patient-Reported Outcome Consortium
Dr. Jason Lundy joined Critical Path Institute in 2010 as the Assistant Director of the Patient-Reported Outcome (PRO) Consortium. After receiving his BS in Economics from Capital University, Dr. Lundy earned an MS in Pharmacy and Health Care Administration from the University of Toledo and a PhD in Pharmaceutical Economics, Policy, and Outcomes Research from The University of Arizona. While at The University of Arizona, Dr. Lundy conducted research assessing the psychometric equivalence of electronic PRO instruments. Upon completing his graduate studies, Dr. Lundy was employed by a large contract research organization, where he was primarily engaged in PRO assessments. Dr. Lundy works closely with Dr. Stephen Joel Coons to support PRO and ePRO consortia activities and operations.
Klaus Romero MD, MS
Director, Clinical Research
Dr. Klaus Romero is a native of Colombia and a Clinical Pharmacologist. He has worked as a clinical research consultant for Astra-Zeneca Colombia, and as a clinical pharmacologist for the CIEO Foundation, a non-profit organization focused on drug safety research and pharmacovigilance in Colombia. In 2003, he planned, organized, and implemented the Colombian National Police Health Services' Pharmacovigilance system, which is still operating today. He is a member of the American College of Clinical Pharmacology and the American Society for Clinical Pharmacology and Therapeutics. He has conducted research on endemic channels for non-steroidal anti-inflammatory drug-related gastropathy, antibiotic-related dysglicemia, pharmacoepidemiology, and patient education. Dr. Romero earned an MD from Javeriana University, and an MS in Pharmacology from the Colombian National University, both in BogotÃ¡. Dr. Romero specialized in medical epidemiology at the El Bosque University, where he was part of the faculty as Assistant Professor of Pharmacology and as Instructor for the American Heart Association's BLS, ACLS, and ACLS-EP courses. He is fluent in English, Spanish, German, and Portuguese, and he is the author of two books on drug toxicology, used by several schools of medicine in Colombia.
Diane Stephenson, PhD
Executive Director, Coalition Against Major Diseases
Dr Diane Stephenson is a neuroscientist by training with 30 years combined experience in academic neuroscience and drug discovery. She is passionate about translational science and
is dedicated to the discovery of therapies to treat diseases of the nervous system. In her academic career, Diane focused her research on Amyotrophic Lateral Sclerosis and Alzheimer's disease. While in industry she focused on drug discovery for Alzheimer's disease, stroke, and Parkinson's disease.
Diane has over 55 scientific publications and six patents in the neuroscience area. Her specific areas of technical expertise include neuroimaging, neuropathology and animal model characterization. As an ambassador for public-private partnerships, she has initiated numerous external academic collaborations including worldwide alliances.
Prior to joining C-Path in 2011, Diane focused her attention on autism spectrum disorders and in 2007 she embarked on an effort with two Pfizer co-workers to garner support to address the unmet medical need in autism. As a result, in 2009 Pfizer became the first large pharmaceutical company to announce the formation of a dedicated unit devoted to discovering and developing new therapies for the treatment of autism.
Diane received her undergraduate degree in Biochemistry at University of California, Santa Barbara and her PhD in Medical Neurobiology from Indiana University.
Elizabeth Gribble Walker, PhD
Interim Director of PSTC
Dr. Liz Walker joined Critical Path Institute as Assistant Director of the Predictive Safety Testing Consortium in January, 2008. Her professional experience includes preclinical program development and oversight of biologic drugs for auto-immune and oncology indications; design and interpretation of mechanistic toxicology, combination safety, and GLP toxicology studies; and medical writing in support of regulatory submissions. Other scientific interests include biomarkers, validation of animal and alternative in vitro models, developmental toxicology, molecular signaling in cell cycle control, and systems biology approaches to toxicology. Dr. Walker received her PhD in Toxicology from the University of Washington focusing on mechanisms of low dose toxicant impact on cell fate during neurodevelopment.
Raymond Woosley, MD, PhD
President Emeritus and Former Chairman of the Board
Prior to founding Critical Path Institute in 2005, Dr. Raymond Woosley was Vice President for The University of Arizona (UA) Health Sciences Center and Dean of the UA College of Medicine. He also served as Associate Dean of Clinical Research and Chair of the Department of Pharmacology at Georgetown University School of Medicine. Dr. Woosley was a professor at Vanderbilt University Medical School and the first US scientist for GlaxoSmithKline's initial US operations. Dr. Woosley earned his Ph.D. in Pharmacology from the University of Louisville, his M.D. from the University of Miami. He completed post-doctoral training in pharmacology, internal medicine, and clinical pharmacology. Dr. Woosley's research has been published in over 265 peer-reviewed publications and 50 book chapters. He is a member of the National Academy of Science's Institute of Medicine's Drug Forum.