AAADV - Key Persons
Job Titles:
- Member of the AAADV - ASCO - CDDF Program Committee
Job Titles:
- Associate Professor of Radiation Oncology at Harvard Medical School
- Associate Professor, Radiation Oncology, Harvard Medical School Disease Center Leader, Radiation Oncology, Center for Neuro - Oncology, Dana - Farber Cancer Institute
Dr. Alexander is an associate professor of radiation oncology at Harvard Medical School and is disease center leader in radiation oncology for the Center for Neuro-Oncology at Dana-Farber Cancer Institute.
Dr. Alexander's clinical interest in tumors of the central nervous system. His research focuses on regulatory and translational science, particularly with regards to the generation of meaningful preclinical and early phase clinical data to support the development of novel therapies and biomarkers.
He received his medical degree at the University of Michigan and complete a radiation oncology residency at the Harvard Radiation oncology program. He is board certified in radiation oncology.
Job Titles:
- Head
- Vice President
- Vice President and Head of Global Regulatory Affairs for Oncology and in Vitro Diagnostics, Bayer
Dr. Kalidas is vice president and head of global regulatory affairs for oncology and in vitro diagnostics at Bayer. She leads a team of global regulatory strategists who are responsible for developing appropriate global strategies for programs in all stages of drug development and for the registration of in vitro diagnostics. Programs in her group include VITRAKVI® (larotrectinib), STIVARGA® (regorafenib), XOFIGO® (Radium-223), ALIQOPA® (copanlisib), NEXAVAR® (sorafenib) and darolutamide, among others.
Claire Friedman, MD is an assistant attending in the Gynecologic Medical Oncology Service at Memorial Sloan Kettering Cancer, with an additional appointment in the Phase 1 Early Drug Development service. She is engaged in the development of new treatment paradigms for gynecologic cancers that incorporate checkpoint blockade and other immune-based strategies, as well as spearheading efforts within her service to examine mechanisms of checkpoint blockade resistance. Dr. Friedman also is one of the clinical leads for MSK-SPECTRUM, a multi-modal prospective study of spatio-temporal determinants of tumor evolution, treatment and response in high grade serous ovarian cancer.
Job Titles:
- Chief Executive Officer
- Chief Executive Officer of the National Brain Tumor Society
David Arons is the Chief Executive Officer of the National Brain Tumor Society. Prior to joining NBTS, he served in leadership and external positions at the American Cancer Society in Minnesota, the Center for Lobbying in the Public Interest and at Independent Sector. As an attorney, he previously represented patients facing disabilities and serious health conditions. He is the author of several books, including Power in Policy: A Funder's Guide to Advocacy and Civic Participation, Strengthening Nonprofit Advocacy, and A Voice for Nonprofits. David has served on the National Cancer Institute's Council of Research Advocates and Clinical Trials Advisory Committee. In 2016, David was named to the Blue Ribbon Panel of experts selected to help advise the National Cancer Moonshot, led by former Vice President, now President Biden.
Job Titles:
- Professor
- Professor of Medical Oncology and Pharmacology, Emory University
Winship Cancer Institute, Dr. Harvey serves as director of the Phase I Clinical Trials Unit, and as medical director of the Clinical Trials Office.
Dr. Harvey, PharmD, is Professor in the Department of Hematology and Medical Oncology with a joint appointment in the Department of Pharmacology and Chemical Biology at Emory University School of Medicine. He serves as director of Winship Cancer Institute's Phase I Clinical Trials Unit and as chair of the Data and Safety Monitoring Committee. Dr. Harvey is a Fellow of the American College of Clinical Pharmacy and a Fellow of the Hematology/Oncology Pharmacy Association. He has established an active clinical pharmacology research program in cancer at Emory with the goal of using pharmacokinetic, pharmacodynamic, and other tools to improve individualization of therapy and clinical outcomes. Dr. Harvey is also active nationally and internationally in several cancer and pharmacology professional organizations. He is a past President of the Hematology and Oncology Pharmacy Association, an international professional organization. Dr. Harvey obtained his BS Pharmacy and Doctor of Pharmacy degrees at the University of North Carolina at Chapel Hill (UNC). He completed subsequent training at the University of Kentucky Medical Center and School of Pharmacy. Dr. Harvey specialized in Hematology/Oncology at UNC, where he was on staff and faculty for 8 years prior to coming to Grady Hospital in Atlanta, where he served as a clinical specialist in hematology and oncology and director of the hematology and oncology residency program.
Job Titles:
- Member of the Executive Committee
- Chief of Medical Oncology in the Oncology Center of Excellence
- Director, Division of Oncology Products
Director, Division of Oncology Products 1 Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Dr. Julia A. Beaver is the Chief of Medical Oncology in the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA) and Deputy Director (acting) in the Office of Oncologic Diseases in the Center for Drug Evaluation and Research at FDA. She was previously the Director of the Division of Oncology 1. Prior to serving as Division Director, she was Breast Cancer Team Leader and then Supervisory Associate Division Director. Through her time at FDA, she has spearheaded the authorship of multiple FDA Guidances for Industry including guidances related to expansion of eligibility criteria, male breast cancer, placebos and blinding, and metastasis-free survival.
