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Appendix E
Committee Member and
Staff Biographies
COMMITTEE MEMBERS
Gilbert S. Omenn, M.D., Ph.D. (Chair), is a professor of Medicine, Genetics,
Public Health, and Computational Biology at the University of Michigan,
where he also serves as director of the Center for Computational Medicine
& Bioinformatics and the Proteomics Alliance for Cancer Research. From
1997 to 2002, Dr. Omenn was chief executive officer and executive vice
president for Medical Affairs of the University of Michigan Health System.
His research interests include cancer proteomics, chemoprevention of can-
cers, public health genetics, science-based risk analysis, and health policy.
Dr. Omenn served as associate director, Office of Science and Technology
Policy, and associate director, Office of Management and Budget, in the
Executive Office of the President in the Carter Administration. He was
president of the American Association for the Advancement of Science
in 2006. He received his M.D. magna cum laude from Harvard Medical
School and his Ph.D. in Genetics from the University of Washington. His
advice is sought from nonprofit organizations, pharmaceutical companies,
and biotechnology companies. Dr. Omenn serves on scientific advisory
boards and boards of directors for several companies in the pharmaceutical/
biotechnology realm.
Catherine D. DeAngelis, M.D., is editor-in-chief emerita of the Journal of
the American Medical Association and a professor at the Johns Hopkins
University School of Medicine (Pediatrics) and the Johns Hopkins Univer-
sity School of Public Health (Health Services Administration). From 1990
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to 1999 she was vice dean for Academic Affairs and Faculty, Johns Hopkins
University School of Medicine, and from 1994 to 2000, she was editor of
Archives of Pediatrics and Adolescent Medicine. She also has been a mem-
ber of numerous journal editorial boards. She has authored or edited 11
books on pediatrics and medical education and has published more than
250 peer-reviewed articles, chapters, and editorials. Most of her recent
publications have focused on conflict of interest in medicine, on profes-
sionalism and integrity in medicine, on women in medicine, and on medi-
cal education. Dr. DeAngelis is a former council member of the National
Academy of Sciences, Institute of Medicine; a fellow of the American Asso-
ciation for the Advancement of Science; and a fellow of the Royal College
of Physicians. She has served as an officer of numerous national academic
societies, including past chair of the American Board of Pediatrics and chair
of the Pediatric Accreditation Council for Residency Review Committee of
the American Council on Graduate Medical Education. She currently serves
on the Advisory Board of the U.S. Government Accountability Office. She
received her M.D. from the University of Pittsburgh’s School of Medicine,
her M.P.H. from the Harvard Graduate School of Public Health (Health
Services Administration), and her pediatric specialty training at the Johns
Hopkins Hospital. She also has been awarded seven honorary doctorate
degrees and has received numerous awards for humanitarianism and medi-
cal excellence.
David L. DeMets, Ph.D., is currently professor in the Department of Bio-
statistics and Medical Informatics at the University of Wisconsin–Madison.
Since receiving his Ph.D. from the University of Minnesota, he has been very
active in the design, conduct, and analysis of clinical trials in several disease
areas. Following a postdoctoral appointment at the National Institutes of
Health (NIH) (1970-1972), he spent 10 years (1972-1982) at the National
Heart, Lung, and Blood Institute, where he became chief of the Biostatistics
Research Branch. In 1982, he joined the University of Wisconsin School of
Medicine, where he founded and chaired the Department of Biostatistics
and Medical Informatics until 2009. He is currently assistant director for
Biostatistics and Medical Informatics for the University of Wisconsin Insti-
tute for Clinical and Translational Research, funded in part by NIH. He has
coauthored or edited four texts, including Fundamentals of Clinical Trials,
now in its fourth edition, as well as texts on statistical methods for clinical
trials, principles for data monitoring committees, and case studies for data
monitoring. Dr. DeMets is a recognized international leader in statistical
research and methods for the analysis of clinical trials. He has collaborated
in the development of statistical methods for the sequential analysis of
outcome data and the design of clinical trials. He has extensive national
and international clinical trial experience and has served on and chaired
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APPENDIX E
numerous NIH and industry-sponsored Data Safety and Monitoring Com-
mittees for clinical trials in diverse disciplines. He served on the Board of
Scientific Counselors of the National Cancer Institute and Board of Direc-
tors of the American Statistical Association, and has been president of the
Society for Clinical Trials and president of the Eastern North American
Region of the Biometric Society. He is a fellow of the American Statistical
Association, International Statistics Institute, Society for Clinical Trials,
American Association for Medical Informatics, and American Association
for the Advancement of Science.
Thomas Fleming, Ph.D., is professor of Biostatistics and Statistics and a full
member in the Division of Public Health Sciences at the Fred Hutchinson
Cancer Research Center. He chaired the Department of Biostatistics from
1993 to 2006, and until 2007 directed the Biostatistics/Epidemiology Core
in the University of Washington Center for AIDS Research. He also served
as director of the Statistical Center for the HIV/AIDS Prevention Trial Net-
work of the National Institute of Allergy and Infectious Diseases (NIAID)
from 1993 to 2007. For 25 years, Dr. Fleming has been a special govern-
ment employee with the U.S. Food and Drug Administration (FDA). He has
served as chair or a member of data monitoring committees for approxi-
mately 200 industry- and government-sponsored clinical trials. He was
involved in the development and coordination of NIAID’s national clinical
trials program for the prevention and treatment of HIV infection and AIDS
and is a member of the Therapeutics Research Working Group in the Office
of AIDS Research.
