A neutral third party created to support the FDA's Critical Path Initiative

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C-Path Leadership Team

Carolyn Compton, MD, PhD
President and CEO

Raymond WoosleyDr. Carolyn Compton was most recently the Director of the Office of Biorepositories and Biospecimen Research (OBBR) and the Executive Director of the Cancer Human Biobank (caHUB) project at the National Cancer Institute. In these capacities, she had leadership responsibility for strategic initiatives that included the Innovative Molecular Analysis Technologies for Cancer program, the Biospecimen Research Network program, and the NCI Community Cancer Centers project. She is an adjunct Professor of Pathology at the Johns Hopkins School of Medicine.

She received her MD and PhD in degrees from Harvard Medical School and the Harvard Graduate School of Arts and Sciences. She trained in Pathology at Harvard's Brigham and Women's Hospital and is boarded in both Anatomic Pathology and Clinical Pathology. She came to the NCI from McGill University where she had been the Strathcona Professor and Chair of Pathology and the Pathologist-in-Chief of McGill University Health Center from 2000-2005. Prior to this, she had been a Professor of Pathology Harvard Medical School, the Director of Gastrointestinal Pathology at the Massachusetts General Hospital, and the Pathologist-in-Chief of the Shriners' Hospital For Crippled Children, Boston Burns Unit for 15 years. During this time she served as the Chair of the Pathology Committee of the Cancer and Leukemia Group B for 12 years. Her research interests are in colon and pancreatic cancer as well as epithelial biology and wound healing.

Dr. Compton has held many national and international leadership positions in pathology and cancer-related professional organizations. She is a Fellow of the College of American Pathologists and a Fellow of the Royal Society of Medicine. Currently, she is the Chair of the American Joint Committee on Cancer (AJCC), serves on the Executive Committee of the Commission on Cancer of the American College of Surgeons, and serves as the Pathology Section Editor for Cancer. She is a past Chair of the Cancer Committee of the College of American Pathologists and was Editor of the first edition of the CAP Cancer Protocols (Reporting on Cancer Specimens) used as standards for COC accreditation. Among her awards are the ISBER Award for Outstanding Achievement in Biobanking, the NIH Director's Award, the NIH Award of Merit, and the CAP Frank W. Hartman Award. She has published more than 500 original scientific papers, reports, review articles, books and abstracts.

 

 

Raymond Woosley, MD, PhD
Founder

Raymond WoosleyPrior 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.

 

 

Richard T. Myers
Chief Operating Officer

Rick MyersRick 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 creating 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, and the Arizona State Commerce Global Network Board. He is the immediate past Chair of the Southern Arizona Leadership Council, an association of local CEOs focused on improving Tucson and Southern Arizona. Mr. Myers is recognized for his leadership and team building skills, as well as his organizational systems. He earned his Bachelor of Science in Mechanical Engineering at the University of Alabama.

 

 

Marietta Anthony, PhD
Director, Rockville Office

Marietta AnthonyDr. Marietta Anthony joined Critical Path Institute in 2006 and currently works with patient advocacy organizations in the Coalition Against Major Diseases. Dr. Anthony worked on medication safety in the AZ Center for Education and Research on Therapeutics. 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 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.

 

 

Enrique Aviles
Director, Data Standards and Management

Enrique AvilesEnrique Aviles has over 25 years' experience in program management and product development for the IT industry. Previous executive roles in the IT industry include storage program management, client technical support, storage product development, and product marketing. Mr. Aviles 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.

 

Thorir D. Bjornsson, MD, PhD
Executive Director, Critical Path to Tuberculosis Drug Regimens Regulatory Science Consortium

Thorir BjornssonDr. Thorir 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 (BMS) 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 National Institutes of Health 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, Consortia Operations

Steve BroadbentSteve Broadbent is responsible for the overall project management and operational support of Critical Path Institute's consortia. In cooperation with consortia directors, Mr. Broadbent helps plan and execute work to ensure successful delivery of each consortium's goals. He is also implementing tools and strategies that will improve efficiency 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 of large, diverse organizations in four countries. 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.