Dr. Beaver has also published multiple regulatory research projects and co-leads the OOD/OBP Next Generation Sequencing Translational Research Laboratory. She serves on the Liquid Biopsy Blood Profiling Atlas in Cancer (Blood-PAC) committee and has particular expertise in Precision Oncology. Dr. Beaver also is an Assistant Professor of Oncology, part-time, at Johns Hopkins University where she is a member of the Johns Hopkins Breast Cancer Group. Dr. Beaver graduated magna cum laude from Princeton University and then earned her medical degree from the University of Pennsylvania School of Medicine. She completed a residency in Internal Medicine at Johns Hopkins University School of Medicine, followed by a fellowship in Medical Oncology at The Johns Hopkins Sidney Kimmel Cancer Center.
Job Titles:
- Member of the Executive Committee
- Senior Investigator, Division of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program / National Cancer Institute
Elad Sharon, MD, MPH, joined the NCI Cancer Therapy Evaluation Program (CTEP) in December 2011 as a Senior Investigator in the Investigational Drug Branch, where he works with academia and industry to develop promising new cancer therapies. His portfolio includes antibody-drug conjugates, immune checkpoint inhibitors and other agents. Dr. Sharon co-directs immunotherapy trials at CTEP and serves as an attending physician in NCI's Developmental Therapeutics Clinic. As part of his work in immunotherapy drug development, he has made a major effort to advance the understanding of immune-related adverse events, including the establishment of the Alliance-NIH irAE Biorepository. In addition, Dr. Sharon is the co-Principal Investigator of the AIM-NIVO trial, evaluating the use of nivolumab for patients with pre-existing autoimmune disease. With the advent of Cancer Moonshot, Dr. Sharon has served as the co-chair of the Adult Immunotherapy Implementation Team to help the NCI accelerate cancer care innovation.
Dr. Sharon is on program committees for several major oncology meetings. He has chaired the NIH-AACR Joint Conference on Cancer, Autoimmunity, and Immunology. He has also served on the committee and chaired several ASCO pre-annual meeting seminars on the Economics of Cancer Care. Dr. Sharon works on patterns of care projects with NCI's Healthcare Delivery Research Program using SEER data and with NCI's Surveillance Research Program to evaluate emerging practice patterns. He has worked with several providers of data to evaluate real world evidence for use in drug development and patient safety analyses, through collaborations with the FDA, Friends of Cancer Research, and other stakeholders in the field.
Dr. Sharon received his M.D. from Baylor College of Medicine in Houston, Texas in 2003. He completed his internal medicine residency at Emory University in 2006 and his Hematology/Oncology Fellowship at the NIH in 2011, while obtaining a Master of Public Health degree at the Harvard University in 2009. His fellowship research focused on clinical trials in mesothelioma. During his fellowship at the NCI, he had previously worked as a guest at the Brookings Institution. He serves as an associate editor of JNCI Cancer Spectrum and on the editorial board of JCO Clinical Cancer Informatics.
Job Titles:
- Vice President of Regulatory Strategy at GRAIL
Elizabeth (Liz) Mansfield, PhD, is the Vice President of Regulatory Strategy at GRAIL. Prior to GRAIL, Liz was Deputy Office Director for Personalized Medicine and Director of the Personalized Medicine Staff in the Office of In Vitro Diagnostic Devices (OIVD) in the Center for Devices at the FDA, where she developed a program to address companion and novel diagnostic devices. She also previously served as a Senior Policy Analyst in OIVD, managing policy and scientific issues, and served in other positions at the FDA including Scientific Reviewer and Genetics Expert. Previously at Affymetrix, Liz was the Director of Regulatory Affairs (2004-2006).
She holds a PhD from Johns Hopkins University and completed further postdoctoral training at the National Cancer Institute (NCI) and the National Institute for Arthritis, Musculoskeletal, and Skin Diseases (NIAMS).
Job Titles:
- Member of the Executive Committee
- Merck Research Laboratories
- Senior Vice President and Therapeutic Area Head Oncology, Early Development Merck Research Laboratories
Dr. Rubin has focused on cancer drug development for over 25 years, initially as a faculty member at the Dana- Farber Cancer Institute, then as a senior leader of the Cancer Institute of New Jersey, where he served as the
Director of the Investigational Therapeutics Division of that institution. His research efforts focused on mechanisms of resistance to DNA topoisomerase-targeting drugs and his laboratory cloned TOPORS, a novel topoisomerase I- and p53-interacting tumor suppressor gene. In 2008 he was recruited to Merck to lead the clinical oncology development team. Under his leadership, the clinical oncology group underwent a transformational change in an effort to realize the potential of cancer immunotherapy. He led the initial development of the anti-PD-1 antibody pembrolizumab, which was the first anti-PD-1 therapy approved in the U.S., and in the identification of the significant activity of this breakthrough therapeutic across several cancer types. In 2014 Dr. Rubin was asked to head up Oncology Early Development for Merck, and in this role he oversees development of a promising and expansive early pipeline, as well as translational oncology research activities.
