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Appendix B Biosketches of the Workshop Speakers Cindy Brach, M.P.P., is a senior health policy researcher at the Agency for Healthcare Research and Quality (AHRQ). She is AHRQâs lead on cultural competence and sits on a number of cultural competence advisory groups. In addition to her own cultural competence research, she has overseen the development of guides to assist health plans in implementing culturally and linguistically appropriate services and a research agenda for cultural competence in health care. Currently Ms. Brach is spearheading AHRQâs health literacy activities, coordinating AHRQâs work in developing mea- sures and improving the evidence base, and integrating health literacy activities throughout AHRQâs portfolios. Daniel Budnitz, M.D., M.P.H., is a medical officer with the Division of Healthcare Quality Promotion, Centers for Disease Control and Pre- vention (CDC), where he directs projects to monitor medication safety. His primary activity is directing and managing the National Electronic Injury Surveillance SystemâCooperative Adverse Drug Event Surveil- lance ÂProject. Dr. Budnitz has also worked to develop public health data standards and public health responses to disease outbreaks, terrorism, and natural disasters. Dr. Budnitz received a B.A. (Government) from Harvard University, and an M.D. and M.P.H. (Epidemiology) from Emory University. After completing residency training in internal medicine at the Hospital of the University of Pennsylvania, he served as an epidemic intelligence service officer with CDCâs Injury Center. He currently is a commander in the U.S. 57
58 Standardizing medication labels Public Health Service and, as clinical assistant professor of internal medi- cine, Emory University, he is a practicing, board-certified internist. William Bullman, M.A.M., joined the staff of the National Council on Patient Information and Education (NCPIE) in 1985, assuming staff leader ship in 1995. Under his guidance, in 1995 NCPIE produced two authorita- tive resources on prescription medication adherence: Prescription Medicine Adherence: A Review of the Baseline of Knowledge and Topical Bibliography on Prescription Medicine Adherence. The Council also developed a series of provider- and setting-specific Recommendations for Action to Advance Prescription Medicine Adherence. In 1996 the Council collaborated with the American Medical Association (AMA) on the development of AMAâs Guidelines for Physicians for Counseling Patients About Prescription Medica- tions in the Ambulatory Setting. In 2000 Mr. Bullman, representing NCPIE, collaborated with the Food and Drug Administrationâs (FDAâs) Center for Drug Evaluation and Research on the organization and implementation of the Cyber-Smart Safety Coalition. He also coordinated the development of NCPIEâs âTalk About Prescriptionsâ Month (annually in October) and managed the annual national awareness campaign from 1986 to 1995. Prior to joining NCPIE, Mr. Bullman served from 1979 to 1984 as community program development specialist with the National High Blood Pressure Education Program under a contract to Kappa Systems, Inc., from the Heart, Lung, and Blood Institute of the National Institutes of Health. He also served, from 1972 to 1978, as administrator for the R  ockville Community Clinic in Rockville, Maryland. Mr. Bullman received a B.A. from the University of Maryland in Col- lege Park and an M.A.M. from George Washington University in Wash- ington, D.C. Vanessa Cajina, M.P.A., coordinates and organizes regionally based advo- cacy efforts for the Latino Coalition for a Healthy California (LCHC). By engaging local leaders, LCHC has built a strong network of community- based organizations throughout California that take an active role in state policy and legislation. LCHC is Californiaâs only statewide organization that focuses specifically on Latino health by engaging in policy develop- ment, community education, and research. Focus areas include access to health care, reducing health disparities, and community health. LCHC has led the state in providing the baselines for cultural and linguistic standards in Californiaâs Medicaid program, as well as legislation and research to prevent childhood obesity and increase the number of Latinos working in the health professions. Prior to joining LCHC, Ms. Cajina coordinated a county program to increase outreach, enrollment, retention, and utilization efforts for Cali-
