2024 Design and Management of Cancer Clinical Trials Course

Dr. Lutzky graduated from Universidade Federal do Rio Grande do Sul Medical School, Brazil, in 1980, completed his residency in Internal Medicine at Mount Sinai Medical Center in Miami, and went on to a fellowship in Hematology/Oncology at Columbia University in New York. He was on the faculty of University of California, Irvine until 1994, when he relocated Miami. He was Melanoma Program Director and Chair of Cancer Research at Mount Sinai Cancer Center in Miami Beach, Florida. His main interest is the search for new treatments for melanoma and other cutaneous and ocular malignancies.

Dr. Chiuzan is an Associate Professor in the Institute of Health System Science and Co-Lead of the Data Science and Statistics Core, Quantitative Intelligence at Northwell Health, NY. Before that she was an Assistant Professor in the Department of Biostatistics at Mailman School of Public Health, Columbia University. Her research area focuses on development of early-phase clinical trial designs (applications to targeted and immunotherapeutic agents) and leveraging real-world evidence to improve trial outcomes and increase diversity of populations in clinical trials.

She is passionate about teaching biostatistics in health sciences, and she has a strong record of mentoring MS students, MD/PhD students, and clinical fellows (five recipients of the ASCO Young and Career Development Awards). She has held leadership positions as the President of the American Statistical Association (New York City Chapter) and Board Member of the Society for Clinical Trials. Dr. Chiuzan is also a faculty and organizer member of the Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Network (SCION) Workshop.

Dr. Alderuccio is a clinical investigator who specializes in the study and treatment of patients with lymphoma. His research efforts focus on drug development and testing risk-adapted approaches based on PET/CT and circulatory biomarkers for treatment selection. He is a member of the Translational and Clinical Oncology Research Program at the University of Miami Sylvester Comprehensive Cancer Center, where he is interested in utilizing quantitative image analysis for risk stratification and evaluation of novel therapies in lymphoma. He received his MD from Instituto Universitario de Ciencias de la Salud—Fundación Barceló in Buenos Aires, Argentina, before deciding to move to the United States to pursue a career in clinical research and drug development in oncology.

As Director of the Biostatistics Core, Dr. Kim is responsible for providing support for protocol development, review and analysis for clinical studies, and statistical expertise for research collaborations with Cancer Center investigators in all disciplines across the spectrum of basic, clinical and population sciences. Prior to joining UCSF, Dr. Kim directed the Biostatistics Unit for the Cancer and Blood Diseases Institute at Cincinnati Children’s Hospital Medical Center. Notable collaborations included Children's Tumor Foundation’s Neurofibromatosis (NF) Therapeutic Consortium that builds up a preclinical pipeline for screening candidate drug therapies in animal model systems. Dr. Kim also developed a research program in novel clinical trial designs that incorporates biomarker information and aims to optimize patient benefits. With her expertise in trial design, she has served on the faculty for the AACR Methods in Cancer Biostatistics Workshop and the Winn Diversity in Clinical Trials Career Development Award program.

Dr. Kim is also Professor of Biostatistics in the Department of Epidemiology and Biostatistics, continuing academic contributions to the field of biostatistics and providing biostatistical support broadly on campus. Trained as a mathematical statistician, Dr. Kim is an independent statistical method researcher with research interest in non- and semi-parametric statistics, and longitudinal and survival data analysis. She has been supported by NIH and National Science Foundation (NSF) awards, and published in prestigious journals such as the Annals of Statistics and the Journal of the American Statistical Association. Her recent research focuses on causal inference using structured data for comparative effectiveness research and patient-centered outcomes research. Supported by the Patient-Centered Outcome Research Institute (PCORI), Dr. Kim and her research team study optimal handling of the complex data structure both in the treatment selection decision process and the outcome analysis to minimize bias and maximize efficiency of the causal inference. Application studies of the project include pediatric Crohn’s disease (CD) and kidney transplant study.

