Working Group: Member Bios

Jonathan S. Berg, MD/PhD, is an Assistant Professor of Genetics at the University of North Carolina at Chapel Hill. He is a Clinical Geneticist in the Cancer and Adult Genetics Clinics at UNC Hospitals and a member of the Lineberger Comprehensive Cancer Center. Dr. Berg also serves as Associate Director of the Carolina Center for Genome Sciences, an interdisciplinary group of genome scientists at UNC that promote research, training, and applications of genomics.Dr. Berg’s research focuses on the use of next-generation sequencing technologies for gene discovery in hereditary cancer susceptibility and translation of these emerging methods as a “universal diagnostic test” for a broad range of genetic conditions.
Dr. Berg is a co-PI on a NHGRI U01 “Clinical Sequencing Exploratory Research” project awarded to UNC and led by Dr. James Evans. The project, entitled “NCGENES,” examines whole exome sequencing as a diagnostic test for genetic disorders in diverse patient populations: hereditary cancer susceptibility, genetic cardiovascular conditions, and neurodevelopmental disorders. One of the central aspects of the NCGENES project is the investigation of the impact of incidental findings on patients and their families. This effort, being carried out in collaboration with colleagues in the Center for Genomics and Society and the School of Public Health at UNC, will utilize the concept of “binning” the genome as a model through which to explore the ethical, legal, and social implications of incidental findings discovered by genome-scale sequencing tests. We anticipate that the categorical framework that we have established will facilitate the informed consent, informatics analysis, and return of incidental findings in a clinical context.

Dr. Berg attended Emory University and attained his MD and PhD at the University of North Carolina at Chapel Hill. He then pursued Residency training in Clinical Genetics at Baylor College of Medicine in Houston, TX and is board certified by the American Board of Medical Genetics and a Fellow of the American College of Medical Genetics.

Ned Calonge, MD, MPH, is the President and CEO of The Colorado Trust, a philanthropic foundation dedicated to advancing the health and well-being of the people of Colorado. He is an Associate Professor of Family Medicine at the Colorado School of Medicine, University of Colorado, Denver, and an Associate Professor of Epidemiology at the Colorado School of Public Health.

Outside of the Trust, Dr. Calonge is a member and past President of the Colorado Medical Board, which licenses and regulates physicians. He teaches epidemiology, biostatistics and research methods at the University of Colorado Schools of Medicine and Public Health. He is a member of the Delta Dental Foundation Board, and chairs the Board of Directors for LiveWell, Colorado.

Nationally, Dr. Calonge is the Chair of the United States Preventive Services Task Force and a member of the Centers for Disease Control and Prevention’s (CDC’s) Task Force on Community Preventive Services. He the chair of the CDC’s Evaluating Genomic Applications for Practice and Prevention (EGAPP) Workgroup, and is a member of the Advisory Committee on Heritable Disorders in Newborns and Children in the Maternal and Child Health Bureau in the Health Resources and Services Administration.

Dr. Calonge received his BA in Chemistry from The Colorado College, his MD from the University of Colorado and his MPH from the University of Washington; he is board certified in both Family Medicine and Preventive Medicine. Prior to coming to the Trust, Dr. Calonge was the Chief Medical Officer of the Colorado Department of Public Health and Environment.

Dr. Campos-Outcalt is the Associate Chair for the University of Arizona College of Medicine, Department of Family and Community Medicine, Phoenix Campus. He is also a member of the faculty of the University of Arizona College of Public Health and the director of the MD/MPH program. He is Board certified in both Family Medicine and Preventive Medicine/Public Health and is a practitioner and educator of public health and family medicine. He currently serves as a scientific analyst for the American Academy of Family Physicians (AAFP) and as the AAFP liaison to the Advisory Committee on Immunization Practices of the CDC and to the United States Preventive Services Task Force.