APPENDIX B 59 forniaâs Medicaid and SCHIP programs and was part of the design panel for a county program to provide universal childrenâs health insurance. She also oversees LCHCâs legislation on prescription drugs and mental health. She is currently completing a masterâs of science in community development at the University of California, Davis. Terry C. Davis, Ph.D., is professor of medicine and pediatrics at Louisiana State University Health Sciences Center in Shreveport (LSUHSC-S), where she also heads the Behavioral Science Unit of the Feist-Weiller Cancer Center. For the past 20 years, she has led an interdisciplinary team inves- tigating the impact of patient literacy on health and health care. A pioneer in the field of health literacy, her seminal achievements include develop- ment of the Rapid Estimate of Adult Literacy in Medicine (REALM), the most widely used literacy test in health care settings, and production of videotapes that have personalized the problem of low health literacy. Dr. Davis chaired Louisianaâs statewide Health Literacy Task Force, the first legislatively mandated health literacy group in the nation. She currently serves on the master faculty of the American Medical Associ- ationâs (AMAâs) Train-the-Trainer Health Literacy Curriculum and is a member of the Healthy People 2010 Health Literacy/Health Communica- tion Section and the Food and Drug Administrationâs (FDAâs) Drug Safety and Risk Management Advisory Committee. Dr. Davis has published more than 90 articles and book chapters related to health literacy, health communication, and preventive medi- cine. As director of the doctor/patient communication course at LSUHSC and as a frequent speaker at national conferences, she has integrated her research findings into practical lessons for medical students and residents, as well as practicing physicians, pharmacists, and nurses. Dr. Davis, together with investigators at the University of North Carolina and the University of California at San Francisco, developed and tested a diabetes self-management guide funded by the American College of Physicians Foundation (ACPF), which has distributed more than 400,000 copies to our nationâs physicians. She was recently awarded National Institutes of Health (NIH) funding for a five-year Health Literacy Intervention to improve cancer screening in Louisiana Federally Qualified Health Clinics. She is currently working with faculty at Northwestern University and Emory University to improve patient comprehension of medication labels. This research has received significant media notice by the New York Times and USA Today, NPR, CBS, ABC, and the BBC. William Dolan, M.D., currently serves on the AMA-BOT Awards and Nom- inations Committee, the Group Practice Advisory Committee, the Task Force on Quality, Safety and Electronic Health Records, and the Health
60 Standardizing medication labels System Reform Task Force. In addition, he is also on the AMA Council on Ethical and Judicial Affairs. As a lead physician in a well-publicized class action suit against managed care companies, Dr. Dolan helped win $140 million in pay- ments for New York physicians. More important, the lawsuit resulted in widespread reform of oppressive institutionalized business practices that had frustrated New York physicians for many years. As president of the Medical Society of the State of New York (MSSNY) and chairman of its board of trustees, Dr. Dolan was instrumental in leading the society into the 21st century as a founding member of the MSSNY Strategic Planning Task Force. The MSSNY Young Physicians Section also recognized Dr. Dolan for his leadership in championing issues of importance to younger physicians. A practicing orthopedic surgeon and clinical professor at the Uni- versity of Rochester, New York, Dr. Dolan was a member of Gov. George Patakiâs Health Care Reform Act Quality Task Force and the committee to study proposed regulation of office-based surgery. Dr. Dolan also devel- oped the Medical Quality Assurance Task Force, a statewide coalition of health care provider organizations that focus on eliminating errors in delivery of patient care. An active leader in the second-largest indepen- dent practice association in the United States, Dr. Dolan is well aware of physiciansâ fiscal, strategic, and practice management issues. He also is an active board member of the Medical Liability Mutual Insurance Company, the largest medical liability carrier in the country. A native of Brooklyn, New York, Dr. Dolan attended Dalhousie Uni- versity Medical School and obtained the M.D. cum laude with many honors, including Alpha Omega Alpha. He served as a lieutenant com- mander in the U.S. Navy. Merrill J. Egorin, M.D., is codirector of the Molecular Therapeutics/Drug Discovery Program at the University of Pittsburgh Cancer Institute (UPCI) and a professor of medicine and pharmacology at the University of Pitts- burgh School of Medicine. Dr. Egorinâs research focuses on rational development and applica- tion of antineoplastic agents. He serves as principal investigator on a National Cancer Institute-funded contract evaluating the pharmacoki- netics, metabolism, and pharmacodynamics of antitumor agents being considered for clinical trials and is the coâprincipal investigator of a National Cancer Instituteâfunded cooperative agreement for conducting Phase I studies at UPCI. Key concepts regularly addressed in Dr. Egorinâs research involve the pharmacokinetic and pharmacodynamic relation- ships of investigational and licensed antineoplastic agents and how those relationships can be assessed and modeled.
