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.
Hartley M. (Lee) Jones
Lee was diagnosed with Stage IV colon cancer in March 2004, and since undergoing 18 rounds of chemotherapy and a liver resection in July 2006 has been cancer free. Lee has a BA in Psychology and an MBA in Finance. He has had a successful executive career in government, banking, consulting and not-for-profit organizations.
To help others to survive and thrive after a cancer diagnosis, Lee became active with Fight Colorectal Cancer as a research advocate and became a member of the Georgetown Oncology Institutional Review Board (IRB). Also, he is a patient advocate member of the SWOG Survivorship Committee and the PCORI Clinical Trials Advisory Panel (CTAP), is on the Boards of the Cancer Action Coalition of Virginia (CACV), the Ruesch Center (Georgetown University) and the Cancer Policy and Advocacy Team (CPAT) of the National Coalition for Cancer Survivorship, has been a peer research proposal reviewer for ASCO, PCORI and the DOD, and is a member of ASCO, the Colorectal Cancer Roundtable and the Alliance for Regenerative Medicine (ARM). Lee has collaborated on several projects sponsored by The Friends of Cancer Research, including defining tolerability, reporting adverse events and tightening exclusion criteria, and has been a speaker at Ruesch Center, AAADV, CPAT and NCCN conferences.Close
President, HMJ Financial Services LLC
Advocacy & Community Volunteer
Duke Morrow MDiv, DMin
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
Jonathan Cosin MD
Dr. Jonathan Cosin is the Director of Gynecologic Oncology and Head of the Gynecologic Oncology Disease Management Team for The Hartford Healthcare Cancer Institute and Associate Professor of Ob/Gyn at the University of Connecticut. Dr. Cosin completed his residency in Ob/Gyn at Baystate Medical Center followed by a Fellowship in Gynecologic Oncology at The University of Minnesota. He served on the Faculty of the University of Minnesota from 1998-2001. From 2002-2012 he was director of Gynecologic Oncology at The Medstar Washington Hospital Center. He served as a physician member, Vice Chair and then Chair of the Medstar Oncology IRB from 2004-2008 and physician member from 2010-2011. He has been with Hartford Healthcare at the Hospital of Central Connecticut since 2012.
Dr. Cosin is a member of the NRG Clinical Trials Group and has served as GOG PI at the Medstar WHC Cancer Institute and served on the GOG Phase I Subcommittee while at the University of Minnesota. He currently serves on the HHC Cancer Institute Protocol Review Committee. He is the co-author on several GOG publications.
Dr. Cosin is a Full Member of the Society of Gynecologic Oncology and has served on the Media Response, Clinical Practice and Education Committees and is a SGO Congressional Ambassador. He is also a Fellow of the American College of Surgeons and currently serves as the SGO liaison to the American Joint Committee on Cancer.
Dr. Cosin’s clinical practice includes all aspects of Gynecologic Oncology including radical and minimally invasive surgery and medical oncology. He is also actively involved in humanitarian work having made over 30 international trips to Grenada, West Indies, The Philippines and Israel.Close
University of Connecticut
New Britain, CT
Paul Frankel PhD
With a PhD in Applied Mathematics from Brown, and fellowships at NIH, in addition to 20 years at City of Hope in biostatistics, Dr. Frankel has a consistent record as a statistician interested in improving the human condition through high quality cancer research. He has co-authored papers in pre-clinical research, prevention (both pre-clinical and clinical), and clinical trials for a large variety of cancers totaling over 100 publications and looks forward to continuing to use his experience and training to improve patient options.Close
City of Hope
Michael Hamrell PhD
Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in drug development, clinical research, compliance and regulatory affairs for over 35 years. He has worked in pharmaceuticals, contract research, government, and biotech industries, in domestic and international regulatory affairs and clinical research. Dr. Hamrell also worked at the National Institutes of Health, and as a reviewer in the Center for Drug Evaluation & Research at the Food and Drug Administration.
Dr. Hamrell spent a number of years doing basic research, first as a Research Fellow at Duke University and later as an Assistant Professor of Pharmacology at the McGill University Cancer Center. Dr. Hamrell has a Ph.D. degree in Pharmacology from the University of Southern California and a B.S. in Biochemistry from the University of California, Los Angeles. Dr. Hamrell has received numerous awards for his research, teaching and professional work. He also holds an appointment as Adjunct Professor of Regulatory and Quality Sciences at the University of Southern California School of Pharmacy International Regulatory Program, as Instructor at Eastern Michigan University Clinical Research Program and as Adjunct Professor at the Massachusetts College of Pharmacy & Health Sciences.