Dr. Alderuccio is a clinical investigator who specializes in the study and treatment of patients with lymphoma. His research efforts focus on drug development and testing risk-adapted approaches based on PET/CT and circulatory biomarkers for treatment selection. He is a member of the Translational and Clinical Oncology Research Program at the University of Miami Sylvester Comprehensive Cancer Center, where he is interested in utilizing quantitative image analysis for risk stratification and evaluation of novel therapies in lymphoma. He received his MD from Instituto Universitario de Ciencias de la Salud—Fundación Barceló in Buenos Aires, Argentina, before deciding to move to the United States to pursue a career in clinical research and drug development in oncology.

Dr. Lutzky graduated from Universidade Federal do Rio Grande do Sul Medical School, Brazil, in 1980, completed his residency in Internal Medicine at Mount Sinai Medical Center in Miami, and went on to a fellowship in Hematology/Oncology at Columbia University in New York. He was on the faculty of University of California, Irvine until 1994, when he relocated Miami. He was Melanoma Program Director and Chair of Cancer Research at Mount Sinai Cancer Center in Miami Beach, Florida. His main interest is the search for new treatments for melanoma and other cutaneous and ocular malignancies.

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.

Dr. Welford has been a basic scientist faculty member in clinical departments for the entirety of his career. Dr. Welford's laboratory investigates mechanisms of radiation responses in cancer cells, the effect of hypoxia on cancer metabolism and signaling, and space radiobiology as it impacts radiation-induced carcinogenesis. The main interests in the lab are brain and renal cancer models, taking advantage of similarities in their poor responses to therapy and hypoxic phenotypes, with the overall aims of identifying novel therapeutic pathways and targets. Clinical interactions are essential to the realization of these goals.

Dr. Welford is currently the Biology Division Chief in the Department of Radiation Oncology at the University of Miami, where he oversees all of the biology research; Assistant Director for Faculty Development in the NCI-designated Sylvester Comprehensive Cancer Center, where he heads the early-career faculty mentoring program supporting all of the basic science junior faculty; and Co-Leader of the Sylvester Tumor Biology Research Program.

Dr. Le received her medical school and radiation oncology training at University of California, San Francisco. She joined Stanford in 1997. Her research focuses on translating laboratory findings to the clinic and vice versa in head and neck cancer (HNC), specifically in tumor hypoxia, radiation resistance, Galectin-1, and salivary gland stem cells. Clinically, she has led multicenter phase II and III clinical trials, testing the addition of novel drugs as radiosensitizer or radioprotector with chemoradiotherapy in HNC. She has received grant support from ASCO and ASTRO, as well as P01, R01, and R21 grants from the NIH. She was inducted into the Fellowship of the American College of Radiology (FACR), the American Society of Therapeutic Radiology and Oncology (FASTRO) and the Institute of Medicine/National Academy of Medicine (IOM/NAM). She was also honored with the Caltech Distinguished Alumni Award in 2015. Administratively, she is the Co-Director of the Radiation Biology Program at the Stanford Cancer Institute and the Group Chair of the NRG Oncology, which is the largest group in the NCI National Clinical Trial Network (NCTN). She used to chair the Head and Neck Disease Site Committee of NRG Oncology before becoming the group chair. She has served as a reviewer for several cancer related journals and NIH study sections. She has also been actively involved in many committees of national and international organizations such as ASTRO, ASCO, AACR, and ARS.

Dr. Iasonos has been at MSKCC since 2005, after working about three years for Bristol Myers Squibb in Oncology. She has collaborated primarily with investigators studying ovarian cancer and also with investigative teams studying bladder cancer, lymphoma, and health outcomes. Through her collaborations with investigators in gynecology (Departments of Surgery, Medicine, and Pathology) she is exploring various biomarkers and assessing relationships to histology, metastasis, and clinical outcome. She has been involved in vaccine trials as a second line therapy in ovarian cancer patients, and identifying valid endpoints for maintenance trials. Her methodological interests focus on model-based designs that guide the dose escalation in phase I trials, and in the past few years she has focused on the design of early-phase trials that involve dose expansion cohorts or basket trials. She is currently an Associate Editor for JCO, a Society of Clinical Trials elected board member, and a co-chair of Research Council at Memorial Sloan Kettering.

In addition to the Department of Medicine, Dr. Goodman holds appointments in the University of Miami’s Departments of Philosophy and PublicHealth Sciences, and the School of Nursing and Health Studies.