Dr. Rubin has authored over 100 original, peer-reviewed publications and book chapters related to oncology translational research, clinical trials, and drug development. He has served frequently as a member of National Cancer Institute and American Cancer Society study sections, as well as on program committees for the American Association of Cancer Research (AACR) and the American Society of Clinical Oncology. He is a co-chair of the Cancer Steering Committee of the Biomarkers Consortium, Foundation of the National Institute of Health, a member of the Science Policy and Governmental Affairs Committee for AACR, and was a member of the National Cancer Moonshot Initiative/Blue Ribbon Panel Working Group on Expanding Clinical Trials.
Job Titles:
- Professor of Medicine at Harvard Medical School
Dr. Hidalgo is the Theodore W. and Evelyn G. Berenson Professor of Medicine at Harvard Medical School, chief of the division of Hematology and Oncology and director of the Rosenberg Clinical Cancer Center at the Beth Israel Deaconess Medical Center.
His main focus of research has been new drug development in pancreatic cancer. His group popularized the used of Avatar mouse models for cancer research and recently contributed to the development and approval of Nab-paclitaxe for pancreatic cancer treatment.
Dr. Hidalgo trained in medicine and medical oncology at Hospital "12 de Octubre" in Madrid and at the University of Texas Health Science Center in San Antonio, and completed a fellowship in anticancer drug development at the Institute of Drug Development in San Antonio. He received his medical degree from the University of Navarra in Pamplona, Spain, and a Ph.D. from University Autonoma of Madrid .
Job Titles:
- Chairman, Professor Surgery, Pathology and Immunology, Duke University
Job Titles:
- Member of the Executive Committee
Job Titles:
- Member of the Executive Committee
- Chairman, Duke University
- Delivery Address Accelerating Anticancer Agent
- George Barth Geller Professor of Cancer Research Professor of Surgery, Immunology and Pathology Director, Surgical Science Applied Therapeutics Section, Duke University
Dr. Lyerly is the George Barth Geller Professor of Cancer Research, professor of surgery, immunology and pathology, and director of the surgical sciences applied therapeutics section at Duke University, and former director of the Duke Comprehensive Cancer Center. He is an internationally recognized expert in cancer therapy and immunotherapy, has published over 300 scientific articles and book chapters, and has edited ten textbooks on surgery, cancer immunotherapy and novel cancer therapies. He serves on the editorial board of 12 scientific journals.
Dr. Lyerly was appointed in 2008 by President George Bush to serve on the National Cancer Advisory Board, which oversees the National Cancer Institute, where he served until 2014. He has served as chair of the Cancer Centers Subcommittee and served on the Global Health Subcommittee of the National Cancer Advisory Board. He has served on the National Institutes of Health (NIH) Council of Councils, and on the board of the NIH Office of AIDS Research. He has also been a member of the scientific advisory boards of Susan G. Komen and the Burroughs Wellcome Foundation.
He is a highly sought after consultant and advisor and has served on the Cancer Center's external advisory boards for the M.D. Anderson Cancer Center, University of Michigan, University of Chicago, University of Alabama, University of Arizona, Boston University and Purdue University. He has served as an advisor to the University of Washington and Case Western Reserve Clinical and Translational Science Institutes.
Job Titles:
- Member of the Executive Committee
- Associate Chief and Senior Investigator, Cancer Therapy Evaluation Program National Cancer Institute
Dr. Chen joined the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI) in 2000. She currently serves as associate chief of the Investigational Drug Branch 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 been closely involved in the NCI's efforts on novel agent combinations and is a 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.
She is on the organizing committee of the International Symposium of Anti-angiogenesis Therapy, the scientific committees for the EORTC-AACR-NCI Annual Meeting on Molecular Targeted Therapy, the ASCO-NCI-EORTC Annual Biomarkers Symposium, and the Biotherapy Development Association.
Dr. Chen has been an invited speaker at national and international meetings on cancer drug development strategies, and is the first or coauthor of more than 50 original and review papers in peer-reviewed journals including the Journal of Clinical Oncology, Nature Reviews, and the New England Journal of Medicine.
Job Titles:
- Member of the Executive Committee
Job Titles:
- Member of the AAADV - ASCO - CDDF Program Committee
- Fellow of the Royal Netherlands Academy of Arts
- Managing Director, Cancer Drug Development Forum
Jaap Verweij, M.D., Ph.D is an Emeritus Professor of Medical Oncology, and former Dean of the Faculty of Medicine at Erasmus University Medical Centre. He served as chair of the Department of Medical Oncology, and chair of the Daniel den Hoed Cancer Center at the Erasmus University Medical Centre from 2008-2013, and as Dean of the Faculty of Medicine and Vice-Chairman of the Board of directors of Erasmus University Medical Center from April 2013 - September 2017. He also served as Founding Dean of the Faculty of Life Sciences at the University of Siegen, Germany, from October 2017 - November 2019.
