May 31 - June 1, 2006
Below are biographical sketches for each content expert and moderator who will lead the breakout session discussions on May 31, 2006. The content experts and moderators will summarize the May 31st breakout session discussions for presentation on June 1, 2006. The content experts and moderators are identified by breakout session.
Information Technology
Charles Jaffe, M.D., Ph.D.
Content Expert
Dr. Jaffe is the senior global strategist for the Digital Health Group at Intel Corporation. Previously, he was the Vice President of Life Sciences at SAIC and the Director of Medical Informatics at AstraZeneca Pharmaceuticals. He completed his medical training at Johns Hopkins and Duke Universities, and was a postdoctoral fellow at the National Institutes of Health and at Georgetown University. Formerly, he was President of InforMed, an informatics consultancy to pharma. He has been a principal investigator for more than 200 clinical trials, is the immediate past-chair of the Clinical Information Systems workgroup of the American Medical Informatics Association, and is a board member of various organizations for information technology standards. Currently, he holds an appointment in the Department of Engineering at Penn State University. He is the contributing editor of Biosilico and has published on a range of subjects, including clinical management, informatics deployment, and health care policy.
Rebecca Kush, Ph.D.
Content Expert
Dr. Kush is a founder and the President of the Clinical Data Interchange Standards Consortium (CDISC), which is a nonprofit organization that has established worldwide industry standards to support the acquisition, exchange, submission, and archive of clinical trial data. The current CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health care.
Dr. Kush has over 25 years of experience in clinical research and related areas, including work for the National Institutes of Health, academia, a global contract research organization, and pharmaceutical companies in the United States and Japan. Prior to dedicating full-time as President of CDISC, Dr. Kush founded Catalysis, Inc., a consulting company that focuses on strategy, project management, and process analysis and redesign, particularly associated with the implementation of new technology and associated processes for "electronic clinical trials." Among numerous publications, Dr. Kush is the lead author of the book, eClinical Trials: Planning and Implementation, which conveys the vision of linking clinical research and health care.
Dr. Kush earned a Ph.D. in physiology and pharmacology from the University of California (UCSD) School of Medicine in La Jolla, California. She currently serves on the Board of Directors for the U.S. Health Information Technology Standards Panel (HITSP) and the Drug Information Association (DIA), and she was recently invited to join the Scientific Advisory Group of the International Clinical Trials Registry Platform, recently established by the World Health Organization.
Wayne Kubick, M.B.A.
Moderator
Mr. Kubick was a founding member of the Board of Directors for the Clinical Data Interchange Standards Consortium (CDISC) where he also chairs the technical committee and leads the Submission Data Standards team. He is also a founding member of the Health Level Seven (HL7) Regulated Clinical Research Information Management technical committee and has been a principal investigator on a U.S. Food and Drug Administration (FDA) Cooperative Research and Development Agreement to develop data submission review technologies. In his spare time, he is Senior Vice President at Lincoln Technologies, a subsidiary of Phase Forward, Waltham, Massachusetts, specializing in clinical data architectures, data mining and analysis technologies, electronic regulatory submissions, and information technology strategies and processes for clinical development. He was formerly Chief Information Officer and Vice President of Information Technology at PAREXEL International. He has also worked for BBN Software Products and the Analytical Sciences Corporation. Mr. Kubick possesses over 20 years of information systems experience, holds a B.A. from the University of Illinois and an M.B.A. from Boston University, and is a frequent speaker at industry conferences.
Session List
Data Management
Meredith Nahm, M.S., CCDM
Content Expert
Ms. Nahm is the Director of Clinical Data Integration at the Duke Clinical Research Institute (DCRI), and has been with the DCRI for over 8 years. The DCRI is an academic nonprofit clinical research organization that is part of Duke University Medical Center. Ms. Nahm has over a decade of experience in data management, programming, and quality control. She recently completed a 3-year term on the Society for Clinical Data Management (SCDM) Board of Trustees. She served as the Chairman for the Society for Clinical Data Management's Good Clinical Data Management Practices (GCDMP) Committee from 1998-2001, and authored the GCDMP sections on Measuring and Assuring Data Quality. Ms. Nahm currently serves as the past Chair of the Clinical Data Interchange Standards Consortium (CDISC) Industry Advisory Board (IAB).
Duke and the DCRI have a history of being early implementers of Health Level-7 (HL7) and CDISC standards. Ms. Nahm has served a leadership role in these efforts, and is working with the data standards development efforts in Cardiology and Tuberculosis on two Roadmap contracts. She currently serves a leadership role in the Data and Statistical Center for the National Institute on Drug Abuse Treatment (NIDA) Clinical Trials Network.
