Sylvester Design and Management of Cancer Clinical Trials Course

Dr. Alderuccio is a clinical investigator who specializes in the study and treatment of patients with lymphoma...

Dr. Kurzrock is a world-renowned leader in precision oncology and rare cancers research. She is the Associate Director of Clinical Research for the Medical College of Wisconsin Cancer Center, Associate Director of Precision Oncology at the Linda T. and John A. Mellowes Center for Genomic Sciences and Precision Medicine and the founding director of the Michels Rare Cancers Research Laboratories at the MCW Cancer Center. She is recognized as one of the world’s 25 most important voices in precision medicine and one of the most highly cited scientists globally. She has authored over 950 scientific and medical publications. Dr. Kurzrock is the Chair for the Early Therapeutics and Rare Cancers Committee (SWOG NCI) — one of the largest clinical trials cooperative groups in the country — and has been the principal investigator for more than 100 early-phase clinical trials, leading eight life-changing drugs to FDA approval. In 2022, Dr. Kurzrock and the DART rare cancer study team received the National Cancer Institute Director’s Award of Merit for outstanding work.

Dr. Sharifi is a prostate cancer medical oncologist and physician-scientist, and the overall focus of his laboratory is to identify how steroid metabolism governs prostate cancer resistance to hormonal therapies, including development of castration-resistant prostate cancer (CRPC). Advanced prostate cancer responds initially to gonadal testosterone deprivation therapy, but tumors eventually become resistant and progress because they acquire the metabolic capability of regenerating intratumoral androgens. His work in this field has uncovered the dominant pathway to DHT synthesis (Chang, et al. PNAS. 2011), identified the first example of a gain-of-function missense in the rate-limiting steroidogenic enzyme that increases DHT synthesis (Chang, et al. Cell. 2013), promotes the development of CRPC in patients (Hearn, et al. Lancet Oncology. 2016; Hearn, et al. JAMA Oncology. 2018; Hearn, et al. JAMA Oncology. 2020). His group has identified novel abiraterone metabolites that are found in patients, may redefine the mechanism of abiraterone action and are pharmacologically manipulable (Li, et al. Nature. 2015, Li, et al. Nature. 2016 and Alyamani J Clin Invest. 2018). He also discovered an aberration in glucocorticoid metabolism that is critical for drug resistance (Li, et al. eLife 2017) and is pharmacologically reversible by targeting H6PD (Li, et al. Science Translational Medicine 2021). Most recently, he identified the first post-translational modification of 3βHSD1 that is required for its cellular activity and synthesis of DHT, suggesting a strategy to counter the aggressive disease and poor outcomes conferred by the gain-of-function missense (Li, et al. J Clin Invest 2023). As Scientific Director of the Desai Sethi Urology Institute at the University of Miami Miller School of Medicine, he also direct program development efforts.

In his roles at Sylvester Comprehensive Cancer Center and the University of Miami, Dr. Moskowitz oversees cancer-related clinical care...

Dr. Rodriguez is Associate Director of Community Outreach and Clinical Research Lead of the Thoracic Site Disease Group...

[Add bio here]

As Senior Vice President of Extramural Discovery Science (EDS) at the American Cancer Society (ACS), Dr. Annunziata leads a team of scientific directors and staff to identify the most innovative and promising research from research grant applications to end cancer as we know it for everyone. In addition to leading the grant Peer Review process, she builds and fosters critical relationships with cancer researchers across the nation and with international scientific communities.

Dr. Annunziata has been a leader in innovative cancer research in the laboratory and in clinical trials. Her laboratory established the NF-kappB signaling pathway as important for ovarian cancer stem cells and their progression. This work led to an investigator-initiated clinical trial using the SMAC mimetic class of drugs, which has now moved to a multi-center trial to test the efficacy of SMAC mimetic in combination with standard chemotherapy for patients with chemo-refractory, recurrent ovarian cancer. She also developed the field of intraperitoneal cellular immunotherapy. This is a type of immunotherapy where the patient’s own cells are engineered to attack cancer cells. Since ovarian cancer grows predominantly in the abdomen, Dr. Annunziata reasoned that the therapy would be most effective if administered directly to the site of the cancer. She tested different types of cells in the immune system – both innate and adaptive – along with cytokines to support the immune cells. The next steps will be to combine the components to maximize their anti-cancer activity.

In addition to her research, Dr. Annunziata has chaired scientific peer review committees for both laboratory and clinical research grant proposals. These include committees across the National Institutes of Health (NIH), the American Society of Clinical Oncology (ASCO), and the Department of Defense

Dr. Landgren is a board-certified Hematologist-Oncologist who specializes in multiple myeloma; smoldering myeloma; monoclonal gammopathy of undetermined significance (MGUS); and related plasma cell disorders. His research approaches include detailed genomic characterization of tumor cells and cells in the bone marrow microenvironment, partnered with novel drug development, and advanced methods to rule out minimal residual disease (MRD).