Benjamin Djulbegovic is Professor of Medicine and Oncology at the University of South Florida & H. Lee Moffitt Cancer Center & Research Institute. He also serves as a Division Chief and Director of Center for Evidence-based Medicine and Health Outcome Research. His major academic research interest lies in the area of evidence-based medicine, decision-analysis, clinical reasoning, systematic reviews /meta-analysis and comparative effectiveness research, ethics of clinical trials, practice guidelines, outcomes research, the impact of clinical trials and the role of uncertainty in medicine. He has extensively published and taught on these subjects. As of May 2010, Dr. Djulbegovic has published more than 175 papers in peer-review journals, 138 abstracts and two books related to evidence-based decision-making with application to hematology and oncology, in one of the first published attempts to systematically identify all key decisions in a given medical field. As a researcher and practicing physician, he continues to delve on the issue related to rational principles of decision-making to individuals and populations, as well as the ethical and scientific requirements posed to research involving humans to address uncertainties about the effects of health care interventions. Dr. Djulbegovic’s is an R01- funded investigator and his research has been continuously supported both by private entities and the NIH.

Theodore G. Ganiats, MD, is Professor and Interim Chair in the Department of Family and Preventive Medicine at the University of California San Diego (UCSD) School of Medicine and Executive Director of the UCSD Health Services Research Center. Dr. Ganiats attended the UCSD School of Medicine where he also completed his Family Medicine residency. Dr Ganiats’ outcomes research focuses on quality of life assessment and cost-effectiveness analysis, including evaluations of both smaller, local projects and larger, more systems-levels health care delivery change. This work has involved work that is both theoretical and applied. Due to his interest in evidence-based medicine, he has chaired or served on over 40 national guideline and quality improvement panels and research projects. He is a member of the Institute of Medicine. His teaching includes two Masters-level courses on health services, including quality improvement and accountability at the micro and macro levels, and one on decision analysis. Dr Ganiats remains clinically active, giving him the additional perspective of the practicing clinician.

Cecile Janssens is professor of translational epidemiology in the department of Epidemiology of the Rollins School of Public Health, Emory University, Atlanta, USA. Her research concerns the translation of genomics research to applications in clinical and public health practice, with a focus on the predictive ability and utility of genomic risk prediction. She has published many methodological studies on how to assess the predictive ability and utility, and supervised assessments of the predictive ability in empirical studies for various common multifactorial diseases. She recently co-chaired a workshop that developed reporting guidelines for genetic risk prediction studies, the GRIPS Statement, and chaired a workshop for the European Commission that proposed quality criteria for health checks.
Cecile Janssens has published over 150 papers in international scientific journals and received three prestigious personal grants, most recently the European Research Council Starting grant, which together totaled over 2.7M$. She is a lecturer in many graduate and post-graduate courses in local, national and international programs, and coordinates a summer course on Translational Research in Genomic Medicine at Emory. Before moving to the USA, she was chair of the Dutch Association of Community Genetics and Public Health Genomics and board member of the Netherlands Association for Human Genetics. She still is an active member of the Health Council of the Netherlands.

Roger D. Klein, MD, JD is Medical Director at BloodCenter of Wisconsin and Clinical Assistant Professor of Pathology at the Medical College of Wisconsin. His primary academic and clinical interests involve the translation of molecular genetic knowledge into clinical laboratory tests for the evaluation and management of human malignancies and other diseases. In addition, Dr. Klein has an active research program on the ethical, legal and social implications of the Human Genome Project, with particular emphases in the areas of intellectual property and the regulation of clinical laboratories and in vitro diagnostic devices. Dr. Klein is Chair-Elect of the Association for Molecular Pathology’s (AMP) Professional Relations Committee, and is a member of AMP’s Economic Affairs Committee. He has served on the College of American Pathologists (CAP) “Biochemical and Molecular Genetics,” and “Point-of-Care Testing” Resource Committees, is currently a member of the CAP “Molecular Oncology” Resource Committee, and serves on the American Medical Association (AMA) Molecular Pathology CPT Coding Workgroup. Dr. Klein is a consultant to the FDA’s Clinical and Molecular Genetics Advisory Panel, a member of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), a member of the Clinical Laboratory Standards Institute (CLSI) Subcommittee on Establishing Molecular Testing in Clinical Laboratory Environments. Dr. Klein pursued his undergraduate and medical degrees and an internship in Internal Medicine at Case Western Reserve University in Cleveland, Ohio. He completed residency training in Laboratory Medicine along with a fellowship in Molecular Genetics at Yale University School of Medicine in New Haven, Connecticut, followed by a fellowship in Molecular Genetic Pathology at Mayo Clinic in Rochester, Minnesota. He is board-certified in Clinical Pathology and Molecular Genetic Pathology. Dr. Klein earned his law degree at Yale Law School, where he was an articles editor for the Yale Journal on Regulation and was named Olin Fellow for Law and Public Policy Studies. He is licensed to practice law in the District of Columbia and Ohio. Dr. Klein has multiple peer-reviewed articles, and also is a member of the Editorial Advisory Boards of the journals Pharmacogenomics and Expert Review of Molecular Diagnostics.

