NCI Early Drug Development (Speaker Bios)

Dr. Abdel Karim is the Director of the Phase I Program at Inova Schar Cancer Institute and Professor of Medicine-University of Virginia. Her clinical and research interests are focused on Phase I clinical trials and the personalized approach of therapy for lung cancer. She is the study chair of S1929 clinical trial at SWOG that focuses on personalized therapy for SLFN11 small cell lung cancer.

Dr. Nagla Abdel Karim received her MD from Cairo University- Faculty of Medicine. She subsequently received her training in Internal Medicine/Medical Oncology at the NCI-Cairo University. and she obtained her Master of Science degree followed by PhD, where the latter was through a channel program with the University of Washington.

She did a year of Post-doctoral fellowship at MD Anderson in Cancer Prevention, followed by one-year Research fellowship at The University of Washington.

She did a residency in Internal Medicine at Fairview-Cleveland Clinic Hospitals in Cleveland, Ohio followed by a 3-year clinical fellowship in Hematology/Oncology at The University of Cincinnati then became Assistant Professor of Medicine at Ohio State University then re-joined the University of Cincinnati again in September 2011 as an Assistant Professor then Associate Professor till 2018. She was the Professor of Medicine-Division of Hematology/Oncology and the Director of the Thoracic Oncology at the Medical College of Georgia-Augusta-Georgia since 2018 till 2022.

During all that time, she was an Investigator and Co- investigators of several Clinical Trials as well as a lead investigator on several translational research projects.

Dr. Nusayba Bagegni, MD, is Assistant Professor in the Department of Medicine, Division of Oncology, at Washington University School of Medicine in St. Louis. She is an Associate Member of Siteman Cancer Center and serves as Associate Medical Director of Clinical Research in the Division of Oncology. Dr. Bagegni specializes in the treatment of patients with breast cancer. Dr. Bagegni earned her medical degree with research distinction from the University of Iowa Carver College of Medicine. She completed a residency in Internal Medicine at Barnes-Jewish Hospital. While at Washington University School of Medicine, she went on to complete a fellowship in hematology/oncology, serving as Chief Fellow, where she received the Hanna Jean Khoury Outstanding Graduate Award. Dr. Bagegni is board-certified in internal medicine, medical oncology, and hematology. Dr. Bagegni has research interests focused in breast cancer clinical trials and developmental therapeutics. She is the Breast Cancer Clinical Trials Portfolio Leader at Siteman Cancer Center. She serves as a Principal Investigator for several clinical trials. She is a member of the Siteman Cancer Center Protocol Review and Monitoring Committee. Dr. Bagegni is also involved in trainee medical education, having received the Washington University Hematology/Oncology Fellowship Program 2021 Teacher of the Year Award. Dr. Bagegni is a member of ASCO and AACR. She is a member for the NCCN Anti-emesis Guidelines Panel. She is breast cancer committee member for Alliance, HCRN and ACCRU, as well as the Siteman Cancer Center Breast Cancer Equity Group.

Dr. Kristina Fanucci MD, MHS completed her undergraduate training at MIT, medical school at Tufts University School of Medicine, Internal Medicine residency at Brown University, Hematology/Oncology fellowship at Yale University, and will be joining the Breast Oncology group at Dana Farber Cancer Institute in the fall. Her research focuses on development of novel therapeutics.

Thatcher Heumann, MD, MPH, is a medical oncologist in the Division of Hematology and Oncology within the Department of Medicine at Vanderbilt University Medical Center (VUMC). He earned a dual MD and Master of Public Health in Epidemiology from Emory University School of Medicine, and completed his Internal Medicine residency at New York University Langone & Bellevue Hospital. He did additional medical oncology subspecialty training at Johns Hopkins University. Having joined Vanderbilt in 2022, Dr. Heumann seeks to expand effective treatment options for patients with gastrointestinal malignancies through novel clinical trials paired with excellent patient care. His research pursuits center on bringing promising laboratory science to the bedside. In addition to providing standard of care treatments, Dr. Heumann has been awarded the ASCO Conquer Cancer Young Investigator Award for developing and leading early-phase clinical trials using novel anti-cancer medications and therapeutic combinations to help improve outcomes for patients with cancers of the liver and biliary system.

Maha Hussain, MD, FACP, FASCO, is the Genevieve Teuton Professor of Medicine in the Division of Hematology-Oncology, Department of Medicine, and the Deputy Director, and leader of the GU Oncology Program at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine.

