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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Study Methodologies for Diagnostics in the Postmarket Setting, May 12, 2011

The Food and Drug Administration (FDA) has announced a public workshop of Study Methodologies for Diagnostics in the Postmarket Setting.

The purpose of the workshop was to provide a forum for discussion among FDA, governmental agencies, academia, physicians and various stakeholders with expertise in epidemiology, statistics, diagnostics and biomedical research to advance the methodologies for diagnostics in the postmarket setting.


Date, Time and Location

This meeting was held May 12, 2011 at the following location:

FDA White Oak Campus
10903 New Hampshire Ave
The Great Room (Room 1503), White Oak Conference Center, Bldg 31
Silver Spring, MD, 20903

Webcast

Agenda and Presentations

8:30-8:40AM Study Methodology for Diagnostics in the Postmarket Setting
8:30-8:35AMWelcome and Announcements - Hui-Lee Wong, PhD, Epidemiologist, Division of Epidemiology, FDA/CDRH/OSB
8:35-8:40AMOpening Remarks - William Maisel, MD,MPH, Deputy Director for Science, FDA/CDRH
8:40-9:30AM Session 1: Evaluation of Diagnostic Devices through Total Product Life Cycle
Moderator: Hesha Duggirala, PhD, Epidemiologist, Division of Epidemiology, FDA/CDRH/OSB
8:40- 9:00AMPremarket Evaluation of Diagnostics
Robert L. Kramm, MD, Medical Officer, FDA/CDRH/ODE
9:00-9:20AM  Postmarket Surveillance of Diagnostics
Jill Marion, Team Leader, Division of Patient Safety Partnerships, FDA/CDRH/OSB
Jean M. Cooper, DVM, Associate Director, Surveillance and Outreach Programs/FDA/CDRH/OIVD
9:20-9:30 AM

Unique Opportunities for Advancing the Methods and Infrastructure for Postmarket Studies of Medical Devices
Danica Marinac-Dabic , MD , PhD, Director, Division of Epidemiology, FDA/CDRH/OSB