Dr. Offit is Chief of the Clinical Genetics Service and Vice Chairman for Academic Affairs in the Department of Medicine at Memorial Sloan-Kettering Cancer Center in New York. He is a Member of the Cancer Biology and Genetics Program at the Sloan-Kettering Institute and Vice-Chairman of the Program in Cancer Prevention, Control and Population Research at MSKCC.
Dr. Offit trained in clinical oncology and cancer genetics and joined the faculty at Memorial Sloan-Kettering Cancer Center in 1988, where he focused on molecular cytogenetic studies of non-Hodgkin’s lymphoma. In 1992, he organized one of the first genetic risk assessment programs seeing both adult and pediatric cancer patients and their families affected by hereditary malignancies. In 1996, Dr. Offit’s research group discovered the most common mutation associated with hereditary breast and ovarian cancer, present in those of Ashkenazi Jewish ancestry. His group also published the first prospective study showing efficacy of genetic testing combined with preventive ovarian surgery for women carrying BRCA mutations. Recently, he has conducted whole genome association studies to elucidate low penetrance cancer predisposition alleles, and is actively engaged in policy discussions relating to the most responsible means to clinically translate these research findings.

Dr. Offit attended Princeton University, the Harvard Medical School, and the Harvard School of Public Health. He was one of the initial members of the Working Group on Cancer Genetics of the National Cancer Institute and chaired the Sub-Committee on Cancer Genetics of the American Society of Clinical Oncology. Dr. Offit is a recipient of a career research award from the American Cancer Society.

Stephen G. Pauker, MD, MACP, FACC, ABMH, is professor of medicine and psychiatry at Tufts University School of Medicine and Tufts Medical Center. He is a member of the Division of Clinical Decision Making, Informatics and Telemedicine, which he founded thirty years ago. Dr. Pauker recently stepped down from his role as Associate Physician-in-Chief at the Tufts Medical Center from 1995-2008.

Board-certified in internal medicine, cardiology and medical hypnosis, Dr. Pauker is a member of the Institute of Medicine of the National Academies of Science, of the Association of American Physicians and of the American Society for Clinical Investigation. He is a past president of the Society for Medical Decision Making, now serving as its historian. He is a Master of the American College of Physicians, a Fellow of the American College of Medical Informatics, the American College of Cardiology, and the American Society for Clinical Hypnosis. He is president-elect and a fellow of the Society for Clinical and Experimental Hypnosis.

Dr. Pauker’s research has been in both clinical decision making and medical informatics. He has authored over 250 scientific papers in health policy, decision making, informatics, cardiology, and the study of how physicians reason. He has published widely on the applications of quantitative tools and reasoning in clinical medicine. He designed and implemented one of the first computer programs to apply artificial intelligence techniques to medicine and developed some of the basic techniques of clinical decision making and cost-effectiveness analysis. His decision analyses include a model to support prospective parents deciding about prenatal diagnosis and models that have examined the cost-effectiveness of screening.

Dr. Pauker has participated in numerous consensus conferences (sponsored by NIH, by the Institute of Medicine, the American College of Physicians, American College of Chest Physicians, and the National Blue Cross Blue Shield Technology Evaluation Committee). He has been an active participant in developing the conferences methodologies and classification schemata for evaluating the quality of clinical evidence and the relation between quality of evidence and the strength of clinical effect. He is a member of MEDCAC, the Medicare Evidence Development and Coverage Advisory Committee. Dr. Pauker is both a methodologist and an active clinician.

