NCI Early Drug Development (Speaker Bios)

Speaker Bios

Moderators
  • HELEN CHEN
    HELEN X. CHEN, M.D.
    Associate Branch Chief, IDB, National Cancer Institute, DCTD/CTEP/IDB

    Dr. Helen Chen joined the Cancer Therapy Evaluation Program (CTEP) of National Cancer Institute (NCI) in 2000. She currently serves as Associate Chief of the Investigational Drug Branch (IDB) Section III, which focuses on the clinical development of antibody-based therapeutics, active immunotherapies, MAPK and RTK inhibitors as well as antiangiogenic agents. She has also been closely involved in NCI’s efforts on novel agent combinations and is member of the NCI Experimental Therapeutics Committee. Dr. Chen graduated from the Shanghai First Medical College of the Fudan University in China. She is board-certified in Medical Oncology after completing the Fellowship Training at Georgetown University Medical Center, Washington D.C. Dr. Chen also serves on external scientific committees including the International Symposium of Anti-angiogenic Therapies and Immunotherapy and the FDA-ASCO-AACR-sponsored Accelerating Anticancer Agent Development and Validation Workshop. She has presented at national and international meetings on strategies of combining novel and targeted agents, early drug development as well as antibody-based therapeutics and antiangiogenic therapies. She is the first or coauthor of over 50 original and review papers in peer-reviewed journals including Journal of Clinical Oncology, Nature Reviews, and New England Journal of Medicine.

  • Steven Gore
    Steven Gore, M.D.
    Acting Branch Chief, National Cancer Institute, DCTD/CTEP/IDB

    Steven Gore, MD, earned his undergraduate and doctoral degrees at Yale, performed his residency at the University of Chicago and his oncology fellowship at Johns Hopkins. He rose from instructor to full professor at Johns Hopkins, and, in 2013, he became professor of medicine and director of hematologic malignancies at Yale. He joined the Investigational Drug Branch at CTEP in 2020. Dr. Gore is an internationally recognized expert in drug development in leukemia. His research career focused on the development of drugs with epigenetic targets for the treatment of myeloid disease, and he has played a major role in the incorporation of epigenetic modifiers in the treatment of myeloid malignancies. Among his many other accomplishments, Dr. Gore served on the NCI Leukemia Steering Committee beginning in 2015 and served as co-chair from 2017 until he joined CTEP. Dr. Gore is author or co-author of over 200 scholarly publications including primary research papers, book chapters, books, reviews, and practice guidelines.

  • S. Percy Ivy
    S. Percy Ivy, M.D.
    Associate Branch Chief, IDB, National Cancer Institute, DCTD/CTEP/IDB

    S. Percy Ivy, MD, is the Associate Chief (2005-present) of the Investigational Drug Branch (IDB), which is part of the Cancer Therapy Evaluation Program (CTEP) in the Division of Cancer Treatment and Diagnosis of the National Cancer Institute. She received her medical and subspecialty training at Tulane University Medical School, Vanderbilt University Medical Center, and the National Cancer Institute, respectively. During her fellowship, she worked in the Molecular Pharmacology Section which focused on the molecular mechanisms of drug resistance mediated by the ABC transporter genes in models of breast cancer and carcinogenesis. She is currently an Adjunct Professor of Pediatrics at the George Washington University School of Medicine on the faculty at Children's National Medical Center, where she attends in the leukemia clinic.

  • Lorraine Pelosof
    Lorraine Pelosof, M.D., Ph.D.
    Physician, National Cancer Institute, DCTD/CTEP/IDB

    Lorraine Pelosof grew up in Dallas and graduated from The University of Texas at Austin. She completed her MD and her PhD in Molecular and Cell Biology at Washington University in St. Louis and then completed her Internal Medicine Residency at The University of Texas Southwestern Medical Center. Following residency, she completed her fellowship training in Medical Oncology at Johns Hopkins where her research focused on DNA promoter methylation in gastrointestinal tumors. After serving as an Assistant Professor in the Division of Hematology/Oncology at UT Southwestern, she moved back to Maryland where she was a Medical Officer on the GI oncology team in the Office of Oncologic Diseases at the U.S. Food and Drug Administration. After several years at the FDA, Lorraine recently joined the Investigational Drug Branch in CTEP.

