North American Advisory Council

Sue Dubman is Senior Director of System and Data Architecture at Genzyme, serving in the role of chief data officer, and Chairperson of CRIX International's North American Advisory Council (NAAC). Sue has more than 20 years of experience in information technology with a specialization in life sciences and healthcare. Prior to Genzyme, Sue was Vice President of Information Technology at Theravance. Before Theravance, Sue was Director of Biomedical Informatics at the NCI, where she helped lead several major programs that are widely recognized for their potential to change the way research is done, drugs are developed, and patients and providers interact with the health care enterprise. These include the Cancer Biomedical Informatics Grid or caBIG™; the joint FDA/NCI Inter-Agency Oncology Task Force initiative which become the first rendition of CRIX and included both the initial Janus (CDISC SDTM data repository) and FIREBiRD pilots; a CDISC-HL7-FDA-NCI collaboration called BRIDG; and a translational research platform (caIntegrator) to enable genomic medicine. Sue completed work towards her PhD at Brown University in population sciences and received her MA and BA from the University of Missouri.

Laura Esserman is Professor of Surgery and Radiology at the University of California, San Francisco (UCSF) and the Director of the UCSF/Mt. Zion Carol Franc Buck Breast Care Center. Dr. Esserman received her undergraduate degree from Harvard and her MD from Stanford University, where she completed her surgical residency and an oncology fellowship. After completing her medical training, she was awarded a Hartford Fellowship to enable her to pursue her MBA at the Stanford University School of Business. Dr. Esserman has a joint appointment in the Departments of Surgery and Radiology and is affiliate faculty for the Institute for Health Policy Studies and Medical Informatics Program. She is also the Co-leader of the Breast Oncology Program of the UCSF Cancer Center.

Dr. Rebecca Kush is a Founder and the President and CEO of the Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization with a mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. Dr. Kush has over 25 years of experience in clinical research and related areas, including project management and monitoring, conducting clinical trials, medical writing and process analysis and redesign on a global basis. She has worked for the National Institutes of Health, academia, a global contract research organization and pharmaceutical companies in the U.S. and Japan. Prior to dedicating full-time as President of CDISC, Dr. Kush founded Catalysis, Inc.

Dr. Kush earned a Ph.D. in Physiology and Pharmacology from the University of California (UCSD) School of Medicine in La Jolla, CA. She has a BS in Chemistry and Biology.

Connie DeAbreu is a Programme Delivery Manager within Global Clinical Information Services at Astra Zeneca. In this role, Ms. DeAbreu is responsible for the management of a global clinical information services portfolio of global capability programmes.

Ms. DeAbreu has more than sixteen years of experience in the information services area of the pharmaceutical industry. For the last nine years, she has been involved in study management, investigator site management, drug safety, data management, and clinical process and procedures.

Rachel Carle is a Senior Director of Regulatory Operations at Genzyme Corporation. She has worked in the pharmaceuticals and biotech industry for 18 years in various roles within Regulatory Affairs departments. Ms. Carle worked on specific product development projects until 1997, when she established Genzyme's Regulatory Operations group. Her current responsibilities in Regulatory Affairs include Global Submissions Publishing; Information and Document Management; RA Technical Projects and Programs; and Resource Planning and Metrics.

As Vice President at NovaQuest, Peter Payne is responsible for the development of relationships at a strategic level with a portfolio of biotechnology companies and Venture Capital funds. Directing in-depth portfolio analysis to create proactive development and commercialization strategies, he proposes innovative business models and customized solutions to further the development of customers' products.

During his 24 years in the pharmaceutical and related industries, Mr. Payne has held a variety of positions covering pre-clinical and exploratory research, clinical development, sales management and business management.

Mr. Payne gained his initial experience in the pharmaceutical industry with Wellcome, Sterling Drug and Glaxo.

Mr. Payne received an Honors degree in pharmacology from the University of Manchester, UK, and has completed postgraduate training in Executive Leadership at the University of North Carolina's Kenan-Flagler Business School and Corporate Finance at the University of Chicago Graduate School of Business. He has presented his work at more than a dozen professional conferences around the world.

Susan Foley is an investment professional with over 24 years experience in the institutional investment management business. Previously a partner of Harris Bretall, LLC (1989-2006) -Harris Bretall was recently purchased by Federated Investors of Pennsylvania. In addition to her portfolio management responsibilities, Ms. Foley sat on the Board of Directors and chaired the investment policy committee.

Ms. Foley is a Chartered Financial Analyst, Chartered Investment Counselor and member of both the Security Analyst's of San Francisco and of AIMR. She has served on boards of corporations and charitable organizations. Her work as a patient advocate includes: as a member on the Executive Steering committee for Breast Cancer Trials.Org, the Center of Excellence for Breast Cancer Care at UCSF, Quantum Leap Foundation and a recent panelist at the conference series sponsored by the Department of Defense to Develop a Blueprint for Advancing Quality Healthcare.