The Miller School of Medicine’s Institute for Bioethics and Health Policy has been designated a World Health Organization Collaborating Center in Ethics and Global Health Policy, one of 13 in the world and the only one in the United States.

He chairs the Ethics Committee of AMIA (American Medical Informatics Association), for which organization he co-founded the Ethical, Legal and Social Issues Working Group. He is a Fellow of the American College of Medical Informatics (FACMI) and the American College of Epidemiology (FACE). In Florida, he directs the Florida Bioethics Network. He chairs the UHealth/University of Miami Hospital and Clinics Ethics Committee and the Adult Ethics Committee for Jackson Memorial Health System.

Dr. Goodman’s research has emphasized issues in health information technology and in epidemiology and public health. His latest book, Ethics, Medicine, and Information Technology: Intelligent Machines and the Transformation of Health Care (Cambridge University Press 2016) identifies and analyzes a number of issues in biomedical informatics, including cancer informatics.

Dr. Kobetz serves in multiple roles at the University of Miami (UM). As the first Chief Health Equity Officer and Vice President for Health Equity, she is responsible for developing novel strategies to reduce persistent health disparities and increase access to quality healthcare for South Florida. As the Associate Director for Community Outreach and Engagement at the Sylvester Comprehensive Cancer Center (Sylvester) she oversees center-wide community outreach and engagement efforts, leading programs that deliver Sylvester’s resources to diverse and underserved communities across South Florida, including the Game Changer mobile clinics, which mitigate barriers by directly bringing cancer screenings, health information, and research opportunities to individuals in the catchment areas.

Dr. Kobetz is a Tenured Professor in the Departments of Medicine, Public Health Sciences, and Obstetrics and Gynecology at UM’s Miller School of Medicine and a recipient of the John K. and Judy H. Schulte Senior Endowed Chair in Cancer Research.

She earned a Master's in Public Health from Rollins School of Public Health at Emory University (1999) and joined the University of Miami after completing her PhD at the University of North Carolina at Chapel Hill, Gillings School of Public Health (2004). Soon after, Dr. Kobetz established Patnè en Aksyon (Partners in Action), the University’s first-ever community-academic partnership in Little Haiti, the largest enclave of Haitian settlement outside of Haiti, and remains committed to integrating diverse stakeholders into the translational research continuum. As part of her community-based research program, Dr. Kobetz has partnered with firefighters –characterized by excess cancer risk – and leads the Firefighter Cancer Initiative (FCI), a University-wide interdisciplinary program to address this disparity. Such efforts have been locally, regionally, and nationally recognized and serve as an important approach to developing new community-based models for cancer prevention and achieving sustainable health and social change in underserved communities.

Dr. Bilusic is a board-certified medical oncologist who treats genitourinary tumors (adrenal, kidney, prostate, bladder, and testis). His current research interests focus on tumor immunology and the development of novel immunotherapy approaches for prostate cancer and other genitourinary tumors using therapeutic cancer vaccines, antibodies, immune modulators or immune checkpoint inhibitors, not only as monotherapies but in combination with other therapies as part of an immuno-oncology programmatic effort.

Dr. Bilusic received his MD degree from the University of Zagreb School of Medicine in Croatia and completed his PhD training at the University of Split School of Medicine in Croatia. In addition, he completed a postdoctoral research fellowship in physiological genomics at the Medical College of Wisconsin's Human and Molecular Genetics Center in Milwaukee, WI. He successfully completed a clinical fellowship in medical oncology and hematology at the National Cancer Institute (NCI) and the National Heart, Lung, and Blood Institute (NHLBI), in Bethesda, MD.

Dr. Bilusic served as an assistant professor (genitourinary medical oncology) at the Fox Chase Cancer Center/Temple Health from 2012 – 2016 and then joined the NCI Genitourinary Malignancy Branch in 2016 as an Associate Research Physician (equivalent to Associate Professor). During his time at the NCI, he also served as Associate Program Director, NIH Hematology Oncology Fellowship Program from July 2016 – July 2018, and then as Program Director from July 2018 – July 2021. In 2017, Dr. Bilusic received the National Institutes of Health Director's Award as a member of the NIH Hematology Oncology Fellowship Team for extraordinary resourcefulness and initiative. His passion for teaching and mentoring has earned multiple awards at NIH and NCI.