  • Cheryl Pickett-Gies
    Cheryl Pickett-Gies, M.D., Ph.D.
    Physician, National Cancer Institute, DCTD/CTEP/IDB

    Cheryl Pickett-Gies, MD, PhD, joined the Investigational Drug Branch and CTEP in 2020. Her current portfolio includes immune check point inhibitors and modulators, antibody drug conjugates, bispecific and other antibody based therapeutics. She is also director of the IDB/CTEP externship/ fellowship program. Dr. Pickett earned her PhD in biochemistry at the University of California (UC) Davis and her MD at the University of Colorado. She completed residency in Internal Medicine at UC Davis and a clinical and research fellowship in Endocrinology at the University of Colorado. She subsequently held academic appointments at the University of Colorado and the University of Washington Medical Centers before moving from academia to oncology clinical development positions in the biotech/pharma sector, first at Merck and later at Amgen. Dr. Pickett's early research focused on the mechanisms by which growth factors and hormones modulate activity of protein kinases; subsequently including work to elucidate how aberrancies in these signal transduction mechanisms modulate gene transcription and cell growth in tumor models. During her fellowship and academic appointments her clinical focus was on diagnosis and management of endocrine tumors; she was co-founder of a multidisciplinary endocrine tumor clinic at the University of Washington. Upon moving to biotech/pharma research in 2004, she has established broad oncology clinical trial expertise developing and conducting trials across phases 1-3, covering a wide range of compounds, mechanisms of action, and tumor indications.

  • Rabih Said
    Rabih Said, M.D.
    Physician, National Cancer Institute, DCTD/CTEP/IDB

    Dr. Rabih Said earned his MD from Lebanese University, Beirut, Lebanon, in 2002. He is ECFMG certified. He finished his Internal Medicine Residency and Hematology/oncology fellowship training at Northwell Health Staten Island University hospital in New York, NY, in 2011. From 2011 to 2012, Dr. Said was at MD Anderson Cancer Center for a special fellowship training in the Investigational Cancer Therapeutics (ICT) department focusing on designing, writing, and conducting early drug development trials (phase 1 trials) for patients with advanced cancer. In 2012, Dr. Said joined the University of Texas Health Science Center as an assistant professor in the Medical Oncology Division and as visiting assistant professor at the ICT department at MD Anderson Cancer Center where he conducted several phase 1 trials as principal investigator and co-investigator. In 2016, Dr. Said moved to Lebanon and joined the prestigious St. George Hospital University Medical Center and the University of Balamand as an associate professor where he was appointed as hematology/oncology fellowship director. He was also a consultant on the Lebanese national medical oncology committee of the Lebanese Ministry of Public Health. Dr. Said is board certified in both hematology and medical oncology.

Speakers
  • Sarah Adams
    Sarah Adams, MD
    Gynecology Oncology, Professor, Dept. Obstetrics & Gynecology, Associate Director of Translational Research, University of New Mexico Comprehensive Cancer Center

    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.

  • Jan Beumer
    Jan H. Beumer, Pharm.D., Ph.D., DABT
    Professor of Pharmaceutical Sciences and Medicine, UPMC Hillman Cancer Center

    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 Carducci
    Michael A. Carducci, M.D.
    AEGON Professor in Prostate Cancer Research, Hopkins Kimmel Cancer Center

    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.

  • Atish Choudhury
    Atish D. Choudhury, M.D., Ph.D.
    Senior Physician, Dana-Farber Cancer Institute

    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.

  • Diwakar Davar
    Diwakar Davar, MD
    Phase I/II trial of rhIL-12 and pembrolizumab in PD-1 relapsed/refractory solid tumors, Hillman Cancer Center, University of Pittsburgh

    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.

  • Jacqueline Garcia
    Jacqueline S Garcia, M.D.
    Assistant Professor, Dana-Farber Cancer Institute

    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.

  • Stephanie Lheureux
    Stephanie Lheureux, M.D., Ph.D.
    Dr, University Health Network

    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.

  • Livius Penter
    Livius Penter, MD
    Max-Eder Research Group Leader, Charité - Universitätsmedizin Berlin

    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.

  • Rory Shallis
    Rory M Shallis, M.D.
    Assistant Professor, Yale School of Medicine - Yale Cancer Center

    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.

  • Jacob Thomas
    Jacob Thomas, M.D.
    Assistant Professor of Clinical Medicine, USC Norris Cancer Hospital

    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.