2014 Program Committee
PROGRAM COMMITTEE CO-CHAIRS
Raymond DuBois, M.D., Ph.D.
Dr. DuBois is executive director of Arizona State University’s Biodesign Institute as well as the Dalton Chair in ASU’s College of Health Solutions with joint appointments in chemistry and biochemistry. In addition, he has a joint appointment with the Mayo Clinic, co-leading the cancer prevention program. ASU’s Biodesign Institute is a unique interdisciplinary research endeavor devoted to bio-inspired innovation using nature’s building principles as a guideline for addressing a range of problems and challenges in health care, sustainability and security. Dr. DuBois came to ASU from The University of Texas MD Anderson Cancer Center in Houston, where he served as provost and executive vice president, and professor of cancer biology and cancer medicine. At MD Anderson he was responsible for developing and overseeing research strategy, faculty, the School of Health Professions, graduate education programs and initiatives, and Global Academic Programs. Prior to his tenure at MD Anderson Dr. DuBois was director of the Ingram Cancer Center, the B.F. Byrd Jr. Professor of Medical Oncology and professor of medicine, cell biology and cancer biology at Vanderbilt University Medical Center. After joining the faculty at Vanderbilt, he was promoted to full professor in six years, his research having advanced the understanding of colorectal cancer and having led to the development of promising cancer prevention and treatment strategies. From 1998 to 2004, Dr. DuBois directed Vanderbilt’s Division of Gastroenterology, Hepatology and Nutrition. The author of more than 135 peer reviewed publications, Dr. DuBois began his academic research career in 1991 as an assistant professor at Vanderbilt. He received a bachelor's degree in biochemistry from Texas A&M University (1977), a doctorate in biochemistry from The University of Texas Southwestern Medical Center in Dallas (1981) and a medical degree from The University of Texas Health Science Center in San Antonio (1985). From 1985 to 1991, he completed his postgraduate training at the Johns Hopkins Hospital as an intern and resident on the Osler medical service, followed by a fellowship in gastroenterology and postdoctoral research fellowship with Nobel Laureate Daniel Nathans. He is a Fellow of the American Association for the Advancement of Science, is a past president of the American Association for Cancer Research and serves on the executive committee of the Aspen Cancer Conference. In addition, he is a founding scientific advisor for both the National Colon Cancer Research Alliance and Stand Up To Cancer.
Thomas Fleming, Ph.D.
Dr. Fleming is Professor and Chairman in the Department of Biostatistics and Professor of the Department of Statistics at the University of Washington School of Public Health and Community Medicine. He is also a full member in the Division of Public Health Sciences at the Fred Hutchinson Cancer Research Center. In 1987 he was elected a fellow of the American Statistical Association and in 1988 he was the recipient of the Spiegelman Award from the American Public Health Association in recognition of outstanding contributions to public health research, especially in the areas of oncology and HIV infection. In 2002, he was the recipient of the FDA Commissioner's Special Citation Award for extraordinary contributions to the Agency. Dr. Fleming has been involved in AIDS research efforts for nearly 20 years as an advisor to the National Institute of Allergy and Infectious Diseases (NIAID), as a collaborator in NIAID's multi-center multi-institution AIDS cooperative groups, as a consultant to industry, as an advisor to the FDA, as an educator, and as a researcher of new statistical methodology. Dr. Fleming was involved in the development and coordination of NIAID's national clinical trials program for the prevention and treatment of HIV infection and AIDS. Dr. Fleming also served as an advisor to the FDA for 18 years and has been a voting member of numerous advisory committees for the Center for Drug Evaluation Research and the Center for Biologics Evaluation Research. Since 1987, Dr. Fleming has been a member of the DAIDS Data Monitoring Committee that oversees trials conducted by ACTG and CPCRA, and has served as the chair or a member of data monitoring committees for over 100 industry- and government-sponsored clinical trials. Dr. Fleming also served as the Co-PI of the HIVNET Statistical Center and chair of the HIVNET and HPTN Study Monitoring Committees. In the HPTN, Dr. Fleming served as statistician to the perinatal working group, and as lead statistician on five perinatal studies, three of which are completed, including the pivotal HIVNET 012 trial.