9:30-9:40AM BREAK
9:40-11:45AM Session 2: Potential Gaps in the Postmarket Studies and Surveillance of Diagnostic Devices
Moderator: Ellen Pinnow, MS, Branch Chief, Division of Epidemiology, FDA/CDRH/OSB
9:40-9:55AMCurrent Methodological Challenges of In Vitro Diagnostics at the Postmarket Setting
Steve Gutman, MD, MBA, BlueCross Blue Shield Evidence Based Practice Center
9:55-10:10AMPoint-of-care Diagnostics in Post-Approval Settings
Elliot Cowan, PhD, Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, FDA/CBER/OBRR
10:10-10:25AMPostmarket Surveillance of Medical X-ray Imaging
CAPT Sean M. Boyd, MPH, Deputy Director, Division of Mammography Quality and Radiation Programs, FDA/CDRH/OCER
10:25-10:40AMGaps and Challenges of Diagnostics for Glaucoma
Gadi Wollstein, MD, Associate Professor and Director, Ophthalmic Imaging Research Laboratories University of Pittsburgh School of Medicine
10:40-10.55AMFramework for Postmarket Study Design for Diagnostics in Primary Care
Matthew Thompson, MD, MPH, DPhil, Associate Professor, Oregon Health and Science University
10.55-11.10AMCardiac Monitoring Devices: Clinical Alarm Fatigue
Barbara J. Drew, RN, PhD, FAAN, FAHA, Lillian and Dudley Aldous Professor of Nursing Science Clinical Professor of Medicine, Cardiology University of California, San Francisco
11:10-11:45AM PANEL: Potential Gaps and How We Can Address Them
Moderator: Kristen Meier, PhD, Mathematical Statistician, FDA/CDRH/OSB
Felipe Aguel, PhD, Food and Drug Administration
Robert L. Kramm, MD, Food and Drug Administration
Robert L. Becker Jr, MD, Food and Drug Administration
Danica Marinac-Dabic, MD, PhD, Food and Drug Administration
Steve Gutman, MD, MBA, BlueCross BlueShield
Elliot Cowan, PhD, Food and Drug Administration
CAPT Sean M. Boyd, MPH, Food and Drug Administration
Gadi Wollstein, MD, University of Pittsburgh
Matthew Thompson, MD, MPH, DPhil, Oregon Health and Science University
Barbara J. Drew, RN, PhD, FAAN, FAHA, University of California, San Francisco
11:45-12:45PM LUNCH
12:45-3:10PM Session 3: Methodologies for Postmarket Studies for Diagnostic Devices
Moderator: Michelle Tarver-Carr, MD, PhD, Epidemiologist, Division of Epidemiology, FDA/CDRH/OSB
12:45-1:00PMDirect Measures of Diagnostic Utility Based on Diagnostic Risk Models
Frank E. Harrell Jr, PhD, Professor, Vanderbilt University School of Medicine
1:00-1:15PMExamining Cardiovascular Imaging with Instrumental Variable Techniques in Medicare Enrollment and Claims Databases
Jersey Chen, MD, MPH, Assistant Professor of Medicine, Yale School of Medicine
1:15-1:30PMMethodological Issues in Postmarketing Surveillance of Diagnostic Imaging Modalities
Ilana Gareen, PhD, Assistant Professor, Brown University
1:30-1:40PM BREAK
1:40-1:55PMPostmarket Surveillance of Rapid Human Immunodeficiency Virus Assays
Laura G. Wesolowski, PhD, Epidemiologist, National Center for HIV/AIDS , Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention
1:55-2:10PMEpidemiological Resources in the US Armed Forces for Surveillance of Diagnostic Devices
COL Robert F. DeFraites, MD MPH, COL MC, Director, Armed Forces Health Surveillance Center
2:10-2:25PMEvaluation of Semi-automated Liquid-based Cytology Tests Using External Data
Marina Kondratovich, PhD,Associate Director for Clinical Studies, FDA/CDRH/OIVD
2:25-3:00PM PANEL: Next Steps for Study Methodologies
Moderator: Estelle Russek-Cohen, PhD, Acting Division Director, FDA/CBER/OBE
Alicia Toledano, ScD, Statistical Collaborative, Inc.
Gene A. Pennello, PhD, Food and Drug Administration
Frank E. Harrell Jr. PhD, Vanderbilt University
Jersey Chen, MD, MPH, Yale University
Ilana Gareen, PhD, Brown University
Laura G. Wesolowski, PhD, Centers for Disease Control and Prevention
COL Robert F. DeFraites, MD MPH, COL MC, Armed Forces Health Suveillance Center
Marina Kondratovich, PhD, Food and Drug Administration
3:00-3:10PM BREAK
3:10-5:10PM Session 4: Evidence Synthesis and Knowledge Management for Diagnostic Devices
Moderator: Xue Ying Sharon Liang, MD, PhD, Epidemiologist, Division of Epidemiology, FDA/CDRH/OSB
3:10-3:25PMMeta-analyses for Evaluating Performance of Medical Tests
Thomas A. Trikalinos, MD, PhD, Co-Director Tufts Evidence-based Practice Center, Associate Director, Center for Clinical Evidence Synthesis
Institute for Clinical Research and Health Policy Studies, Tufts Medical Center
3:25-3:40PMBringing Together Evidence Generation and Evidence Synthesis to Improve Colon Cancer Genetic Testing and Treatment Decisions
Katrina A.B. Goddard, PhD, Senior Investigator, Kaiser Permanente Northwest, Center for Health Research Northwest
3:40-3:55PMComparative-Effectiveness of Imaging Tools
Gregory Klein, PhD, Senior Researcher, University of Washington
3:55-4:10AMElectronic Health Records for the Postmarket Assessment of Diagnostics: Patient Community
Kenneth Mandl, MD, MPH, Co-Director, Centers of Disease and Control Center of Excellence in Public Health Informatics; Associate Professor, Harvard-MIT Division of Health Sciences and Technology
4:10-4:25PMExploration and Visualization of Postmarket Data
Jian Ying Hu, PhD, Thomas J. Watson Research Center, International Business Machine (IBM) Corp.
4:25-5:00PM PANEL: Future Directions
Moderator: Elisabeth U. Kato, MD, MRP, Medical Officer, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality
Steve Gutman, MD, MBA, BlueCross BlueShield
Wendy Nilsen, PhD, National Institutes of Health
Živana Težak, PhD, Food and Drug Administration
Thomas A. Trikalinos, MD, Tufts University
Katrina A.B. Goddard, PhD, Kaiser Permanente
Gregory Klein, PhD, University of Washington
Kenneth Mandl, MD, MPH, Harvard University
Jian Ying Hu, PhD, IBM Corp.
5:00-5:15 PM WRAP-UP and SUMMARY

