NCI Early Drug Development (Speaker Bios)

Sarah Adams, MD, Professor and Fellowship Research Mentor, graduated from University of Chicago Pritzker School of Medicine where she also completed her OB-GYN residency. She completed her GO fellowship at University of Pennsylvania Hospital in 2009, and stayed on as faculty at Penn with a research appointment in the Ovarian Cancer Research Center. Dr. Adams joined the UNM GO division in 2012 where she maintains active clinical practice and leads a translational research lab focused on ovarian cancer immunology. She is the Co-leader of the Cancer Therapeutics Research Program for the UNM Comprehensive Cancer Center P30 grant and the Associate Director of the Translational Science for the UNM Comprehensive Cancer Center. She is nationally recognized for her work in immunology of ovarian cancer and novel immuno-oncology clinical trials.

Dr. Baker’s cancer-relevant research interests broadly cover translational and clinical pharmacology of anti-cancer agents. Recently, her laboratory has focused on the preclinical development of anti-cancer agents for the treatment of acute myeloid leukemia (AML), with an emphasis on tyrosine kinase inhibitor (TKI) drug combinations. Dr. Baker’s research interests include developmental therapeutics for AML, clinical pharmacology of tyrosine kinase inhibitors, variability in anti-cancer drug disposition and investigational anti-cancer drug development.

Dr. Beumer is a tenured Professor of Pharmaceutical Sciences with a secondary appointment in the School of Medicine at the University of Pittsburgh and holds the distinction of Diplomate of the American Board of Toxicology (DABT). He is intimately involved in the design, execution, supervision, and data analysis of PK and metabolic studies covering the entire spectrum of preclinical vitro-vivo, clinical phase 1, 2, 3, and post-marketing studies, with funding in each phase. Dr. Beumer is PI on one of only 3 NCI N02 Preclinical Pharmacology Contracts, mPI of one of the two U24 PK consortia supporting the NCI ETCTN efforts, and he is mPI of one of only 8 clinical ETCTN UM1 Grants, funding the Pittsburgh Cancer Consortium. He directs the Cancer Pharmacokinetics and Pharmacodynamics Facility (CPPF) of the UPMC Hillman Cancer Center (HCC), traditionally also the PK core of the NSABP-RTOG-GOG (NRG) and ALLIANCE. He has served as co-chair of the NCI Investigational Drug Steering Committee (IDSC), is co-chair of the IDSC Pharmacology Task Force, and is a founding member of the “TDM in oncology” committee of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT).
Dr. Beumer has ~200 peer-reviewed publications and has presented at national and international venues. He is also the Editor-in-Chief (U.S.) of the journal Cancer Chemotherapy and Pharmacology and was awarded the 2021 Michaele Christian Oncology Drug Development Award and Lectureship by the National Cancer Institute Cancer Therapy Evaluation Program.
Dr. Beumer’s interests are the development of anticancer agents partnering with both NCI and pharmaceutical partners, focusing on early trials that aim to study the pharmacology (PK/PD) of these novel agents (first-in man, mass balance, organ dysfunction, etc.).

Michael A. Carducci, MD, FACP, FASCO
AEGON Professor in Prostate Cancer Research
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The Johns Hopkins University School of Medicine
Baltimore Maryland

Dr. Carducci is the AEGON Professor in Prostate Cancer Research and the Vice Chair for Solid Tumor Oncology at the Hopkins Kimmel Cancer Center. His clinical research focus is on the evaluation of new therapies for urologic cancers, primarily prostate and renal cancer. His collaborations have led to the development of agents such as temsirolimus in renal cell cancer, denosumab for skeletal related events in prostate cancer, and the use of docetaxel in hormone-sensitive metastatic prostate cancer. He has been PI of the NCI U01/UM1 for Early Drug Development supporting ETCTN efforts at Hopkins since 2001. Dr. Carducci has received the Michaele Christian Award for Oncology Drug Development. He is a member of the Miller-Coulson Academy of Clinical Excellence. Before taking on the Vice Chair role, he serves as Associate Director for Clinical Research in the Hopkins Kimmel Cancer Center, served 13 years as Chair of the GU Oncology Committee of ECOG-ACRIN, and 10 years as the Associate Editor for GU Cancers for the Journal of Clinical Oncology.