Chief among Dr. Fleming’s research interests are survival analysis,
sequential analysis, and the design and analysis of clinical trials, with a
special interest in regulatory issues. In 1987 he was elected a fellow of
the American Statistical Association. He has received numerous awards,
including American Public Health Association’s Spiegelman Award, the
FDA Commissioner’s Special Citation Award, the School of Public Health’s
Outstanding Teacher Award, and was the 2007 Greenberg Lecturer at the
University of North Carolina. Dr. Fleming received his master’s degree and
Ph.D. from the University of Maryland, College Park. He has authored
or coauthored several books and more than 200 research articles in peer-
reviewed journals.
Gail Geller, Sc.D., M.H.S., is a professor in the Department of Medicine
at Johns Hopkins University, with joint appointments in the Department
of Pediatrics and the Bloomberg School of Public Health’s Departments of
Health, Behavior & Society and Health Policy & Management. She is also
co–deputy director of the Greenwall Postdoctoral Fellowship Program in
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Bioethics & Health Policy in the Berman Institute of Bioethics, and is affili-
ated with the McKusick-Nathans Institute of Genetic Medicine.
Dr. Geller’s research has centered on the ethical and psychosocial impli-
cations of genetics and genomics. She has been a member of the National
Institute of Health’s (NIH’s) Cancer Genetics Studies Consortium and
Informed Consent Consortium, and cochaired the Task Force on Informed
Consent for Cancer Susceptibility Testing. Her focus on informed consent
for genetic testing stems from a broader interest in communication and deci-
sion making under conditions of uncertainty and the intrapersonal, inter-
personal, cultural, and institutional forces that affect it. This overarching
theme is reflected in Dr. Geller’s other areas of scholarship, including the use
of complementary and alternative medicine and the care of children, young
adults, and families affected by chronic, life-limiting disorders (recently, she
received one of the NIH “challenge” grants to explore this issue). Dr. Geller
also has longstanding interests in research ethics and integrity (she is a
member of the ethics core of the Johns Hopkins Clinical and Translational
Science Awards program) and in medical education. Dr. Geller has served
on numerous panels, including the scientific review panel for the Ethical,
Legal and Social Issues Program at the NIH’s National Human Genome
Research Institute; and the Board of Directors of the American Society for
Bioethics & Humanities. She is a fellow of the Hastings Center. She received
her B.S. from Cornell University and her doctorate from the Johns Hopkins
School of Public Health with concentrations in Bioethics and Social and
Behavioral Sciences.
Joe W. Gray, Ph.D., received undergraduate training in Engineering Physics
from the Colorado School of Mines and a Ph.D. in Nuclear Physics from
Kansas State University. He joined the Biomedical Sciences Division of the
Lawrence Livermore National Laboratory, where he became increasingly
active in the development of a broad range of analytic techniques useful
in the study of human and model cancers. Dr. Gray became a profes-
sor of Laboratory Medicine and Radiation Oncology at the University of
California, San Francisco (UCSF) in 1991 to develop clinical applications
of these tools. He was interim director at the UCSF Helen Diller Family
Comprehensive Cancer Center from 1995 to 1997 and served as program
leader for Cancer Genetics and Breast Oncology. Dr. Gray was associate
laboratory director for Life Sciences and director of the Life Sciences Divi-
sion at the Lawrence Berkeley National Laboratory (LBNL) from 2003
to 2010. He joined Oregon Health and Science University (OHSU) in
2011 as the Gordon Moore Endowed Chair, where he serves as chair of
the Department of Biomedical Engineering, director of the OHSU Center
for Spatial Systems Biomedicine, and associate director for Translational
Cancer Research in the Knight Cancer Institute. He continues as a visiting
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APPENDIX E
senior scientist at the LBNL and emeritus adjunct professor of Laboratory
Medicine at UCSF. He is a member of the National Cancer Institute (NCI)
Board of Scientific Advisors and the National Academy of Sciences (NAS)
Nuclear and Radiation Studies Board. Dr. Gray’s current research program
explores mechanisms by which genomic, transcriptional, and proteomic
abnormalities occur in selected cancers; elucidates how these abnormalities
contribute to cancer pathophysiology; and assesses the ways in which cells
carrying these abnormalities interact with the microenvironment to influ-
ence responses to gene-targeted therapies.
Dr. Gray’s work is described in more than 390 publications and in 68
U.S. patents. He has won many distinguished awards, including the United
States Department of Defense’s Innovator Award, Susan G. Komen Founda-
tion’s Brinker Award for Scientific Distinction, and the American Associa-
tion for Cancer Research’s Team Science Award.
Daniel F. Hayes, M.D., is the clinical director of the Breast Oncology
Program at the University of Michigan Comprehensive Cancer Center
(UM CCC), where he is the Stuart B. Padnos Professor of Breast Cancer
Research and a professor in the Department of Internal Medicine, Divi-
sion of Hematology Oncology at the University of Michigan School of
Medicine. Dr. Hayes’ professional training and career have been directed
toward bridging the gap between laboratory and clinical research. In
1992, he assumed the role as the medical director of the Breast Evalua-
tion Center at Dana-Farber Cancer Institute (DFCI) until 1996, when he
moved to Georgetown University and spent the next 5 years establishing
a successful collaboration with Dr. Marc E. Lippman. In 2001, both Drs.