H. Kim Lyerly, M.D.
Dr. Lyerly is the George Barth Geller Professor of Cancer Research and Professor of Surgery at the Duke University Medical Center. He has been named by his peers as one of North Carolina’s most outstanding clinical physicians. In addition, he is an internationally recognized expert in cancer therapy and cancer immunotherapy and has published nearly 200 scientific articles and has edited 10 textbooks on surgery, cancer immunotherapy, and novel cancer therapies. He serves on the editorial board of 12 scientific journals. In 2008, Dr. Lyerly was appointed to the National Cancer Advisory Board by President George Bush and was named chair on the Cancer Centers sub-committee of the NCAB. Dr. Lyerly is a highly sought advisor and currently serves on the external advisory boards of the M.D. Anderson Cancer Center, the University of Michigan Cancer Center, the University of Chicago Cancer Center, the University of Alabama Cancer Center, the Boston University Cancer Center, and the Purdue Cancer Center. He also serves as an advisor to the University of Washington, and Case Western Reserve Clinical and Translational Science Institutes. He is currently a member of the Scientific Advisory Board of Susan G. Komen for the Cure. He has previously served as chairperson of the executive committee of the integration panel of the Congressionally Directed Medical Research Programs in Breast Cancer. He also served on American Society of Clinical Oncology’s Grants Selection Committee, of which he served as chair in 2006. Dr. Lyerly is a member of the American College of Surgeons, of which he is a fellow. He was invited by former North Carolina Governor Michael Easley to serve on the Advisory Commission of the NC State Museum of Natural Sciences. In 2010, Dr. Lyerly was reappointed as a member of the NC Advisory Committee on Cancer Coordination and Control by Governor Bev Perdue.
Richard Pazdur, M.D.
Dr. Pazdur is presently the Director of the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration. This Office was formed in 2005 to consolidate the review of drugs and therapeutic biologics for the diagnosis, treatment, and prevention of cancer as well as the review of drugs and therapeutic biologics for hematologic diseases and for medical imaging. Dr. Pazdur's position facilitates coordination of oncology activities across all FDA Centers and ensures an ongoing outreach and collaboration between FDA, the National Cancer Institute, and other cancer-related organizations within and outside of the government. Dr. Pazdur was the Director of the Division of Oncology Drug Products from September 1999 to May 2005. Prior to joining the FDA, Dr. Pazdur was Professor of Medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. Dr. Pazdur was on the faculty of the M. D. Anderson Cancer Center from 1988 to 1999. During his tenure at the M. D. Anderson Cancer Center, Dr. Pazdur held administrative positions of Assistant Vice President for Academic Affairs, Associate Director of Clinical Trials Administration (Division of Medicine) and Director of Educational Programs (Division of Medicine). Dr. Pazdur's main research interests are in clinical trial design and drug development of anti-cancer agents in advanced colorectal cancer. He has performed numerous phase I, II, III, and adjuvant therapy trials in this disease. Dr. Pazdur has published over 300 articles, book chapters and abstracts. Dr. Pazdur was on the faculty of Wayne State University, Detroit, Michigan from 1982 to 1988. He received his undergraduate degree from Northwestern University (Evanston, Illinois), his M. D. degree from Loyola Stritch School of Medicine (Maywood, Illinois), and completed clinical training at Rush-Presbyterian St. Luke's Medical Center (Chicago, Illinois) and the University of Chicago Hospitals and Clinics.
Chandini Portteus, M.P.H.