Dr. Choudhury is a medical oncologist and clinical/translational investigator within the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and Assistant Professor of Medicine at Harvard Medical School. He received a BA in Chemistry from Johns Hopkins University and received his MD PhD from Columbia University. He currently serves as Chair of the Gelb Center for Translational Research, and his research interests include investigation of genetic and epigenetic biomarkers from circulating free DNA from patients with metastatic cancer, biomarker studies from other banked human specimens from patients participating in clinical trials, and clinical investigation in novel therapeutics and treatment strategies in prostate cancer.

Translational medical oncologist clinically focused on melanoma, cutaneous SCC and drug development. Heavy translational interest focused on multi-omic approaches to understanding response/resistance to immunotherapy in cancer.

Our clinical and translational efforts center around investigating the following scientific areas:
a) The role of the intestinal microbiome in mediating response/resistance to PD-1 immune checkpoint blockade.
b) The role of innate agonism in synergy with PD-1 blockade.
c) Evaluating novel immune checkpoint blockades in particular TIM-3, TIGIT in patients.

To study these areas, we design clinical trials and evaluate biospecimens. Highlights include:
a) High pathologic response rate when TLR9 agonist CMP-001 is combined with PD-1 inhibitor Nivolumab.
b) Microbiome modulation resensitizes primary refractory melanoma patients to PD-1 therapy. FIH trial published in Science (Davar, Science 2021), metagenomic biomarkers published in Nat Med (McCulloch and Davar, Nat Med 2022). Follow up trials testing this in melanoma, and NSCLC.

Andre De Souza is a first year clinical fellow in the Advanced Developmental Therapeutics Training Program. Prior to joining the NCI, he was an Assistant Professor of Medicine at Brown University for 5 years, treating genitourinary tumors as an Oncologist. He was a member of the Brown University Genitourinary Translational Disease Research Group and collaborated in 10 publications with the Computational biology, Urology and Pathology departments. He was a recipient of the Dean`s Teaching Award, a co-director of the Molecular Tumor Board, a co-investigator in 30 clinical trials and a Principal Investigator in 5 clinical trials. He continues to collaborate in presentations and publications in translational oncology in prostate cancer and urothelial carcinoma. He is a co-author in Cecil Essential and 10 book chapters and has 30 publications in Oncology. His interests include biomarkers of synthetic lethality such as MTAP-deleted tumors and agnostic biomarkers such as HER2 tumors.

Katherine Fuh, MD, PhD is an Associate Professor and the John A. Kerner Chair in Gynecologic Oncology in the Department of Obstetrics and Gynecology at University of California, San Francisco (UCSF). She is the Director of Translational and Basic Research for the Division of Gynecologic Oncology. She completed her Gynecologic Oncology fellowship program at UCSF and Stanford. She also combined clinical fellowship with advanced research training to complete a PhD degree in Cancer Biology at Stanford University. She was also a NIH supported K12-Reproductive Scientist Development Program (RSDP) Scholar.
         She leads a basic and translational lab targeting treatment resistance in ovarian and endometrial cancer with a focus on the tumor microenvironment. She is the principal investigator of multiple grants from the NCI, American Cancer Society (ACS), Foundation for Women’s Cancer (FWC), Ovarian Cancer Research Alliance (OCRA), Mary Kay Foundation, American Board of Obstetrics and Gynecology (ABOG), and the Gynecologic Oncology Group (GOG). She serves on national committees for clinical trials and translational research including Translational Co-Chair for the Uterine Corpus Committee for the NRG Clinical Trials Group. She is the international PI for GOG-3059/ENGOT OV-66 which is a Phase 3, Randomized Study in combination with batiraxcept, an AXL inhibitor, for platinum-resistant ovarian cancer as well as the PI for NRG-GY027 which is a neoadjuvant chemotherapy trial in combination with an AKT inhibitor ipatasertib in advanced stage ovarian cancer. She is also on the translational team for NRG-GY020 which is a Phase 3 randomized trial of radiation +/- pembrolizumab for newly diagnosed, early stage, high intermediate risk mismatch repair deficient endometrioid adenocarcinoma of the endometrium (PI: F. Backes) as well as a Phase 2 trial on bevacizumab and atezolizumab in recurrent endometrial cancer (PI: K. Moore). Her lab is committed to developing treatments for patients with gynecologic cancers.