Lippman and Hayes joined the UM CCC to continue their translational
science. Dr. Hayes serves on scientific advisory boards for biotechnology
companies.
Dr. Hayes has been influential in both clinical and laboratory studies of
the diagnosis and treatment of breast cancer. With his colleague, Dr. Donald
Kufe, Dr. Hayes published the first reports concerning the development
of the CA15-3 blood test, which is currently used world-wide to evaluate
patients with breast cancer. He has become an internationally recognized
leader in the use of this and other tumor markers, such as human epidermal
growth factor 2 (HER2). Dr. Hayes and his colleagues have also reported
ground-breaking results regarding circulating tumor cells in metastatic
breast cancer and the pharmacogenomics of tamoxifen. He is considered to
be an expert in the field of clinical research of breast cancer, especially new
hormonal and chemotherapeutic treatments, and lectures and publishes on
the management of patients with breast cancer. Dr. Hayes has been chair of
the Solid Tumor Correlative Sciences Committee of the Cancer and Leuke-
mia Group B, and now holds similar positions in the Southwest Oncology
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Group and the U.S. Breast Cancer Intergroup. He cochairs the Expert Panel
for Tumor Marker Practice Guidelines for the American Society of Clini-
cal Oncology, and he is on the editorial boards of several leading cancer
journals. He received a bachelor’s degree in biology and a master’s degree in
biochemistry at Indiana University. He received his M.D. from the Indiana
University School of Medicine, followed by a residency in Internal Medicine
at the University of Texas Health Science Center at Dallas and a fellowship
in Medical Oncology at Harvard’s DFCI.
I. Craig Henderson, M.D., spent the first 25 years of his career conduct-
ing clinical and translational research, first at the National Cancer Insti-
tute, then at Dana-Farber Cancer Institute from 1973 to 1992, where he
founded the Breast Evaluation Center (1980), and then at University of
California, San Francisco (UCSF), as a professor of Medicine and chief
of Medical Oncology (1992-1995). Currently, he is an adjunct professor at
UCSF, where he sees patients, teaches, and participates in the Breast Cancer
Specialized Program of Research Excellence (SPORE). In 1995 he became
chair and CEO of SEQUUS Pharma. When it merged with Alza in 1999 he
became a member of the Alza Board and a senior consultant to the com-
pany until 2001, when Alza was purchased by Johnson & Johnson. In 2000
he created a new biotechnology company, Access Oncology, Inc. (AOI),
which was merged with Keryx Biopharmaceuticals in 2004. He continued
as president of the combined entity until 2008.
Highlights of Dr. Henderson’s career include principal investigator of
the national trial that established paclitaxel as a treatment for early breast
cancer; chair of the Early Breast Cancer Trialists Group (“Oxford Over-
views”) for 10 years; and chair of the Breast Committee of the CALGB
from 1989 to 1995. He founded the Bay Area Breast Cancer Translational
Research Program, which has received multiple SPORE awards. From 1989
to 1992, he was a member and chair of the U.S. Food and Drug Adminis-
tration’s (FDA’s) Oncologic Drug Advisory Committee. Dr. Henderson has
served on the Blue Cross Blue Shield Association Medical Advisory Panel
for more than 19 years and the Medicare Coverage Advisory Commit-
tee for 3 years. During his tenure at SEQUUS, FDA approved two drugs,
Amphotec and Doxil; Doxil was the first drug application submitted under
accelerated approval regulations. AOI and Keryx in-licensed four oncology
and four non-oncology drugs between 2000 and 2006, including a first-in-
class Akt inhibitor, perifosine. Dr. Henderson serves on data monitoring
committees for government- and industry-sponsored clinical trials; he also
serves on scientific and medical advisory boards for organizations conduct-
ing technology assessments in health care. Dr. Henderson has published
nearly 300 books and papers.
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Larry Kessler, Sc.D., is professor and chair, Department of Health Services,
University of Washington. Dr. Kessler served as director of the Office of Sur-
veillance and Biometrics, Center for Devices and Radiological Health, U.S.
Food and Drug Administration, until 2008. From 1984 to 1995, he headed
and developed the Applied Research Branch at the National Cancer Insti-
tute. In 2001, he spent a year as a visiting scientist at the Fred Hutchinson
Cancer Research Center and served on the faculty of the Department of
Health Services. His current research focus in on cost-effectiveness and
diagnostic value of medical technology in screening for cancer and other
diseases. He is a collaborator on a number of national projects, including
CanCORS, studies of outcomes and patterns of care of both colorectal
cancer and lung cancer. The goal is to examine what kinds of treatment
certain types of patients receive and how the process of obtaining the best
cancer care can be improved. Dr. Kessler received his B.S. in mathematics
from Boston University and his Sc.D. in Health Services Administration
from Johns Hopkins University.
Stanley N. Lapidus, B.S.E.E., currently serves as president of SynapDx Cor-
poration of Southborough, MA, a company he founded in 2009. SynapDx
is developing an assay for early detection of autism based on measuring
changes in RNA expression patterns derived from peripheral blood cells.
In 2003, he cofounded Helicos BioSciences Corp. of Cambridge, MA, and
served as CEO until 2008 and chair of its board of directors until 2010. He
continues to serve as a member of the board. Helicos developed the world’s
first commercial single-molecule DNA sequencer. In 1995, he founded
EXACT Sciences Corp. He served as president and CEO of EXACT until
2000 and then served as chair of its board of directors through 2005.