APPENDIX B 61 Dr. Egorin received his M.D. and training in internal medicine from the Johns Hopkins University School of Medicine and Hospital. Early in his career, he joined the Baltimore Cancer Research Center, then part of the National Cancer Institute. In 1981 he became a staff physician at the Uni- versity of Maryland Hospital, where he rose to the position of professor of medicine, pharmacology and experimental therapeutics, and oncology. Dr. Egorin was recruited to UPCI in 1998 to lead its clinical and preclinical pharmacology activities. Dr. Egorinâs professional affiliations include a fellowship in the Amer- ican College of Physicians and memberships in the American Association for Cancer Research, the American Society for Clinical Oncology, the American Society for Clinical Pharmacology and Therapeutics, and the American Society for Pharmacology and Experimental Therapeutics. He serves on the editorial boards of several medical journals and is Âeditor-in- chief of Cancer Chemotherapy and Pharmacology. Dr. Egorin has authored or coauthored numerous book chapters and more than 175 articles in peer- reviewed journals. William Ellis, R.Ph., M.S., is the executive director and chief executive officer of the American Pharmacists Association (APhA) Foundation. The APhA Foundation, headquartered in Washington, D.C., is a nonprofit organization affiliated with APhA, the national professional society of pharmacists in the United States. The APhA Foundation has expertise in designing programs that seek to create a new medication use system in the United States where patients, pharmacists, physicians, and other health care providers collaborate to dramatically improve the cost and quality of consumer health outcomes. Mr. Ellis oversees all APhA Foundation activi- ties, including awards programs, research initiatives, and related consult- ing services. He serves on the Healthcare Practitioner Advisory Council of the National Committee on Quality Assurance, and represents APhA on the National Quality Forum. Mr. Ellis received his B.S. in pharmacy from the Philadelphia College of Pharmacy and Science (1985), completed a one-year postgraduate program in association management, and has an M.S. in health education from St. Josephâs University (1994). Alan Goldhammer, Ph.D., is deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA). In this position he manages activities of the Regulatory Affairs Coordinating Committee, maintaining a liaison with the Food and Drug Administration on important drug regulatory issues. Prior to coming to PhRMA, Dr. Goldhammer was executive direc- tor, technical affairs, for the Biotechnology Industry Organization (BI). He also served as regulatory affairs consultant to the International Food
62 Standardizing medication labels Biotechnology Council, a Washington-based organization that devel- oped scientific criteria for assuring the safety of foods produced through biotechnology. Before joining the BI, Dr. Goldhammer was a senior staff fellow in the Clinical Endocrinology Branch at the National Institutes of Health. He held an NIH postdoctoral fellowship at Cornell University. He has a B.A. in chemistry from the University of California, Santa Barbara, and a Ph.D. in biological chemistry from Indiana University. He is a member of the American Chemical Society and the American Association for the Advance- ment of Science. George Isham, M.D., M.S., is medical director and chief health officer for HealthPartners. He is responsible for Quality and Utilization Management, chairs the Benefits Committee, and leads Partners for Better Health, a pro- gram and strategy for improving member health. Before his current posi- tion, he was medical director of MedCenters Health Plan in ÂMinneapolis. In the late 1980s, he was executive director of University Health Care, an organization affiliated with the University of WisconsinâMadison. Dr. Isham received his M.S. in preventive  medicine/administrative medicine at the University of WisconsinâÂMadison and his M.D. from the University of Illinois. He served his internship and residency in internal medicine at the University of ÂWisconsin Hospital and Clinics in Madison. His practice experience as a primary care physician included 8 years at the Freeport Clinic in Freeport, Illinois, and 3½ years as clinical assistant professor in medicine at the University of Wisconsin. HealthPartners is a consumer-governed Minnesota health plan, formed through the 1992 affiliation of Group Health, Inc., and MedCenters Health Plan. HealthPartners is a large managed health care organization in Minne- sota, representing nearly 800,000 members. Group Health, founded in 1957, is a network of staff medical and dental centers located throughout the Twin Cities. MedCenters, founded in 1972, is a network of contracted physi- cians serving members through affiliated medical and dental centers. Susan Johnson, Pharm.D., Ph.D., received her Pharm.D. and Ph.D. in clini- cal pharmacy from Purdue University and came to the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administra- tion in 1990. She was a clinical reviewer in the Division of Pulmonary and Allergy Drug Products for 10 years, before moving to CDERâs Review Standards Staff in 2000 and then to the Office of New Drugs Immediate Office in 2002. Since 2004, Susan has served as the associate director of the Office of Nonprescription Products and acting director of the Division of Nonprescription Regulation Development.