Ms. Portteus is Chief Mission Officer at Susan G. Komen®, the world’s largest breast cancer organization. She provides strategic leadership and management of Komen’s key mission areas: research, community health, public policy and global programs. Her oversight includes an active research portfolio of more than $300 million in funding worldwide and community health outreach that serves millions of women and families annually through funding of education, screening, psychosocial and medical services to 2,000 Komen grantees. She also leads the strategic direction and operation of Komen’s work in 30 countries and directs Public Policy programs addressing major issues in breast cancer, including access to cancer care and federal research funding. Ms. Portteus works closely with Susan G. Komen’s staff, leaders and advisors to translate high-level strategy into programs that will have an impact on the lives of breast cancer patients and the communities Komen serves. She is an advisor, leader, and influencer in the non-profit and cancer communities and serves on a number of advisory boards and committees, such as the International Cancer Partners, The Health Research Alliance, the American Association of Public Health, Cancer Prevention Research Institute of Texas, C-Change, and the American Society of Clinical Oncology. Prior to her work at Komen, she served as a member of clinical research and public health teams at the University of Texas-Houston School of Public Health and Parkland Hospital, University of Texas Southwestern Medical Center and Children’s Medical Center of Dallas. Early in her career, she worked for Knoll Pharmaceutical Company, and throughout the years has partnered with a wide range of industry sponsors, while supporting and coordinating clinical trials in psychiatry, to building strategic partnerships and initiatives focused on alleviating the burden of cancer. Ms. Portteus received her Bachelor of Arts in psychology and biology from Austin College in Sherman, Texas, and her masters of public health from the University of Texas at Houston.
Gregory Reaman, M.D.
Dr. Reaman is the Associate Director for Oncology Science in the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research of the United States Food and Drug Administration. He is the Founding and Immediate Past Chair of the Children's Oncology Group (COG). The COG is comprised of over 200 member institutions, dedicated to clinical, translational, and epidemiology research in childhood cancer. Dr. Reaman is a Professor of Pediatrics at The George Washington University School of Medicine and Health Sciences and a member of the Division of Hematology-Oncology at the Children's National Medical Center in Washington, D.C., which he directed for more than 17 years, and Executive Director Emeritus of the Center for Cancer and Blood Disorders. Dr. Reaman serves or has served on the Editorial Boards of Leukemia, Journal of Clinical Oncology, Journal of Pediatric Hematology/Oncology, Pediatric Blood and Cancer, The Oncologist, Cancer, and Physicians Data Query (PDQ), National Cancer Institute as well as www.PLWC.org (People Living with Cancer). He has served as an Associate Editor of Cancer and Leukemia and Lymphoma. He held the position of Executive Director for Scientific and Medical Affairs for the National Childhood Cancer Foundation and was a member of its Board of Trustees. Previously, he served on the Board of Directors of the American Cancer Society and chaired its Task Force on Children and Cancer. Dr. Reaman served on the Board of Directors of the American Society of Clinical Oncology and has served on the ASCO Patient Education Committee, the Education and Program Committees, the Grant Selection Committee, and was the Chair of the ASCO Membership Committee. Also, he was a member of the Food and Drug Administration's Oncologic Drugs Advisory Committee and has chaired its Pediatric Subcommittee. He was a member of the NIH Roadmap Working Group. He serves on the Scientific Steering Committee of the United Kingdom Children's Cancer and Leukaemia Group, the External Advisory Board of the Cancer Treatment and Research Center at the University of Texas Health Science Center at San Antonio and is a Senior Advisor to the Middle East Childhood Cancer Alliance. Additionally, he is a member of the Data Safety Monitoring Board of the National Cancer Institute's Clinical Oncology Program, and a member of the NCI's Translational Research Working Group. His research interests are in the biology and treatment of childhood acute leukemia and new drug development for pediatric cancers. He is the author of more than 300 peer- reviewed manuscripts and 16 book chapters.
Richard Schilsky, M.D.