His main scientific interests are new drug development, including the performance of clinical phase I and early phase II trials, and the inclusion of pharmacokinetics and pharmacodynamics in these studies. He also has a major interest in the design aspects of early clinical studies. Besides his clinical activities, he has been the chairman of the Early Clinical Studies Group of the European Organisation for Research and Treatment of Cancer (EORTC) from 1993-1996, chairman of the EORTC Soft Tissue and Bone Sarcoma Group from 1996-1999, chairman of the EORTC New Treatment Committee, the EORTC New Drug Advisory Committee, and Vice President of EORTC. He has also been president of the Connective Tissue Oncology Society (CTOS), chairman of the RECIST working group, and chairman of the Scientific Council of the Dutch Cancer Foundation. He has been editor of the European Journal of Cancer and associate editor of the Journal of Clinical Oncology. He served as vice-chairman in the Board of Governors of the Dutch Cancer Foundation from 2011-2019, and as member of the Board of Directors of the American Society of Clinical Oncology (ASCO) from 2016-2020. He has been non-executive Medical Director of Octimet Pharmaceuticals from 2016-2020. He currently serves, as Managing Director of the Cancer Drug Development Forum (CDDF) in Brussels, Belgium, and as senior advisor to the University of Siegen, Germany, and as advisor for several pharmaceutical companies.
In 2011 Jaap Verweij was appointed as fellow of the Royal Netherlands Academy of Arts and Sciences, and in 2017 as Fellow of the American Society of Clinical Oncology (ASCO). He has authored or co-authored over 700 scientific papers, and has given numerous lectures on a variety of topics at international meetings.
Job Titles:
- Member of the Executive Committee
- Principal Investigator
- Deputy Director for the Laura
- Director, Perlmutter Cancer Center / New York University
Dr. Weber is deputy director for the Laura and Isaac Perlmutter Cancer Center, and is head of experimental therapeutics and professor of medicine at New York University's Langone Medical Center in New York City. His research interests lie in the monitoring and characterization of T cell responses to immunotherapeutic treatments in cancer patients, and in the establishment of in vitro models to facilitate the understanding of how immune modulating antibodies amplify T cell responses in patients. He is also interested in the mechanisms by which achieving autoimmunity induces regression of cancer. His clinical interests are in the immunotherapy of melanoma and other malignancies, with a focus on adoptive immunotherapy, epigenetic therapy and the use of immune modulating antibodies.
Dr. Weber is the principal investigator of several ongoing studies funded by the National Cancer Institute, including trials in clinical drug development and managing the autoimmune side effects of immunotherapy for melanoma. He has served as principal investigator and director of the Moffitt Cancer Center's Specialized Programs of Research Excellence (SPORE) grant for skin cancer and melanoma research from the National Cancer Institute.
Job Titles:
- Head of Translational, Oncology Regulatory Science, Strategy & Excellence, AstraZeneca
Job Titles:
- Member of the Executive Committee
Job Titles:
- Member of the Executive Committee
- Development Scientist
- Vice President, Clinical Pharmacology and Regulatory Science, Certara
Dr. Bullock is a recognized drug development scientist with clinical pharmacology and regulatory experience focused in the therapeutic areas of hematology/oncology and coagulation. She has unique insight in pediatric development, oncology dose-finding strategy and streamlining development for breakthrough therapies and accelerated approval. Bullock was a key leader in the scientific thinking for the basis of the U.S. Federal Drug Administration's (FDA) acceptance of PK/PD development approaches for biosimilar products.
Prior to her role at Certara, Dr. Bullock was the clinical pharmacology team leader for the oncology/hematology team in the division of clinical pharmacology 5, which collaborated with the division of hematology products in the Center for Drug Evaluation and Research at the FDA. She also spent three years as a primary reviewer for investigational new drugs and new drug applications in the division of reproductive and urologic products and the division of drug oncology products.
Dr. Bullock received her doctor of pharmacy from Drake University and completed a clinical pharmacology drug development fellowship with the State University of New York at Buffalo and Novartis Pharmaceuticals.
Job Titles:
- Member of the AAADV - ASCO - CDDF Program Committee
- FASCO / Chief Medical Officer, American Society of Clinical Oncology ( ASCO )
Job Titles:
- Associate Director
- Associate Director, Division of Cancer Treatment and Diagnosis at National Cancer Institute
Lisa Meier McShane, Ph.D., is Associate Director, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute, National Institutes of Health, where she heads the Biometric Research Program, comprising Biostatistics and Computational and Systems Biology Branches. She earned a Ph.D. in Statistics from Cornell University and is a Fellow of the American Statistical Association. She is an internationally recognized expert on precision medicine clinical trial design; development of tumor markers and omics predictors for prognosis, therapy selection, and disease monitoring; and reporting guidelines for health research studies. Her statistical research interests include biomarker-driven clinical trial design, analysis of high-dimensional omics data, multiple comparisons methods, surrogate endpoints, and biomarker assay analytical performance assessment.