EXACT develops non-invasive, DNA-based methods for early detection
of colorectal cancer and its precursor lesions. In 1987 he founded Cytyc
Corporation, now part of Hologic Corporation. He served as president
and CEO until 1994. Cytyc developed and markets the leading Pap test
for cervical cancer. Mr. Lapidus currently serves as a board member of
Daktari, T2 BioSystems, and Precision Therapeutics, Inc. All are diagnostics
companies. Mr. Lapidus holds more than 30 issued U.S. patents, primarily
in the field of early detection and diagnosis of cancer. In addition to his
entrepreneurial activities, Mr. Lapidus holds academic appointments in the
Pathology Department at Tufts University Medical School and the Harvard/
Massachusetts Institute of Technology Division of Health Sciences Technol-
ogy. He earned a B.S.E.E. from Cooper Union in New York City in 1970.
He has served as a trustee of Cooper Union since 2002.
Debra G. B. Leonard, M.D., Ph.D., is professor, vice chair for Labora-
tory Medicine, director of the Clinical Laboratories and director of the
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Pathology Residency Training Program in the Department of Pathology
and Laboratory Medicine at Weill Cornell Medical College and New York-
Presbyterian Hospital. In 2009, Dr. Leonard was appointed chief diversity
officer for Weill Cornell Medical College. She is an expert in molecular
diagnostics for genetic, cancer, and infectious diseases. She is certified by the
American Board of Pathology in Anatomic Pathology, and by the American
Boards of Pathology and Medical Genetics in Molecular Genetic Pathology.
Currently, Dr. Leonard is a member of the IOM Roundtable on Translating
Genomic-based Research for Health and chair of the Diagnostic Applica-
tions Working Group of this Roundtable. Dr. Leonard is a past member
of the Secretary’s Advisory Committee on Genetics, Health, and Society to
the U.S. Department of Health and Human Services’ Secretary Michael O.
Leavitt, and a past president of the Association for Molecular Pathology.
She has spoken widely on various molecular pathology test services, the
future of molecular diagnostics, and the impact of gene patents on molecu-
lar pathology practice and patient access to molecular diagnostic testing
services. Dr. Leonard occasionally provides advice to pharmaceutical and
medical instrument companies on specific projects. She is the editor of two
Molecular Pathology textbooks. Most recently, Dr. Leonard received the
2009 Leadership Award from the Association for Molecular Pathology.
Her M.D. and Ph.D. were completed at the New York University School of
Medicine, where she also did her postgraduate clinical training in Anatomic
Pathology, including a surgical pathology fellowship.
Harold Moses, M.D., is the director emeritus of the Vanderbilt-Ingram
Cancer Center; Hortense B. Ingram Professor of Molecular Oncology;
professor of Cancer Biology, Medicine, and Pathology; and the founding
and current director of the Frances Williams Preston Laboratories. After
residency training in Pathology at Vanderbilt and postdoctoral research
training at the National Institutes of Health, he spent 5 years as a faculty
member in Pathology at Vanderbilt and 12 years at the Mayo Clinic, the
last 6 of which were as chair of the Department of Cell Biology. He returned
to Vanderbilt 25 years ago as professor and chair of the Department of Cell
Biology in the School of Medicine. Fifteen years ago he became the found-
ing director of the Vanderbilt Cancer Center with a concurrent appointment
as the B.F. Byrd, Jr., Professor of Clinical Oncology. He resigned as chair of
the Department of Cell Biology in 1998 to devote more time to the Cancer
Center, now named the E. Bronson Ingram Cancer Center. At the end of
2004, he became director emeritus of the Vanderbilt-Ingram Cancer Center
and the Hortense B. Ingram Professor of Medical Oncology. Dr. Moses
graduated from Berea College and then earned an M.D. from Vanderbilt
University School of Medicine.
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William Pao, M.D., Ph.D., is associate professor of Medicine, Cancer
Biology, and Pathology/Microbiology/Immunobiology at Vanderbilt Uni-
versity and the Ingram Associate Professor of Cancer Research, director of
the Division of Hematology/Oncology, and director of Personalized Cancer
Medicine at Vanderbilt-Ingram Cancer Center. He has developed a basic
and translational research program that made seminal contributions to the
understanding of molecular mechanisms in lung cancer pathogenesis. His
work has identified new molecular mechanisms of sensitivity and resistance
of lung cancers to EGFR tyrosine kinase inhibitors and has yielded impor-
tant insights into a molecular understanding of lung adenocarcinoma in
never smokers. Based on these discoveries, he has developed and success-
fully tested new anticancer therapies in animal models and humans. His
work has helped change the standard of care in lung cancer. More recently,
his laboratory has established a high-throughput screen to identify kinase
fusions in cancers using next-generation sequencing technologies. Dr. Pao
has received multiple honors and awards, including an American Society for
Clinical Oncology Young Investigator Award, a Clinical Scientist Develop-
ment Award from the Doris Duke Charitable Foundation, a V Foundation
grant, the Hope Now Award from the Joan’s Legacy Foundation, and a
Stand Up To Cancer Innovative Grant Award from the American Asso-
ciation for Cancer Research. He was elected to the American Society for
Clinical Investigation in 2011. Dr. Pao obtained his M.D. and Ph.D. at Yale
University, did his residency training in Internal Medicine at New York
Presbyterian Hospital-Weill Cornell Campus, and completed his medical
oncology fellowship training at Memorial Sloan-Kettering Cancer Center.