Ms. Nahm is a frequent presenter at industry meetings, and publishes in the clinical trial operational literature. Her research interests include quantitative evaluation of common Clinical Data Management (CDM) practices, and quantitative evaluation of data quality. She received undergraduate and master's degrees in nuclear engineering from North Carolina State University.
Elsa Villarino, M.D., M.P.H.
Content Expert
Dr. Villarino is the team leader for the TB Trials Consortium at the Clinical and Health Systems Research Branch for the Centers for Disease Control and Prevention. Dr. Villarino earned an M.D. from Universidad Autonoma de Baja California in Tijuana, Baja California, Mexico and an M.P.H. from San Diego State University in San Diego, California.
Therese Brown Gibson
Moderator
Ms. Gibson is a health programs director at Aspen/Lockheed Martin Information Technology Health Research Division. She has 20 years experience in health communications with eight years' experience specific to managing recruitment and retention for clinical research studies. Ms. Gibson served on the executive committee of the Juvenile Diabetes Research Foundation's (JDRF) Genetics of Kidneys in Diabetes (GoKinD) Study, organizing and directing call center operations and study recruitment. She worked previously with Type 1 Diabetes TrialNet, organizing that network's central call center operations and supporting its development of recruitment materials. She directed the participant retention and compliance program for the Diabetes Prevention Program and has experience directing additional recruitment efforts for both publicly funded and industry-funded clinical studies. Ms. Brown received her B.A. from St. Edwards University in Austin, Texas and pursued graduate studies at the LBJ School of Public Affairs at the University of Texas.
Session List
Recruitment and Retention
Kenneth A. Getz, M.B.A.
Content Expert
Mr. Getz is the chairman of CISCRP, a nonprofit organization that he founded to educate and raise public awareness of the clinical research enterprise, and a senior research fellow at the Tufts Center for the Study of Drug Development. Mr. Getz is also the founder and former CEO of CenterWatch, a leading publisher in the clinical trials industry and one of two businesses that he has created and sold.
A well-known speaker at conferences, symposia, universities, and corporations, Mr. Getz has published over 100 articles and chapters in peer-review journals and books. He is also the author of a nationally recognized book for patients and their advocates entitled Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials. Mr. Getz manages an angel investment fund and serves on a variety of boards and committees including the Institute of Medicine's Clinical Research Roundtable, the Board of Directors of the DIA Foundation, the Consortium to Examine Clinical Research Ethics at Johns Hopkins University, the Clinical Data Interchange Standards Consortium (CDISC), and Harvard Medical School's Osher Institute Leadership Council. He is on the editorial boards of Controlled Clinical Trials, Research Practitioner, and the Drug Information Journal and writes a bimonthly column for Applied Clinical Trials.
Mr. Getz holds an M.B.A. from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor's degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch, Mr. Getz worked for over 7 years in management consulting where he assisted biopharmaceutical companies develop and implement business strategies to improve clinical development performance.
Jennifer Backhouse
Content Expert
Ms. Backhouse has lived all her life in England where she gained a B.Sc. (hons) in pharmacology from King's College London in 1998. Her career so far has been quite varied but has always been linked to her passion and commitment to health care. Ms. Backhouse is currently managing the Mid Anglia Cancer Research Network, which is one of 34 networks in England that make up the National Cancer Research Network (NCRN).
The NCRN provides the National Health Service (NHS) with the infrastructure to support cancer clinical trials in England. Their aim is to improve the speed, quality, and integration of research with the ultimate aim of improving patient care. NCRN was established by the Department of Health in April 2001 and has already succeeded in more than doubling patient accrual into cancer clinical trials.
Away from the office, Ms. Backhouse has had the chance to take part in some unusual trips for charity including dog sledding in Lapland and turtle conservation in Thailand.
Frances Heilig, M.P.A.
Moderator
Ms. Heilig is the Director of Aspen/Lockheed Martin Information Technology's Health Communications Division. Ms. Heilig brings nearly 20 years of experience in targeted health communications strategies; outreach and promotions to general and special audiences; strategic partnerships; community-based marketing; management of an array of public awareness programs; and grassroots and national health communications program development and implementation. Of particular note is Ms. Heilig's extensive knowledge of issues related to participant enrollment and retention in clinical trials. She leads a department focused on research-based, targeted communications on health issues, including HIV/AIDS, cancer, complementary and alternative medicine, and clinical trials. Ms. Heilig served as senior counsel and director of multiple communications programs with the National Institutes of Health (NIH), national nonprofit associations, and university medical centers. She has directed teams specializing in public information, technical assistance, clinical services, media relations, public relations, and creative design. Ms. Heilig received her master of public affairs and her B.A. in political science and urban studies from the University of North Carolina at Greensboro.
