Public Engagement and Clinical Trials New Models and Disruptive Technologies: Workshop Summary (2012) / Chapter Skim
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Appendix C: Participant Biographies
Appendix C: Participant Biographies
Pages 101-124
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From page 101... ...
Her research focuses on the measurement of clinical outcomes and on complex trials evaluating novel device or surgical interventions. She has particular expertise in the design, coordination, and analysis of such multicenter clinical trials.
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From page 102... ...
While in DSI she has been active in developing a risk model for selecting clinical trial sites for inspection, collaborating with the European Medicines Agency and other international regulatory authorities, developing approaches to inspecting electronic data, and instituting process improvements for enforcement actions. Beginning in 2003 she served as branch chief of DSI's Good Clinical Practice Branch II.
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From page 103... ...
A practicing primary care general internist in the Mount Sinai Diagnostic and Treat ment Center, she completed a primary care internal medicine residency at Montefiore Hospital and Medical Center in the Bronx, New York, a pre ventive medicine residency at the University of North Carolina at Chapel Hill where she received her M.P.H. in epidemiology, and a Robert Wood Johnson Clinical Scholars fellowship at University of North Carolina at Chapel Hill.
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From page 104... ...
Brooks' story has been featured in many publications and websites. Always an advocate for people with CF and their families, Brooks is a patient representative on the Protocol Review Committee for the clinical trials network sponsored by the CF Foundation.
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From page 105... ...
Dennis S Charney, M.D., is the Anne and Joel Ehrenkranz Dean of Mount Sinai School of Medicine and Executive Vice President for Academic Affairs of the Mount Sinai Medical Center.
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From page 106... ...
Two years later, he was appointed Dean for Academic and Scientific Affairs for Mount Sinai School of Medicine and Senior Vice President for Health Sciences of the Mount Sinai Medical Center.
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From page 107... ...
In January 2003 he was appointed Dean of Mount Sinai School of Medicine and in March 2003 he assumed the additional position of President and Chief Executive Officer of the Mount Sinai Medical Center. Under his leadership, Mount Sinai entered a new era of innovation in research, education, and clinical care.
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From page 108... ...
After completing his internal medicine residency and chief residency at the University of Washington Hospitals in Seattle, Washington, he pursued a fellowship in Medical Oncology at DFCI and Harvard Medical School, where he has served as an attending physician since 1989.
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From page 109... ...
He has recently completed a sabbatical in biomedical informatics and is currently leading development of VA Informatics resources including clinical trials and translational medicine platforms. Sanford J
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From page 110... ...
She has special expertise in cardiovascular disease, particularly in the design, coordination, and analysis of multicenter trials. She is the PI or co-PI of several Data Coordinating Centers for the NHLBI-sponsored trials, including CT Surgery Clinical Trials Network, the REMATCH trial, and several newer generations of LVAD trials.
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From page 111... ...
Prior to joining Mount Sinai, he served as Director, Division of Adult Translational Research and Treatment Development, at NIMH from 2007 to 2009.
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From page 112... ...
Horowitz, M.D., M.P.H., is Associate Professor of Health Policy and Medicine at Mount Sinai School of Medicine, and a practicing gen eral internist. Her research focuses on using CBPR to address health disparities and improve chronic disease prevention and control.
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From page 113... ...
Michael Krams, M.D., a neurologist by training, has been involved in planning, designing, and implementing adaptive clinical trials for more than a decade. Since 2004 he has -- together with Brenda Gaydos -- cochaired PhRMA's working group on adaptive designs.
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From page 114... ...
Over the past 11 years she has been based full time in East Africa, where she leads a research group whose major research portfolio includes severe malaria, bacterial sepsis, and severe malnutrition. Her work focuses upon understanding the pathophysiology of severe malaria and severe malnutrition and includes clinical trials of emergency interventions to improve outcome.
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From page 115... ...
His research interest in repairing the injured heart has led to clinical trials in autologous skeletal myoblast and cardiac stem cell transplantation. He is an NIH-funded investigator and leader in clinical trial enrollment.
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From page 116... ...
Ramon Murphy is currently in charge of an eight-doctor private practice, closely affiliated with Mount Sinai School of Medicine. The practice, Uptown Pediatrics, has approximately 10,000 patients, 29 employees, and 4 pediatric residents who do all of their outpatient work there.
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From page 117... ...
Dr. O'Dell received his undergraduate degree at the University of Nebraska-Lincoln in electrical engineering and his medical degree and completed a residency and chief residency in internal medicine at the University of Nebraska College of Medicine.
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From page 118... ...
He has spent his career focusing on quantitative methods in clinical and translational research, including the development and application of novel adaptive, Bayesian, and sequential approaches for both exploratory and confirmatory clinical trials.
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From page 119... ...
Dr. Sampson's group is conducting a number of clinical trials to treat food allergy and to understand basic immunologic mechanisms accounting for the eventual development of tolerance.
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From page 120... ...
As part of that unit, Sergel established a unique system of e-mailing doctors and public relations contacts throughout the medical field in order to obtain feedback about developing stories. The e-mail network today includes over 4,000 doctors in 200 specialty areas and over 1,000 public relations professionals at the federal government health agencies, medical centers, hospitals, specialty organizations, pharmaceutical companies, and managed care companies.
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From page 121... ...
This portfolio has included indi vidual bridging awards for postdoctoral fellows, midcareer awards for clinical investigators conducting translational research, and institutional awards for interdisciplinary training programs that bridge the physical/ mathematical and biological sciences. She also represents BWF's interests in consideration of national science policy issues related to BWF's grant making, and is a leader in the community of biomedical research funders.
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From page 122... ...
His long and varied career has included senior leadership roles in the public, nonprofit, academic, and business communities. He is a widely recognized expert in health care policy and finance, Medicare, Medicaid, long-term care, and health care for the homeless, and a much-sought-after speaker and writer in all of those areas.
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From page 123... ...
Christina Zarcadoolas, Ph.D., Associate Professor, City University of New York (CUNY) School of Public Health at Hunter, is a sociolinguist and internationally recognized expert in health literacy and public under
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From page 124... ...
He joined the FDA Division of Cardiovascular Devices (DCD) as a Medical Officer in 1992 and has been actively involved in development and review of clinical trials for many new cardiovascular devices.
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