Adult CIRB - Early Phase Emphasis Members
Edward Kim MD
Edward S. Kim, MD is Chair of Solid Tumor Oncology and Investigational Therapeutics and the Donald S. Kim Distinguished Chair for Cancer Research at the Levine Cancer Institute, Carolinas HealthCare System in Charlotte, NC.
Dr. Kim was previously at The University of Texas MD Anderson Cancer Center in Houston, Texas where he was an Associate Professor of Medicine, Chief of the Section of Head and Neck Medical Oncology and Director of Clinical Research Operations in the Department of Thoracic/Head and Neck Medical Oncology.
Dr Kim received his Bachelor of Science and medical degrees from the Honors Program in Medical Education (HPME) at Northwestern University in Chicago, Illinois, 1996. Dr Kim completed residency in internal medicine at the Baylor College of Medicine in Houston, Texas, 1996-1999, and his fellowship in medical oncology at The University of Texas MD Anderson Cancer Center, 1999-2001.
Dr Kim studies novel targeted agents in the treatment and prevention settings and has expertise in lung, head and neck, as well as thymic cancers. He serves as principal investigator on numerous clinical studies including the Department of Defense Biomarker-based Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) or personalized medicine program in lung cancer. Dr Kim studies novel targeted agents in the treatment and prevention settings and has expertise in lung, head and neck, as well as thymic cancers.
Dr Kim serves on the editorial boards of Journal of Clinical Oncology, Clinical Cancer Research, and Clinical Lung Cancer and is a member of numerous associations and societies, including ASCO, AACR, SWOG and IASLC. Dr Kim is also the recipient of several awards including the ASCO Young Investigators Award and the AACR Scholar in Training Award. He also served as the principal investigator of the MD Anderson SWOG U10 institutional grant and is the recipient of a V Foundation Grant.
Dr Kim is the author or coauthor of more than 100 published articles, book chapters, reviews in journals such as Lancet, Lancet Oncology, Journal of Clinical Oncology, Cancer Discovery, Cancer, and Cancer Prevention Research, involving cancer therapeutics and prevention with chemotherapy and novel targeted agents, with particular emphases on lung cancer and head and neck cancer.
Chair, Solid Tumor Oncology and Investigational Therapeutics
Donald S. Kim Distinguished Chair for Cancer Research
Levine Cancer Institute
Carolinas Healthcare System
Monica Mita MD
Dr. Mita joins the NCI Adult CIRB - Early Phase Emphasis board from the Cedars-Sinai Medical Center where she's the Co-Director of the Experimental Therapeutics Program at the Samuel Oschin Comprehensive Cancer Institute. Dr. Mita's research focuses on the development of early clinical trials of novel therapeutic agents. Dr. Mita has authored more than 75 articles published in peer reviewed publications. She has presented more than 90 abstracts and poster presentations and has lectured at numerous conferences and meetings.
In addition to being a member of the European Society for Medical Board in Internal medicine, Dr. Mita is a member of the American Society for Clinical Oncology, the American Association for Cancer Research and the Southwest Oncology Group, Breast and Early Therapeutics. She earned a diploma at the School of Breast Oncology in Atlanta, Georgia and both a merit award and the Brigid G. Leventhal Award from the American Cancer Society of Clinical Oncology.
After earning her medical degree at the Carol Davila University of Medicine and Pharmacy in Bucharest, Romania, Dr. Mita completed specialty training in oncology and cancer research at Paul Brousse Hospital in Villejuif, France and the Rene Huguenin Center in Saint-Cloud, France. She received additional specialty training in oncology at the Claudius Regaud Center, Purpan Hospital, the Saint-Antoine Hospital and Childrens Hospital, all in France. Dr. Mita performed a fellowship in Medical Oncology and one in Advanced Oncology Drug Development at the University of Texas Health Science Center in San Antonio.Close
Co-Director of the Experimental Therapeutics Program
Samuel Oschin Comprehensive Cancer Institute
Cedars-Sinai Medical Center
Los Angeles, CA
Laura Cleveland BS
Laura Cleveland started advocating for patients when she initiated patient centered meetings for people diagnosed with Chronic Lymphocytic Leukemia. What she thought would be a backyard cookout for 20 people turned out to be a conference for over 250 patients and their family members.
Laura began serving on the CALGB Leukemia and Leukemia Correlative Science Committees as a research advocate and now is Vice Chair of the Alliance Patient Advocate Committee. She serves locally as the Research Subject Advocate for patients on Phase I gene therapy transfer trials at The Ohio State University's James Cancer Center. Laura also volunteers for the Leukemia and Lymphoma Society's First Connection patient matching program. She is the patient advocate on The Ohio State University's Comprehensive Cancer Center's Leukemia SPORE's Internal Advisory Board.
