Adult CIRB - Early Phase Emphasis Members

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.

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.

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.

Linda Morrison BS

Ms. Linda Morrison is the parent of a long-term survivor of Acute Lymphoblastic Leukemia. For 11 years, she worked in a variety of roles for CURE Childhood Cancer Association in Rochester, NY. As Director of Family Programs, Linda managed all aspects of CURE’s educational, emotional support and financial assistance programs benefitting 1,500 newly diagnosed, long-term survivors and bereaved families. As CURE’s Parent Advocate, Linda worked primarily at Golisano Children’s Hospital at Strong in Rochester, NY. She served as a member of the Division of Pediatric Hematology and Oncology’s Psychosocial Team, and provided support for families in all phases of treatment, particularly those who are newly diagnosed, relapsed or facing bereavement. Since 2010, Linda has been a Community Member of the University of Rochester’s Institutional Review Board overseeing oncology and HIV research. Linda grew up in Pittsburgh, PA, graduated from the University of Pittsburgh, raised her family in Rochester, NY, and currently lives with her husband in St. Petersburg, FL.

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.

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.

Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP, FACRP, CCRA

Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located in central CA. He has worked in drug development, clinical research, compliance and regulatory affairs for over 40 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 & Toxicology 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. Dr. Hamrell also holds an appointment as Adjunct Professor of Regulatory and Quality Sciences at the University of Southern California School of Pharmacy International Regulatory Program. He is also a member of the NCI-Early Phase Development central IRB. 

He has published numerous papers in pharmacology, regulatory affairs, medical product development, clinical research, computers and information systems. 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 and Applied Clinical Trials. He currently serves as a member of the Editorial Board of Therapeutic Innovation and Regulatory Sciences.

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.

Saad Khan MBBS

Saad A. Khan, MD is a medical oncologist focused on the treatment of head and neck, thyroid and lung cancers. His research interests include therapeutic clinical trials as well as mechanisms of reducing toxicities that patients experience. His research activities include ongoing clinical trials of targeted and immune therapy in aggressive thyroid malignancies. He is a member of the NRG Head and Neck Committee, the ECOG Head and Neck Core and Thoracic Committees and the National Cancer Institute’s Head and Neck Steering Committee Rare Tumor Task Force.

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.

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. 

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.

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.

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.