Session List
Training and Professional Development
John Hickner, M.D., M.Sc.
Content Expert
Dr. Hickner is a Professor of Family Medicine at The University of Chicago. He received his M.D. degree from Indiana University, completed his family practice training at the Medical University of South Carolina in Charleston in 1978, and earned a master's degree in clinical research design and biostatistics at the University of Michigan School of Public Health in 1995. Dr. Hickner moved to The University of Chicago in September 2003 to be the Associate Chair for Research in the newly established Department of Family Medicine.
From 1978 to 2000, Dr. Hickner practiced the full spectrum of rural family medicine, taught medical students, and led a clinical research program called the Upper Peninsula Research Network at the Upper Peninsula Campus of Michigan State University. From 2000 to 2004, he was the founding director of the American Academy of Family Physicians (AAFP) National Research Network and, in 2001, he established the AAFP Patient Safety Research Center. Patient safety, systems improvement, and quality in primary care practice are his research areas. He is a founding member of the editorial board of The Journal of Patient Safety and on the steering committee of the Chicago Patient Safety Forum.
James Mold, M.D., Ph.D.
Content Expert
Dr. Mold is Professor and Director of the Research Division in the Department of Family and Preventive Medicine at the University of Oklahoma Health Sciences Center in Oklahoma City. He received his M.D. degree from Duke University School of Medicine in 1974 and completed a residency in Family Medicine at Highland Hospital/University of Rochester in 1977. He subsequently completed a mini-fellowship in geriatrics at the University of North Carolina and a master's degree program in biostatistics at the University of Oklahoma College of Public Health.
Dr. Mold is the founder and current Chairman of the Board of Directors of the Oklahoma Physicians Resource/Research Network, a private, not-for-profit, primary care, practice-based research network that includes approximately 100 practices throughout the state of Oklahoma. He has completed a number of network projects involving the epidemiology of and treatment of common clinical conditions, the translation of evidence-based preventive care into practice, and the characterization and dissemination of best administrative and clinical practices. In the process, he has forged collaborative relationships with public health, quality improvement, health insurance, and professional organizations. He serves on the steering committee of the Federation of Practice-Based Research Centers.
Dr. Mold is also a member of the Commission on Science of the American Academy of Family Physicians (AAFP), the North American Primary Care Research Group's Task Force on the Science of Family Medicine, and the Association of Family Medicine Organization's Research Committee. He serves as the AAFP's liaison to the Research Committee of the Society of Teachers of Family Medicine.
Michael Davis, Ph.D.
Moderator
Dr. Davis is a systems manager with more than 20 years experience in managing, analyzing, and designing data systems and all phases of survey research. His background includes requirements analysis, system design and testing, programming, data collection and analysis, and training of systems professionals and end users. As a manager, Dr. Davis has developed project schedules, allocated resources, monitored study progress, and contributed to final reports. He has designed and implemented systems ranging from industry-wide data clearinghouses to intra-organizational data collection for employee assessment. He has worked with leading research firms including Westat; AMS; EDS; Computer Technology Services, Inc.; and NCR.
His experience includes projects using hard copy, CATI, and CAPI data collection. He has been responsible for groups of up to 25 systems professionals working with clients in the private sector as well as state and federal governments.
