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Appendix B Speaker Biographies PANEL 1: PARTICIPANT CENTERED CLINICAL RESEARCH MODERATOR-MYRL WEINBERG MARSHALL H. CHIN, M.D., M.P.H., is Associate Pro- fessor of Medicine, Associate Director of the Robert Wood Johnson Clinical Scholars Program, and Director of the NIDDK Diabetes Research and Training Center Prevention and Control Core at the University of Chicago. He is a gen- eral internist whose research focuses on improving the care and outcomes of vulnerable patients with chronic disease in community health centers. Dr. Chin' s current work tests mul- tifactorial, community-based interventions including rapid quality improvement, chronic disease management, provider training in behavioral change, and patient empowerment. He received the 2001 National Association of Community Health Centers Innovative Research in Primary Care Award. Dr. Chin received his M.D. from the University of Califor- nia at San Francisco, and completed residency and fellow- ship training in general internal medicine at Brigham and Women's Hospital, Harvard Medical School. LAWRENCE W. GREEN, Dr.P.H., is the first director of the CDC Office of Science and Extramural Research and Associate Director for Prevention Research and Academic Partnerships in CDC's Public Health Practice Program Of- fice. He served as Acting Director of CDC's Of lice on Smok- ing and Health and director of the WHO Collaborating Cen- ter on Tobacco and Health, with responsibility for the development and coordination of CDC' s global tobacco con- trol strategy in collaboration with the World Health Organi- zation. Prior to joining the CDC, he served as Director of the Institute of Health Promotion Research and Professor and Head of the Division of Preventive Medicine and Health Pro- motion, Department of Health Care and Epidemiology, at the University of British Columbia. 50 ZELDA TETENBAUM, a science and health educator, is a member of the NIH Director's Council of Public Represen- tatives. Her work as a patient advocate began in 1996 when her adult son was diagnosed with a brain tumor, glioblas- toma multiforme. During her search for information about her son's illness, Ms. Tetenbaum has been involved with the American Brain Tumor Association and the Central Brain Tumor Registry of the United States, and the North Ameri- can Brain Tumor Coalition (NABTC), a network of 13 chari- table organizations dedicated to eradicating brain tumors. Currently, Ms. Tetenbaum serves on NABTC's Board of Directors and as Chairperson of its Advocacy Committee. In addition to her volunteer and advocacy work, Ms. Tetenbaum has devoted much of her professional life to edu- cation. She was a science teacher at a junior high school in Illinois for 21 years. When she retired in 1990, Ms. Tetenbaum worked on a National Science Foundation Teacher Enhancement Program at the U.S. Department of Energy's Argonne National Laboratory. Currently, Ms. Tetenbaum consults for her local school district in Illinois. JEROME W. YATES, M.D., M.P.H., is the National Vice President for Research at the America Cancer Society. Prior to joining ACS, Dr. Yates was the Senior Vice President for Population Sciences at Roswell Park Cancer Institute. At Roswell Park Cancer Institute, he was involved in efforts to improve the prevention program and in the redefining of clinical research priorities across the institute. Previously, Dr. Yates served as the Associate Director for Centers and Community Oncology at the National Cancer Institute, where he was part of the group responsible for the genera- tion and subsequent evaluation of the Community Clinical Oncology Program (CCOP). He was also a participant in the NCI-funded research on pain in connection with the CCOP. Dr. Yates received his M.D. from the University of Illinois in Chicago and an M.P.H. from Harvard.