APPENDIX B 63 Mary Ann F. Kirkpatrick, Ph.D., received a B.S. in pharmacy from the Uni- versity of North Carolina at Chapel Hill and an M.S. in gerontology and a Ph.D. in urban services from Virginia CommonÂwealth University (VCU). Dr. Kirkpatrick has practiced in retail and hospital pharmacies and taught compounding and dispensing in the School of Pharmacy at VCU for 20 years prior to becoming the associate dean for student affairs in the Shenan- doah University Bernard J. Dunn School of Pharmacy. She is a coauthor of the Virginia Medication Management Training program required for all medication aides working in licensed adult care facilities in Virginia and has also engaged in research investigating the readability of patient drug monographs. Dr. Kirkpatrick has received several awards for her research, service and teaching, including an American Society on Aging Research Award (1998), the Virginia Department of Social Services Outstanding Service Award (1993), the VCU School of Pharmacy Teaching Excellence Award (1991), and the Virginia Geriatric Education Center Outstanding Service Award (2001). Gerald McEvoy, Pharm.D., is assistant vice president of drug information at the American Society of Health-System Pharmacists (ASHP) and editor- in-chief of AHFS Drug Information, ASHPâs federally recognized drug compendium. He has established expertise in evidence-based medical publishing, focusing on rational drug therapy and safe medication use, and has led ASHPâs distinguished drug information publishing activities for over 25 years. Dr. McEvoy serves on the board of directors of the National Council on Patient Information and Education (NCPIE), has testified before and advised the U.S. Food and Drug Administration on medication safety communication issues involving consumers, and has spoken internation- ally on the provision of safe medication use information to consumers. Before joining ASHP, Dr. McEvoy was on the faculty of Creighton Uni- versityâs School of Pharmacy in Omaha, Nebraska. He obtained both his B.S. and Pharm.D. in pharmacy from Duquesne University in Pittsburgh and completed a hospital residency at Mercy Hospital in Pittsburgh. Nancy Ostrove, Ph.D., is senior advisor for risk communication in the Office of Planning in Food and Drug Administrationâs (FDAâs) Office of the Commissioner. She is the agency lead in assessing FDAâs risk communica- tion approaches and programs, developing risk communication strategies for the strategic priority area of improving patient and consumer safety, and identifying issues to be brought to the Risk Communication Advisory Committee. Dr. Ostrove was with FDAâs Center for Drug Evaluation and Research
64 Standardizing medication labels from 1989 until 2002, where she was deputy director and branch chief in the Division of Drug Marketing, Advertising, and Communications. Her work focused on research, consulting, and policy development related to communicating prescription drug information to health care professionals and consumers. Dr. Ostrove led the early development of FDAâs âdirect- to-consumerâ (DTC) promotion policies. She also conducted the research and development of FDAâs proposal to revise the format of prescription drug labeling to be more useful for prescribers. She was key in developing FDAâs Medication Guide rules and in research assessing the private-sector effort to ensure that patients getting new prescription medicines receive useful written information about these medicines. Dr. Ostrove received her Ph.D. in social psychology in 1976 from the University of Maryland at College Park and received postdoctoral train- ing in medical psychology from the Uniformed Services University of the Health Sciences. She has taught undergraduate students and conducted applied psychological and marketing research for the private sector. From 2002 to 2003, Dr. Ostrove served as regulatory liaison for Eli Lilly and Company. Virginia Torrise, Pharm.D., is the deputy chief consultant for Pharmacy Benefits Management (PBM) staff at the Department of Veterans Affairs. In the post, she serves as the chief operating officer for the PBM program. Before taking this position, she was the chief of the pharmacy service at the Greater Los Angeles VA health care system. Darren K. Townzen, R.Ph., M.B.A., started his career with Wal-Mart in 1989 as a pharmacist in east Texas. He then moved to Bentonville, Arkansas, in 1995 to manage the drug database and other projects. His current respon- sibilities as director of pharmacy systems for Wal-Mart include systems project management and drug and insurance claim formats and billing. Mr. Townzen graduated from Southwestern Oklahoma University at Weatherford in 1988 with a B.S. in pharmacy and obtained an M.B.A. from Webster University in 2006. Linda Weiss, Ph.D., is a researcher in the Center for Urban Epidemiologic Studies at the New York Academy of Medicine (NYAM). She has a Ph.D. in cultural anthropology from Columbia University and has examined health care access issues among diverse populations including immigrants, people living with HIV/AIDS, the elderly, children, and substance users. She recently served as principal investigator on a study of the availability of translated medication information from New York City pharmacists and is currently directing a follow-up project focused on training pharma- cists and conducting pilot interventions to improve access to multilingual