Rebecca D. Pentz, Ph.D., is professor of Hematology and Oncology in
Research Ethics and professor of Pediatrics at the Emory School of Medi-
cine, as well as Faculty for the Emory Ethics Center in Atlanta. She does
empirical ethics research on issues such as informed consent, Phase I research
(first use of a drug in humans), and genetic confidentiality, as well as help-
ing researchers with their protocols to make them ethically sound. Dr. Pentz
embeds ethics companion studies in most of the major grants from the
Winship Cancer Center at Emory and is working closely with Emergency
Medicine in research that uses the exception from informed consent. She
also is active in pediatrics, having recently completed a multisite NCI-funded
study on family decision making in pediatric bone marrow transplant, and
serving on multiple Children’s Oncology Group committees. Her extensive
empirical research forms the basis of her international speaking and pro-
fessional publications. Dr. Pentz sits on several key committees at Emory,
including the Scientific Review Committee for all cancer research and the
Faculty Advisory Committee to the Dean of the Medical School. She is
actively involved in education at the Cancer Institute as the Course Direc-
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tor for Fundamentals of Clinical Research for second year oncology fellows
and mentor of the postbaccalaureate ethics fellow. In 2000, she moved to
Atlanta from Houston, where she directed the Clinical Ethics Program at the
MD Anderson Cancer Center. As a clinical ethicist, she worked closely with
patients and families, offering help for those struggling with end-of-life issues.
Dr. Pentz chairs the Informed Consent Task Force for the Department of
Health and Human Services Secretary’s Advisory Committee on Blood Stem
Cell Transplantation. She is on the External Scientific Panel of the National
Institutes of Health Genotype-Tissue Expression project. She is a member of
both the St. Jude and the Bone Marrow Transplant Clinical Trials Network’s
Data Safety Monitoring Boards and a member of a Centers for Disease Con-
trol and Prevention’s Institutional Review Board. She is coeditor of the ethics
section of the Oncologist. She was on the Ethical, Legal, and Social Issues
Subgroup in support of the cancer Human Biobank.
Nathan Price, Ph.D., is an associate professor at the Institute for Systems
Biology (ISB) in Seattle, WA. He is also an affiliate associate professor in
the Departments of Bioengineering and Computer Science & Engineer-
ing at the University of Washington, where he advises graduate students
as a member of the Graduate College. Prior to moving to ISB, he was an
assistant professor at the University of Illinois at Urbana-Champaign from
2007 to 2011, where he continues to hold adjunct appointments in the
Department of Chemical and Biomolecular Engineering and the Institute
for Genomic Biology. In 2006, Dr. Price was named one of the inaugural
“Tomorrow’s PIs” as a “rising young investigator” in systems biology by
Genome Technology, and in 2008 was the recipient of the National Insti-
tutes of Health Howard Temin Pathway to Independence Award in Cancer
Research. In 2009, he received a National Science Foundation CAREER
Award to use system biology approaches to guide genome-scale synthetic
biology efforts. In 2010, he received the Young Investigator Award from
the Roy J. Carver Charitable Trust for his work to build genome-scale
biomolecular network models of human glioblastoma (brain cancer). In
2011, he was one of 13 chemical scientists to be named a Camille-Dreyfus
Teacher-Scholar by the Dreyfus Foundation. Dr. Price served on the steering
committee of the Mayo Clinic-University of Illinois Alliance for Technol-
ogy-Driven Medicine from 2010 to 2011. He now serves on the scientific
advisory board of TetraVitae Bioscience, Inc., as well as on the Board of
Directors and Scientific Advisory Board of the P4 Medicine Institute. He is
an associate editor of BMC Systems Biology and Biotechnology Journal,
and a deputy editor-in-chief of PLoS Computational Biology.
John Quackenbush, Ph.D., earned his Ph.D. in Theoretical Particle Physics
from the University of California, Los Angeles, then completed a post-
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APPENDIX E
doctoral fellowship in experimental high-energy physics. After receiving
a fellowship from the National Center for Human Genome Research, he
worked with Glen Evans on the physical mapping of human chromosome
11, and later with Richard Myers and David Cox on large-scale DNA
sequencing of chromosomes 21 and 4. In 1998 he joined the faculty at
the Institute for Genomic Research, where his work focused on the use of
genomic and computational methods for the study of human disease. In
2005 he joined the Dana-Farber Cancer Institute (DFCI), where his work
has increasingly focused on the analysis of women’s cancers, although the
methods he and his group develop can be broadly applied. In 2009 he
launched the Center for Cancer Computational Biology, a Dana-Farber
Strategic Plan Center focused on providing computational support more
broadly to the DFCI research community. Dr. Quackenbush occasionally
provides advice to biotechnology companies on specific projects.
Elda Railey is cofounder of Research Advocacy Network, a nonprofit group
dedicated to advancing patient-focused research. She serves as editor of
the e-newsletter, Network News, and director of the Advocate Institute™,
an innovative concept and learning environment for patient advocates.
Research Advocacy Network has published a tutorial series for advocates,
including: Genomics in Cancer, Biomarkers in Cancer, Pathology and Tis-
sue Research, and Understanding Clinical Trial Design. She served for 12
years with Susan G. Komen for the Cure in various capacities, primarily as
director of Grants and Sponsored Programs, where she led one of the larg-
est programs for private funding of breast cancer research.