Dr. Schilsky is currently the Chief Medical Officer of the American Society of Clinical Oncology. He earned his M.D. at the University of Chicago Pritzker School of Medicine in 1975. Following a residency in Internal Medicine at the University of Texas Southwestern Medical Center and Parkland Memorial Hospital, he received training in Medical Oncology and Clinical Pharmacology at the National Cancer Institute from 1977 to 1981. He then served as Assistant Professor of Medicine at the University of Missouri-Columbia School of Medicine from 1981-1984 when he returned to the University of Chicago. At the University of Chicago, Dr. Schilsky rose to the rank of Professor of Medicine (tenured) and served as Director of the University of Chicago Cancer Research Center (1991-99), as Associate Dean for Clinical Research (1999-2007) and as Chief of the Section of Hematology-Oncology (2009-2012). From 1995-2010, Dr. Schilsky also served as Chairman of the Cancer and Leukemia Group B, an NCI-sponsored national cancer clinical trials group. An international expert in gastrointestinal malignancies and cancer pharmacology, he has served on a number of peer review and advisory committees for the NCI including as a member and chair of the NCI Board of Scientific Advisors and as a member of the Clinical and Translational Research Advisory Committee. Dr. Schilsky also served as a member and chair of the Oncologic Drugs Advisory Committee of the Food and Drug Administration. Dr. Schilsky has served as a member of the Board of Directors of ASCO and of the Conquer Cancer Foundation of ASCO and as ASCO President 2008-2009.
Margaret Foti, Ph.D., M.D. (h.c.)
Dr. Foti is the chief executive officer of the American Association for Cancer Research. The AACR is the oldest and most prestigious cancer research organization in the world. Under her visionary leadership, it has grown to more than 34,000 scientists and physicians working in more than 90 countries, and is renowned as the world's leading organization dedicated to the prevention and cure of cancer. A graduate of Temple University, Dr. Foti has been one of the most influential voices in advancing the field of cancer research, both in the United States and abroad. She was elected president of three professional societies in scholarly publishing and in cancer research. She has also served as a board member, committee member and consultant to a number of other non-profit organizations. There is a legacy of young women and minority scientists whose careers have been advanced as a result of her mentorship and support. Dr. Foti's contributions have been widely recognized by numerous awards from organizations around the world. Her lengthy list of formal recognitions includes honorary degrees in medicine and surgery from three universities in Italy and Spain. Under Dr. Foti's leadership, the AACR has served with distinction as a scientific partner of Stand Up To Cancer. In this capacity, Dr. Foti and the AACR have brought extraordinary expertise and energy to their work with Stand Up To Cancer, especially in the scientific peer review of projects, scientific project management and administration.
Allen Lichter, M.D.
Dr. Lichter is Chief Executive Officer of the American Society of Clinical Oncology. He became has served in this position since October 2006. For the past two decades, Dr. Lichter served at the University of Michigan, first as Chair and Professor of Radiation Oncology, and subsequently as Dean of the Medical School (1998-2006). He was named the first Isadore Lampe Professor of Radiation Oncology, an endowed chair at the University. Dr. Lichter was also honored as a Newman Family Professor of Radiation Oncology in 2000. Prior to his tenure at the University of Michigan, Dr. Lichter was the Director of the Radiation Therapy Section of the National Cancer Institute's Radiation Oncology Branch. A Member of ASCO since 1980, Dr. Lichter has assumed many prominent roles in the Society, including President (1998-1999) and Founding Chair of The ASCO Foundation Board. He has served on ASCO's Board of Directors and as Chair of the Public Issues Committee, Special Awards Selection Committee, and Co-chair of the Fellows Task Force. Dr. Lichter has served multiple terms on ASCO's Scientific Program Committee as well as on the Nominating, Audit, and Finance Committees, and as an Associate Editor of ASCO's Journal of Clinical Oncology. Dr. Lichter has also held board positions with the Liaison Committee on Medical Education, the Accreditation Council for Graduate Medical Education, the American Society for Therapeutic Radiology and Oncology, and the NCI. Dr. Lichter was a co-editor of the textbook Clinical Oncology and several books on breast cancer, and the author of over one-hundred scientific papers. He has served on the editorial boards of Oncology, the Journal of the National Cancer Institute, and the International Journal of Radiation Oncology, Biology, and Physics. Dr. Lichter earned a bachelor's degree (1968) and medical degree (1972) from the University of Michigan. He trained in radiation oncology at the University of California, San Francisco, before joining the faculty at Johns Hopkins.