Dr. McShane serves on the Scientific Advisory Board for Science Translational Medicine and on the Editorial Boards for Journal of Clinical Oncology. She has served on American Society of Clinical Oncology committees that developed guidelines for HER2 and hormone receptor testing in breast cancer, EGFR mutation testing in lung cancer, and biomarkers in early stage breast cancer. She interacts frequently with FDA on biomarker-based initiatives and has served on FDA/CDRH Molecular and Clinical Genetics and Clinical Chemistry and Clinical Toxicology Panels. She has served as a member of Institute of Medicine Committee for Management of the Air Force Health Study Data and Specimens, the Consensus Committee on Management of the Air Force Health Study Data and Specimens-Report to Congress, and the Committee on the State of the Science in Ovarian Cancer Research.
Job Titles:
- Member of the Executive Committee
- Clinical Reviewer
- Deputy Director, Division of Oncology 3
- Medical Oncologist and Deputy Division Director
Lola A. Fashoyin-Aje, MD, MPH, is a medical oncologist and Deputy Division Director in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Food and Drug Administration (FDA).
At the FDA, Dr. Fashoyin-Aje has served as clinical reviewer in the Gastrointestinal (GI) Malignancies team, and as team leader for the Breast Malignancies, Melanoma and Sarcoma, and Gastrointestinal Malignancies clinical teams. In her current role, she provides scientific and policy guidance and oversight to multidisciplinary teams reviewing drugs and biologics under development for the treatment of solid tumor (GI, sarcoma, melanoma) malignancies. She has also served as the Oncology Center of Excellence (OCE) Scientific Liaison for Cancer Disparities and in this role, has led the OCE's efforts to improve inclusion of diverse demographic subgroups in clinical trials and participates in several internal and external scientific and policy working groups. Dr. Fashoyin-Aje also serves on the ASCO Health Equity Committee, the AACR Science of Cancer Health Disparities Scientific Program and Scientific Review committees, and the ASCO Cancer Research Committee.
Prior to joining the FDA, Dr. Fashoyin-Aje completed her residency in internal medicine and fellowship in medical oncology at Johns Hopkins. She completed her undergraduate and graduate training at Columbia University and Yale University, respectively, and earned her medical degree from the University of Rochester.
Job Titles:
- Member of the Executive Committee
Dr. Hidalgo previously served as assistant professor of medicine in hematology and oncology at the University of Texas Health Science Center in San Antonio in 2000. In 2001, he relocated to Johns Hopkins University to serve as director of the Gastrointestinal Oncology Program at the Sidney Kimmel Comprehensive Cancer. In 2009 he became director of the clinical research program at the Spanish National Cancer Center in Madrid and was made vice-director of translational research there in 2011.
Job Titles:
- Director
- Co - Director of Oncology at Australia 's National Health
- Co - Director of Oncology at Australia 's National Health and Medical Research Council Clinical Trials Centre, University of Sydney
- Professor
Dr. Stockler is co-director of oncology at Australia's National Health and Medical Research Council Clinical Trials Centre, and is professor of oncology and clinical epidemiology at the University of Sydney. He is also a consultant medical oncologist at the Concord Repatriation General Hospital and at the Chris O'Brien Lifehouse RPA in Sydney.
Martin Stockler
Professor of Oncology and Clinical Epidemiology, University of Sydney, Oncology Director at the NHMRC Clinical Trials Centre, University of Sydney
Job Titles:
- Member of the Executive Committee
- Director of Global Outreach and Engagement, International Gynecologic Cancer Society Pinkie Hugs LLC
Mary (Dicey) Jackson Scroggins, a 22-year ovarian cancer survivor and health activist, is a writer, producer and founding partner in Pinkie Hugs, LLC (www.pinkiehugs.com), a mother-daughter writing and film production firm specializing in social justice-focused documentaries. She is also director of global outreach and engagement for the International Gynecologic Cancer Society; a co-chair of the advocacy special interest group for the African Organization for Research and Training in Cancer; and a co-founder of In My Sister's Care, an organization focused on improving gynecologic cancer awareness and care for medically underserved women and on eliminating health disparities.
The recipient of the 2016 American Association for Cancer Research (AACR) Distinguished Public Service Award, Mary is a member of the AACR Minorities in Cancer Research Council, the leadership committee for MD Anderson Cancer Center's "Women's Cancer Moon Shots Program," the GOG Foundation and the NRG Oncology Foundation board of directors, the National Cancer Institute's (NCI) investigational drug steering committee, and the "Community Engagement in Genomics" working group of the National Institute for Health's National Human Genome Research Institute. She is also a member of the program steering committee for the NCI-funded Florida-California Cancer Research, Education and Engagement (CaRE 2) Health Equity Center; the director of advocacy and international engagement for the "Globe-athon to End Women's Cancers," an international movement to spread gynecologic cancer awareness and save women's lives; chair of the advocacy council of the Department of Defense (DOD) and SPORE Ovarian Cancer Omics Consortium and of the advocate advisory board of the DOD-funded Consortium for Long-Term Ovarian Cancer Survival; and a co-chair of NRG Oncology's patient advocate committee. Her activism is driven by a commitment to global health equity.