She has reviewed for Komen, Avon-National Cancer Institute (NCI)
Partners in Progress, and the Centers for Disease Control and Preven-
tion, and is a member of the Intercultural Cancer Council and the Exter-
nal Advisory Board of the University of California, San Francisco Breast
Cancer SPORE. She has served on the National Steering Committee for
Redes En Acción: National Latino Cancer Research Network and was the
team leader for the Insurance team for EDICT (Eliminating Disparities in
Clinical Trials). She was honored with the Art of Advocacy award from the
Genetic Alliance in 2005. As a consultant with the Coalition of Cooperative
Groups, she was program coordinator and contributing author on Cancer
Research: A Guide to Clinical Trials Modules on Drug Development,
Surgical and Radiation Therapies and Tissue and Its Use for the Advocate
Training Program. She has served on the Patient Advocate Committee for
the American College of Surgeons Oncology Group. Currently, she serves
on NCI’s Early Detection Research Network and Clinical Proteomics Tech-
nologies for Cancer. She is also a patient advocate for the Lung SPORE at
UT Southwestern/MD Anderson Cancer Center.
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David F. Ransohoff, M.D., is professor of medicine and clinical professor
of epidemiology at the University of North Carolina (UNC) at Chapel Hill.
He graduated from Harvard College and Case Western Reserve School of
Medicine and did his internship and residency at Dartmouth-Hitchcock.
As a fellow in the then-new field of clinical epidemiology, the field con-
cerned with methods of clinical research to study diagnosis and prognosis,
he studied with Alvan Feinstein in Yale’s Robert Wood Johnson Clini-
cal Scholars Program and wrote a paper in the New England Journal of
Medicine that helped establish the field of methods to evaluate diagnostic
tests. After a gastroenterology fellowship at the University of Chicago,
Dr. Ransohoff served on the faculties of Case Western Reserve University,
Yale University, and then UNC, conducting research in the diagnosis and
management of gastrointestinal and other clinical problems. About 15 years
ago, Dr. Ransohoff extended his work in clinical epidemiology and diag-
nosis to include molecular markers for cancer and now collaborates with a
number of National Cancer Institute groups, including the Early Detection
Research Network and the Clinical Proteomic Technology Assessment for
Cancer. At UNC, Dr. Ransohoff has directed the Robert Wood Johnson
Clinical Scholars Program and the National Institutes of Health–funded K30
clinical research curriculum faculty development program.
E. Albert Reece, M.D., Ph.D., M.B.A., is vice president for Medical Affairs,
University of Maryland, Baltimore and the John Z. and Akiko K. Bowers
Distinguished Professor and Dean of the University of Maryland School
of Medicine. He is also a professor in the departments of Obstetrics
and Gynecology, Medicine, and Biochemistry & Molecular Biology. He
completed an internship and residency in obstetrics and gynecology at
Columbia University/Presbyterian Hospital, and a postdoctoral fellow-
ship in Maternal-Fetal Medicine at Yale University School of Medicine.
He remained as faculty at Yale for nearly 10 years, achieving accelerated
promotion to associate professor in 1987. In 1990, went to Temple Univer-
sity to serve as the Abraham Roth Professor and Chair of the Department
of Obstetrics, Gynecology and Reproductive Sciences. Between 2001 and
2006, he served as vice chancellor for Medical Sciences at the University
of Arkansas and dean of the College of Medicine. He moved to his current
position in 2006.
He has published extensively in the scientific literature: 11 books; 5
monographs; and more than 500 articles, chapters, and abstracts. He is
a member of many national scientific organizations. He served as chair of
the Association of American Colleges’ Council of Deans. He serves or has
served on many governmental and civic organizations and committees,
such as the U.S. Food and Drug Administration, the Institute of Medicine,
the National Institutes of Health, the Department of Health and Human
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APPENDIX E
Services Secretary’s Committee on Infant Mortality, The March of Dimes
Birth Defects Foundation, the Massachusetts General Hospital Scientific
Advisory Committee, the Board (chair) of the Nelly Berman Classical Music
Institute, and the Agnes Irwin School for Girls. He has received numerous
special recognitions and awards, including the Distinguished Leadership
Award in 2009 and the 2010 Berson Medical Alumni Achievement Award
in Health Sciences from his alma mater, New York University School of
Medicine. Originally from Jamaica, West Indies, Dr. Reece completed a B.S.
magna cum laude from Long Island University; an M.D. from New York
University School of Medicine; a Ph.D. in Biochemistry from the University
of the West Indies, Kingston, Jamaica; and an M.B.A. from the Fox School
of Business & Management of Temple University.
Daniela M. Witten, Ph.D., is an assistant professor in the Department of
Biostatistics at the University of Washington, an adjunct assistant profes-
sor in the Department of Statistics at the University of Washington, and
an affiliate investigator at the Fred Hutchinson Cancer Research Center.