Session List
Financial Practices
Donna Marinucci
Content Expert
Ms. Marinucci has more than 25 years of experience working in cancer related fields. She is Vice President of Operations for the Coalition of Cancer Cooperative Groups. Ms. Marinucci serves as the Coalition's project director for the National Cancer Institute's program, the Cancer Trials Support Unit (CTSU); she established the infrastructure to operate the CTSU's Regulatory Support System and audit programs. She is co-leader of the CTSU Financial Management Panel, and a member of the Regulatory, Audit, Independent Clinical Research Site Review, Education and Training, and Quality Control Panels. She is the Director of Operations for the Eastern Cooperative Oncology Group (ECOG), Chair's Office. Among her responsibilities is oversight of contracting for all pharmaceutical industry-supported ECOG studies, Group-wide. She is a member of ECOG's Executive Review Committee, Informatics and Eligibility Criteria Working Groups, and Fiscal Oversight Committee. She serves as a member of Working Group IV/V, Summit Series on Cancer Clinical Trials, and as a member of the Per Case Reimbursement Working Group, C-Change (formerly National Dialogue on Cancer). Ms. Marinucci was recently engaged in the capacity of technical advisor for the C-Change, A Guidance Document for Implementing Effective Clinical Trials, V1.2, June 7, 2005. For the NCI Center for Bioinformatics, she is on the Steering Committee of the Clinical Research Exchange (CRIX). She is also a member of the Cooperative Group Remote Data Entry Coordinating Committee. Ms. Marinucci has extensive experience with clinical trials operations at the Coalition and as the Director of Operations for the Drexel University Clinical Trials Research Center. Additionally, she has experience working at two NCI designated cancer centers. She has served as the administrator for clinical programs and Assistant Director of the Kimmel Cancer Center's Clinical Trials Support Service at Thomas Jefferson University, Philadelphia, Pennsylvania and as the Administrative Director for ambulatory services of the Fox Chase Cancer Center, Philadelphia, Pennsylvania.
Deborah Roth, M.S.
Content Expert
Ms. Roth is the Chief Operating Officer of the Duke Clinical Research Institute (DCRI). The DCRI is an academic nonprofit clinical research organization that is part of Duke University Medical Center.
Ms. Roth has served in administrative and management roles in the health care and clinical research sectors for 20 years. Prior to joining the DCRI, she served as Assistant Chief Operating Officer of Duke University Hospital and Administrative Director of the Duke Heart Center. Prior to her tenure at Duke, Ms. Roth worked at the Hillhaven Corporation and the American Heart Association.
Ms. Roth received a master's degree in health policy and management from the Harvard School of Public Health and a B.A. in biology, Phi Beta Kappa, from Clark University. She also completed the Administrative Fellowship Program at Duke University Hospital.
Sadie Bennett
Moderator
Ms. Bennett is a Project Manager at Aspen/Lockheed Martin Information Technology Health Research Division. Ms. Bennett has 30 years of experience conducting qualitative and quantitative research studies including instrument design, Web and CATI survey administration, focus group moderation, in-person interviews, and mail data collections. She has designed and moderated numerous focus groups involving protocol development, selection of focus group participants, facilitation of discussions, and targeted analysis and reporting of individual and combined focus group data. She has also facilitated multiple telephone and in-person peer review sessions. Ms. Bennett was actively involved in evaluation activities for the IECRN project. She played a key role in the design of the mixed mode data collection including multiple survey instruments targeted to various audiences. Ms. Bennett participated in the instrument design, developed Web survey programming specifications, managed a team of Web survey programmers, and authored and published online survey instruments. She was also involved in the development of a logic model for data collection and analysis.
Ms. Bennett was involved in the design of the data collection methodology and employee survey instrument, as well as protocol development and facilitation of focus group discussions for a CDC DVH data collection effort. She is also survey methodologist and lead analyst for survey evaluations of the National Center for Complementary and Alternative Medicine (NCCAM) information services, the National Library of Medicine (NLM) communication services, and a planned ODS survey of academic institutions. In addition, she has developed OMB packages for a wide range of formative, survey, and program evaluation data collection instruments. Ms. Bennett has completed graduate-level coursework in survey methodology at the University of Maryland, and received her B.A. in Economics and Political Science from American University.
Session List
Network Operations
Kevin A. Peterson, M.D., M.P.H., FRCS(Ed), FAAFP
Content Expert
Dr. Peterson is an Associate Professor in the Department of Family Medicine and Community Health at the University of Minnesota Medical School. He has directed the Minnesota Academy of Family Physicians Research Network, a group of 200 family physicians involved in research for 15 years, and served two terms as chair of the Federation of Practice Based Research Network representing over 6000 primary care physicians involved in practice based research. He also currently serves on the Commission on Science for the American Academy of Family Physicians (AAFP). He is principal investigator for the electronic Primary Care Research Network (ePCRN), sponsored by the NIH Roadmap: Re-engineering the Clinical Research Enterprise, and serves as chair of the network development group; IMPACT, a randomized controlled clinical trial of interventions to improve diabetes care in primary care clinics sponsored by the National Institute of Diabetes, Digestive and Kidney Disorders (NIDDK, NIH); and is the University of Minnesota site-principle investigator for the ACCORD Trial, a large diabetes clinical trial sponsored jointly by the National Heart Lung and Blood Institute (NHLBI, NIH), and NIDDK.
David A. Schoenfeld, Ph.D.