 

Martha Brumfield, PhD
Director, International Relations

Martha BrumfieldMost recently, Dr. Martha 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 her 20 years at Pfizer, Dr. Brumfield held a variety of leadership positions in which she led regulatory teams responsible for the U.S., European, 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 an 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.

 

Stephen Joel Coons, PhD
Executive Director, Patient-Reported Outcomes (PRO) Consortium

Stephen Joel CoonsPrior to joining Critical Path Institute, Dr. Stephen Joel 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 BS in pharmacy from the University of Connecticut, Dr. Coons 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 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 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.

 

Eslie Dennis, MBChB, FCP
Executive Director, Predictive Safety Testing Consortium, and
Executive Director, Polycystic Kidney Disease
Consortium

Eslie DennisDr. Eslie Dennis is the Executive Director of both the Predictive Safety Testing Consortium (PSTC), and the Polycystic Kidney Disease Consortium at Critical Path Institute. She has ten years of experience in clinical practice in internal medicine, hematology, and laboratory research in the area of tuberculosis, and fourteen years of experience in the pharmaceutical industry, where she held a variety of senior-level positions. Immediately prior to joining C-Path, Dr. Dennis was Vice President and Medical Head Northeast for Novartis Pharmaceuticals Corporation, where she led a field-based medical affairs team responsible for communicating medical information, scientific data, and customer insights to company headquarters, as well as developing customer and patient-focused medical strategies in partnership with key stakeholders. She is an experienced presenter on topics ranging from access to medicines to clinical relevance in trial design. Dr. Dennis has been involved in activities such as regulatory negotiations with the U.S. Food and Drug Administration, training development, global market research, strategic and budget planning, safety risk management, and interactions with South Africa's Ministry of Health. She created and led the Novartis Office of Grants and Education, spearheading the design, development, and implementation of its best-in-class automated grants processing website. Dr. Dennis was also a Medical Advisor with Merck, Sharp & Dohme in South Africa, working with a small core group to establish medical affairs and support an expanding business. Dr. Dennis received her MBChB from the Godfrey Huggins School of Medicine in Harare, Zimbabwe, and was the recipient of the Winston Churchill, Margaret Low, and Prankard-Jones Scholarships, as well as the Guy Elliot Bursary. She is a Fellow of the College of Physicians of South Africa.

 

Debra Hanna, PhD
Associate 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 and Executive Director, Coalition Against Major Diseases

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, NIH’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.

 

Linda Johnson
Director, Sponsored Programs

Linda JohnsonLinda 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.

 

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

Klaus RomeroDr. 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 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 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.

 

 

Lisa Romero
Director, Communications

Lisa Romero has twenty years of experience leading communications, public relations, and marketing programs in a wide variety of corporate and nonprofit environments as both an employee and a consultant. Additionally, Lisa has served as an Adjunct Instructor, teaching upper-division undergraduate advertising, marketing, and writing classes. She joined Critical Path Institute in early 2010 to oversee internal and external communications strategy and functions, and is responsible for advancing and protecting organizational brand integrity and consistency across all consortia and programs. Lisa received her Bachelor of Science in Justice Studies from Arizona State University.

 

 

Diane Stephenson, PhD
Associate Director, Coalition Against Major Diseases

Diane StephensonDr. Diane Stephenson is a neuroscientist by training with 30 years combined experience in academic neuroscience and drug discovery. She is passionate about biomedical science and has a long time dedication to the discovery of therapies to treat diseases of the nervous system. Diane received her undergraduate degree in Biochemistry at University of California, Santa Barbara and her Ph.D. in Medical Neurobiology from Indiana University. In her academic career, Diane focused her research on Amyotrophic Lateral Sclerosis and Alzheimer's disease while in industry she investigated mechanisms of degeneration in 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. Most recently, Diane has focused her attention on autism spectrum disorders. In 2007, she embarked on an effort with two Pfizer coworkers to garner support to addressing 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 joined Critical Path Institute as Associate Director of the Coalition Against Major Diseases in August 2011.

 

Elizabeth Gribble Walker, PhD
Director, Regulatory Strategy and Submissions

Elizabeth WalkerDr. 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.