A graduate of Harvard College, Dr. Pauker received his medical degree from Harvard Medical School in 1968. He completed an internship at Boston City Hospital and residency training at Massachusetts General Hospital. He also served a clinical fellowship in cardiology at the New England Medical Center Hospital and a research fellowship in cardiology at Massachusetts General Hospital. In 2010 he received a career achievement award from the Society for Clinical and Translational Science for his work in moving research from the bench to the bedside.

Margaret Piper, PhD, MPH is the Director of Genomics Resources at the Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center (TEC, www.bcbs.com/tec), an Agency for Healthcare Research and Quality (AHRQ)-funded Evidence-based Practice Center (EPC). She has been with TEC since 1994, joining the staff full-time in 1999. Her experience at TEC has focused on systematic reviews of medical technology, including topics in autoimmunity and transplantation, oncology, laboratory medicine, and genomics/genetic testing. Dr. Piper has authored over 30 TEC systematic reviews and reports and co-authored 5 AHRQ-EPC reports.

Among other outreach activities, Dr. Piper has served on the Centers for Medicare and Medicaid Services’ Medicare Evidence Development & Coverage Advisory Committee and on a work group for the Institute for Quality in Laboratory Medicine. In addition to these activities, Dr. Piper has given presentations on evidence-based evaluation of genetic tests at meetings organized by the Institute of Medicine, Agency for Healthcare Research and Quality, and the National Cancer Institute.

Prior experience includes over 13 years of managing a variety of clinical diagnostic laboratory departments in both academic hospital and commercial clinical laboratory settings, designing and evaluating new laboratory diagnostics for biomedical industry, consulting with physicians, publishing, and volunteer teaching for professional organizations in laboratory medicine. In 2000, Dr. Piper received a Distinguished Service Award from the American Society of Clinical Pathologists Commission on Continuing Education. Following a mid-career National Cancer Institute fellowship in cancer prevention and control, which included obtaining an MPH in epidemiology, Dr. Piper gained experience in cancer epidemiology at the NCI and subsequently at the Centers for Disease Control and Prevention, with a focus on cancer genetics. Dr. Piper has a BS in molecular biology (University of Wisconsin—Madison), a PhD in immunology (Duke University), and an MPH in epidemiology (Emory University).

Dr. Carolyn Sue Richards is currently professor of Molecular and Medical Genetics and Scientific Director, Molecular Diagnostic Center at Oregon Health & Science University. Dr. Richards received her Ph.D. from Baylor College of Medicine and is certified by the American Board of Medical Genetics in Clinical Biochemical/Molecular Genetics. She has been a molecular genetic laboratory director for 18 years.

Dr. Richards is a Founding Fellow of the American College of Medical Genetics (ACMG), and is the Chair of the ACMG Laboratory Quality Assurance Committee. She is also a member of the Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) Area Committee on Molecular Methods, and Co-Chair of the CLSI Working Group on Molecular Diagnostic Methods for Genetic Diseases. She is on the Board of Directors of the Wolfson Institute for Preventive Medicine as well as the American College of Medical Genetics (2007-2013) and an Advisory Board member for the Eurogentest Network.

Dr. Richard’s research interests are germline mutations in cancer genes and ultra-rare genetic disorders. The focus of her laboratory in recent years has been the development of a sequence-based approach to identify germline mutations in cancer genes and defining the biological and functional significance of sequence variants in the dystrophin gene. New directions include clinical research collaborative projects focusing on mutational analysis of Rett syndrome patients (MeCP2 gene) and Fanconi anemia patients (FANC genes).

Dr. Strickland is the Dean of the College of Nursing and Health Sciences at the Florida International University. Previously Dr. Strickland was a professor in the Nell Hodgson Woodruff School of Nursing at Emory University in Atlanta, Georgia and a professor in the School of Nursing of the University of Maryland at Baltimore. She has taught at the University of North Carolina at Greensboro and North Carolina Agricultural and Technical State University, Greensboro. She has held nursing positions at Davidson County Health Department and Harlem Hospital Center in New York City.