PROGRAM COMMITTEE MEMBERS
Julia Beaver, M.D.
Dr. Beaver is a medical officer for the Breast Cancer Group in the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. She graduated from Princeton University magna cum laude in 2001 and received her M.D. degree from The University of Pennsylvania School of Medicine in 2007. She served both her Internal Medicine Residency (completed in 2010) and Fellowship in Medical Oncology (completed in 2013) at The Johns Hopkins Hospital. Dr. Beaver’s fellowship research was in breast cancer genomics, circulating tumor DNA and the development of predictive biomarkers.
Julie Bullock, Pharm.D.
Dr. Bullock is team leader for the Oncology/Hematology team in the Division of Clinical Pharmacology 5, which services the Division of Hematology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Prior to becoming team leader she was a primary reviewer for Investigational New Drugs and New Drug Applications reviewed in the Division of Reproductive and Urologic Drug Products (2004-2006) and the Division of Drug Oncology Products (2006-2009). Dr. Bullock received her doctor of pharmacy from Drake University in 2002 and completed a clinical pharmacology drug development fellowship with SUNY at Buffalo and Novartis pharmaceuticals in 2004. Dr. Bullock has been with the FDA since 2004 and has expertise in the challenges of clinical pharmacology development for oncology products.
Helen Chen, M.D.
Dr. Chen is a licensed medical oncologist, and joined the National Cancer Institute in 2000. She is currently the Associate Chief and senior investigator at the Cancer Therapy Evaluation Program. She has been responsible for strategic planning and oversight of NCI’s clinical development programs for signal transduction agents including HER2/EGFR, IGF-1R and RAF/MEK targeting agents, anti-angiogenesis therapies and antibody-based therapeutics. She is also involved in NCI’s initiatives in biomarkers and novel combination strategies, and serves on the NCI Experimental Therapeutics Committee, Angiogenesis Task Force, and the Clinical Assay Development Program. Dr. Chen is also on the organizing committee of the International Symposium of Anti-angiogenesis Therapy, the scientific committees for the EORTC-AACR-NCI Annual Meeting on Molecular Targeted Therapy, the ASCO-NCI-EORTC Annual Biomarkers Symposium, and Biotherapy Development Association. She has been an invited speaker at national and international meetings on cancer drug development strategies, and is the first or coauthor of more than 30 original and review papers in peer-reviewed journals including Journal of Clinical Oncology, Nature Reviews, and New England Journal of Medicine.
Ms. Darien is Executive Vice President of Programs and Services at the Cancer Support Community where she oversees research, programs, education, and patient and family services. As a cancer survivor herself, she brings a wealth of personal and professional experiences to her position. Prior to joining CSC, she was a director of The Pathways Project - a radically inclusive organization that creates communities and catalyzes movements that put people at the center of health care research and delivery. Ms. Darien previously served as executive director of the Samuel Waxman Cancer Research Foundation. In this role, she was committed to developing collaborations across all segments of the cancer community to fulfill the Foundation’s goal of finding effective cures and preventing cancer by creating a collaborative team of world-class scientists, the Institute Without Walls, to translate cancer research discoveries from the bench to the clinic. Prior to joining SWCRF, Ms. Darien was editor-in-chief of CR magazine and director of the American Association for Cancer Research Survivor and Patient Advocacy Program where she led initiatives to foster mutually beneficial and enduring partnerships among leaders of the cancer survivor, patient advocacy and scientific communities through collaborations, communications and education. She was previously the editor-in-chief of MAMM, a consumer magazine dedicated to women with breast and reproductive cancer. Ms. Darien served as Chair of the NCI Director’s Consumer Liaison Group. She is a member of the Strategic Advisory Group of the Center for Patient Partnerships at the University of Wisconsin and the Steering Committee of the Data Liquidity Coalition. She has served on the Secretary’s Advisory Committee on Health, Genetics and Society and the faculties of the AACR/ASCO Methods in Clinical Cancer Research Workshop, and the advisory board of the Health Advocacy Program at Sarah Lawrence College. She has received several awards for her work, including: the Avon Foundation Media Leadership Award, the LYMPHAdvocate Award from the Cure for Lymphoma Foundation, and the Sisters’ Network Media Leadership Award. Ms. Darien is a graduate of Sarah Lawrence College.