Nationally, Laura has spoken at the AACR Annual Meeting and to many patient groups in the United States and Canada. She serves as the patient voice for The CLL Consortium's Data and Safety Monitoring Committee, and training lead at the Coalition of Cancer Cooperative Group's Patient Advisory Board. This is Laura's fourth year to serve as faculty for AACR /ASCO's Clinical Trials Methods Course; training new oncologists to write their first clinical trial protocol.
Prior to her service as an advocate, Laura worked as an educator and educational administrator for almost twenty years. Laura is a 14 year Chronic Lymphocytic Leukemia survivor, who is grateful to watch her family of three children grow and thrive. She lives with her husband and children in Powell, Ohio.
Susan Krivacic MPAff
Ms. Krivacic is a 26 year lymphoma cancer survivor. During her personal journey with cancer, she harnessed her professional cancer research knowledge to share with and help others afflicted by cancer. Ms. Krivacic has been a co-facilitator and member of Cancer Anonymous (CA) in Austin, Texas (now known as Friends of Cancer Anonymous) since 1989. In 1990, she founded a local young adult cancer support group. She continues her local support work with cancer patients by helping them navigate the world of cancer treatments and survivorship, accompanying many of them to their initial oncology visits.
Ms. Krivacic currently divides her time between patient advocacy and running her own consulting company- PBG Consulting, LLC, a strategic management consulting firm. Ms. Krivacic is a current patient advisor to and member of the national organization: Patient's Against Lymphoma (PAL). She is a current scientific board member serving on a Commercial Central Independent Review Boards (IRB) located in Austin, Texas and has been a past member of another Board. Additionally, she served as a Member of the US Secretary's Advisory Committee on Human Research Protections (SACHRP) from 2011-2014.
As a patient advocate, she frequently presents and consults on advocacy and survivorship issues, on cancer clinical research and drug development, and also serves on a number of oncology advisory boards. She has served and continues to serve as a Patient Advocate on many programs: Patient Representative and Consultant program at the Food and Drug Administration, clinical research workshops: FDA and Duke University: "Accelerating Anticancer Agent Development and Validation Workshop", AACR, 2009 and 2015, and the National Comprehensive Cancer Networks (NCCN) Treatment Guidelines NHL Panel since 2011. She has received several awards for her work as an Advocate, including the FDA Commissioner's Special Citation Award in 2004 for the Development of a Guide for Patient Representatives Serving on FDA Advisory Committees.
Ms. Krivacic's former professional career included leadership roles within the contract clinical research and life sciences industries. Ms. Krivacic received her Bachelor of Arts degree from the University of Texas, Austin, Texas in 1981, and a Master of Public Affairs, with a concentration in Health Policy, from Lyndon Baines Johnson School of Public Affairs at the University of Texas, Austin, in 1982. She was a Fulbright Scholar at the University of Zagreb, Yugoslavia, in 1984.Close
Independent Patient Advocate to non-profit cancer organizations and other Non-Profit Organizations (NPOs).
Founder, Principal, and Consultant of PBG CONSULTING, LLC
Duke Morrow M.D.
Mr. Morrow is a second career minister (now retired), having spent much of his adult life as a mechanical engineer involved in automatic machine design and administration. His IRB experience includes service to the University of Michigan Health System IRBs, since 2006, focused on oncology, general medical, privacy, and behavioral science as a non-scientist member and prisoner advocate. He is an expedited and single member reviewer.
He serves on the NIH All of Us Research Program IRB (formerly Precision Medicine Initiative) as a community member and prisoner advocate. He is a member of the Biomedical Research Alliance of New York’s SBER IRB.
He is a member of PRIM&R’s Diversity Advisory Group, and a member of Detroit Diversity Power’s advisory board, a handicapped access advocacy organization.
University of Michigan
Ann Arbor, MI
Jan Beumer PharmD, PhD
Jan Hendrik Beumer was appointed Associate Professor in the Department of Pharmaceutical Sciences at the University of Pittsburgh, School of Pharmacy in July 2014.