Katherine Fuh, MD, PhD is an Associate Professor, John A. Kerner Chair in Gynecologic Oncology, and Director of Translational and Basic Research in Gynecologic Oncology at University of California, San Francisco (UCSF). She returns to UCSF in July 2022 after 9 years on faculty at Washington University in St. Louis. She completed a residency in OB/Gyn at Stanford and Gynecologic Oncology fellowship at UCSF and Stanford. She also completed the Advanced Research Training (ARTS) program and has a PhD in Cancer Biology from Stanford. She has been honored as a NIH-supported K12 Reproductive Scientist Development Program (RSDP) Scholar and GOG Foundation Scholar Investigator.
       She leads a NCI-funded basic and translational lab developing new treatments and biomarkers in ovarian and endometrial cancer within the tumor microenvironment. She serves as the Translational Co-Chair for NRG Uterine Corpus, Co-Chair of the Translational Research GOG Investigator Council, Vice Chair of the Research and Grants Committee for FWC, Chair of the Evaluations Committee for RSDP, and Co-Director of the K12 WRHR program at UCSF. Her lab-based research on AXL led to the international Phase 3 trial GOG-3059/ENGOT OV-66: Paclitaxel +/- Batiraxcept, an AXL inhibitor, for platinum-resistant ovarian cancer. She is also the PI for NRG-GY027, neoadjuvant chemotherapy with an AKT inhibitor ipatasertib in advanced stage ovarian cancer. She is also a Project Co-Leader for the Route 66 SPORE in Endometrial Cancer. She is a member on the scientific advisory board for the Ovarian Cancer Research Alliance (OCRA), member of the NCI-Uterine Task Force, Deputy Editor for Gynecologic Oncology Reports, and a mentor for the SGO/GOG-F BRIDGES for 2023 and 2024.

Dr. Jacqueline S. Garcia is an Assistant Professor of Medicine at Harvard Medical School. She is a clinical/translational investigator in the Adult Leukemia Program at the Dana-Farber Cancer Institute and an attending physician at the Brigham & Women’s Hospital. She graduated from University of Illinois at Chicago College of Medicine and completed her internship and residency training in Internal Medicine at the University of Chicago. She next completed Hematology and Oncology Fellowship training at Stanford University. She joined Dana-Farber in 2015. Dr. Garcia’s research focuses on the design and execution of scientifically based early phase clinical and proof-of-concept studies in advanced myeloid malignancies, including MDS, myelofibrosis and acute myeloid leukemia. Much of her research centers on identifying novel therapeutic opportunities to leverage the anti-apoptotic pathway in chemoresistant leukemia and to address or prevent post-transplant relapse in the context of investigator-initiated trials (IIT). She is a Principal Investigator for several clinical trials, including IIT, ETCTN/CTEP, and pharmaceutical studies. Her research has received support from the National Institutes of Health/National Cancer Institute, Leukemia and Lymphoma Society, and Conquer Cancer Foundation.