Jesús Gómez-Navarro, M.D.
Dr. Gómez-Navarro is the Head of Clinical Research and Head of Development, Oncology Therapeutic Area Unit, at Takeda. He is a board certified medical oncologist with over 13 years of experience in the research & development of biopharmaceuticals plus over a decade in the clinical care and academic settings. Dr. Gómez-Navarro came in 2009 to Millennium from Pfizer Global R&D, where he served as clinical lead for Pfizer's Immuno-oncology program, overseeing a portfolio of several cancer vaccines and monoclonal antibodies spanning the preclinical to post-proof of concept stages and a clinical team that included up to eight clinicians. Prior to joining Pfizer, he was a Research Assistant Professor and Director of Clinical Programs in the Division of Human Gene Therapy at University of Alabama at Birmingham (UAB), and served as Attending Physician, Medical Oncology at Hospital General Yague, in Burgos, Spain. He has received Young Investigator Awards from the American Society of Gene Therapy, the American Society of Transplant Physicians, and the American Association for Cancer Research, as well as the Recognition for Excellence in Cancer Research by the Comprehensive Cancer Center, UAB. Dr. Gómez-Navarro was a Fellow of the Cure for Lymphoma Foundation and of the Susan G. Komen Foundation, and also received research funding from the NIH and from the Department of Defense.
Joseph Gootenberg, M.D.
Dr. Gootenberg is Deputy Division Director of the Division of Biologic Oncology Products 2, Office of Oncology Drug Products, Centerfor Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). Prior to joining the FDA Dr. Gootenberg was Director of Pediatric Hematology/Oncology at the Vincent T. Lombardi Cancer Center and Department of Pediatrics, Georgetown University School of Medicine. Dr. Gootenberg graduated from Harvard College and received his M.D. degree from the Albert Einstein College of Medicine. He served his Pediatric Residency at Boston Children’s Hospital, and completed his Fellowship in Pediatric Hematology/Oncology at the National Cancer Institute where he pursued postdoctoral training in cellular immunology and cytokines in the laboratory of Dr. Robert Gallo.
Ms. Haugen is a 14-year inflammatory breast cancer survivor, and is the National Breast Cancer Coalition Field Coordinator for South Dakota and a graduate of all of the NBCC Project LEAD science training courses. She participated in the NBCC Measuring What Matters Project. She has consumer experience in cancer research peer and programmatic review and currently serves as the Chair of the Department of Defense Breast Cancer Research Program Integration Panel. She has also served as a consumer reviewer for the California Breast Cancer Research Program, and as a member of the National Quality Forum Clinician-Level Cancer Care Steering Committee and the Patient Outcomes Steering Committee. Ms. Haugen serves as a community representative board member on the Sanford Health Institutional Review Board for community cooperative group cancer clinical trials, and is a board member of the National Cancer Institute Adult Central IRB. She recently completed service as the consumer representative to the Advisory Board of the Consumer Operated and Oriented Plan Program. She has served on the South Dakota State Advisory Council for the American Cancer Society and is a member of the South Dakota Women’s Cancer Network. She also has experience as a public policy advocate and as an NCI Specialized Programs of Research Excellence advocate. She spent over 30 years in the information technology industry and serves as a board member in higher education and long-term care. She has an undergraduate degree in mathematics and a certificate in public health.
