A neutral third party created to support the FDA's Critical Path Initiative
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C-Path Leadership Team
Raymond Woosley, MD, PhD
President and CEO
Dr. Raymond Woosley is the founding President and Chairman of the Board of The Critical Path Institute (C-Path). Dr. Woosley is also the Director of the Arizona Center for Education and Research on Therapeutics that is funded by a grant to C-Path from the Agency for Healthcare Research and Quality. Prior to founding C-Path, Dr. Woosley was Vice President for The University of Arizona (UA) Health Sciences Center and Dean of the UA College of Medicine. He was Associate Dean for 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 Glaxo'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 and completed post-doctoral training in pharmacology, internal medicine and clinical pharmacology. His 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.
Marietta Anthony, PhD
Associate Director, AZ Center for Education & Research on Therapeutics
Dr. Anthony joined C-Path in the fall of 2006. Before joining C-Path, Dr. Anthony played a leadership role in health policy and oversaw large research programs for federal agencies and universities. She has directed research on women's health at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). She was also the Deputy Director of the Office of Women's Health for the FDA. She founded and directed the National Center of Excellence in Women's Health at The University of Arizona and was Director of Women's Health Research at Georgetown University. Dr. Anthony received her Ph.D. in medical microbiology and immunology from the UCLA School of Medicine and also completed a post-doctoral fellowship in biological chemistry.
Joseph R. (Bob) Assenzo, PhD
Executive Director of Education
Dr. Assenzo led the Drug Information Association from 1996 through 2004 as Executive Director. Prior to that appointment, Dr. Assenzo was Vice President of Regulatory Affairs and Project Management and Senior Advisor for Novo Nordisk in Copenhagen, Denmark. Dr. Assenzo was also Executive Director of U.S. Pharmaceutical Regulatory Affairs, Medical Communications, and Pharmacovigilance at the Upjohn Company. Dr. Assenzo received degrees in civil engineering from Northeastern University and environmental engineering from Harvard University and completed his Ph.D. in biostatistics from the College of Public Health, University of Oklahoma.
Thorir D. Bjornsson, MD, PhD
Co-Director, CPTR Regulatory Science Consortium
Dr. Bjornsson has held academic appointments at Duke University Medical Center in Durham, North Carolina, and at Jefferson Medical College in Philadelphia, Pennsylvania. During his academic career, Dr. Bjornsson maintained an active research laboratory and clinical research unit, funded by federal and foundation grants, and industry support. In his biopharmaceutical industry career, Dr. Bjornsson led global early clinical development across all therapeutic areas, first at Bristol-Myers Squibb in Princeton, New Jersey, and subsequently at Wyeth Pharmaceuticals in Collegeville, Pennsylvania. At both companies, he led numerous cross-functional initiatives aimed at improving specific scientific, organizational, or operational issues, such as back-up compound strategies, translational medicine, biomarker laboratory, early development cycle times, and unmet medical need assessment. Dr. Bjornsson is the author or co-author of approximately 225 published papers, abstracts, and book chapters. He is the recipient of numerous awards and honors, including Nanaline Duke Scholar at Duke University, Samuel M.V. Hamilton Family Professor of Medicine at Jefferson, President's Award at BMS, and Team-of-the-Year Award at Wyeth. He has served on numerous national selection committees, including the NIH Pharmacology Study Section and the PhRMA Foundation's Clinical Pharmacology Selection Committee. Dr. Bjornsson is a graduate of the Medical School of the University of Iceland. After initial clinical training in hematology/oncology, he trained in clinical pharmacology at Stanford University Medical Center. Dr. Bjornsson's specialties include early clinical drug development; clinical pharmacology; translational medicine and therapeutics; experimental medicine; preclinical candidate assessment and selection; drug development; pharmaceutical predictivity; biomarker applications; quantitative pharmacology; dose range selection; clinical safety margins; biological/clinical knowledge representation; portfolio strategies; and unmet medical needs assessment.
Steve Broadbent, MBA
Director of Consortia Operations
Mr. Broadbent is responsible for the overall project management and operational support of Critical Path Institute's consortia. In cooperation with consortia directors, Steve helps plan and execute work to ensure successful delivery of each consortium's goals. He is also implementing tools and strategies that will improve the efficiencies and productivity across consortia. Mr. Broadbent is a certified Project Manager and retired IBM executive with 30 years of experience in product development and management large diverse organizations in four countries. He earned a bachelor of science in electrical engineering from the University of Idaho and a Masters of Business Administration from the Eller College of Management at The University of Arizona.