Biosketches

TIMEPARTICIPANTBIOSKETCH
8:40-9:00AMRobert L. Kramm, MD Dr. Lee Kramm is a board certified Ophthalmologist with a Masters' degree in Biomedical Engineering. He earned his graduate degree from the Tulane University School of Engineering and his medical degree is from the University of Miami School of Medicine. Following medical school he received general and surgical training in Ophthalmology from the Rocky Mountain Lions Eye Institute at the University of Colorado in Denver. He is currently a medical officer and scientific reviewer in the Division of Ophthalmic, Neurological and ENT Devices in the Office of Device Evaluation where he has served for four years. In his position as a medical officer at FDA, Dr. Kramm reviews ophthalmic diagnostic devices and serves on several internal FDA working groups whose goal is to improve and bring consistency to the premarket regulation and clinical evaluation of in vivo diagnostic devices within the Office of Device Evaluation.
8:40-9:00AMRobert L. Becker Jr, MD Robert Becker is Chief Medical Officer for the Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH), FDA, with special attention to inter-office coordination on regulation of newly emerging genetic/genomic IVD's. Dr. Becker previously served as Director, Division of Hematology and Immunology Devices, in OIVD. He is experienced in regulation of IVD’s aimed at cell- and tissue-based specimens (e.g. classical hematology, flow cytometry, cytology, histopathology), plus blood coagulation tests, and immunoserologic tests. Dr. Becker earned his MD and PhD in Immunology at Duke University, and he is board certified in anatomic and clinical pathology. He served in the United States Air Force as a pathologist at the Armed Forces Institute of Pathology, Washington, DC from 1983 to 2004, specializing in urologic pathology and with research and clinical service applying image analysis and flow cytometry to diagnostic pathology.
9:00-9:20AMJill MarionJill Marion is currently a biomedical engineer and team leader with the Division of Patient Safety Partnerships in FDA’s Office of Surveillance and Biometrics. Jill leads FDA’s LabNet program, which focuses on postmarket surveillance of medical devices used in the clinical laboratory setting. Jill has been in her position at FDA for 5 years.
9:00-9:20AMJean M. Cooper, DVMDr. Cooper is currently the Associate Office Director for Surveillance and Outreach in the Office of In Vitro Diagnostic Devices at the Food and Drug Administration. Prior to joining the FDA, Dr. Cooper practiced veterinary medicine. In 1990, she joined the Center for Veterinary Medicine at FDA as an application reviewer then in 1999 transferred to the Chemistry and Toxicology branch chief position in CDRH. Dr. Cooper became the Director for the Division of Chemistry and Toxicology when the Division for Clinical Laboratory Devices was carved out of ODE to become the Office of In Vitro Diagnostic Devices. Dr. Cooper has served in her current position for the past 2 years.
9:20-9:30AMDanica Marinac-Dabic, MD, PhDDanica Marinac-Dabic, MD, PhD is a Director of the Division of Epidemiology at the Center for Devices and Radiological Health, Food and Drug Administration. She is a physician and epidemiologist with the background in obstetrics, gynecology and perinatal epidemiology. Dr. Marinac-Dabic leads three postmarket programs at CDRH:
(1) Post-Approval Studies Program, that encompasses the design, review, monitoring and oversight of the post-approval studies mandated as a condition of approval;
(2) Postmarket Surveillance Studies Program, in charge of postmarket studies mandated under Section 522 of the Act; and
(3) Epidemiologic Research Program, designed to build medical device regulatory research infrastructure and conduct independent epidemiologic research studies to ensure CDRH science-based regulatory decision making. Dr. Marinac-Dabic serves as the Chair of the CDRH Human Subject Research Review Committee, the Chair of the CDRH Epidemiologic Research Council and the Member of the FDA Research Quality Assurance Board. Dr. Marinac-Dabic earned her M.D., Master of Science Degree in Human Reproduction and Ph.D. in Epidemiology from the University of Belgrade Medical School, Belgrade, Yugoslavia. Dr. Marinac-Dabic is the author of several book chapters, manuscripts and presentations on various topics in the field of medical device epidemiology and surveillance.
9:40-9:55AMSteve Gutman, MD, MBADr. Gutman is an Associate Director of Technical Evaluation Center at BlueCross BlueShield; he joined the program in January 2010.  He was previously professor of pathology and a founding member of the University of Central Florida’s new medical school.  Prior to that, he was with the FDA for 17 years as a regulatory scientist, where he was a founding member and director of the Office of In Vitro Diagnostic Evaluation and Safety (OIVD) within the Center for Devices and Radiological Health.  OIVD regulates in-home and laboratory diagnostic tests; as a result of his experience, Dr. Gutman has broad clinical knowledge as well as extensive expertise in evaluating evidence supporting diagnostic test utility.  Earlier, he served as chief of the Clinical Laboratory at the Buffalo Veteran’s Administration Center.  He has been a prolific speaker at many different types of meetings throughout his career, and has recently been invited to serve on panels convened by the Institute of Medicine and the College of American Pathologists.