Beyond traditional clinical criteria for complete remission, Dr. Landgren has developed several novel strategies designed to identify minimal residual disease (MRD) detection post-therapy using cell-, molecular-, and imaging-based methods. The overall goal with these studies is to identify the last remaining tumor cells, to comprehensively characterize them and define novel treatment targets, and to use this knowledge to seek a cure for myeloma. Dr. Landgren leads the clinical and research operations of the Myeloma Program at Sylvester Comprehensive Cancer Center at University of Miami.

Dr. Landgren is renowned for his contributions to myeloma clinical care and research. He has a strong track-record in drug development, has served as PI for a large number of clinical trials, designed and conducted a series of studies to define biological mechanisms of transformation from myeloma precursor disease to multiple myeloma, is a frequent speaker and faculty member for national and international meetings on myeloma and hematologic malignancies, is a member of several editorial boards, serves as reviewer for grants and for several high-impact journals, and is the leader of research governance committees and multi-disciplinary research teams. He has been recognized as Chief of Myeloma at three major institutions: Sylvester Comprehensive Cancer Center at the University of Miami, Memorial Sloan Kettering Cancer Center, and the National Cancer Institute at the National Institutes of Health.

Since 2015, Dr. Samimi has served as a Program Director in the Breast and Gynecologic Cancer Research Group, Division of Cancer Prevention (DCP), National Cancer Institute (NCI), managing the ovarian and endometrial cancer prevention grant portfolios. She also serves as Director of the NCI Cancer Prevention Clinical Trials Network (CP-CTNet), which supports early phase clinical trials to assess the safety, tolerability and potential of cancer preventive interventions. She also serves as scientific lead of endometrial and ovarian cancer prevention trials within CP-CTNet. Dr. Samimi’s research interests include molecular mechanisms of ovarian cancer etiology and progression, and identification of women and families at high risk for ovarian cancer.

Dr. Sekeres earned a medical degree and a master's degree in clinical epidemiology from the University of Pennsylvania...

Dr. Shah is a medical oncologist and clinical team lead on the Breast, Gynecologic, and Supportive Oncology team within the Division of Oncology 1, Office of Oncologic Diseases at FDA. She joined the FDA in 2019, after completing her internal medicine residency at Vanderbilt University, and her medical oncology and clinical pharmacology fellowships at Johns Hopkins, where she also served as the Chief Oncology Fellow. She has an interest in improving tolerability of oncology therapies through dosage optimization and is the Clinical Lead for Project Optimus, an Oncology Center of Excellence initiative to reform the dosing paradigm for oncology therapeutics. She enjoys hiking and birding in her spare time.

TBA

Ms. Chadwell is a licensed and certified genetic counselor...

Ms. Hagen graduated from the University of Cincinnati Genetic Counseling Program...

Ms. Jackson serves as a Clinical Research Coordinator and Program Manager at Cincinnati Children’s...

Ms. Raski is a board-certified genetic counselor at Ann & Robert H. Lurie Children's Hospital...

[Add bio here]

Dr. Hantel is a health services researcher, hematologic oncologist, and ethics consultant at Dana-Farber Cancer Institute (DFCI) and Harvard Medical School. He received his MD from Loyola University Chicago and his MPH from the Harvard School of Public Health. He completed internal medicine and hematology/oncology training and a fellowship in medical ethics at the University of Chicago and completed a postdoctoral fellowship in cancer population sciences at the Dana-Farber/Harvard Cancer Center.

His research program leverages health services methods to address ethical dilemmas in cancer discovery and delivery. Specific interests include patient access to and participation in clinical research, the intersection of climate change with cancer health, and the clinical applications of artificial intelligence. For this, Dr. Hantel has received research funding and awards from the National Institutes of Health, American Society for Clinical Oncology, American Cancer Society, Blood Cancer United, Greenwall Foundation, and Alliance for Clinical Trials in Oncology.

Mr. Palmisano is a Senior Data Scientist at the University of Miami Health System, where he works at the intersection of artificial intelligence, clinical trials, and healthcare operations. His work focuses on the design, deployment, and evaluation of applied AI systems that support oncology clinical trial workflows within regulated healthcare environments.

Mr. Palmisano currently serves as lead architect for U-ACCESS, an AI-powered cancer center enrollment support system developed to assist research teams with clinical trial prescreening and patient–trial matching. This work applies agentic and multi-agent AI orchestration approaches to integrate clinical data and trial eligibility criteria, emphasizing transparent, human-in-the-loop system design that augments investigator and coordinator decision-making. Prior to his current role, Mr. Palmisano supported enterprise AI initiatives through the University of Miami Health System’s AI Center of Excellence as an IT Portfolio Manager, contributing to governance, delivery frameworks, and applied machine learning efforts across clinical and operational domains. His background in mathematics, applied data science, and healthcare IT leadership informs an applied AI research perspective grounded in real-world clinical workflows, operational trust, and responsible deployment.

Dr. Voigt is a graduate of the State University of Haiti School of Medicine...

Dr. Kobetz serves in multiple roles at the University of Miami (UM)...

Dr. Vidot is a cannabis and psychedelics epidemiologist certified in cannabis patient care...