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APPENDIX B PANEL 2: MODEL COLLABORATIONS AMONG COMMUNITY/ DISEASE ADVOCATES, RESEARCHERS, AND SPONSORS MODERA TOR - LARRY GREEN JENNIFER BRYSON is the Director of Corporate Affairs at Genentech, Inc., a leading biotechnology company head- quartered in South San Francisco, CA. Ms. Bryson brings extensive experience in advocacy relations and longstanding relationships with the cancer community and other patient advocacy groups. She has been instrumental in the growth of innovative collaborations between Genentech and patient communities. During the development of Herceptin, a novel breast cancer therapy, Ms. Bryson facilitated a unique and lasting partnership between the company and breast cancer advocates, which helped quickly enroll clinical trials and make the treatment widely available to patients. Before join- ing Genentech in 1999, Ms. Bryson held positions at Ketchum Public Relations and Bass and Howes, Inc in Washington, DC. Prior to her work at these firms, Ms. Bryson worked on several statewide campaigns for women candidates. She holds a bachelor's degree from Mount Holyoke College. KENNETH A. BERTRAM, M.D., Ph.D., F.A.C.P., Colo- nel, U.S. Army Medical Corps, is the Director of the Con- gressionally Directed Medical Research Programs (CDMRP) at Fort Detrick, Maryland. He directs all facets of the DOD breast cancer, prostate cancer, ovarian cancer, neu- rofibromatosis, and other peer reviewed medical research programs, totaling $2.2 billion for the USAMRMC. COL Bertram holds an Assistant Professor appointment at the Uniformed Services University of the Health Sciences. He obtained both his Ph.D. and his M.D. from the University of Minnesota. He then moved to Madigan Army Medical Cen- ter, where he completed his Internal Medicine residency and Hematology/Oncology Fellowship and later served as Chief, Hematology/Oncology Service. COL Bertram has conducted translational research in breast cancer and participated as a site Principal Investigator in the Southwest Oncology Group clinical trials. LESLIE FORD, M.D., is Associate Director for Clinical Research and Acting Deputy Director of the Division of Cancer Prevention at the National Cancer Institute. She is responsible for the overall direction, conceptualization, plan- ning, and coordination of cancer prevention clinical trials at NCI. She has over 20 years experience in bringing cancer clinical trials into community medical practices. As Chief of the Community Oncology and Rehabilitation Program, she expanded the Community Clinical Oncology Program (CCOP), through which more than 10,000 men and women are accrued each year to NCI-sponsored treatment and pre- 51 vention clinical trials. She received her B.S. and M.D. from SUNY Buffalo. KEN OLDEN, Ph.D., was named as the third director of the National Institute of Environmental Health Sciences (NIEHS) and the second director of the National Toxicology Program (NTP) in June 1991. Dr. Olden is a cell biologist and biochemist by training, and has been active in cancer research for almost three decades. He was director of the Howard University Cancer Center and professor and chair- man of the Department of Oncology at Howard University Medical School (1985-1991), Washington, D.C., before join- ing NIEHS. He joined Howard in 1979 as Associate Direc- tor for Research after a stint at the National Institutes of Health, first as a senior staff fellow, second as an expert, then a research biologist in the Division of Cancer Biolo~v and Diagnosis, National Cancer Institute. ~7~ FRAN M. VISCO, J.D., is the first President of the Na- tional Breast Cancer Coalition (NBCC) and a member of its Board of Directors. Formed in May 1991, NBCC is a grassroots advocacy organization of more than 600 member organizations and 70,000 individual members. Ms. Visco is an honors graduate of St. Joseph's University and of Villanova Law School where she was an editor of The Villanova Law Review and a chair of the Women's Law Caucus. In 1993, President Clinton appointed Ms. Visco to the President's Cancer Panel and she was re-appointed for a second term in 1996. Ms. Visco, who was elected to chair the Integration Panel of the Department of Defense Peer- Reviewed Breast Cancer Research Program, is the first con- sumer to chair this panel. Ms. Visco co-chaired the National Action Plan on Breast Cancer and serves on the National Cancer Policy Board. Ms. Visco is a breast cancer survivor. PANEL 3: INCREASING THE ROLE OF THE PUBLIC IN RESEARCH OVERSIGHT MODERATOR- QUETA BOND ANGELA BOWEN, M.D., established the Western Institu- tional Review Board (WIRB) in 1968 and has been the presi- dent since 1991. She is a graduate of Mississippi State Uni- versity and completed her postgraduate education in research, medicine and endocrinology at the University of Washington. Dr. Bowen has been active in clinical research, as well as a consulting endocrinologist for over thirty years. Her research interests have included tuberculosis, diabetes, circadian rhythms and effects of hormone replacement therapy. She is an accomplished speaker and a respected author. Dr. Bowen participated in the working group to dis- cuss revisions to the Declaration of Helsinki and in the de- velopment of the Ethics Committee guidelines for develop- ing countries. She is active in human subject protection.