Dr. Hussain is a practicing oncologist, internationally renowned expert and clinical researcher in genitourinary oncology particularly prostate and bladder cancer. Her research, funded by federal grants and contracts, is focused on the development of novel therapeutics integrating scientific advances into clinical trials and has contributed to significantly impacting the standards of care for patients with metastatic hormone sensitive and castration resistant prostate cancer.

Dr. Hussain has served in a variety of scientific leadership roles including the Chair of the SWOG Advanced Prostate Cancer Subcommittee (1994-2012), member (2009-2014) and Chair (2013-2014) of the Integration Panel of the U.S. Army Medical Research and Materiel Command Prostate Cancer Research Program, and a member (2004-2008) and Chair (2007- 2008) of the U.S. Food and Drug Administration Oncology Drug Advisory Committee. Dr. Hussain has served as a member of the NCI-Cancer Biomarker Study Section and the NCI’s Prostate cancer task force. She currently serves as an EAB member for six NCI-designated cancer centers and the UCLA Prostate Cancer SPORE. She also serve as a member of the UK (Prostate cancer UK) Research Strategy Group EAB.

Dr. Hussain is the author/coauthor of more than 300 scholarly articles and book chapters. She serves/has served on the editorial boards for several national and international specialty journals; She currently serves as the deputy editor for JCI.
Since joining the American Society of Clinical Oncology in 1990, Dr. Hussain has served on numerous committees and boards and was elected member of the ASCO Board of Directors (2016-2020).

Brian Ko is a medical oncologist in the Advanced Developmental Therapeutics Training Program (ADTTP) at the National Cancer Institute (NCI) of the National Institutes of Health (NIH). He holds an AB degree from Harvard University, MD degree from the University of Illinois, and completed both his internal medicine residency and medical oncology/hematology fellowship at Montefiore Medical Center. He is currently working on conducting early phase oncology clinical trials at the NCI Developmental Therapeutics Clinic (DTC).

Dr. Ma is a Professor of Medicine at Washington University in St. Louis and is the co-leader of the Breast Cancer Research Program at Siteman Cancer Center. She has led several biomarker directed, investigator initiated trials including neoadjuvant studies of endocrine agents in combination with inhibitors against PI3K pathway or the CDK4/6 in patients with locally advanced estrogen receptor positive breast cancer. She is the study chair for the Alliance A011106 (ALTERNATE) trial, a phase III trial that compares the endocrine sensitive disease rate between neoadjuvant fulvestrant or fulvestrant plus anastrozole and anastrozole in postmenopausal women with ER-rich HER2- breast cancer, and to prospectively validate the endocrine sensitive disease, defined by mPEPI=0 or pathologic complete response, as an intermediate biomarker to identify patients with excellent relapse-free survival, for whom chemotherapy may be avoided. She is the study chair for the Phase I/II study of fulvestrant and abemacilcib with or without copanlisib in patients with endocrine resistant ER+/HER2- advanced breast cancer (NCI 10287). She led the MutHER trial in HER2-mutated breast cancer which demonstrated the efficacy of neratinib regimens in this patient population. Preclinical studies in her laboratory has led to the ongoing Phase I/II trials in patients with metastatic triple negative breast cancer (NCI 10382). Her research has been funded by NIH/NCI, DOD, BCRF, Komen and industry partners.

Dr. Mansfield is a medical oncologist at Mayo Clinic with a focus on thoracic malignancies and early therapeutics. He is co-director of the Precision Cancer Therapeutics group within the Center for Individualized Medicine. He has played a significant role in clinical trials leading to FDA approval of agents for thoracic malignancies including atezolizumab for small cell lung cancer, pralsetinib for RET-fusion non-small cell lung cancer and the combination of ipilimumab with nivolumab for mesothelioma. His laboratory runs many translational projects to discover and validate biomarkers in thoracic malignancies.

Neha Mehta-Shah, MD, MSCI is an Associate Professor of Medicine at Washington University in St. Louis where she specializes in T-cell lymphomas. She completed her undergraduate and medical school at Northwestern University and then completed residency at New York Presbyterian-Weill Cornell Medical Center. She was selected as chief resident at Memorial Sloan Kettering where she completed fellowship in 2016. She then completed a Masters of Science in Clinical Investigation at Washington University in St. Louis. She has been recognized with multiple career development awards from ASH, the Lymphoma Research Foundation, the T-cell Leukemia Lymphoma Society, the Alliance Scholar Award, Paul Calabresi K12 Award, and most recently the LLS Scholar in Clinical Research Award. She has a clinical interest in lymphomas, specifically: peripheral and cutaneous T-cell lymphoma and currently leads multiple local and national trials in T-cell lymphoma. She is an Associate Program Director for the Washington University Hematology/Oncology Fellowship Program.