Dr. Rohit Jain is an Associate Member in the Moffitt Cancer Center Department of Genitourinary Oncology. Dr. Jain earned his MBBS at Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai, India. He completed an Internal Medicine Residency at Johns Hopkins University/Sinai Hospital of Baltimore. Dr. Jain recently completed a Hematology-Oncology Fellowship at Roswell Park Cancer Institute University at Buffalo, New York. Dr. Jain’s clinical interests are urothelial, renal, prostate and testicular cancers with a major focus in urothelial cancers. His research interests are primarily in urothelial and kidney cancers. Dr. Jain is involved in biomarker research as well as developing innovative clinical trials for patients.

Bose is a Senior Scientist at the Center for DNA Damage and Repair, Dana-Farber Cancer Institute, where he leads biomarker assay development and implementation in pre-clinical and clinical specimens. He also works closely with the Cancer Therapy Evaluation Program at NCI and collaborates extensively with the Experimental Therapeutics Clinical Trails Network. He also serves as the translational co-leader of an early-phase drug development project team. In this role, he has developed over twenty fit-for-purpose biomarker assays that interrogate DNA damage, replication stress, cell cycle regulation and growth factor/cytokine signaling that are at various stages of clinical validation either as predictive or pharmacodynamic biomarker assays. These assays have been incorporated in over a dozen early-phase clinical trials and have been proven valuable in the development of inhibitors that target PARP1/2, ATR, CHK1, CDK4/6, CDK12, MEK, TOPO-I antibody-drug conjugate, POLQ and PIK3CA in combination with Platinum compounds, Gemcitabine, Sapacitabine and Immune checkpoint inhibitors. Among the assays, the RAD51-assay for assessing deficiency in homologous recombination mediated DNA damage repair in real-time is the most advanced and will enter clinical testing as a companion biomarker for identifying patients who are likely to derive benefit from drug combinations that include PARP1/2 inhibitors. Bose holds a Ph.D. from the Weizmann Institute of Science in Molecular Cell Biology where he worked on the structure, signaling and trafficking of the EGFR family of receptors and ligands. He completed post-doctoral work at the Dana-Farber Cancer Institute/Harvard Medical School where he worked on NF-kB signaling in Breast cancer and trained in biomarker development and pathology.

Panagiotis (Panos) Konstantinopoulos is Director of the Center for BRCA and Related Genes at Dana-Farber Cancer Institute, Director of Translational Research in the Division of Gynecologic Oncology, and an Associate Professor of Medicine at Harvard Medical School. He is a clinical and translational investigator on gynecologic malignancies with a focus on the areas of DNA Damage and Repair and Immunotherapy. Dr. Konstantinopoulos completed medical school in University of Patras in Greece and did his medical oncology training at Beth Israel Deaconess Medical Center and Harvard Medical School. He also received a Master's degree in Clinical Investigation from Harvard Medical School and Massachusetts Institute of Technology (MIT) Department of Health Sciences and Technology

STEPHANIE LHEUREUX MD, PhD is a Medical Oncologist, Clinician Investigator, Site Lead of Gynecology Oncology and co-director of the Beyond Chemotherapy Program at Princess Margaret Cancer Centre. She holds the Westaway Chair in Ovarian Cancer Research and is an Associate Professor of Faculty of Medicine at the University of Toronto. Her clinical and academic interests are focused in gynecologic cancers and early drug development with an emphasis on translational research and have garnered two ASCO Merit awards. She received the 2019 Career Development Award from the American Society of Clinical Oncology (ASCO) and the 2021 Young Investigator Award from University of Toronto Division of Medical Oncology. Internationally, she is co-Chair of the Translational Research Committee and Director representing Princess Margaret Consortium at the international Gynecologic Cancer InterGroup (GCIG). She is also a member of the Gynecologic Cancer Steering Committees at the US National Cancer Institute. In the last five years, she has >60 peer-reviewed publications in widely cited journals such as CA: Cancer Journal for Clinicians, Clinical Cancer Research, JAMA Oncology, Journal of Clinical Oncology, Lancet, Lancet Oncology and Gynecology Oncology. She is principal investigator or co-principal investigator of different clinical trials and in several large-scale peer reviewed funding opportunities from the Canadian Cancer Society Research Institute, Conquer Cancer Foundation/American Society for Clinical Oncology, Ontario Institute for Cancer Research, Ovarian Cancer Canada and Terry Fox Research Institute that converge preclinical and clinical areas of interest.