9:55-10:10AMElliot Cowan, PhD Dr. Elliot Cowan serves as Chief of the Product Review Branch in the Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) and is responsible for the review of all blood donor screening tests and retroviral diagnostics. He also assumed major responsibility for all issues related to rapid HIV testing, including device approval and drafting of policy. He has represented the FDA to discuss tests and testing in many different forums, including the Centers for Disease Control and Prevention, federal advisory committees, industry and professional roundtables, briefings for the Secretary of Health and Human Services, and the World Health Organization. He is also a member of the Laboratory Technical Working Group in the Office of the Global AIDS Coordinator for the President’s Emergency Plan for AIDS Relief (PEPFAR), serving as Chair of the HIV Diagnostics Subcommittee and providing technical assistance for laboratory quality assurance issues in PEPFAR focus countries. Prior to joining CBER at FDA in 1993, Dr. Cowan was at the National Institutes of Health. Dr. Elliot Cowan received his B.A. from Williams College in 1977 and his Ph.D. in Biology and Biomedical Sciences (Cellular, Developmental, and Systemic Biology) from Washington University in St. Louis.
10:10-10:25AMCAPT Sean M. Boyd, MPHCAPT Sean M. Boyd serves as a Director Regulatory Operations Officer and Acting Deputy Director of the Division of Mammography Quality and Radiation Programs in the Office of Communication, Education and Radiation Programs at FDA’s Center for Devices and Radiological Health (CDRH). In this capacity he is responsible for CDRH enforcement programs that ensure the safe manufacture of x-ray systems used for medical diagnostic imaging. These programs also ensure quality of mammographic procedures performed by facilities in the U.S., which aid in the early detection of breast cancer. CAPT Boyd joined CDRH in 1999, and since that time has managed several aspects of FDA’s electronic radiation control program impacting a variety of medical, consumer and commercial electronic products. Previously in CDRH, he worked in the areas of device electromagnetic compatibility and radiation therapy medical devices. CAPT Boyd began his career as a regulatory researcher and engineering analyst with FDA’s Winchester Engineering and Analytical Center in Winchester, MA. He received his undergraduate degree in Biomedical Engineering from Boston University and his Masters in Public Health from the Uniformed Services University of the Health Sciences.
10:25-10:40AMGadi Wollstein, MDDr. Wollstein is an Associate Professor in ophthalmology, glaucoma specialist and the Director of the Ophthalmic Imaging Research Laboratory in the University of Pittsburgh Medical Center (UPMC) Eye Center and the University of Pittsburgh School of Medicine. After completing his clinical training in Israel, Dr. Wollstein has been a fellow in Moorfields Eye Hospital, London, UK, conducting researches on glaucoma detection with confocal scanning laser ophthalmoscopy. Dr. Wollstein had a second fellowship in Tufts-New England Medical Center, Boston, MA where he investigated the use of imaging devices to detect and follows patients with glaucoma. Since 2003, Dr. Wollstein is directing a research group that pioneered in numerous aspects of ocular imaging. Dr. Wollstein’s research has been awarded by the National Institute of Health and other leading funding sources. He has published more than 80 peer-reviewed manuscripts and a substantial number of book chapters and review articles. He is an active reviewer for most of the ophthalmic journals and several bioengineering journals and a scientific reviewer for numerous national and philanthropic funding organizations.
10:40-10:55AMMatthew Thompson, MD, MPH, DPhil.Dr Thompson is Associate Professor in the Department of Family Medicine at Oregon Health & Science University, and Senior Clinical Scientist at the University of Oxford Department of Primary Health Care. He has extensive experience in primary care research, particularly in the areas of infectious disease, paediatrics, and diagnostics. He is Co-Director of the Oxford Centre for Monitoring and Diagnosis (www.madox.org), a research center funded by the UK National Institute for Health Research which is dedicated to improving diagnostic and monitoring strategies used for acute and chronic conditions in primary care. This initiative also includes a horizon scanning system for new and emerging diagnostic technologies. Other ongoing research studies include primary research and systematic reviews of diagnostics in primary care, particularly the use of new diagnostic and point of care technologies. Dr Thompson has over 60 peer reviewed publications, and has been awarded major grant funding from the UK’s National Institute of Health Research, and Health Technology Assessment (HTA) Programmes. Dr Thompson’s clinical background is in Family Medicine. He is a member of the HTA Programme Diagnostics and Screening Panel in the UK, and is Editorial Advisor to several medical journals including the British Medical Journal.