APPENDIX B 65 medication instructions. Other current work includes  participation in a study of the role of Asian immigrant institutions in HIV prevention and education, an examination of neighborhood predictors of health behaviors and health outcomes, and a multisite evaluation of programs to integrate opioid treatment into HIV primary care. Previous work at NYAM includes a study of language and other barriers to health insurance and health care for children in immigrant families, a study of the ethical responsibilities of hospital trustees, and an evaluation of programs to support adherence to HIV medications. Roger Williams, M.D., has been the executive vice president and chief exec- utive officer of the United States Pharmacopeia (USP) since April 2000. Working with a staff of nearly 400, Dr. Williams provides strategic leader ship for USP at the direction of USPâs board of trustees. He also serves as chair of the Council of Experts, USPâs scientific body, which continu- ously revises the United States Pharmacopeia and National  Formulary (USPâNF). Since joining USP, Dr. Williams has led a reengineering effort designed to ensure that USPâs products and services meet the needs of its constitu- encies. These constituencies include practitioners and patients/Âconsumers who seek safe, effective, and good-quality therapeutic products, as well as pharmaceutical manufacturers, compounding professionals, and many other stakeholders. Dr. Williams has reorganized the structure of the Council of Experts, brought focus to its science-based decisions, and aligned USPâs efforts with other pharmacopeias throughout the world. He has established stakeholder forums that promote communication with and input from pharmaceutical and dietary supplement manufac- turers, compounding professionals, patient safety advocates, and USPâs membership. Dr. Williams is USPâs lead representative for international activities and outreach efforts to the many professional groups and societies who share USPâs public health mission. The strength of USPâs public programs has allowed USP to expand its public health mission both nationally and internationally. USP established a site in India in 2006 and in 2005 opened a sales office in Basel, Switzerland. The USPâNF was published in Span- ish in 2005. Michael Wolf, Ph.D., M.P.H., is an assistant professor in the Center for Health- care Studies at Northwestern Universityâs Feinberg School of ÂMedicine. He is a faculty fellow at the Institute for Health Services Research and Policy Studies and on senior staff for the Chicago VA Healthcare ÂSystemâs Midwest Center for Health Services and Policy Research. Dr. Wolf is an alumnus of Valparaiso University and earned his Ph.D. at the University
66 Standardizing medication labels of Illinois and his M.P.H. at Northwestern University. Prior to his current position at the center, Dr. Wolf received postdoctoral training in health services research at the Institute for Health Services Research and Policy Studies, which culminated in his receiving the Pfizer Health Literacy Ini- tiative Scholarâs Award. He is also a member of the Robert H. Lurie Com- prehensive Cancer Center and recently received the Coleman Foundation Young Investigator Fellowship for conducting cancer research. Dr. Wolfâs research interests focus on the reduction of health disparities, health com- munication, HIV/AIDS and cancer prevention, and health promotion. Alastair J. J. Wood, M.D., F.A.C.P., received his M.D. from St. Andrewâs University and Dundee Medical School in Scotland. He joined the faculty at Vanderbilt University School of Medicine in 1978, where he became tenured professor of both medicine and pharmacology and attending physician at Vanderbilt Medical School. He was assistant vice chancellor for clinical research (1999â2004) and associate dean, ÂVanderbilt Medical School (2004â2006), before being appointed emeritus professor of medi- cine and emeritus professor of pharmacology in 2006. His current aca- demic appointments are professor of medicine and professor of pharma- cology at Weill Cornell Medical College, New York. Dr. Wood is a member of many societies and has received numerous honors, notably election to membership in the Institute of Medicine of the National Academy of Sciences, the American Association of Physi- cians, and the American Society for Clinical Investigation. He is honorary f  ellow, American Gynecological and Obstetrical Society (AGOS), and has fellowship in the American College of Physicians, the Royal College of Physicians of London, and the Royal College of Physicians of Edinburgh. He was the 2005 recipient of the Rawls-Palmer Award from the American Society for Pharmacology and Experimental Therapeutics in recognition of âDrug investigation that brings the effects of modern drug research to the care of patients.