Job Titles:
- Acting Associate Director
- Member of the Executive Committee
- Medical Officer, Sarcoma
Medical Officer, Sarcoma/Melanoma Team, Division of Oncology Products 2; Scientific Liaison, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Dr. Chuk is acting associate director for safety in the Office of Hematology and Oncology Products in he Center for Drug Evaluation and Research at the U.S. Food and Drug Association. (FDA).
Job Titles:
- Dr. Susan Love Foundation 's Scientific Advisory Council
- President of the Breast Cancer Care & Research Fund ( BCCRF ) in Los Angeles
Michele Atlan is an 8-year breast cancer survivor and a patient & research advocate. After her diagnosis, Michele became certified as an Emergency Medical Technician. In 2015, she graduated from Project LEAD, the National Breast Cancer Coalition's (NBCC) scientific training program, and subsequently took part in the Advanced Project LEAD pilot program. Michele now participates as a frequent Project LEAD mentor to help her fellow patient advocates understand the science of breast cancer.
Currently serving as president of the Breast Cancer Care & Research Fund (BCCRF) in Los Angeles, Michele has participated as a consumer reviewer for the Department of Defense's Breast Cancer Research Program and is a member of the California Breast Cancer Research Program's (CBCRP) Advisory Council. Recently, Michele was a finalist and the Audience Award winner for the CBCRP's "Global Challenge to Prevent Breast Cancer" competition. She coauthored an article expanding on this contest submission that was subsequently published in the International Journal of Environmental Research and Public Health in 2019.
In addition, Michele is a current member of the Dr. Susan Love Foundation's Scientific Advisory Council. Starting in 2018, she was an alternate board member of the NBCC and participated in their 2020 Artemis Project research think tank.
Job Titles:
- Member of the Executive Committee
- Professor of Medicine, Associate Director of Innovative Medicine, Yale Cancer Center
As associate director of Innovative Medicine at Yale Cancer Center, Dr. LoRusso is a nationally recognized expert in developing new cancer drugs through clinical trials.
She pioneered significant advances in medical oncology, drug development and early phase clinical trials in her work at Wayne State University's Barbara Karmanos Cancer Institute as director of both the Phase I Clinical Trials Program and of the Eisenberg Center for Experimental Therapeutics.
Dr. LoRusso joined the Board of Scientific Counselors for the National Cancer Institute (NCI) and has served as the co-chair of their Cancer Therapy Evaluation Program Investigational Drug Steering Committee, the Board of Directors and numerous scientific committees of the American Association for Cancer Research, the education and scientific committees of the American Society of Clinical Oncology, and many peer-reviewed study sections and NCI committees.
Dr. LoRusso earned the Michigan State University Distinguished Alumni Award in 2014, an honorary doctor of science degree in 2015, and was honored as one of the National Organization of Italian American Women's Three Wise Women in 2017.
Job Titles:
- Member of the Executive Committee
- Team Leader
Dr. Liu is a team leader in the Division of Clinical Pharmacology V of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). Prior to joining the FDA, she worked as a senior pharmacokineticist at Merck & Co. She obtained her Ph.D. in pharmaceutics with a focus on pharmacokinetics/pharmacodynamics modeling and simulation from the University of Florida, concurrently earning a master's degree in statistics. She also earned a master's degree in pharmaceutics and a B.S in pharmacy from West China University of Medical Sciences.
In her current role at the FDA, Dr. Liu works in the area of oncology products with a focus on applying clinical pharmacology principles, including quantitative methods, to optimize the development of oncology drug products, such as dose selection and study design. She also has an interest in the application of machine learning, big data and real world evidence to advance precision medicine.
Job Titles:
- Member of the Executive Committee
- Director of the Division of Biometrics V
- Director, Division of Biometrics V, Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Dr. Sridhara is director of the Division of Biometrics V in the Office of Biostatistics which supports the Office of Hematology Oncology Products in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA).
Dr. Sridhara has contributed to the understanding of statistical issues unique to the area of oncology disease such as evaluation and analysis of time to disease progression. Her research interests include evaluation of surrogate markers and design of clinical trials. She has organized, chaired and given invited presentations at several workshops, and has worked on regulatory guidance documents across multiple disciplines. She has published extensively in refereed journals and presented at national and international conferences. She is an elected fellow of the American Statistical Association.
Prior to joining FDA, Dr. Sridhara was a project statistician for the AIDS vaccine evaluation group at EMMES Corporation, and was an assistant professor at the University of Maryland Cancer Center.
Job Titles:
- Director
- Member of the Executive Committee
- Director, Division of Molecular Genetics
Director, Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostic Devices and Radiological Health, Center for Devices and Radiological Health
Dr. Philip is a director in the Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostic Devices and Radiological Health at the Center for Devices and Radiologic Health at the U.S. Food and Drug Administration (FDA). At the FDA, she has been involved in many diverse activities including premarket clearance/approval, manufacturer assistance and post-market regulatory compliance actions. In addition, she has been an ongoing participant in FDA multi-center reviews in companion diagnostics/complementary diagnostics, and is actively working to develop regulatory framework for liquid biopsy tests and NGS-based oncology assays.