Content Expert
Dr. Schoenfeld is the Director of the Massachusetts General Hospital Biostatistics Center, Professor of Medicine at the Harvard Medical School, and Professor at the Department of Biostatistics at the Harvard School of Public Health. In 2004, Dr. Schoenfeld was elected a member of the Food and Drug Administration Pulmonary-Allergy Advisory. He received his Ph.D. and M.A. from University of Oregon in Eugene, Oregon.
No Moderator Required
Session List
Management and Governance
Ira Shoulson, M.D.
Content Expert
Dr. Shoulson received his medical degree in 1971, postdoctoral training in medicine (1971-73) and neurology (1975-77) at the University of Rochester, and in experimental therapeutics at the National Institutes of Health (1973-75). He is the Louis C. Lasagna Professor of Experimental Therapeutics and Professor of Neurology, Pharmacology and Medicine at the University of Rochester School of Medicine in Rochester, New York. Dr. Shoulson founded the Parkinson Study Group (1985) and the Huntington Study Group (1994), international academic consortia devoted to research and development of treatments for Parkinson's disease, Huntington's disease, and related neurodegenerative and neurogenetic disorders. He has served as principal investigator of the NIH-sponsored trials, Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP), the Prospective Huntington At Risk Observational Study (PHAROS), and more than 30 other multicenter controlled trials. He is the chair of the executive committees of the Huntington Study Group and the Parkinson Study Group, an associate editor of Archives of Neurology, and a recent member of the National Institute of Neurological Disorders and Stroke Council.
Andrew A. Nierenberg, M.D.
Content Expert
Dr. Nierenberg is a graduate of the Albert Einstein College of Medicine of Yeshiva University, Bronx, New York. He did his residency in psychiatry at New York University/Bellevue Hospital in New York City. He then went on to become a Robert Wood Johnson Clinical Scholar at Yale University, studying clinical epidemiology. He continued his trek north to join the faculty at Harvard, first to direct one of the Affective Disorders Inpatient Units and then to direct the Affective Disorders Outpatient Unit at McLean Hospital in Belmont, Massachusetts. Dr. Nierenberg then joined the Psychiatry Department at Massachusetts General Hospital in Boston where he is currently Associate Director of the Depression Clinical and Research Program and Medical Director of the Bipolar Programs, as well as Associate Professor of Psychiatry at Harvard Medical School.
He has published over 190 original articles, and over 35 chapters and reviews, and has been listed among the best doctors in North America for the treatment of mood and anxiety disorders since 1994. Dr. Nierenberg was involved in both the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) and the Sequential Treatment Alternatives to Relieve Depression (STAR*D) NIMH contracts, two unprecedented clinical trials that will include thousands of patients with mood disorders. In 2005, Dr. Nierenberg was appointed as the Director of the NIMH Bipolar Trials Network, a new infrastructure for the next generation of bipolar disorder clinical trials.
Patricia Dolan Mullen, Dr.P.H., M.L.S.
Moderator
Dr. Mullen received her doctorate in public health and her master's degree in library science from the University of California, Berkeley. She is currently Professor of Behavioral Sciences and Health Education and Training Director at the Center for Health Promotion Research and Development, School of Public Health, University of Texas-Houston Health Science Center. She is Adjunct Professor of Behavioral Science at the University of Texas M.D. Anderson Cancer Center and Adjunct Professor of Social Psychology at the University of Houston. She has served on numerous panels developing or overseeing clinical guidelines, including the Agency for Healthcare Research and Quality's (AHRQ's) Smoking Cessation and Treating Tobacco Use and Dependence Clinical Practice Guideline Panels, the Department of Health and Human Services' (HHS's) Expert Panel on the Content of Prenatal Care, and the National Heart, Lung, and Blood Institute's (NHLBI's) Clinical Applications Prevention Advisory Committee. She is Vice Chair of the Centers for Disease Control and Prevention's (CDC's) Community Preventive Services Task Force. Dr. Mullen developed and managed demonstration and evaluation projects and provided technical assistance on preventive and primary care services for the HHS Office of Disease Prevention and Health Promotion. She has been principal investigator or co-principal investigator for more than 20 prevention and public health research grants, including several for CDC and the National Cancer Institute (NCI). She has served on ad hoc review panels for the Division of Research Support and other NIH institutes, the Robert Wood Johnson Foundation, and the U.S. Department of Veterans Affairs. She sits on the editorial boards of several health education journals and is ad hoc reviewer for American Journal of Public Health, as well as other distinguished publications.
Session List