Dr. Strickland earned a doctoral degree in child development and family relations from the University of North Carolina, Greensboro. She took a master’s degree in maternal and child health nursing from Boston University, Massachusetts, and received a bachelor’s degree in nursing from North Carolina Agricultural and Technical State University, Greensboro. She received Honorary Doctorate of Science degrees from the Ohio Medical College, Toledo, Ohio; and Grand Valley State University, Allendale, Michigan.

Dr. Strickland is the founding editor of the Journal of Nursing Measurement. She has also served on the editorial boards or review panels of Advances in Nursing Science, Research in Nursing and Health, Nursing Outlook, Journal of Professional Nursing, Scholarly Inquiry for Nursing Practice: An International Journal, Encyclopedia of Nursing Research, Health Care for Women International, Nursing Leadership Forum, and the American Journal of Public Health. Dr. Strickland also initiated the development of the Nursing Citation Index. In addition to her many other professional activities, she has been a member of the Advisory Committee to The Director of the National Institutes of Health, National Center for Nursing Research National Advisory Council, Chairperson of the Board of Directors of the American Journal of Nursing Company, a member of the U.S. Congressional Black Caucus Health Brain Trust, and served as an intern to former U.S. Congressman Ralphe Metcalfe (D-Ill.).

Dr. Strickland has been recognized for her outstanding contributions to nursing through her election to the American Academy of Nursing, the youngest person ever elected into the Academy. A former columnist for the Baltimore Sun, her column titled “Nurse’s Station,” which appeared regularly in the health magazine section of the Morning and Evening Sun, won two health journalism awards in 1988. Six volumes of Measurement of Nursing Outcomes series , for which she identified the need and co-edited, won eight “American Journal of Nursing Book of the Year” Awards. Dr. Strickland has been selected as a Kellogg National Fellow, a fellowship program in leadership for the nation’s top young professionals. She was also an Endowment for the Humanities Fellow in Bioethics and an American Nurses’ Association Minority Doctoral Fellow, and selected as a Ford Foundation Fellow.

An internationally known specialist in nursing research, measurement, evaluation, maternal and child health and parenting, Dr. Strickland is frequently called upon as a consultant nationally and internationally, and has presented more than 200 lectures, speeches and workshops. Her research on expectant fathers has been featured in over 80 newspapers (including the Washington Post and the Chicago Tribune) and on over l,200 radio stations internationally. An Associated Press story about her NIH funded study of premenstrual syndrome (PMS) appeared in numerous newspapers across the nation, and has been featured on three television news programs. Dr. Strickland was one of the Emory site principal investigators for the Women’s Health Initiative (WHI), one of the largest known clinical trial of its kind which studied 168,000 postmenopausal women nationally over the course of 9 years. She has appeared on national television shows including on NBC’s “Frank Field’s Health Field Show,” “Straight Talk,” ABC’s “Nightly News with Peter Jennings” and on several local television programs. In addition to contributing to professional journals, she has written or contributed to 21 books.

Sean Tunis, MD, MSc. is the Founder and Director of the Center for Medical Technology Policy in Baltimore, Maryland. CMTP’s main objective is to improve the quality and relevance of clinical and health services research by providing a neutral forum for collaboration among experts, stakeholders and decision makers. Dr. Tunis was a member of the Institute of Medicine Committee on Initial National Priorities for Comparative Effectiveness Research. He advises a wide range of domestic and international public and private health care organizations on issues of comparative effectiveness, evidence based medicine, clinical research, reimbursement and health technology policy.

Through September of 2005, Dr. Tunis was the Director of the Office of Clinical Standards and Quality and Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS). In this role, he had lead responsibility for clinical policy and quality for the Medicare and Medicaid programs, which provide health coverage to over 100 million US citizens. Dr. Tunis supervised the development of national coverage policies, quality standards for Medicare and Medicaid providers; quality measurement and public reporting initiatives, and the Quality Improvement Organization program. As Chief Medical Officer, Dr. Tunis served as the senior advisor to the CMS Administrator on clinical and scientific policy. He also co-chaired the CMS Council on Technology and Innovation

Dr. Tunis joined CMS in 2000 as the Director of the Coverage and Analysis Group. Before joining CMS, Dr. Tunis was a senior research scientist with the Technology Assessment Group, where his focus was on the design and implementation of prospective comparative effectiveness trials and clinical registries. Dr. Tunis also served as the Director of the Health Program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate Committee on Labor and Human Resources, where he participated in policy development regarding pharmaceutical and device regulation.