Job Titles:
- Independent Consultant
- Member of the AAADV - ASCO - CDDF Program Committee
- Member of the Executive Committee
- Independent Consultant, Former Head of Clinical Cancer Research, and Head of Regulatory Oncology Research Policy, Bristol Myers Squibb
Dr. Canetta held numerous roles at Bristol-Myers Squibb (BMS), including head of clinical cancer research; head of development, life cycle management; vice president, oncology global clinical research; and vice president, global R&D oncology policy. His work resulted in the introduction of 18 new BMS drugs for general medical use and the approval of over 50 regulatory dossiers for additional indications/formulations including some outside of oncology.
Prior to his time at BMS, Dr. Canetta conducted clinical trials in lymphomas and gastrointestinal tumors at the Istituto Nazionale Tumori in Milan.
After retiring from BMS in 2015, Dr. Canetta has been consulting for and collaborating with not-for-profit organizations, advocacy groups, government agencies and professional societies.
Job Titles:
- Executive Vice President
- Member of the AAADV - ASCO - CDDF Program Committee
- Member of the Executive Committee
- FSCT, FASCO / Professor Emeritus, University of Chicago
Dr. Schilsky is the former Chief Medical Officer (CMO) and Executive Vice President of ASCO. Formerly the Chief of Hematology/Oncology in the Department of Medicine and Deputy Director of the University of Chicago Comprehensive Cancer Center, he is a highly respected leader in the field of clinical oncology. He specializes in new drug development and treatment of gastrointestinal cancers. Dr. Schilsky is a Past President of ASCO, having served in the role during 2008-2009, and is also a Past Chair of one of the National Cancer Institute's Cooperative Groups, Cancer and Leukemia Group B (CALGB).
Dr. Schilsky's impressive experience and many accomplishments in both clinical medicine and clinical research reflect his deep passion for cancer medicine. He has spent the majority of his career at the University of Chicago, where he joined the faculty in 1984, subsequently rising to the rank of Professor of Medicine and serving in many roles, including Associate Dean for Clinical Research in the Biological Sciences Division and Director of the University of Chicago Cancer Research Center.
From 1995 to 2010, Dr. Schilsky served as Chair of the Cancer and Leukemia Group B (CALGB), a national cooperative clinical research group funded by the National Cancer Institute (NCI). He has extensive experience working with both the NCI and the Food and Drug Administration (FDA) having served as a member and chair of the NCI Board of Scientific Advisors, as a member of the NCI Clinical and Translational Research Committee, and as a member and chair of the Oncologic Drugs Advisory Committee of the FDA. Dr. Schilsky has served on the editorial boards of many cancer journals, including the Journal of Clinical Oncology. He presently serves on the editorial board of the New England Journal of Medicine.
Early in his career, he worked in the Clinical Pharmacology Branch of the Division of Cancer Treatment at the NCI and was an Assistant Professor in the Department of Internal Medicine, Division of Hematology and Oncology at the University of Missouri-Columbia School of Medicine. He was also the head of the hematology/medical oncology unit at the Harry S. Truman Veterans' Administration Hospital in Columbia, Missouri.
Job Titles:
- Member of the Executive Committee
Job Titles:
- Member of the Executive Committee
- Team Lead, Office of Clinical Pharmacology, U.S. Food and Drug Administration
Stacy S. Shord, PharmD, BCOP, FCCP, is the Deputy Director in the Division of Cancer Pharmacology II in the Office of Clinical Pharmacology within U.S. Food and Drug Administration. Dr. Shord received her Doctor of Pharmacy from University of Maryland School of Pharmacy in 1997. She then completed a Pharmacy Practice residency at the University of Pittsburgh Medical Center, an Oncology Pharmacy Practice residency at UNC Hospitals, and a fellowship in Oncology Pharmacotherapy at the UNC Eshelman School of Pharmacy.
Dr. Shord joined the faculty at the University of Illinois at Chicago College of Pharmacy in 2001 as an assistant professor where her research focused on drug metabolism in patients with cancer and hematological diseases. She joined the Food and Drug Administration in 2009 and served as a primary reviewer and Lead Pharmacologist in the Office of Clinical Pharmacology and an Associate Director of Labeling in the Office of Oncologic Diseases. Special interests include labeling and pediatric drug development. Dr. Shord earned her Board Certification in Oncology Pharmacy in 2000. She has authored more than 50 peer reviewed papers and 10 book chapters. Dr. Shord is a member of ASCPT, ASCO, ACCP and HOPA.
Job Titles:
- Member of the Executive Committee
Dr. Prowell is breast cancer scientific liaison in the Office of Hematology and Oncology Products at the U.S. Food and Drug Administration (FDA) and assistant professor of oncology in the Breast Cancer Program at the Johns Hopkins Kimmel Comprehensive Cancer Center. She was the principal architect of the FDA's policy on accelerated approval using pathological complete response as a novel regulatory endpoint in the neoadjuvant high-risk breast cancer setting, and was a member of the Cancer Moonshot Blue Ribbon Panel Cancer Immunology Working Group.