â Dr. Wood has served on a number of editorial boards. He was a member of the New England Journal of Medicine editorial board from 2004 to 2006; he was the drug therapy editor of the New England Journal of Medicine from 1985 to 2004; and he is on the editorial board of Clinical Pharmacology and Therapeutics and the Scientist. He has previously served on the editorial boards of the British Journal of Clinical Pharmacology and Biopharmaceutics and Drug Disposition. He authored a chapter in ÂHarrisonâs Principles of Internal Medicine on adverse drug reactions for the 9th through the 15th editions. Dr. Wood was chairman of the Food and Drug Administrationâs (FDAâs) Nonprescription Drugs Advisory Committee until 2006 and
APPENDIX B 67 chaired the 2005 FDA Advisory Committee on Cox-2 inhibitors. He pre- viously served as a member of the FDAâs Cardiovascular and Renal Advi- sory Committee and Nonprescription Drugs Advisory Committee. He has been both a member and chair of NIH study sections and has served in a similar capacity for various philanthropic grant-giving bodies. He has served as a director of pharmaceutical companies, including Antigenics, Symphony Neurodevelopment, and Symphony Evolution. He has also served as a consultant to pharmaceutical companies, investors, and aca- demic institutions. He has provided congressional testimony and directly interacted with and advised senior White House officials, legislators, and the secretary of health on matters related to public health. He is a frequent commentator in the national press on issues related to medicine and pharmaceuticals. His research interests have been focused on understanding the mech- anisms for interindividual variability in drug response, with a particular focus on the molecular genetics of adrenergic receptors, ethnic differences in drug response, vascular response, and the genetics of drug metabolism. His research has been continuously funded by the National Institutes of Health and has resulted in over 280 articles, reviews, and editorials. Albert W. Wu, M.D., M.P.H., is an practicing internist and professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, with joint appointments in epidemiology, international health, medicine, and surgery. He received his B.A. and M.D. from Cor- nell University and completed an internal medicine residency at the Mount Sinai Hospital and University of California (UC) San Diego. He was a Robert Wood Johnson clinical scholar at UC San Francisco, and received an M.P.H. from UC Berkeley. His research and teaching focus on patient outcomes and quality of care. He has studied the handling of medical errors since 1998 and has published influential papers including âDo house officers learn from their mistakesâ in JAMA in 1991; âTo tell the truthâÂethical and practical issues in disclosing medical mistakes to patientsâ in the Journal of General Internal Medicine; and âMedical error: the second victimâ in the BMJ. He was coâprincipal investigator of an Agency for Healthcare Research and Quality (AHRQ)-funded grant to develop a web-based incident reporting system for intensive care units. He is prin- cipal investigator of the AHRQ-funded Johns Hopkins DEcIDE Center to conduct rapid, policy-relevant studies of comparative effectiveness. He is studying video vignettes of disclosures to patient and their families and has developed an award-winning educational video on disclosure titled âRemoving insult from injury: disclosing adverse events.â He was a member of the Institute of Medicine Committee on Identifying and Preventing Medication Errors and is a member of the Hopkins Quality
68 Standardizing medication labels and Safety Research Group. He is senior advisor to the World Alliance for Patient Safety. Mara Youdelman, J.D., L.L.M., has been a staff attorney in the National Health Law Programâs Washington, D.C., office for over 4 years. She works on issues such as language access, civil rights, Medicaid, and racial and ethnic disparities in health care. She received her J.D. from Boston University School of Law and her L.L.M. from Georgetown University Law Center.