Dr. Stephen Liu is an oncologist in Washington, District of Columbia and is affiliated with multiple hospitals in the area, including MedStar Washington Hospital Center and MedStar Georgetown University Hospital. He received his medical degree from University of Maryland School of Medicine and has been in practice between 11-20 years. Dr. Stephen Liu has expertise in treating lung cancer, breast cancer, prostate cancer, among other conditions.

Dr. Stephen V. Liu, MD, is a thoracic medical oncologist and an Associate Professor of Medicine at Georgetown University. He is the Director of Thoracic Oncology and the Head of Developmental Therapeutics at the Georgetown University Lombardi Comprehensive Cancer Center in Washington, DC. Dr. Liu received his undergraduate degree at Johns Hopkins University, his medical degree from the University of Maryland, and his Internal Medicine training at the University of Pennsylvania. He completed a fellowship in Hematology & Oncology at the University of Southern California and joined the faculty of Georgetown University in 2013. He is also the co-host of the official IASLC podcast, Lung Cancer Considered.

Rana R. McKay, MD, FASCO is an Associate Professor of Medicine and Urology at the University of California San Diego, Associate Director of Clinical Sciences, and Co-Leader of the Genitourinary Oncology Program at the Moores Cancer Center. She is a medical oncologist who specializes in treating people with urogenital cancers. Her research interests include advanced therapeutics, precision medicine, and biomarker development. Her work has appeared in peer-reviewed publications such as The New England Journal of Medicine, Nature, Lancet, Journal of Clinical Oncology, Clinical Cancer Research, Cancer, among others. She is a member of the NCI Renal Task Force, NCI Prostate Cancer Task Force, NRG RCC Cadre Leader, Alliance Advanced Prostate Cancer Cadre Leader, and member of the NCCN Prostate Cancer Guidelines panel. She has been named a Top Doctor in San Diego. Dr. McKay earned her medical degree at the University of Florida College of Medicine before completing her residency at Johns Hopkins Hospital, Johns Hopkins University. She completed a fellowship in Oncology/Hematology at the Dana-Farber Cancer Institute, Harvard Medical School.

Dr. Priscilla Merriam is a Senior Physician at Dana-Farber Cancer Institute, where she serves as the Clinical Director of the Sarcoma Center. Her clinical work focuses on the care of individuals with soft tissue sarcoma, bone sarcomas, and gastrointestinal stromal sarcomas. She is a clinical investigator, with leadership of trials in various mesenchymal tumors, including desmoid fibromatosis, leiomyosarcoma, gastrointestinal stromal tumors, angiosarcoma, and others.

Livius Penter is a Clinician Scientist at Charité - Universitätsmedizin Berlin, Germany with a strong interest in bioinformatics, single cell genomics and tumor immunology. He received his MD from Charité in 2014 and successfully defended his medical thesis (Dr. med.) in 2015. After work as Junior Clinician Scientist with Leo Hansmann at Charité from 2015 to 2019, he completed his postdoctoral research training in Cathy Wu’s lab at Dana-Farber Cancer Institute from 2019 to 2023.
Since 2023 he is leading his own research group supported by funding from the Max-Eder Research Group program from the German Cancer Aid (Deutsche Krebshilfe) focused on AML, immunotherapies and allogeneic stem cell transplantation.

Dr. Shallis received his MD from Rutgers-Robert Wood Johnson Medical School, completed his residency training at Brown University-Rhode Island Hospital and fellowship training at Yale-New Haven Hospital.