Dr. Pommier is a leader on DNA topoisomerase biology and biochemistry, and their cancer relevance. He revealed the interfacial inhibition paradigm based on molecular mechanisms of topoisomerase inhibitors and has championed its broad relevance for molecular pharmacology and drug discovery. He discovered the indenoisoquinolines as novel Top1 inhibitors, which are in clinical development, and the mitochondrial topoisomerase gene, TOP1mt. To understand the determinants of response to topoisomerase inhibitors, he is studying the repair pathway centered on tyrosyl-DNA-phosphodiesterases (TDP1 and TDP2) and poly (ADP-ribose) polymerases (PARP). As Chief, Dr. Pommier oversees the Branch’s clinical/translational research program, which emphasizes new approaches to cancer treatments targeting DNA, epigenetic and chromatin, and connected biomarkers.

I am a tenured professor and co-leader of the Experimental Therapeutics (ET) program at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC) in Baltimore and a member of the Van Andel Research Institute Stand up to Cancer (VAI-SU2C). I graduated with a PhD from the Royal postgraduate Medical School UK and performed my postdoctoral training at the University of Chicago with Janet Rowley and Michelle Le Beau. I have spent more than 20 years studying the contribution of DNA damage and altered repair of DNA double strand breaks (DSBs) to genomic instability in multiple cancer types. My past work focused on the contribution of the highly error-prone and alternative non-homologous end-joining (alt NHEJ) pathway to mechanisms for increased chromosome instability in cancers, including acute myeloid leukemias (AML). In recent years, my laboratory turned its focus to the study of mechanisms to inhibit DSB repair as a therapeutic strategy in cancer, using Poly (ADP-ribose) polymerase inhibitors (PARPis). We reported that combining DNA methyltransferase inhibitors (DNMTis) and PARPi talazoparib induced synergistic cytotoxicity in vitro and anti-cancer effects in vivo in multiple cancer models. Importantly, we demonstrated that this drug combination also induced a pathogen mimicry response (PMR) to include IFN and inflammasome signaling, that is dependent on stimulator of interferon genes (STING). This DNMTi/PARPi-induced PMR also leads to decreased DSB repair or a BRCAness phenotype in BRCA-proficient cancers, sensitizing to PARPis. This preclinical data has led to investigator-initiated phase 1 clinical trials in AML, led by Dr Maria Baer (UMGCCC) and TNBC, led by Dr Kathy Miller (IU), funded by the VAI-SU2C. This work has also led to recent NCI SPORE project funding.

Dr. Schneekloth received his undergraduate degree from Dartmouth College in 2001 where he worked with Prof. Gordon Gribble. He then moved to Yale University and obtained a Ph.D. from the chemistry department with Prof. Craig Crews in 2006. As a graduate student he studied natural product total synthesis and developed the first cell-permeable PROTAC molecules. He then pursued an NIH postdoctoral fellowship with Prof. Erik Sorensen at Princeton University where he worked on the development of a new multicomponent reaction and the application of this reaction to the synthesis of analgesic natural products. He returned to Yale in 2009 where he worked as a medicinal chemist at the Yale Small Molecule Discovery Center. In 2011, Dr. Schneekloth joined NCI where his research involves using synthetic chemistry and high throughput chemical biology approaches to develop chemical probes of RNA, with a particular emphasis on targeting RNA with druglike small molecules.

Dr. Geoffrey I. Shapiro received his PhD in 1987 and his MD in 1988 from Cornell University, followed by postgraduate training in internal medicine at Beth Israel Hospital, Boston, where he served as chief medical resident. He completed a fellowship in medical oncology at Dana-Farber Cancer Institute, during which he investigated the role of cell-cycle-related proteins in lung cancer. He joined the Dana-Farber faculty in 1994. Dr. Shapiro's practice is based in the Center for Cancer Therapeutic Innovation, where he develops and leads early phase clinical trials primarily focused on cell cycle and DNA repair inhibitor therapeutics and provides mentoring to early career investigators. As Senior Vice President, Developmental Therapeutics, he leads DFCI efforts for National Cancer Institute (NCI)-sponsored clinical trials developed through the Experimental Therapeutics Clinical Trials Network (ETCTN) and works integrally with multiple disease groups within the Institute.