In July 2021, Dr. Bilusic joined Sylvester Comprehensive Cancer Center / University of Miami Health System as GU Medical Oncology Team Lead. He is board-certified in medical oncology, hematology, and internal medicine.

Gayle Jameson is a Nurse Practitioner who has cared for adults living with cancer for more than 40 years. She is certified as an Advanced Oncology Nurse (AOCN) and is especially interested in the care of patients with pancreatic cancer, early cancer drug development and symptom management.

In her role as Clinical Investigator at the Oncology Clinical Trials Department, HonorHealth Research Institute (HRI) in Scottsdale, Arizona, she has been Principal Investigator (PI) on multiple phase I, II, and investigator-initiated studies and Sub-investigator on more than 100 phase I and II anti-tumor clinical trials. She incorporates translational science in clinical trial designs by working with bench science colleagues at Translational Genomics Institute (TGEN), and as a member of the SU2C Pancreatic Cancer Dream Team. Gayle also was the site Principal Investigator on an international study that led to the approval of Onivyde™ plus 5FU and leucovorin for patients with metastatic pancreatic cancer. She published a study in JAMA Oncology 2020 that demonstrated significant improvement in the overall survival in patients with advanced pancreatic cancer. Gayle has presented her work nationally and internationally. As a pioneer of the role of an NP as a Clinical Investigator in early Cancer Drug Development, she served as Founder and Co-Director of the “Inaugural Oncology Nurse Practitioner Clinical Investigator Intensive Course,” a collaborative project of HRI and City of Hope, held at HonorHealth in 2018 and repeated in 2020. Gayle has also been honored as a recipient of the Oncology Nursing Society’s 2019 Lifetime Achievement Award, and the 2020 Luminary Award in GI Cancers by The Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown Lombardi Comprehensive Cancer Center.

Dr. Penedo, Sylvester Professor of Psychology and Medicine at the University of Miami, is an internationally recognized expert in cancer survivorship and psychosocial oncology. He received his PhD in clinical health psychology at the University of Miami and completed a clinical residency at the University of Pittsburgh Medical School Western Psychiatric Institute and an NIH post-doctoral fellowship in psychosocial oncology and behavioral medicine at the University of Miami Department of Psychology and Sylvester. From 2000 until 2012, he held a faculty position in the Department of Psychology at the University of Miami. In 2012, he joined the Feinberg School of Medicine at Northwestern University in Chicago and was awarded the inaugural Roswell Park endowed chair in the Department of Medical Social Sciences. At Northwestern, he served as leader of the cancer control and survivorship research program and director of survivorship at the Robert H. Lurie Comprehensive Cancer Center where he also created and served as the first director of the Cancer Survivorship Institute, a behavioral translational research and clinical care institute. He rejoined Sylvester and the Department of Psychology in 2018.

His work evaluates the role of sociocultural, biobehavioral, and psychosocial mechanisms underlying disease activity and health outcomes, and the efficacy of evidence-based psychosocial interventions in promoting optimal chronic disease management and health outcomes in cancer. His work also involves translational research evaluating the impact of symptom and toxicities monitoring and management in ambulatory oncology, patient reported outcomes (PROs) in survivorship care, precision oncology and phase 1 trials, as well as the implementation of evidence-based behavioral interventions delivered within health systems and the community to improve patient and system level outcomes. He has been continuously funded by the NIH for the past 20 years.

Dr. Rodriguez is Associate Director of Community Outreach and Clinical Research Lead of the Thoracic Site Disease Group of the NCI-designated Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. She has a special interest in early-phase clinical trials and is an active member of the Translational and Clinical Oncology Research Program at Sylvester Comprehensive Cancer Center.

Dr. Rodriguez received her bachelor's degree from Columbia College and her medical degree from State University of New York (SUNY) Downstate College of Medicine. She completed her internal medicine residency at Columbia University’s New York-Presbyterian Hospital and her medical oncology fellowship at the University of Pennsylvania. Dr. Rodriguez also has a master’s degree in Public Health from the Universidad Autonoma de Madrid, Spain. She has given numerous lectures as invited speaker on issues related to lung cancer and healthcare disparities.