He is focused on the care and research of patients with myeloid malignancies, particularly acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). He currently participates as an investigator in a number of clinical trials, serves as Study Chair of several NCI-funded trials, aimed at improving the outcomes of patients with AML and MDS.

Dr. Shallis also maintains research interest in epidemiological, outcomes and effectiveness research as it pertains to the hematologic malignancies with a goal of identifying barriers to effective care and ultimately strategies to improve the outcomes of patients with these malignant diseases. Dr. Shallis conducts research with the Cancer Outcomes, Public Policy and Effectiveness Research (COPPER) Center at Yale University.

Dr. Shallis has presented his research at multiple regional, national and international meetings and is a member of the National Comprehensive Cancer Network (NCCN) clinical guidelines for MDS and AML panels. He is an author on more than 100 peer-reviewed publications and book chapters, most of which as first author and has served as an ad hoc reviewer for many journals including Leukemia, Haematologica, Blood Advances, among others.

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 Biomedical Sciences 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 2021 and stayed on as a Staff Clinician in 2023, where she continues to use her training, experience, and expertise to bring novel therapeutic options to patients through early phase clinical trials.

Jacob Thomas, MD is an assistant Professor of Clinical Medicine at Keck Medical Center of USC and USC Norris Comprehensive Cancer Center. He is currently serving as the Service Chief of Medical Oncology at Los Angeles General Medical Center, the Chair of the Phase I Committee, and is vice chair of the Clinical Investigations Committee (CIC) at USC. He is an active clinical investigator and has a passion for novel drug development for patients with advanced solid tumor malignancies, with a focus on patients with lung and head and neck cancers. He has published on drug development and presented findings at many national conferences. He was awarded NIH funding to conduct a phase 2 trial of a novel drug combination in head and neck cancer that is accruing patients nationally through the ETCTN. He is also working to improve accrual of racial and ethnic minority groups to clinical trials in order to provide increased access to novel therapeutics to all patients.

Brian Van Tine, M.D., Ph.D. is a Professor of Medicine and Pediatrics in the Department of Medicine at Washington University in St Louis. He is the Sarcoma Program Director, Director of the Phase 1 Program at Alvin J. Siteman Cancer Center and Co-Director of the Adolescence and Young Adult Program at Siteman Cancer Center. Dr. Van Tine received his Bachelors of Science degree from the Departments of Chemistry and Biochemistry at The University of Arizona in 1995. Dr. Van Tine completed his M.D./Ph.D. degrees at the University of Alabama at Birmingham in 2005. His thesis research focused on the role of Human Papilloma Virus (HPV) in the development of cervical cancer with Profs. Louis T. Chow and Thomas R. Broker. After completing his M.D., Ph.D., he came to Washington University in St. Louis/Barnes Jewish Hospital where he did his Internal Medicine Residency and Medical Oncology Fellowship. He joined the laboratories of James J.D. Hsieh, M.D., Ph.D. and then Matthew Ellis, M.B., B.Chir., Ph.D., where he pursued his postdoc fellowship studying mouse genetics and genomics while clinically specializing in the treatment of sarcoma. His translational laboratory identified a common defect in sarcoma, the loss of ASS1 expression. His lab is currently working toward translating this finding to the clinic via clinical trials. They were the first to report that argininosuccinate synthetase 1 is silenced in ~90% of sarcomas, which renders them susceptible to arginine deprivation therapy and glutaminase inhibitors because they cannot synthesize arginine. He has demonstrated that arginine starvation overcomes gemcitabine resistance in sarcoma, a concept being formally tested in a phase II prospective clinical trial. Finally, the laboratory was the first to identify the loss of malic enzyme 1 (ME1) in synovial sarcoma, a finding that has direct therapeutic consequences, as well as PHGDH dependency in osteosarcoma.