Dr Beumer has established an active program of healthy volunteer drug-drug interaction studies, designed several phase I studies of novel combinations of anticancer agents, and has extensively researched pyrimidine anticancer drug pharmacology. He is an expert in preclinical and clinical metabolic studies, with a focus on mass balance studies. He also serves as Director of the University of Pittsburgh Cancer Institute Clinical Pharmacology Analytical Facility, which also functions as the core facility of the Gynecologic Oncology Group (GOG) and the Cancer and Leukemia Group B (CALGB). Through these roles, he is intimately involved in the design, execution, supervision and data analysis of numerous pharmacokinetic and metabolic studies of anti-cancer drugs covering the entire spectrum from preclinical to clinical phase II studies. For several years, he has been a co-investigator and is currently co-PI on an NCI N01 Animal Pharmacology Contract and I am co-PI of the UPCI NCI/CTEP U01 Phase I Grant.
Dr Beumer's goal is to study the translational pharmacology of anticancer drugs and to play a critical role in facilitating and mediating the preclinical and clinical drug development process. The translational science that is conducted in his laboratory provides significant contributions to the cancer research community at the University of Pittsburgh Cancer Institute, the Department of Pharmacutical Sciences, as well as at the NCI, various cooperative groups, other academic centers, and the pharmaceutical industry with the eventual goal of enhancing the quality of care of our cancer patients.Close
Susan Groshen PhD
Dr. Groshen joins the NCI Adult CIRB - Early Phase Emphasis board from the USC/Norris Comprehensive Cancer Center as the Director of the Biostatistics Core Resource where she co-ordinates the activities of the members of the Core and is the primary link with the clinical/translational cores at the Cancer Center: the Clinical Investigations Support Office, the Clinical Research Informatics Core, and the Translational Pathology Core Facility.
Dr. Groshen devotes over 95% of her time at USC to supporting the cancer research activities at the Cancer Center with a focus on clinical research. She's currently a statistical editor for the Journal of the National Cancer Institute, a member of the editorial board for Clinical Cancer Research, a member of the Data Safety Monitoring Board (DSMB) for the Phase III trials that are conducted via the Children's Oncology Group, and an alternate member on the NCI Genitourinary Cancers Steering Committee (GUSC). Additionally, she's a member of the Clinical Trials Task Force (reporting to the NCI Investigational Drug Steering Committee) and the Bladder Cancer Task Force (reporting to the NCI GUSC). Dr. Groshen is also the Director of the Biostatistics Shared Resource for the NCI-funded program project entitled "Biology and Therapy of High Risk Neuroblastoma" (funded by P01 CA 081403) and is Director of the Biostatistics Core for the Phase I trials conducted as part of the California Cancer Consortium with Pennsylvania (funded by U01 CA 62505).Close
Director of the Biostatistics Core Resource
Department of Preventive Medicine
USC/Norris Comprehensive Cancer Center
Los Angeles, CA
C. Michael Jones M.D., M.S.C., FACP
Dr. Michael Jones is the Medical Director of the Baptist New Albany Medical Center (NCORP) and Associate Professor of Medicine at the University of Tennessee. Dr. Jones received his medical degree from the University of Alabama and his master’s degree in Healthcare Economics and Policy from the London School of Economics and Political Science. He completed his fellowship in Hematology/Oncology at John’s Hopkins Hospital where in the laboratory of Dr. Manfred Mayer, he discovered that patients with PNH were deficient in the complement regulatory protein (CD55) and demonstrated that antibodies against the complement components could block hemolysis.
Dr. Jones served as Medical Officer of the Laboratory of Immunodiagnosis at the National Cancer Institute from 1979 – 1982. There in collaboration with Dr. Ronald Herberman, he described the first functioning human T-cell hybridoma.
Dr. Jones joined the faculty at the University of Texas Medical School and MD Anderson Hospital in 1982 and became the Associate Division Director for Hematology/Oncology for the University of TX Medical School. His own R01 focused on tumor immunology for which he was awarded four U.S. patents. He served on the Committee for the Protection of Human Subjects for ten years and was principal investigator of the T32 training grant in academic hematology/oncology for the University of Texas MD Anderson Cancer Center.
Dr. Jones’ own practice was among the first to receive the ASCO QOPI Award and he has been named one of the “Top Doctors” in Memphis by Memphis Magazine on several occasions and a Healthcare Hero for the City of Memphis.
Dr. Jones belongs to numerous societies including ASCO, ASH and AAI. He currently serves on the NCI Gastrointestinal Steering Committee for hepatobiliary malignancies. He has been the principal investigator for over 50 trials in clinical oncology research. He is proud to have trained numerous graduate students, house staff and fellows for which he has received the University of Texas mentorship award.Close
Medical Director of the Baptist New Albany Medical Center (NCORP)
Associate Professor of Medicine
University of Tennessee
Judith E Karp MD
Judith E. Karp, MD is Professor Emerita, Oncology and Medicine, The Johns Hopkins University School of Medicine. Dr. Karp served on the University of Maryland Medical School IRB from 1997-2002 and on The Johns Hopkins Sidney Kimmel Cancer Center Clinical Research Committee IRB from 2002-2007.