Dr. Sarah Shin received her medical degree and masters in public health at the University of Miami Miller School of Medicine. She completed her internal medicine residency at the University at Buffalo Jacobs School of Medicine and her sub-specialty training in hematology/oncology at Roswell Park Comprehensive Cancer Center. She joined the Advanced Developmental Therapeutics Training Program with the Developmental Therapeutics Clinic in the Division of Cancer Treatment and Diagnosis at the NCI as an advanced clinical fellow in July 2021 to pursue her interest in early phase drug development. Since joining, she has also been active within the Clinical Trials Diversity and Inclusion Committee to help promote diversity, equity, and inclusion into clinical trials at the NCI. Since June 2023, Dr. Shin stayed on as a Staff Clinician at the Developmental Therapeutics Clinic, where she continues to use her training, experience, and expertise to bring novel therapeutic options to patients through early phase clinical trials.

Dr. Spreafico is Associate Professor at the University of Toronto and Clinician Investigator in the Division of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, University Health Network, Toronto, Canada. Her previous training includes a PhD in translational research in the Program for Evaluation of Targeted Therapies at the University of Colorado, USA, and a subspecialty fellowship in experimental therapeutics at the Princess Margaret Cancer Centre.
Dr. Spreafico serves as the Head and Neck Medical Oncology Disease Site Lead and Director of the Phase I Drug Development Fellowship at the Princess Margaret Cancer Centre. Dr. Spreafico is a member of the CCTG Head and Neck Disease site Executive Committee. She serves on the US NCI Head and Neck Cancer Steering Committee rare tumor task force, and she is the Co-Chair of the NRG Oncology Recurrent/Metastatic H&N Cancer Working Group.
Dr. Spreafico's full-time academic practice and research include early phase clinical trials, with disease-specific interests in skin/melanoma, and head and neck cancers. Her translational research focuses on immuno-oncology-based, microbiome and cancer interception-driven studies and she leads as PI, CCTG, NRG and NCI CTEP early phase investigator-initiated clinical trials.

Dr. Sarah Taylor is an Assistant Professor of Gynecologic Oncology. The focus of her clinical and translational research is in the development and implementation of early phase clinical trials for individuals with gynecologic malignancies. Her research is focused within the University of Pittsburgh Cancer Institute/UPMC Hillman Cancer Center’s (HCC) Phase I Translational Research Team, which is a multi-specialty group focused on the development, promotion and execution of novel phase I oncologic clinical trials. She is a PI for Experimental Therapeutics Clinical Trials Network (ETCTN). She is the lead for gynecologic oncology trials within Hillman Cancer Center (HCC) Phase I Team and site PI for NRG Oncology Phase I Group and as well as local PI on multiple trials in the Gynecologic Oncology Disease Team portfolio. Her work within the Magee-Womens Research Institute focuses on correlative biomarker development and identifying targetable pathways for drug development. This has led to collaborations with translational scientists, allowing for true bench to bedside innovation for clinical trial development and design. Her collaborations extend to colleagues within the Women’s Cancer Research Group at the University of Pittsburgh School of Nursing. As an interdisciplinary team of researchers, they focus on overlapping research interests regarding patients’ quality of life, health services research, and patient-reported outcomes. This work is crucial to addressing all aspects of cancer care, which extends beyond cancer directed therapies. This ongoing work recognizes the importance of care the spans the life of an individual who lives with and survives cancer.

Jonathan A. Webster, MD is an Assistant Professor in the Division of Hematologic Malignancies within the Department of Oncology at Johns Hopkins. As a member of the Leukemia Program, he treats patients with AML, ALL, and CML. His research focuses on the development of clinical trials incorporating novel agents and combinations in the treatment of ALL and AML with a focus on post-transplant maintenance strategies to prevent disease relapse.

Dr. Timothy Yap is a Medical Oncologist and Physician-Scientist based at the University of Texas MD Anderson Cancer Center. He is an Associate Professor in the Department for Investigational Cancer Therapeutics (Phase I Program), and the Departmentof Thoracic/Head and Neck Medical Oncology. Dr. Yap is the Medical Director of the Institute for Applied Cancer Science, a drug discovery biopharmaceutical unit where drug discovery and clinical translation are seamlessly integrated. He is also the Associate Director of Translational Research in the Institute for Personalized Cancer Therapy, which is an integrated research and clinical trials program aimed at implementing personalized cancer therapy and improving patient outcomes. Prior to his current position, Dr. Yap was a Consultant Medical Oncologist at The Royal Marsden Hospital in London, UK and National Institute for Health Research BRC Clinician Scientist at The Institute of Cancer Research, London, UK.