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NANCY DU:BLER, L.~.~., is the Director of He Division of :Bioethic$, :Dep~ment Q! FipidemtQ}ogy and Social Medi- c~ne at MonteOore Medical Center and P[Q~SSOr 0[ Epide- miology and Social Medic~rte am the Albert :~nstein College of Medicine. She received her B.A. from Bam~ College and her LL.B~ Tom the Harvard Law School. Ms. Dubler directs the Bioethics Consultation Service at Monteiore Medical Center (hounded In Ig78) as a support for analysis of difficult clinical cases presenting ethical issues in the health ewe setting. She lectures extensively and is the author of numerous Stales and books. She Is Co-Director of the Certificate Program in Bioethics Ed the Medical Hum~i- t~es' conducted jointly by Montefiore Medical Cente~lAlbe~ Einstein College Of Medicine with The Hanford Institute Q! Geriatric Nursing a! NOW YQ~ University. DACTYL UNDERMAN, M.O., is the C=l W. Walter Dis- tinguished Professor of Medicine and Medical Education at Harvard Medical School In 130~0n, Massachusetts. He pre- v~usly served on the faculty of lI~rard Medical School groin 1960 to 1972, and was simultaneously on He stab of He Massachusetts Gertem} Hospital. From 1972-77 he was Ch~an of the Department of Medicine at Seward Medic cal School. He then reWmed to Awed Medical School. Dr. Federmm has served as Ch~= of the Amencan :Bo~d v! :~ Medicine' Cha~ of the Federated Council for In~al Medicine, and Resident of the Amenean College Q! Phys~c~s. He ~s a member of the Insulate of Medicine. He has received numerous awards Ruing the AAMC,s Abraham FIe~ner Award for fished Service to Medi- c~ Education In 200 ~ ~ Dr. Federm~ Waived his M.~. Mom Awry Medical School. His clinical trmmog at Massachu- setups ~~ Hospital was [Q1Iv~ed by rese=ch Awing the Na0~ Institutes of Health He holds ~ D.Sc.7 honons CAUSE, [(Qua M(. Sims SChOQ! Q! Medicine. GREG KOSM, Mad.' Is the first Elton of the new ~~- crat (;}~0ce far HuTn~ Research Protections (CAMP,) within He Office of the Secretory of the Department of locale =d Bump Sewices. He also chmrs the Humar~ Subjects Re- se~ch Subcommittee (HS:RS) of the Nations Science and Technology Council's Committee on Science. for to jo~- ing OHRP? Dr. Koski spent more than thirty years at Ha~d, dunng which he p~tic~ed ~ ember facet of aca- =e I~ =d human research. Under his leadership, the Once ~r Bump Rese=ch Pro~cUons is moving from reactive comph=~-~used system of oversight Ad sanc- dons {Q ~ Dative system focused on p~vendon of he to subjects~a system In which performance excellence is achieve Rough education, support md quality im~?rove- menl;. In colia6oradon with the Food Ad D=g Ad~mstra- bon, the National It~St~S of Realm and Q(her ~~ agen- cies? his office is working to indents new op~-~mt~es to make on system [OF ~tecUon of bump suffers more cfO- cient and mow effective. ENGAGING THE PUBLIC IN THE CLINICAL i ~T~PR~E MA~Q~ A. SPEARS, Ph.D., ~s the F~ecubve :~:rector of the Association for the Accr-ed~tat~n of Lunar Research Protection Programs (AAH~PPy, which employs a ~Q100- tary, peer-~nven, educational model of accreditation. She served at the National Bioethics Advisory Commission from 1999-2001, both as project Erector ~r a repot on He re- search oversight system arid as Acting Executive Director. Or. Speers was Deity Associate