Virginia Kwitkowski, R.N., M.S., ANCP-BC
Ms. Kwitkowski joined the U.S. Food and Drug Administration as a Senior Clinical Analyst in 2006. She is currently a clinical team leader in the Division of Hematology Products within the Office of Hematology and Oncology Products. In this role, she provides leadership to a team of clinical reviewers who review Investigational New Drug Applications and New Drug Applications for benign and malignant hematology indications. Prior to joining the FDA, Ms. Kwitkowski was a Nurse Practitioner in the Medicine Branch of the National Cancer Institute.
Louise Perkins, M.S., Ph.D.
Dr. Perkins is the Chief Science Officer of the Melanoma Research Alliance (MRA). She joined MRA in February 2013 after having spent five years as Chief Scientific Officer at the Multiple Myeloma Research Foundation (MMRF), and a distinguished industry career that included leadership of oncology research programs at Bayer Pharmaceuticals and Schering-Plough. While at the MMRF, Dr. Perkins was responsible for the development and execution of MMRF’s scientific strategy, and also led the continued expansion of its venture philanthropy investments. Under her guidance, MMRF’s Genomics Initiative sequenced the first myeloma tumor genome and comprehensively analyzed 250 myeloma patient samples with an array of genomic technologies, including next-gen sequencing. Prior to her role at MMRF, she was Director of Cancer Research at Bayer Pharmaceuticals, and previously she led a cancer research group at the Schering-Plough Research Institute. Dr. Perkins holds a Ph.D. and M.S. in Biological Chemistry from the University of Michigan, and has conducted postdoctoral studies at Princeton University’s Department of Molecular Biology. She has a B.S. in Zoology from the University of North Carolina at Chapel Hill.
Tatiana Prowell, M.D.
Dr. Prowell received her B.A. in English from Bard College and her M.D. from The Johns Hopkins University School of Medicine with election to Phi Beta Kappa Honor Society and Alpha Omega Alpha Honor Medical Society. She completed a residency in Internal Medicine in the Osler Housestaff Training Program and a fellowship in Medical Oncology in the Breast Cancer Research Program, both at Johns Hopkins Hospital. Dr. Prowell has received the American Society of Clinical Oncology Young Investigator Award and twice received the Pearl M. Stetler Research Fund for Women Award for her breast cancer research. In 2006, Dr. Prowell joined the FDA, where she currently serves as Breast Cancer Scientific Lead within the Office of Hematology & Oncology Products. She has recently helped to pioneer use of pathological complete response as a novel endpoint for accelerated approval of agents to treat high-risk, early-stage breast cancer. Dr. Prowell is also an Assistant Professor of Oncology at The Johns Hopkins University School of Medicine and sees patients in the second opinion breast cancer clinic at the Sidney Kimmel Comprehensive Cancer Center.
Jane Reese-Coulbourne, M.S. ChE.
Ms. Reese-Coulbourne is the Executive Director of the Reagan-Udall Foundation for the FDA (Foundation). Created by Congress, the Foundation supports the mission of the FDA by identifying, funding, and supporting public private partnerships and projects that will provide the highest caliber science and technology, to enhance the safety and effectiveness of FDA regulated products. Her background includes experience in patient advocacy, industry and government. As an employee of the Procter & Gamble Company for more than 10 years, she worked in production operations, chemical engineering, government regulation, new technology and product/brand start-ups. Later working with other Fortune 500 companies, she consulted in strategic planning, reengineering/restructuring, new technology plans and start-ups, and total quality management in unionized manufacturing and utility operations. Her diagnosis of breast cancer led to her interest in health research and patient advocacy, serving as Executive Vice President of the National Breast Cancer Coalition, and then as a consultant to the Director of the National Cancer Institute, as well as to leaders in not-for-profit advocacy organizations, foundations, and biotechnology /pharmaceutical companies. Ms. Reese-Coulbourne holds a BS in Chemistry from the University of Mary Washington and an MS in Chemical Engineering from the University of Virginia.
Mace Rothenberg, M.D.