Her research involves the development of statistical tools for the analy-
sis of large-scale biological datasets, such as gene expression, DNA copy
number, and DNA sequence data. As a graduate student, Dr. Witten held
a National Defense Science and Engineering Graduate Fellowship (2006-
2009) and won the Gertrude Cox Scholarship from the American Statistical
Association (2008). She has held the Genentech Endowed Professorship in
Biostatistics at the University of Washington (2010-2011). Recent awards
include the David Byar Young Investigator Award from the American
Statistical Association (2011) and the National Institutes of Health Direc-
tor’s Early Independence Award (2011-2016). Dr. Witten currently serves
as an associate editor for the Journal of Computational and Graphical
Statistics. Dr. Witten did her training at Stanford University, where she
received a bachelor’s degree in mathematics and biology with honors and
distinction, and a doctorate in statistics.
STAFF
Christine Micheel, Ph.D., was the study director for the Institute of Medi-
cine (IOM) Committee on the Review of Omics-Based Tests for Predicting
Patient Outcomes in Clinical Trials and the Committee on Qualification
of Biomarkers and Surrogate Endpoints in Chronic Disease. She worked
on other topics, including nanotechnology and oncology, access to rou-
tine vaccines under Medicare Part D, implementing colorectal cancer
screening, and multi-site Phase III clinical trials and the National Cancer
Institute Cooperative Groups. Prior to her work at the IOM, Dr. Micheel
completed a postdoctoral position at the IBM Almaden Research Center
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314 EVOLUTION OF TRANSLATIONAL OMICS
in San Jose, California, where she studied interactions between bio-
molecules and nanomaterials. She completed her Ph.D. in chemistry at
the University of California, Berkeley in 2005, under the direction of Paul
Alivisatos and with the support of a Howard Hughes Medical Institute
Predoctoral Fellowship. Dr. Micheel volunteered in the library at the
Women’s Cancer Resource Center in Oakland, California, a community
resource for women with cancer and their families. Dr. Micheel obtained
her bachelor’s degree at Washington University in St. Louis, Missouri,
where she graduated magna cum laude with a major in chemistry. Her
undergraduate studies were supported by a Compton II Fellowship (now
known as the Florence Moog Fellowship) for pursuit of studies in the
fields of biology and chemistry.
Sharyl Nass, Ph.D., is director of the Institute of Medicine (IOM’s) National
Cancer Policy Forum (NCPF). As a study director and senior program offi-
cer at the IOM, she has worked with the Board on Health Sciences Policy,
the Board on Health Care Services, and the National Cancer Policy Board
and Forum. Her previous work at the IOM focused on topics that include
developing cancer biomarkers, improving cancer clinical trials, formulating
strategies for large-scale biomedical science, developing technologies for the
early detection of breast cancer, improving breast imaging quality standards,
assessing the impact of the Health Insurance Portability and Accountability
Act (HIPAA) Privacy Rule on health research, and facilitating contraceptive
research and development. She is also an adjunct faculty member at the
University of Maryland School of Nursing, where she lectures on cancer
biology, detection, and treatment. With a Ph.D. in Cell and Tumor Biol-
ogy from Georgetown University and postdoctoral training at the Johns
Hopkins University School of Medicine, she has published research on the
cell and molecular biology of breast cancer. She also holds a B.S. in Genet-
ics and an M.S. in Endocrinology/Reproductive Physiology, both from the
University of Wisconsin–Madison. In addition, she studied developmental
genetics and molecular biology at the Max Planck Institute in Germany
under a fellowship from the Heinrich Hertz-Stiftung Foundation. Dr. Nass
was the 2007 recipient of the IOM’s Cecil Award for Excellence in Health
Policy Research and the 2010 recipient of a National Academy of Sciences
Distinguished Service Award.
Laura Levit, J.D., is a program officer at the Institute of Medicine (IOM),
where she has worked with the Board on Health Care Services and the
National Cancer Policy Forum. She started at the IOM as a Christine
Mirzayan Science and Technology Graduate Fellow in winter 2007 and that
year received the IOM Rookie Award. Her previous work at the IOM has
focused on topics that include the HIPAA Privacy Rule, comparative effec-
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APPENDIX E
tiveness research, the oncology workforce, and regulatory hurdles to per-
sonalized medicine. She graduated from the University of Virginia School
of Law in May 2006 and was admitted into the Virginia Bar Association in
October 2006. In law school, Ms. Levit worked for several different non-
profit organizations that focused on health and mental health care policy,
including the Treatment Advocacy Center, the National Research Center
for Women & Families, the Bazelon Center, and the World Federation for
Mental Health. She completed her undergraduate studies at the College of
William and Mary, receiving a B.S. with honors in psychology.
Erin Balogh, M.P.H., is an associate program officer for the Institute of
Medicine Board on Health Care Services and the National Cancer Policy
Forum (NCPF). She has directed three NCPF workshops on patient-
centered cancer treatment planning, precompetitive collaboration, and
combination cancer therapies, and staffed three consensus studies focus-
ing on omics-based test development, the national clinical trials system,
and evaluation of biomarkers and surrogate endpoints. She completed her
M.P.H. in Health Management and Policy at the University of Michigan
School of Public Health, and graduated summa cum laude from Arizona
State University with bachelor’s degrees in microbiology and psychology.
Ms. Balogh interned with AcademyHealth in Washington, DC, and worked
as a research site coordinator for the Urban Institute in Topeka, Kansas.
Previously, Ms. Balogh was a management intern with the Arizona State
University Office of University Initiatives, a strategic planning group for
the university.