10:55-11:10AMBarbara J. Drew, RN, PhD, FAAN, FAHADr. Barbara Drew is a Professor at the University of California, San Francisco. The primary goal of Dr. Drew's research is to improve cardiac monitoring techniques and practices for more accurate diagnosis of arrhythmias and myocardial ischemia. She serve on the Board of Directors and was the President of the International Society of Computerized Electrocardiology, whose membership is comprised of basic, clinical, and engineering scientists from around the world who are interested in the heart's electrical activity. She has also taken leadership roles in the development of guidelines to promote improvements in electrocardiographic monitoring in hospital and pre-hospital settings with the ultimate aim of improving patient outcomes. Dr. Drew is a fellow of the American Academy of Nursing, the American Heart Association's Council of Cardiovascular Nursing, is active in the American Association of Critical-Care Nurses, and is an editorial board member and manuscript reviewer for many cardiovascular and critical care journals. Her research has been consistently funded by NIH and she has published over 200 articles and research abstracts. She is the recipient of numerous awards, including the 2009 Distinction in Teaching Award at UCSF, a Senior Fulbright Scholar Award, the Lillian & Dudley Aldous Endowed Chair Professorship, and the 1997 Martha Hill New Investigator Award from the American Heart Association.
11:10-11:45AMKristen Meier, PhDKristen Meier, PhD,is a Mathematical Statistician in the Division of Biostatistics at FDA’s Center for Devices and Radiological Health. Dr. Meier received her PhD in statistics from North Carolina State University in Raleigh, NC in 1990. Before coming to FDA in 1995, she worked as a staff fellow in statistics at the National Institute of Environmental Health Sciences, NIH and then as a mathematical statistician for the USDA Food Safety and Inspection Service. She reviews submissions for in vitro diagnostic devices and diagnostic devices in ophthalmology, neurology and cardiology. She also contributes to the development of FDA statistical guidance and guidance for diagnostic devices. Dr. Meier has been an active participant in Clinical Laboratory Standards Institute (CLSI) standards development and has served as a member of CLSI’s Area Committee for Evaluation Protocols and various subcommittees.
11:10-11:45AMRobert L. Becker Jr, MDRobert Becker is Chief Medical Officer for the Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH), FDA, with special attention to inter-office coordination on regulation of newly emerging genetic/genomic IVD's. Dr. Becker previously served as Director, Division of Hematology and Immunology Devices, in OIVD. He is experienced in regulation of IVD’s aimed at cell- and tissue-based specimens (e.g. classical hematology, flow cytometry, cytology, histopathology), plus blood coagulation tests, and immunoserologic tests. Dr. Becker earned his MD and PhD in Immunology at Duke University, and he is board certified in anatomic and clinical pathology. He served in the United States Air Force as a pathologist at the Armed Forces Institute of Pathology, Washington, DC from 1983 to 2004, specializing in urologic pathology and with research and clinical service applying image analysis and flow cytometry to diagnostic pathology.
11:10-11:45AMFelipe Aguel, PhDFelipe Aguel is the Branch Chief of the Cardiac Electrophysiology and Monitoring Branch in the Division of Cardiovascular Devices. Dr. Aguel earned his bachelor’s degree and PhD in biomedical engineering from Tulane University in 1996 2001, respectively where he developed computational models of cardiac arrhythmias. He then worked as a postdoctoral fellow at Johns Hopkins University from 2001-2003, where he conducted research on arrhythmia mechanisms using cell culture and computational modeling techniques. He has been at FDA’s Center for Devices and Radiological Health since 2003.
12:45-1:00PMFrank E. Harrell JrDr. Harrell received his PhD in Biostatistics from the University of North Carolina. He was on the faculty of Duke University for 17 years and of the University of Virginia for 7 years. He founded the Division of Biostatistics and Epidemiology at the University of Virginia School of Medicine and the Department of Biostatistics at Vanderbilt University. His specialties are development of accurate prognostic and diagnostic models, model validation, clinical trials, observational clinical research, technology evaluation, quantifying predictive accuracy, and missing data imputation. Dr. Harrell is an Associate Editor for Statistics in Medicine, a Fellow of the American Statistical Association and is the 2008 Mitchell Lecturer for the Department of Statistics, Glasgow University. He was an FDA expert consultant and a member of the NIH Biostatistical Methods and Research Design Study Section. He is the author of the first and third most cited papers (on development of prognostic models) in the history of Statistics in Medicine and has 198 peer-reviewed publications (5 with >1000 citations). His latest areas of emphasis are pharmaceutical safety, flexible Bayesian clinical trial design and Bayesian analysis, graphical and tabular methods for reporting analyses from clinical trials, and predictive modeling and model validation, especially as applied to medical diagnosis and prognosis.
1:00-1:15PMJersey Chen, MD, MPHDr. Jersey Chen is a board-certified cardiologist and health services researcher in the Department of Internal Medicine, Section of Cardiovascular Medicine at Yale University. Dr. Chen research interests include quality of care, cost-effectiveness analysis, and clinical epidemiology of cardiovascular disease. His current research focuses on evaluating regional variation in cardiovascular imaging and exploring statistical methods to evaluate the relationship between imaging and patient outcomes, and is funded by the Agency for Healthcare Quality and Research. He received his M.D. and Masters in Public Health degrees from Yale University.