Dr. Rothenberg is Senior Vice President of Clinical Development and Medical Affairs for the Oncology Business Unit of Pfizer Pharmaceuticals. He is responsible for overseeing clinical research and development activities as well as post-marketing evaluation and monitoring for all oncology products. He chairs the Strategy, Alignment, Innovation, and Operational Excellence Team and the Portfolio Strategy Team within CDMA. He is a member of the Oncology Business Unit Leadership Team, the Chief Medical Officer’s Leadership Team, the Pfizer Portfolio Strategy and Investment Group, and Pfizer’s Senior Leadership Council. Dr. Rothenberg came to Pfizer in 2008 after more than 20 years in academia where he focused on early-stage drug development, clinical trial design, and the coordinated laboratory-clinical evaluation of new therapies for gastrointestinal cancers. While in academia, Dr. Rothenberg’s work was critical to the development and eventual Food and Drug Administration approval of irinotecan (CPT-11, Camptosar®) in 1996 and oxaliplatin (Eloxatin®) in 2002 for colorectal cancer, as well as gemcitabine (Gemzar®) in 1996 for pancreatic cancer. At Pfizer, Dr. Rothenberg’s group has been successful in obtaining regulatory approval for sunitinib (Sutent®) for pancreatic neuroendocrine tumors in 2011, crizotinib (Xalkori®) for ALK+ non-small cell lung cancer in 2011, axitinib (Inlyta®) for renal cell carcinoma in 2012, and bosutinib (Bosulif®) for Ph+ chronic myelogenous leukemia in 2012. Dr. Rothenberg is the recipient of the American Cancer Society’s Lane W. Adams Quality of Life Award, honoring him as one of the nation's top cancer caregivers and the American Society of Clinical Oncology’s Statesman Award, honoring him for more than 20 years of service to the organization, the specialty of oncology and cancer patients. He received his B.A. magna cum laude from the University of Pennsylvania in 1978 and his M.D. degree from the New York University School of Medicine in 1982. He received his post-graduate training in Internal Medicine at Vanderbilt University from 1982 to 1985 and in Medical Oncology at the National Cancer Institute from 1985 to 1988.
Mark Velleca, M.D., Ph.D.
Dr. Velleca heads the Leukemia and Lymphoma Society’s (LLS) office of public policy in Washington D.C. In this position, he oversees the strategy and implementation of LLS's legislative and regulatory policy initiatives. He is also responsible for patient access, education and advocacy, as well as professional education programs at LLS. A scientist and board-certified physician, Dr. Velleca has experience in both academic research and clinical medicine as well as executive management in the private sector. He was the founder and senior vice president of CGI Pharmaceuticals, guiding CGI from its inception through its establishment as a drug discovery company that brought multiple drug candidates from research into clinical trials. Gilead Sciences acquired CGI in 2010, whereupon he served as a senior advisor at Gilead until joining LLS in 2012. He has also served on the board of directors and scientific advisory boards of several other biotechnology companies. Earlier in his career, Dr. Velleca was an attending physician at Yale-New Haven Hospital and on the clinical faculty at Yale Medical School. He earned a B.S. Cum Laude from Yale University and an M.D. and a Ph.D. from Washington University in St. Louis. His broad experience base in science, medicine, and drug development have provided important insights into the challenges that patients can face in gaining access to high quality, affordable health care.
Jura Viesulas, M.S., Ed.D.
Dr. Viesulas coordinates the Outreach Program in the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration. In this role she organizes workshops, monitors office publications, and coordinates other outreach activities. Prior to joining the FDA, Dr. Viesulas was Manager of Professional Services at the American Chemical Society where she organized over 20 workshops and published numerous career manuals and guidelines for chemists. During her academic career she was Coordinator of General and Organic Chemistry at Temple University, Philadelphia. She is author and producer of General Chemistry Laboratory Video Demonstrations and several web courses for chemists. She received her M.S. in Biochemistry from Wayne State University and her Doctor of Education from Temple University.