Sarah Domnitz, Ph.D., was a Christine Mirzayan Science and Technology
Policy Graduate Fellow with the Board on Health Care Services and the
National Cancer Policy Forum. She received a Ph.D. in physiology and
biophysics from the University of Washington in 2011 with support from
a National Institutes of Health predoctoral training grant. Her research
focused on proteins that facilitate chromosome movement during cell divi-
sion. While a graduate student, she worked as an intern at the biotech-
nology company Amgen, Inc., and she received a certificate in Molecular
Medicine, a program designed to teach scientists to apply advances in the
basic sciences to the understanding, diagnosis, and treatment of human dis-
ease. Prior to entering graduate school, she worked as a research technician
studying Alzheimer disease at Massachusetts General Hospital. She received
a B.S. in biopsychology from the University of Michigan.
Julia E. Dooher, Ph.D., was a Christine Mirzayan Science and Technol-
ogy Policy Graduate Fellow from January to May 2011. She is currently
a postdoctoral fellow at Johns Hopkins University, Division of Pediatric
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316 EVOLUTION OF TRANSLATIONAL OMICS
Oncology, laboratory of Dr. Alan Friedman, where she studies biochemical
mechanisms contributing to pediatric leukemia. She has served with the
Johns Hopkins Postdoctoral Association and on the Vasculitis Foundation
Research Committee. She earned her Ph.D. from the University of Wash-
ington School of Public Health in Seattle, where she studied the cell biology
and biochemistry of HIV capsid assembly under the direction of Dr. Jaisri
Lingappa and with the support of a National Science Foundation Graduate
Research Fellowship. She received her B.S. from Tufts University, graduat-
ing magna cum laude, and as an undergraduate was awarded a National
Science Foundation Undergraduate Research Fellowship and a Lemelson
Fellowship for Innovation at Hampshire College. She is a volunteer with the
Incentive Mentoring Program in Baltimore, working with underperforming
high school students. Since 1999 she has tutored middle school and high
school students in biology and other subjects.
Niharika Sathe, M.H.S., joined the Institute of Medicine (IOM) in 2010 as
a research assistant for the Board on Health Care Services. She completed
her M.H.S. in biochemistry and molecular biology with an emphasis on
reproductive and cancer biology at the Johns Hopkins Bloomberg School
of Public Health, and prior to that, graduated from the Johns Hopkins Uni-
versity with her bachelor’s degree in molecular and cellular biology. Prior to
joining the IOM, Ms. Sathe worked on a pediatric opt-out HIV screening
initiative at Children’s National Medical Center in Washington, DC. As an
undergraduate, Ms. Sathe worked as a research assistant for projects on
epigenetic modifiers of Rett Syndrome and clinical trials for retinal implants
in retinitis pigmentosa patients, with the Kennedy Krieger Institute and
Wilmer Eye Institute, respectively.
Michael Park is senior program assistant for the National Cancer Policy
Forum at the Institute of Medicine and has worked at the National Acad-
emies since 2007. Mr. Park received his B.A. in Germanic Studies from Uni-
Mr. Uni-
versity of Maryland in 2006 after studying 2 years abroad on scholarship
in Germany and Italy. Having completed his final year of high school in
Zaragoza, Spain, he is fluent in Spanish, Italian, and German. His primary
interests include public health and urban planning.
Roger Herdman, M.D., is director of the Institute of Medicine (IOM) Board
on Health Care Services. He received his undergraduate and medical school
degrees from Yale University. Following an internship at the University of
Minnesota and a stint in the U.S. Navy, he returned to Minnesota, where
he completed a residency in Pediatrics and a fellowship in Immunology
and Nephrology and also served on the faculty. He served as professor of
Pediatrics at Albany Medical College until 1979. In 1969, Dr. Herdman
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was appointed director of the New York State Kidney Disease Institute in
Albany, NY, and shortly thereafter was appointed deputy commissioner of
the New York State Department of Health (1969-1977). In 1977 he was
named New York State’s director of public health. From 1979 until joining
the U.S. Congress Office of Technology Assessment (OTA), he served as a
vice president of Memorial Sloan-Kettering Cancer Center in New York
City. In 1983, Dr. Herdman was named assistant director of OTA, where
he subsequently served as director from 1993 to 1996. He later joined the
IOM as a senior scholar and directed studies on graduate medical educa-
tion, organ transplantation, silicone breast implants, and the Veterans
Administration national formulary. Dr. Herdman was appointed director
of the IOM/National Research Council National Cancer Policy Board from
2000 through 2005. From 2005 until 2009, Dr. Herdman directed the IOM
National Cancer Policy Forum. In 2007, he was also appointed director
of the IOM Board on Health Care Services. During his work at the IOM,
Dr. Herdman has worked closely with the U.S. Congress on a wide variety
of healthcare policy issues.
Andrew Pope, Ph.D., is director of the Board on Health Sciences Policy at
the Institute of Medicine (IOM). He has a Ph.D. in physiology and bio-
chemistry from the University of Maryland and has been a member of the
National Academies staff since 1982 and of the IOM staff since 1989. His
primary interests are science policy, biomedical ethics, and environmental
and occupational influences on human health. During his tenure at the
National Academies, Dr. Pope has directed numerous studies on topics that
range from injury control, disability prevention, and biologic markers to
the protection of human subjects of research, National Institutes of Health
priority-setting processes, organ procurement and transplantation policy,
and the role of science and technology in countering terrorism. Dr. Pope is
the recipient of the IOM’s Cecil Award and the National Academy of Sci-
ences President’s Special Achievement Award.
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