Dr. Karp started as an Instructor in Oncology and Medicine at The Johns Hopkins University School of Medicine in 1975 and continued on as an Associate Professor through 2002. In 2002 she became a full Professor of Oncology and Medicine in addition to Director, Adult Leukemia Program, Division of Hematologic Malignancies, serving as such until 2013. She has worked at National Cancer Institute, National Institutes of Health from 1990-1996. Her roles and responsibilities included serving as Special Assistant to the Director, NCI and as Program Director, Chemoprevention Branch, Division of Cancer Prevention and Control from 1995-1996. She was a Professor of Medicine and Director, Hematologic Malignancies Program at the University of Maryland from 1997-2002. Dr. Karp has been published over 20 times in a variety of journals including Cancer Treatment Reports, The Journal of Cancer Research, and Blood.
She was the Principal Investigator for more than 15 early phase, investigator-initiated leukemia clinical trials supported by NCI's Cancer Therapy Evaluation Program (U01 mechanism) between 1996-2013. She has served as an ECOG investigator from 2003-2013.
The Johns Hopkins School of Medicine
Andreas Klein M.D.
Dr. Andreas Klein is Associate Chief of the Division of Hematology/Oncology at Tufts Medical Center and Associate Professor of Medicine at Tufts University School of Medicine. Dr. Klein completed fellowship training in Hematology and Medical Oncology at Duke Medical Center and joined Tufts Medical Center in 2001. His clinical practice focuses on the treatment of lymphoma and hematopoietic stem cell transplantation. His translational interests lie in improving patient outcomes through targeting the tumor microenvironment to enhance the effectiveness of high dose chemotherapy and stem cell graft engineering to reduce the risk of graft-versus-host disease. Dr. Klein has served on the IRB for the Tufts Health Sciences campus as a member since 2004 and as Chair since 2010. He also serves as the Director of Regulatory Affairs for the Tufts CTSI.Close
Associate Chief of the Division of Hematology/Oncology, Tufts Medical Center
Associate Professor of Medicine, Tufts University School of Medicine
Gerald O'Neill BS/MS, PharmD, R.Ph
Gerald P. O'Neill joins the NCI Adult CIRB - Early Phase Emphasis board. Dr. O'Neill is from the Memorial Sloan Kettering Cancer Center (MSKCC) where he is currently the Pharmacy Supervisor of the Investigational Drug Service and Chemotherapy Practice. He manages all pharmacy aspects of clinical trials including the supervision of pharmacy support staff working on MSKCC studies.
Dr. O'Neill has over 20 years of experience in Oncology Pharmacy with extensive work in both Institutional and Cooperative Group research efforts. He has served as a member of MSKCC Department of Medicine Protocol Steering Committee since 2001 and has recently been appointed to the MSKCC Institutional Review Board, and ECOG Pharmacy Committee.Close
Pharmacy Supervisor of the Investigational Drug Service and Chemotherapy Practice
Memorial Sloan-Kettering Cancer Center
New York, NY
Natalie Streeter MSN
Dr. Natalie Streeter has been involved in research since 2000. She began her career at the bench in a genomics laboratory at the University of Wisconsin and quickly moved into clinical research. She has worked in a variety of fields such as bone health and aging, HIV/infectious disease and maternal/fetal medicine before finding her passion in oncology. In 2012, she joined the University of Pittsburgh Medical Center/Hillman Cancer Center within their early phase oncology program and grew to the Associate Director of Clinical Research Services for the Hillman Cancer Center and community sites. In 2018, she joined the University of Kansas Cancer Center as Executive Director of Clinical Research Strategy and Operations, with the goal to integrate, enhance, and optimize clinical research to better serve patients in this rapidly changing field. Calling on her laboratory, bedside, nursing, research-coordination and research-administration experiences, she brings a unique perspective to this new role. Additionally, Natalie is eager to drive an ethically sound culture and deliver comprehensive clinical trials which evolve to meet the changing needs of the patients.Close
Executive Director, Clinical Research, Strategy & Operations
University of Kansas Cancer Center
Kansas City, KS
Melanie Thomas M.D.