Martha Brumfield, PhD
Director, International Relations
Most recently, Dr. Martha A. Brumfield was Senior Vice President, Worldwide Regulatory Affairs and Quality Assurance at Pfizer, Inc. Dr. Brumfield led a global team that supported lifecycle pharmaceutical research, development and commercialization through creation and implementation of regulatory strategies and quality assurance oversight. Dr. Brumfield also played a key role in managing the broader company relationships with global regulators, trade associations, academics and others on regulatory policy issues. Dr. Brumfield has been active in several external organizations including PhRMA, CMR, and APEC LSIF and has worked extensively with the PhRMA Simultaneous Global Development program. During 20 years at Pfizer, Dr. Brumfield held a variety of leadership positions in which she led regulatory teams responsible for the US, Europe and Emerging Markets. Dr. Brumfield also served as the company's head of drug safety surveillance and reporting, and managed global adverse event reporting requirements and the integration of Pharmacia's related safety operations. Dr. Brumfield earned a MS and BS in Chemistry from Virginia Commonwealth University, a PhD in Organic Chemistry from the University of Maryland, and served as a post-doctoral fellow at The Rockefeller University.
Marc Cantillon, MD
Director, Coalition Against Major Diseases (CAMD)
Marc has an over 15 years government, academia and pharmaceutical industry record of translational research, drug development and trials. His MD was from Karolinska Institute, postdoctoral training in internal medicine, neurology, psychiatry and rehabilitation, followed by NIH Fellowship in Neuropsychopharmacology and then intramural staff position. He is board certified in psychiatry and geriatrics (American Board of Psychiatry and Neurology). After positions at Georgetown University Washington DC and at the Memory Clinic University of Miami, he worked in positions of increasing responsibility in AstraZeneca, Wyeth and most recently Schering-Plough (Merck). He helped develop multiple innovative drugs for psychosis, mood disorders, pain, and neurodegenerative diseases as Parkinson's and Alzheimer's. He has been an active industry scientific member of consortia to improve drug development methodology : Alzheimer's Disease Neuroimaging Initiative, American College of Neuropsychopharmacology (ACNP), MJ Fox Foundation, Alzheimer's Association at local and national level and in C-Path the Patient Reported Outcomes and CAMD.
Alfred M. Cohen, MD, FACS, FASCRS
Director, Cancer Biosignature Programs
Alfred M. Cohen, MD, FACS, FASCRS, joined the department of surgery at The University of Arizona in 2009 as Professor of Surgery in the Section of Surgical Oncology, and as Surgical Director of the Arizona Cancer Center. Dr. Cohen received his medical degree from the Johns Hopkins University School of Medicine in Baltimore, and completed his general surgery residency at Massachusetts General Hospital in Boston. He obtained surgical oncology and laboratory research training at the National Cancer Institute in Bethesda. Dr. Cohen joined The University of Arizona faculty after leaving the University of Kentucky, where he held the position of Director and Chief Executive Officer of the Lucille P. Markey Cancer Center. In addition, he was interim Executive Vice-President for Health Affairs at the University of Kentucky. Dr. Cohen was Chief of Colorectal Surgery at Memorial Sloan-Kettering Cancer Center in New York for 15 years, and Director of the Colorectal Cancer Disease Management Team. Prior to that, he was Co-Director of Surgical Oncology at the Massachusetts General Hospital in Boston. He has published 300 articles, reviews, and book chapters. He has been the Principal Investigator of many clinical trials in the treatment of colorectal cancer, and was the Chair of the Colorectal Cancer program for the American College of Surgeons Oncology Group. He is a past President of the Society of Surgical Oncology, the New York Clinical Society, and Chair of the Commission on Cancer at the American College of Surgeons.
Stephen Joel Coons, PhD
Director, Patient-Reported Outcomes (PRO) Consortium
Prior to joining C-Path, Dr. Coons was a professor in the College of Pharmacy and the Mel & Enid Zuckerman College of Public Health at the University of Arizona (UA) in Tucson. In addition, he served as co-director of the Arizona Cancer Center's Behavioral Measurements Shared Service. After receiving a B.S. in pharmacy from the University of Connecticut, Dr. Coons completed a hospital pharmacy residency at the VA Medical Center in Phoenix and earned an M.S. in pharmacy, an M.Ed. in higher education, and a Ph.D. in pharmacy (administrative and behavioral sciences) at the UA. His post-doctoral training in health outcomes research was completed at the University of California, San Diego (UCSD). 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. Dr. Coons holds a part-time faculty position at the UA and is a fellow in the American Association of Pharmaceutical Scientists. For the past two decades, the primary focus of his research has been the measurement of patient-reported outcomes.
Linda Johnson
Director, Sponsored Programs
Ms. Johnson has held an administrative position at Critical Path Institute since it began in 2005. She has over thirty years of administrative experience in medical school university departments and central administration at the University of Virginia, Georgetown University and the University of Arizona Health Sciences Center. She created the infrastructure for the new Institute to be eligible to apply for and receive federal grants and contracts. She is responsible for managing all pre-award and post-award grants and contracts, and in addition, provides administrative financial management. Her office has successfully assured adherence to federal and foundation regulations and policies for research awards. She received her BA degree in Biology from Skidmore College.