She is a frequent public speaker and a three-time recipient of the FDA's Excellence in Communication Award, as well as a Giants of Cancer Care Award finalist. A passionate medical educator and mentor, she currently serves on the faculty of the Vail Methods in Clinical Cancer Research Workshop, the Accelerating Anti-Cancer Agent Development and Validation (AAADV) Workshop, the FDA/ASCO Fellows' Day Workshop, the Society for Translational Oncology Fellows' Forum, and the Dana Farber Clinical Investigator Seminar Series, among others. She sees patients in the Johns Hopkins Second Opinion Breast Cancer Clinic and teaches in the medical school and medical oncology fellowship training program.
Dr. Prowell received her BA from Bard College in languages and literature and her medical degree from the Johns Hopkins School of Medicine with election to the Phi Beta Kappa and Alpha Omega Alpha honor societies. She completed her internal medicine residency and medical oncology fellowship at Johns Hopkins Hospital.
Job Titles:
- Associate Director, Regulatory Policy and Intelligence, Gilead
Job Titles:
- Member of the AAADV - ASCO - CDDF Program Committee
- Member of the Executive Committee
- Member of the Fred Hutchinson Cancer Research Center
- Professor Statistics, University of Washington
- Professor, Department of Biostatistics University of Washington School of Medicine
Dr. Fleming is a member of the Fred Hutchinson Cancer Research Center in Seattle and former director of the Statistical Center for HIV/AIDS Prevention Trial Network for the National Institute of Allergy and Infectious Diseases. He has authored or coauthored several books and more than 250 research articles in peer-reviewed journals, many regarding the development of state-of-the-art-methods for the design, conduct and analysis of clinical trials, and others reporting the results of landmark trials including the 2011 publication in the New England Journal of Medicine on prevention of HIV transmission. This research, on which he was senior author, was recognized by Science Magazine to be the scientific "Breakthrough of the Year."
Dr. Fleming has chaired or served on data monitoring committees for more than 100 clinical trials. He is a special government employee for the U.S. Federal Drug Administration (FDA), and for more than 25 years has served as a regular member of several FDA advisory committees and as an invited voting member on more than 100 occasions. He is the recipient of the FDA Commissioner's Special Citation Award for Extraordinary Contribution to the Agency.
At the University of Washington, Dr. Fleming received the Outstanding Teaching Award in the School of Public Health, was the 2009 Distinguished Lecturer for the School of Public Health, and in 2011 was the Ross Prentice Endowed Professor of Biostatistical Collaboration. He was the 2007 Greenberg Lecturer at the University of North Carolina at Chapel Hill, and in 2012 was elected to membership in the Institute of Medicine of the National Academies.
Job Titles:
- Associate Director
- Member of the Executive Committee
Virginia Kwitkowski is associate director of labeling within the Division of Hematology Products (DHP) in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). She is responsible for overseeing all labeling activities within the DHP and advises DHP staff on the incorporation of patient-reported outcomes into clinical trials, and labeling.
Prior to joining the FDA, Kwitkowski was a nurse practitioner in the medicine branch of the National Cancer Institute
Job Titles:
- Vice President Early Development Vice President Early Development, Bristol - Myers Squibb
Job Titles:
- Chief Medical and Scientific Officer, American Cancer Society
William G. Cance, MD, chief medical and scientific officer for the American Cancer Society, is a renowned surgical oncologist and physician-scientist, transformative leader, and champion for innovation. He leads the Society's scientific and medical strategies and manages its research and cancer control departments, providing leadership to areas including intramural and extramural research; prevention and early detection; patient and caregiver support; global cancer control; and health systems engagement. In support of the organization's mission, asd Dr. Cance leverages the Society's rich history of research innovation and cancer control expertise to promote health equity and bring innovation to patients faster.
The American Cancer Society named Dr. Cance to the position in 2019. Prior to joining the Society, he was deputy director and interim director of the University of Arizona Cancer Center, where he led the integration of the university's Tucson- and Phoenix-based research programs and guided the partnership between the Cancer Center and Dignity Health/St. Joseph's Hospital and Medical Center. Dr. Cance was also the Finley & Florence Brown Professor of Cancer Research at the University of Arizona; Professor, interdisciplinary oncology and Professor, surgery at the University of Arizona College of Medicine-Phoenix; and Professor, pharmacy, and toxicology at the University of Arizona College of Pharmacy. He was chair of the Arizona Cancer Coalition for the Arizona Department of Health Services, during which he focused on promoting programs that addressed cancer disparities in underserved populations.
Dr. Cance is a practicing surgical oncologist. His areas of expertise include thyroid cancer, parathyroid disease, and advanced gastrointestinal malignancies. He is the principal investigator for a 25-year National Cancer Institute (NCI) grant focused on focal adhesion kinase, a protein involved in cancer metastasis. He is a former American Cancer Society grantee and has received additional grant funding from the NCI, National Institutes of Health, and US Department of Defense. He holds eight patents and has been involved in several entrepreneurial projects to bring his research advancements to market.
Dr. Cance earned undergraduate and medical degrees from Duke University. He completed a residency in general surgery at Barnes-Jewish Hospital/Washington University School of Medicine and a fellowship in surgical oncology at Memorial Sloan Kettering Cancer Center.