1:15-1:30PMIlana Gareen, PhDDr. Ilana Gareen is an epidemiologist in the Department of Community Health at Brown University.  Dr. Gareen’s research focuses on evaluating new and existing medical technologies. Her work concentrates on the comparative effectiveness of diagnostic imaging tests, including the downstream consequences of medical interventions, in particular the impact that these new technologies have on the medical system, patient health, and patient quality of life. Dr. Gareen has been with the American College of Radiology Imaging Network (ACRIN) since its inception.  She has worked on multiple studies evaluating diagnostic imaging technologies and their impact on patient health, including the National Lung Screening Trial, The National CT Colonography Trial, and the National Oncologic PET Registry.  In addition, she is a co-investigator in the Center for Comparative Effectiveness Research in Cancer Imaging, where she is working with collaborators to merge data from the NLST and NOPR with data from the Centers for Medicare Services to evaluate post-imaging health outcomes and health care utilization.  Dr. Gareen has been interested in the issue of Postmarketing surveillance of medical technologies since early in her research career when she examined the association of intrauterine devices and pelvic inflammatory disease.
1:40-1:55PMLaura G. Wesolowski, PhDLaura G. Wesolowski, PhD has been an epidemiologist with the Special Studies and Diagnostics Team in CDC’s Division of HIV/AIDS Prevention since 2004. She has lead research projects related to HIV rapid test post-marketing surveillance, evaluations of HIV testing algorithms, evaluations of HIV test performance in pregnant women, and has published several manuscripts related to HIV diagnostics. She received her PhD in infectious disease epidemiology from UNC in 2004, and was previously employed by the Georgia Division of Public Health as an infectious disease epidemiologist.
1:55-2:10PMRobert F. DeFraites, MD MPH, COL MCRobert DeFraites is a Colonel in the US Army Medical Corps assigned as the Director, Armed Forces Health Surveillance Center in Silver Spring, Maryland, and Consultant in Preventive Medicine to the Army Surgeon General. He is a native of New Orleans, Louisiana, and earned his undergraduate and medical degrees from Tulane University. He completed a Masters in Public Health at the Johns Hopkins School of Hygiene and Public Health. He is board-certified in Pediatrics and Preventive Medicine. He has co-authored a number medical journal articles and oral presentations on military medicine and public health topics. COL DeFraites is a member of the Association of Military Surgeons of the United States, the American College of Preventive Medicine, and the American Society of Tropical Medicine and Hygiene. He is an adjunct Assistant Professor of Preventive Medicine at the Uniformed Services University of the Health Sciences. His military awards include the Legion of Merit and the "A" designator for proficiency in Preventive Medicine.
2:10-2:25PMMarina Kondratovich, PhDMarina V. Kondratovich, Ph.D., is an Associate Director for Clinical Studies, Personalized Medicine, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, FDA. She graduated with a Ph.D. in Mathematical Statistics from the Department of Statistical Modeling at St. Petersburg State University in Russia. Before coming to FDA in 1999, she worked at universities in both Russia and the Ukraine. For 10 years, she provided statistical reviews for the diagnostic devices in Division of Biostatistics, CDRH; she moved to OIVD two years ago. She has been FDA spokesperson at multiple FDA Advisory Panel meetings; she is an active participant in CLSI standards development and in the ISO.
2.25-3:00PMEstelle Russek-Cohen, PhDEstelle Russek-Cohen, Ph.D., is the acting division director in the Division of Biostatistics in the Center for Biologics Evaluation and Research (CBER) in the Office of Biostatistics and Epidemiology. She came to CBER in February 2010 as Deputy Division Director. Before that she was a team leader in the Diagnostic Devices Branch of the Division of Biostatistics, in FDA’s Office of Surveillance and Biometrics at the Center for Devices and Radiological Health. Dr. Russek-Cohen received a Ph.D. in Biostatistics from the University of Washington, Seattle. Dr. Russek-Cohen was a professor in the University of Maryland’s Biometrics Program for 26 years and Director of the Biometrics Program for her last 5 years at College Park when she retired in 2004 and came to FDA. At UM, she regularly collaborated with scientists and epidemiologists on infectious disease research. She also spent a year of sabbatical leave and several summers at the Biometric Research Branch of the National Cancer Institute working on statistical issues in clinical trials. Her current interests in statistics include the assessment of safety of CBER regulated products and statistical issues in personalized medicine. She is a fellow of the American Statistical Association.