Louis Kirby II, MD,
Co-Chair, biomarkers working group, Coalition Against Major Diseases, (CAMD)
Dr. Kirby is a highly regarded consultant, speaking often at national and international meetings of clinical research groups, sharing his expertise in the business of conducting clinical trials. Before joining C-Path, Dr. Kirby served as Chief Medical Officer of Provista Life Sciences, which is in the process of developing a blood-based biomarker for the diagnosis of Alzheimer's disease. Prior to that, Dr. Kirby was the Founder and CEO of Pivotal Research Centers, which grew to become a large, freestanding clinical trials research center. Dr. Kirby has served as the Principal Investigator on nearly 400 clinical trials, most of them focused on the central nervous system, including over 100 trials in Alzheimer's and Parkinson's diseases. Dr. Kirby is a board certified neurologist (American Board of Psychiatry and Neurology), and worked in one of Arizona's busiest neurology practices, becoming a partner and president within two years of joining that organization. He was Chief of Staff at Thunderbird Medical Center for two years, and served on the Board of Directors of its holding company, Samaritan Health Systems. Dr. Kirby received his BA in the Honors Program with High Honors and Special Honors from the University of Texas at Austin, and his MD from the University of Texas Medical Branch in Galveston, Texas.
Ralph Martel, PhD, MBA
Chief Technology Officer, NBL
Dr. Martel came from High Throughput Genomics (HTG) where as Vice President for Research and Development, he led the commercialization of the company's reagents, consumables, instruments, software and services to enable genomics-driven drug discovery using HTG's patented multiplexed mRNA assays. Prior to that, he worked at Ventana Medical Systems where he was an inventor of Ventana's patented detection kits for automated immunohistochemistry and in situ hybridization. In addition, he developed 12 marketed products that are FDA-approved for in vitro diagnostics. He graduated from Lehigh University with a B.S. in biochemistry and he received his PhD in Biochemistry and his MBA from The University of Arizona.
Richard T. Myers
Chief Operating Officer
Mr. Myers is the Chief Operating Officer for Critical Path Institute. After twenty-five years of service, Mr. Myers retired from IBM Corporation as Vice President of Development, Storage Systems where he was also a member of the Chairman's Senior Management Group. An engineer by training, Mr. Myers led a research and development facility with 1600 scientists developing innovations in mass data storage and retrieval technologies. Post-IBM, Mr. Myers has been very active in the Arizona state and local community as a member of several boards, including Science Foundation Arizona, Tucson Airport Authority, Women's Foundation of Southern Arizona, National Advisory Board for the University of Arizona Science Center, Arizona State Commerce Global Network Board. He is the immediate past Chair of the Southern Arizona Leadership Council; an association of local CEO's focused on improving Tucson and Southern Arizona. Mr. Myers is recognized for his leadership skills, team building and organizational systems. He earned his Bachelor of Science in Mechanical Engineering at University of Alabama.
Wayne Peate, MD, MPH
Medical Director, NBL
Director, PKD Consortium
Dr. Wayne Peate completed his undergraduate education at Stanford, a medical degree at Dartmouth and a Master of Public Health, International Health, at Harvard. Prior to joining C-Path as Medical Director of the National BioSignatures Laboratory and Director of the Polycystic Kidney Disease Consortium, he served as an associate professor at the University of Arizona, College of Medicine and the Mel and Enid Zuckerman College of Public Health. He has written 40 publications, including 10 books and book chapters. Peate volunteered as medical relief physician for 60,000 Somali refugees and founded WellAmerica where municipal employees from 15 agencies receive wellness/fitness services and injury care and prevention.
Dr. Peate's SOP (standard operating procedures) for methicillin resistant staph aureus (MRSA) has been adopted widely by firefighters. He is co-investigator for two federally funded studies: 1) Assessing risk factors for cardiovascular disease in firefighters, and 2) determining associative factors of injury among emergency service employees using a risk management approach.
Klaus Romero MD, MS
Clinical Pharmacologist
Dr. Romero is a native of Colombia and a Clinical Pharmacologist. He has worked as clinical research consultant for Astra-Zeneca Colombia, and worked 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, 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 the Javeriana University, and an MS in Pharmacology from the Colombian National University, both in Bogotá. 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 an Instructor for the American Heart Association's BLS, ACLS and ACLS-EP courses. He is fluent in English, Spanish, German and Portuguese, and is the author of two books on drug toxicology, used by several schools of medicine in Colombia.
Elizabeth Gribble Walker, PhD
Director, Predictive Safety Testing Consortium (PSTC)
Dr. 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.