Dr Hamrell served as a founding Editorial Board member for Applied Clinical Trials and RA FOCUS, as the founding editor of the DIA Forum and as the Editor-in-Chief of the Drug Information Journal , Editor-in-Chief of ACRP Clinical Researcher and Editor -in-Chief of the GCP Q&A Reference Guide and member of the Editorial Board of DIA Global Forum. He currently serves as a member of the Editorial Board of Applied Clinical Trials.Close
Huntington Beach, CA
C. Michael Jones MD, MSC, 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 MD
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
Richard Tuli, MD, PhD
Dr. Tuli is Professor and Director of Radiation Oncology at the USF Health Morsani College of Medicine and Director of Research, Cancer Institute, of Tampa General Hospital. Prior to this he served as Associate Attending and Director of Developmental Therapeutics in the Department of Radiation Oncology at the NCI-designated Comprehensive Cancer Center, Memorial Sloan Kettering Cancer Center in New York.
His clinical and research practice centers around the care of patients with gastrointestinal malignancies. Dr. Tuli’s research is focused on identifying novel mechanisms to improve delivery, efficacy, and mitigate toxicity of radiotherapy and chemotherapy for GI cancers, particularly pancreatic cancer. He has developed and served as Sponsor-investigator for phase 1 and phase 2 trials, and PI of NCTN and industry-sponsored clinical trials in GI cancers. He is an active member of the GI Cancer committees of SWOG, Alliance and NRG, and serves as GI liaison to the Developmental Therapeutics committee of NRG. Dr. Tuli is a contributing member of the Pancreas Task Force of the NCI GI Cancer Steering Committee and has years of experience critically evaluating the scientific merit of clinical trials through service on Protocol Review and Monitoring Committees.
Dr. Tuli has published over 150 research articles, abstracts and book chapters. His research has appeared in several notable peer-reviewed journals for which he also serves on the Editorial Boards and as reviewer. He remains committed to the process of learning, and has mentored many residents, medical and undergraduate students. He is currently a Board Examiner for the American Board of Radiology.
After earning combined MD and PhD degrees from Jefferson Medical College through the NIH sponsored Medical Scientists Training Program, he completed his residency in Radiation Oncology at the Johns Hopkins University School of Medicine, where he also served as Chief Resident. He received additional basic science training as a pre-doctoral fellow at the National Institutes of Health, Bethesda, MD, and clinical research training at the ASCO/AACR Methods in Clinical Cancer Research Workshop, Vail, CO.
Professor and Director, Radiation Oncology
USF Health Morsani College of Medicine
Director of Research, Cancer Institute
Tampa General Hospital
Andrea E. Wahner Hendrickson MD
Andrea Wahner Hendrickson, M.D., is an associate professor in the Division of Medical Oncology and the Department of Molecular Pharmacology at Mayo Clinic in Rochester, MN. She completed her residency in Internal Medicine and her fellowship in Medical Oncology through the Mayo Clinic Clinician Investigator Program in 2012 and subsequently joined the Medical Oncology faculty at Mayo Clinic.
Dr. Wahner Hendrickson’s clinical efforts are focused on caring for women with gynecologic malignancies and she is currently the medical practice chair for gynecologic malignancies. She also is involved in the Early Cancer Therapeutics clinic focusing on early phase clinical trials. She also has served on the Mayo Clinic DSMB since 2014.
Dr. Wahner Hendrickson also has a strong commitment to education. She serves as an associate program director of the Mayo Internal Medicine residency program.Close
Associate Professor of Oncology,
College of Medicine, Mayo Clinic
Song Zhang PhD
Dr. Zhang is a Professor of Biostatistics in the department of Population and Data Sciences, University of Texas Southwestern Medical Center. 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, as well as in experimental design methods for clinical trials with complicated correlation structures, missing data, historical control, and cost constraints. He has received methodological research grants from NIH, NSF, and PCORI. He has published a book titled Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research (2015, Chapman & Hall). Dr. Zhang earned a Doctorate in statistics from the University of Missouri-Columbia.Close
Professor of Biostatistics
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