2.25-3:00PMAlicia Toledano, ScDAlicia Toledano, Sc.D., is Vice-President of Statistics Collaborative, Inc. (SCI) and joined SCI in 2009. Dr. Toledano has expertise in the unique issues of statistical methods for evaluating diagnostic tests, particularly methods for correlated data in medical imaging devices. Dr. Toledano served as a member of the FDA Medical Device Advisory Committee’s Panel for Radiologic Devices from 1999-2003, receiving an Advisory Committee Service Award from the FDA in recognition of distinguished service at the end of her term. She has continued to serve as a consultant to additional FDA panels since 2003. She is a member of the American Statistical Association and the Eastern North American Region of the International Biometrics Society. She was previously on the faculty of Brown University, Center for Statistical Sciences (2000-2005) and The University of Chicago, Department of Health Studies, Cancer Research Center (1993-1999). While at Brown, she served as either as Protocol Statistician, Acting Director (2003) or Deputy Director (2004-2005) on seven multi-center trials run by the American College of Radiology Imaging Network (ACRIN). She received two Outstanding Contribution Awards from ACRIN (2002, 2003). She received her B.S. in Biology from Cornell University (1987) and her M.S. and Sc.D. in Biostatistics from the Harvard School of Public Health (1991, 1993).
2.25-3:00PMGene A. Pennello, PhDDr. Gene A. Pennello is a Mathematical Statistician and Team Leader, Diagnostics Branch, within the Division of Biostatistics at the FDA Center for Devices and Radiological Health. He has been with the Agency over eleven years. Before joining FDA, Gene was a postdoctoral training fellow at the National Cancer Institute, NIH, in the Division of Cancer Epidemiology and Genetics. Dr. Pennello’s interests include Bayesian medical device clinical trials and post-market signal detection, diagnostic device studies, drug/diagnostic combination products, and multiple comparisons. Dr. Pennello received his Ph.D. in Statistics from Oregon State University. He also has a Master’s degree in Statistics, a bachelor of science degree in Statistics, and a bachelor of science degree in Computer Science and Mathematics from the University California at Davis.
3:10-3:25PMThomas A. Trikalinos, MD, PhDThomas A. Trikalinos, MD, PhD is Co-Director of the Tufts Evidence-based Practice Center at the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center. He researches novel methods for integrating knowledge on the comparative effectiveness of alternative strategies in healthcare. He applies machine learning to semi-automate the early stages of research synthesis, develops statistical methods for multivariate meta-analysis, and develops open-source software for citation screening and for advanced meta-analysis. In addition he is working on methodological issues in producing clinical practice guidelines for multimorbid patients, and develops a framework for rating the strength of recommendations on methods. He has published more than 80 articles and is a member of the editorial board of three journals. In his spare time he machines the Webster miniature internal combustion engine from stock metal and designs a microcontroller-based spark ignition system for the engine.
3:25-3:40PMKatrina A.B. Goddard, PhDDr. Goddard is a genetic epidemiologist and biostatistician who focuses on identifying genetic risk factors for various diseases and population-level genetic surveillance. She has been active in genetic research for complex diseases, including prostate cancer, esophageal cancer, Alzheimer’s disease, diabetic nephropathy, cystic fibrosis, severity of symptoms from dengue infection, and genetic risk factors for obstetrical conditions. She is a Co-PI for the ARRA-funded CERGEN study to conduct comparative effectiveness research on genomic applications for colon cancer. She is also a Co-PI for a Knowledge Synthesis Center to synthesize evidence on current and emerging genetic tests and support translation of evidence into clinical and policy recommendations. Dr. Goddard is the director of the NW Biobank, a resource developed to promote genomic research that includes biological samples linked to electronic medical record data from Kaiser Permanente members. She serves on the Board of Directors for the International Genetic Epidemiology Society, and she has been the chair of the Ethical, Social, and Legal Issues Committee for this organization.
3:40-3:55PMGregory Klein, PhDGregory Klein is a Senior Researcher in the Health Services Department at the University of Washington. He is currently serving as Director of the ADVancing  Innovative Comparative  Effectiveness Research in Cancer Diagnostics (ADVICE) project, an ARRA-funded CER joint effort with investigators from the University of Washington, the Fred Hutchinson Cancer Research Center, and the Group Health Research Institute in Seattle. Dr. Klein has a multi-faceted background in medical imaging in the academic and commercial worlds, with an emphasis towards quantitative analysis of PET and MRI data. Prior to his appointment at the University of Washington, he was President and CEO of QuantifiCare, Inc., a core lab that developed imaging devices and managed image-based endpoints for drug and device clinical trials. In previous academic positions at the Lawrence Berkeley National Laboratory and the Johns Hopkins University, Dr. Klein developed imaging reconstruction and quantification methodologies for advanced imaging techniques with applications to oncology, cardiology and neurology. Dr. Klein’s current research focus is comparative effectiveness and cost analyses of imaging diagnostics.