He received a B.S. degree in Biology and History of Science from the Cornell University School of Agriculture, and a medical degree and masters in Health Services Research from the Stanford University School of Medicine. Dr. Tunis did his residency training at UCLA and the University of Maryland in Emergency Medicine and Internal Medicine. He is board certified in Internal Medicine and holds adjunct faculty positions at Johns Hopkins, Stanford and the University of California San Francisco Schools of Medicine.

Marc S. Williams, MD, FAAP, FACMG is an alumnus of the University of Wisconsin-Madison having graduated with a BS in Chemistry in 1977, and an MD in 1981. He did a pediatric residency at the University of Utah from 1981-1984. After two years of solo practice in Hillsdale, Michigan, he joined the Riverside (California) Medical Clinic as a general pediatrician and practiced there until 1991. From 1991 until joining Intermountain Healthcare, Dr. Williams was at the Gundersen Lutheran Medical Center in La Crosse, WI. Hired as a general pediatrician, he eventually pursued fellowship training in Clinical Genetics, and was board certified in this specialty in 1996 and recertified in 2006. In 1999, he gave up general pediatric practice and became the associate medical director of the Gundersen Lutheran Health Plan while maintaining his genetic practice. It was by combining these two areas of expertise that he developed an interest in the role of genetics in health care delivery. He has published and presented extensively on this topic. From January of 2005 to December 2011 he was the director of the Intermountain Healthcare Clinical Genetics Institute in Salt Lake City, Utah. In addition to his administrative duties, Dr. Williams runs a clinic for evaluation of adults with mental retardation, birth defects and genetic disorders. As of January 2012, he is director of the Genomic Medicine Institute for Geisinger Health System in Danville, PA. He is the co-PI of Geisinger’s eMERGE project and medical director of the Clinical Whole Genome Sequencing project. He is a director of the board of the American College of Medical Genetics and in 2009 was elected Vice-President of Clinical Genetics of the College. He has participated in the Personalized Medicine Workgroup of the Department of Health and Human Services’ American Health Information Community Task Force, chaired the CDC’s EGAPP Stakeholder’s Group, was a member of the CDC’s CETT program review board and the Secretary’s Advisory Committee for Genetics, Health and Society, having previously served on the Coverage and Reimbursement Task Force of that group. He is past chair of the Committee on the Economics of Genetic Services of the American College of Medical Genetics, as well as chair of the subcommittee on Health Care Systems of the Section on Genetics and Birth Defects of the American Academy of Pediatrics. He is currently chairing the ACMG Ad Hoc Committee on the Value of a Genetic Diagnosis. He founded the American College of Medical Genetics Quality Improvement Special Interest Group. He is the Editor-in-Chief of the Manual on Reimbursement for Medical Genetic Services. He has authored over fifty articles in the peer-review medical literature and is a frequent presenter at national and international meetings.

Doris Teichler Zallen is Professor of Science-and-Technology Studies at Virginia Tech and founder of Choices and Challenges, an award-winning public bioethics education project. She holds adjunct appointments in the Department of Biochemistry, the graduate program in Genetics, Bioinformatics, and Computational Biology, and the Virginia Tech/Carilion Medical School. In 2007, she was the recipient of the State Council on Higher Education in Virginia (SCHEV) Outstanding Faculty Award.

She earned her undergraduate degree at Brooklyn College, received her doctorate in biology from Harvard University, and conducted post-doctoral research at the University of Rochester. A former laboratory scientist, she has turned her attention to studying the ethical, social, and policy issues arising out of advances in human genetics. She is the author of two books on genetic testing: Does It Run in the Family? A Consumer’s Guide to DNA Testing for Genetic Disorders and To Test or Not to Test: A Guide to Genetic Screening and Risk. Zallen has been a member of the Recombinant DNA Advisory Committee (the RAC) of the National Institutes of Health and of its Human Gene Therapy Subcommittee. During her tenure on the RAC, she chaired the Working Group on Informed Consent. She is currently a member of the Medical Advisory Committee of the National Organization for Rare Disorders (NORD).