As the President and Founder of e-SubmissionsSolutions, Antoinette Azevedo advises all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Ms. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies

Prior to her role at e-Submissions, Ms. Azevedo was director of West Coast Operations for Liquent from 1997 to 2000. Ms. Azevedo was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients in North America and Western Europe. Her experience ranges from developing strategies for document management and electronic publishing, to implementation of fully-validated systems, and production of paper and electronic submissions accepted for review by regulatory authorities worldwide. Antoinette has lectured internationally for RAPS, DIA, at vendor user conferences, and for local regulatory affairs professional groups.

David Bates is Chief, Division of General Medicine, Brigham and Women's Hospital, and is a practicing general internist. He also serves as Medical Director of Clinical and Quality Analysis for Partner's Healthcare Systems. He is a Professor of Medicine at Harvard Medical School and Professor of Health Policy and Management at the Harvard School of Public Health where he co-directs the Program in Clinical Effectiveness. He has been elected to the Institute of Medicine, the American Society for Clinical Investigation, and the American College of Medical Informatics. Trained as a clinical epidemiologist, his primary interest has been the use of computer systems to improve patient care, especially drug safety.

Joyce Niland is Chair and Professor of Information Sciences and Associate Director at the City of Hope Comprehensive Cancer Center. In this role, she oversees 165 faculty and staff within the Departments of Biostatistics, Clinical Research Information Management, and Biomedical Informatics. Collaborating in clinical trials and translational research for over 25 years, Dr. Niland is internationally recognized in the field of biomedical informatics. She has been the Principal Investigator of several peer-reviewed research grants in this area, and currently is the City of Hope PI for the National Cancer Institute's Cancer Biomedical Informatics Grid (caBIG) initiative, to create shared software models and systems to speed cancer research.

Dr. Niland received her BS in Human Biology from Stanford University in 1975, an MS in Physical Therapy from University of Southern California (USC) in 1978, and her PhD in Biometry from USC in 1984.

J. Robert Beck is CIO/ Vice President for Information Services, Deputy Director of the Population Science Division, and Director of the Program in Evaluative Sciences at Fox Chase Cancer Center. In these roles he has responsibility for bioinformatics, biostatistics, health services research, clinical computing and administrative information technology. Dr. Beck, as a principal investigator, has held grants from various institutes within the NIH, and has been a principal and collaborating investigator on many projects sponsored by the NCI and the American Cancer Society.

Dr. Beck's undergraduate education was completed at Dartmouth College in 1974 with a mathematics major modified with biology. After medical school at Johns Hopkins University and a pathology residency, he took a fellowship in Clinical Decision Making at the New England Medical Center. He has held faculty and administrative positions at Dartmouth Medical School, Oregon Health Sciences University, and Baylor College of Medicine.

William M. Matthews is Information Officer for Global Medical and Regulatory Information Technology at Eli Lilly. His prior role was Information Officer for the Global Infrastructure. Since joining Lilly in 1980, William has had a variety of managerial responsibilities within the company relating to clinical trial systems, process reengineering, and manufacturing.

William M. Matthews is Information Officer for Global Medical and Regulatory Information Technology at Eli Lilly. His prior role was Information Officer for the Global Infrastructure. Since joining Lilly in 1980, Mr. Matthews has had a variety of managerial responsibilities within the company relating to clinical trial systems, process reengineering, and manufacturing.

Mr. Matthews currently serves on the PhRMA Information Management Policy and Affairs Coordinating Committee (IMPACC), Indiana University - Health Informatics Program Advisory Board, and the Purdue University Department of Computer Sciences Corporate Partners Program. Mr. Matthews received a BS in Industrial Management from Purdue University. He was awarded an MBA from University of Michigan.

Louis Fiore has over 20 years experience conducting clinical trials and observational studies for the Department of Veterans Affairs Cooperative Studies Program (CSP). He is currently the Director of the CSP Coordinating Center at the VA Boston Healthcare System, and is the Director of Bioinformatics of the CSP nationwide. He is board certified and continues to practice in the specialties of hematology and oncology, as well as serve as the Chair of the Section of General Internal Medicine and Clinical Epidemiology at the VA Boston Healthcare System. He is an Associate Professor of Medicine and Pubic Health at the Boston University Schools of Medicine and Public Health. His immediate interests are to develop web based tools for clinical trials and biospecimen tracking within the CSP. He is also exploring the introduction of standardized data collection and processes across the program.

Charles Jaffe is the CEO of Health Level 7. Previously, he was the Senior Global Strategist for the Digital Health Group at Intel Corporation, 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 post-doctoral fellow at the National Institutes of Health and at Georgetown University. Formerly, he was President of InforMed, an informatics consultancy for research informatics. Over his career, he has been the principal investigator for more than 200 clinical trials, and has served in various leadership roles in the American Medical Informatics Association. He has been a board member on leading organizations for information technology standards, and served as the chair of a national institutional review board. Currently he holds an appointment in the Department of Engineering at Penn State University. He has been the contributing editor for several journals and has published on a range of subjects, including clinical management, informatics deployment, and healthcare policy.