3:55-4:10AMKenneth Mandl, MDDr. Mandl has innovated and published extensively in the areas of personally controlled health records, disease outbreak detection, public health surveillance, and national health information infrastructure. Recognized for his teaching and research, he has received the Barger Award for Excellence in Mentoring at Harvard Medical School and the Presidential Early Career Award for Scientists and Engineers, the highest honor bestowed by the United States government to outstanding scientists and engineers. Mandl co-directs a CDC Center of Excellence in Public Health Informatics. He is a leader of the SMArtPlatforms project—part of a major federal initiative seeking to create an “app store” for health. Mandl is a member of the Advisory Committee to the Director of the CDC and of Lister Hill Center Board of Scientific Counselors at the National Library of Medicine. He is an attending physician in pediatric emergency medicine, a faculty member in the Harvard Medical School Center for Biomedical Informatics and affiliated faculty at the Harvard-MIT Division of Health Sciences and Technology.
4:10-4:25PMJian Ying Hu, PhDJianying Hu is a research staff member at IBM T. J. Watson Research Center, NY. She received the Ph.D. degree in Computer Science from SUNY Stony Brook in 1993. Prior to joining IBM she was with Bell Labs from 1993 to 2000, and Avaya Labs Research from 2001 to 2003.  Her main research interests include statistical pattern recognition, machine learning and data mining, with applications to healthcare informatics, business analytics, document analysis, and multimedia content analysis and retrieval. She served as associate editor of the IEEE Transactions on Image Processing from 2001 to 2005, associate editor of the IEEE Transactions on Pattern Analysis and Machine Intelligence from 2006 to 2010, and Chair of Technical Committee on Reading Systems of the International Association for Pattern Recognition from 2004 to 2008. She is currently on the editorial board of the journals Pattern Recognition, and International Journal on Document Analysis and Recognition. Dr. Hu is a fellow of the International Association of Pattern Recognition and a senior member of IEEE.
4:25-5:00PMElisabeth U. Kato, MD, MRPDr. Kato is a Medical Officer with the Effective Healthcare Program at the Center for Outcomes and Evidence in the Agency for Healthcare Research and Quality (AHRQ), where she oversees comparative effectiveness reviews in the areas of diagnostics and medical devices, and for cardiovascular and pulmonary medicine. Her first career was in international development, after which she returned to the US to complete a medical degree at the University of Maryland. Since then, she has pursued an interest in health technology assessment, first as Senior Medical Research Analyst with Hayes Inc., an independent healthcare technology assessment company, and now with AHRQ.
4:25-5:00PMWendy Nilsen, PhDWendy Nilsen, Ph.D. is a Health Scientist Administrator at the NIH Office of Behavioral and Social Sciences Research (OBSSR). Wendy’s scientific focus is on the science of human behavior and behavior change, including: utilizing mobile technology to better understand and improve health, adherence, the mechanisms of behavior change and behavioral interventions in complex patients in primary care. More specifically, her efforts in mobile (mHealth) Health research include: convening a meeting to address barriers to the utilization of mobile technology in behavioral and social science research; serving on numerous federal mHealth initiatives; and, leading an upcoming mHealth training institute. Wendy is also the chair of the Adherence Network, a trans-NIH effort to enhance and develop the science of adherence. She is also a member of the Science of Behavior Change, Health Economics and HMO Collaboratory working groups. These projects are initiatives funded through the Common Fund that target behavioral and social sciences research to improve health across a wide range of domains. Wendy also chairs the NIH Integrating Health Strategies workgroup that supports the science of behavioral treatments for ‘complex patients’ in primary care.
4:25-5:00PMŽivana Težak, PhDŽivana Težak, PhD, is an Associate Director for Science and Technology in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety, Personalized Medicine Staff, at the Center for Devices and Radiological Health, Food and Drug Administration (FDA). Prior to joining the FDA in 2004, as a scientific reviewer in microbiology, genomics and molecular biology, Dr. Težak held several research and development scientist positions with biotechnology industry, in bioinformatics and array developer companies. Dr. Težak received a Ph.D. in Biochemistry/Molecular Biology from Florida State University in 1997. From 1998 to 2001 she was a research fellow at the University of Pittsburgh Medical Center and Children's National Medical Center, Research Center for Genetic Medicine, working on research projects in human genetics, gene therapy, and high-throughput screening technologies. Her work resulted in a number of publications in peer-reviewed journals, book chapters and proceedings.

Contact Us

For information regarding registration and special accommodations, contact:

  • Susan Monahan
    Office of Communication, Education, and Radiation Programs
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue, Bldg. 66
    Silver Spring, MD 20993
    Phone: 301-796-5661
    Email: Susan.Monahan@fda.hhs.gov

For information regarding the program, contact:

  • Hui-Lee Wong, PhD,
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue,
    Bldg. 66, Room 4611
    Silver Spring, MD 20993
    Phone: 301-796-6234
    Email: huilee.wong@fda.hhs.gov
  • Xueying Sharon Liang, MD, PhD
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue,
    Bldg. 66, Room G450
    Silver Spring, MD 20993
    Phone: 301-796-9601
    Email: xueyingsharon.liang@fda.hhs.gov
  • Ellen Pinnow, MS
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue,
    Bldg. 66, Room 4106
    Silver Spring, MD 20993
    Phone: 301-796-6066
    Email: pinnowe@fda.hhs.gov