Aced ~r Science ~ the Centers for Disease Compel afar Prevention (BLOC) Mom 1995-2000. She held ~ variety of positions ad CDC from 1988-1995: Director Q:{ the Division A TIC Disease Control and Community Inteweintion, Chief of the Aging Ad Statistics Branch? Ad smff epide~Iog~st. Pnor to join- lug CDC, she was ~ faculty member at the University of Texas Mental Branch =d the Adversity of Connecticut. PANEL 4. STEPS TDi IMPROVE THE TRANSLATION AND DISSEMINATION OF THE RESULTS OF CLINICAL RESEARCH MODERATOR - NANCY Sly STEP~NT ~~:Z' M.~., Phyla., is Director Q! the Nations Institute of Arthritis and Musculo$:1~elet~ and Son Diseases at the Nylons ~sUtutes of Health and ~SQ se - ~s as calm of the Demonology :Brmch of the National Cancer Institute. :He received As undergraduate de~e fmm the UT~vers~ty of May his MD from ~~ar~e Medico School, =d ~ Ph.~. n immunology Cow the University of Condors. He has pre- v~ously served ~ the Marion B. Suizberger ~o~ssor of Dermatology ~ the Uniformed Services TJ~vers~ty of the Heath Sciences. Dr. Katz is -the P=s~dent of bmb the Int~- nabonal League of Dermatotog~~ Societies arid the Inter- nationa1 Co~ee of Dermatology. As a It Immunologist, he has contributed to our basic and climes knowledge about fin Ad skin diseases. He is ~ enemas of the IBM. JOHN W. WALSH was diagnosed with Alpha-l Ant~- ryps~n Decency (Alpha-~) ~n 1989. fIe has ded;ica~d his hoe? s work to promoting beseech and Onding a cure for the disorder. In 1995 he estabUsh~ the Alpha-1 Foundation' not-for-~:?rofit corporation dedicated to providing the leader- s~p and resources to increase research, improve health, P[Q- mom worldwide detection, Ad Ond ~ cure for Alpha-~. {n Addison? he is co- - nder of Al~^et' a r~-~-proOt ~s- e~e management comply s~eializ~g exclusively on Al- pha-~' whew he serves ~ hai~an =d Pasadena. Wash se - es as ~ active member of vamps voluntary health agency committees and goYemment~ advisory committees. He has been Deed by He Sect of Heath Ad Camaro Services to serve ~ second term on the Advisory Co~hee on Blood Safety Ad Av~l~itity. He serves on the Ardency Tic Society Public Advisory RoundRable,

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APPENDIX B the National Heart Lung and Blood Institute Public Informa- tion Council, is on the Board of Directors of Primary Im- mune Services, Inc., and is co-founder of the Plasma Users Coalition. BARRY W. WOLCOTT, M.D., serves as Senior Vice President, Senior Medical Editor, Portal Services at WebMD Corporation, employing his experience developing and inte- grating patient-focused decision support systems. In January 2000, he joined CareInsite (which merged with WebMD in September 2000~. Prior to joining WebMD, he was Chief 53 Medical Officer at Access Health. Dr. Wolcott served as as- sociate professor and the first chairman of the Department of Operational and Emergency Medicine at the F. Edward Hebert School of Medicine in Washington, DC from 1982 to 1993. Today, he continues his academic appointment at the F. Edward Hebert School of Medicine and has clinical privi- leges at the Naval National Medical Center in Bethesda, Maryland. Dr. Wolcott graduated from Johns Hopkins Uni- versity School of Medicine in 1970 and completed his Inter- nal Medicine residency at Walter Reed Army Medical Cen- ter in Washington, D.C.