Dr. Melanie Thomas is a medical oncologist, Associate Director for Experimental Therapeutics, and Vice Department Chair of Hematology and Oncology at Gibbs Cancer Center & Research Institute, Spartanburg Regional Healthcare System in Spartanburg, SC. Dr. Thomas is a physician and clinical researcher with an interest in phase I and II clinical trials of novel agents in Hepatobiliary cancers.
Dr. Thomas received an American Society of Clinical Oncology Career Development Award to study targeted therapies in biliary tract cancer. She has led over fifty clinical trials for liver and other gastrointestinal cancers and is an internationally recognized expert in these malignancies. Dr. Thomas has been involved in early phase clinical trials since fellowship and served as the principal investigator of numerous Phase I studies including NCI-CTEP, industry, and investigator-initiated. While previously serving as Associate Director of Clinical Research at the Medical University of South Carolina Hollings Cancer Center, and in her current role at Gibbs Cancer Center, Dr. Thomas created de novo Phase I programs that studied first- in-class compounds and cell-based therapeutics.
Dr. Thomas received her medical degree from the Boston University School of Medicine, completed internal medicine residency at the Beth-Israel-Deaconess Medical Center in Boston, and medical oncology fellowship at The University of Texas M.D. Anderson Cancer Center in Houston, TX. While a faculty member in the Department of Gastrointestinal Medical Oncology at M.D. Anderson, Dr. Thomas was a Chair of the Protocol Review Committee for 6 years, and a physician member of the Institutional Review Board. She received additional clinical research training at the ASCO/AACR Methods in Clinical Cancer Research Workshop in Vail, CO.Close
Associate Director for Experimental Therapeutics
Vice Department Chair of Hematology and Oncology
Gibbs Cancer Center & Research Institute
Kari Wisinski MD
Dr. Wisinski is an Associate Professor of Medicine at the University of Wisconsin (UW) School of Medicine and Public Health in the Division of Hematology and Oncology and a member of the UW Carbone Cancer Center (UWCCC). Her clinical practice is centered on the treatment of patients with breast cancer or at high risk for developing breast cancer. Dr. Wisinski’s research is focused on early phase clinical trials for new agents and investigations of novel targets for breast cancer. Currently, she is the PI or study chair on multiple clinical trials, including a CTEP sponsored investigator-initiated Phase I trial, two sub-protocols of the NCI MATCH study and a R01 funded window trial. Since 2012, she has been Co-Director of the Wisconsin Oncology Network. This is a research network of academic and private practice oncology groups throughout Wisconsin. As Co-Leader of the Big Ten Cancer Research Consortium Breast Cancer Working Group, she has helped steer this network’s first breast cancer trials to activation. Additionally, Dr. Wisinski is the senior clinical investigator for one of these trials.Close
University of Wisconsin, Carbone Cancer Center
Associate Professor of Medicine, Division of Hematology and Oncology
Director of Medical Oncology Inpatient Service
Song Zhang PhD
Dr. Zhang is currently an Associate Professor at the University of Texas Southwestern in the department of Clinical Sciences. His scientific research interest lies in Bayesian statistical methods and their application in longitudinal and survival data analysis, high-throughput data analysis, disease mapping, adaptive design for clinical trials and missing data imputation. He earned a Doctorate in statistics from the University of Missouri-Columbia. Dr. Zhang received a master’s degree in Econometrics, as well as a bachelor’s degree in Management of Information System from Xiamen University, China.
He previously was a postdoctoral fellow at the University of Texas M.D. Anderson Cancer Center.Close
Associate Professor of Clinical Sciences
University of Texas Southwestern Medical Center
Dena S Davis JD, PhD
Dena S. Davis is the Presidential Endowed Chair in Health at Lehigh University where she teaches a variety of courses in bioethics. Dr. Davis received her Bachelor of Arts from Marlboro College, her Juris Doctorate from the University of Virginia, and her PhD in Religion from the University of Iowa. She was a Fellow in the Department of Bioethics at the Cleveland Clinic. Dr. Davis has been a Visiting Scholar at the National Human Genome Research Institute, Arizona State University, and the Hastings Center. She holds an adjunct appointment at Case Western Reserve University's Department of Biomedical Ethics, and is a Faculty Associate in CWRU's Center for Genetic Research Ethics and Law. She is the author of several articles on biomedical ethics and two books, Genetic Dilemmas: Reproductive Technology, Parental Choices, and Children's Futures (Oxford University Press, 2009) and Notes from a Narrow Ridge: Religious Studies and Bioethics (University Publishing Group, 1999), which she coauthored. A third book, How Genes Tell Stories, is in progress.Close
Presidential Endowed Chair in Health