Dr. Rodriguez is Associate Director of Community Outreach and Clinical Research Lead of the Thoracic Site Disease Group of the NCI-designated Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. She has a special interest in early-phase clinical trials and is an active member of the Translational and Clinical Oncology Research Program at Sylvester Comprehensive Cancer Center.

Dr. Rodriguez received her bachelor's degree from Columbia College and her medical degree from State University of New York (SUNY) Downstate College of Medicine. She completed her internal medicine residency at Columbia University’s New York-Presbyterian Hospital and her medical oncology fellowship at the University of Pennsylvania. Dr. Rodriguez also has a master’s degree in Public Health from the Universidad Autonoma de Madrid, Spain. She has given numerous lectures as invited speaker on issues related to lung cancer and healthcare disparities.

As NCI Program Director, Dr. Lukinova reviews the correlative science aspects in ETCTN early phase clinical trials with the specific focus on biomarkers in immunotherapy. She directs and leads multiple research projects on biomarkers in drug development and performs as an active member of Biomarker Review Committee and multiple working groups for development of new cancer treatments and diagnostics. Prior to joining NCI, she served as Associate Director in a private biotech company holding responsibilities in product development for clinical diagnostics. She led a CLIA-certified contract service laboratory, where she validated quantitative clinical assays for highly specific biomarkers in non-alcoholic fatty liver disease and for monitoring levels of 5-fluorouracil in plasma, developed and filed a patent on a new diagnostic assay for Lyme disease, led proof-of-principle studies for an assay to detect blood levels of new oral anticoagulants. Her PhD thesis on early mechanisms of blood coagulation included clinical assay development to detect pathologies in blood clotting and fibrinolysis. After completing postdoctoral training in molecular genetics at The University of Pennsylvania and publishing her findings in Nature and Genetics, she transitioned to biotech industry with the focus on clinical assay development under different platforms and technologies.

Dr. Zhao completed bachelor’s and master’s degrees in Computer Science & Engineering with a focus on Intelligent Systems at the University of Michigan. He then completed his MD at the University of Michigan Medical School. After a transitional year internship at Beaumont Hospital – Dearborn, he returned to the University of Michigan for residency training in radiation oncology. Under the American Board of Radiology’s Holman Pathway, he led multiple cancer genomics and biomarker studies under the mentorship of Dr. Felix Feng. As a physician-scientist, his clinical focus is on the treatment of patients with GU malignancies. His independent translational research laboratory focuses on using advances in sequencing and computational techniques to develop biomarkers of treatment response and resistance, primarily in prostate cancer. Dr. Zhao co-directs the University of Wisconsin Carbone Cancer Center Circulating Biomarker Core with Dr. Josh Lang, where they work on translating liquid biopsy technology into the clinic.

Professor Hall is a chartered statistician with over 20 years’ experience in the design, methodology and analysis of oncology clinical trials. She leads the ICR-CTSU’s portfolio of research in urological and head and neck cancers with focus on the design and analysis of radiotherapy clinical trials.

She is a member of the National Clinical Research Institute (NCRI)’s Clinical and Translational Radiotherapy Research Group (CTRad) Phase 3 Trials and Methodology workstream, and the National Radiotherapy Trials QA (RTTQA) Management Group. She sits on CTRad’s Proton Beam Clinical Trial Strategy Group and leads the methodology workstream of the Cancer Research UK funded Advanced Radiotherapy Network. She is an honorary member of the Royal College of Radiologists, an affiliate ESTRO member and a member of the Society for Clinical Trials.

Professor Hall is a member of the Marie Curie Research Funding Committee, the Yorkshire Cancer Research Advisory Panel and vice chair of Cancer Research UK’s Clinical Research Monitoring Committee. Professor Hall sits on the independent data monitoring and trial steering committees for a number of international and national clinical trials.

Dr. Murthy is a Professor of Radiation Oncology at Tata Memorial Hospital, Mumbai, India, a premier cancer centre. His area of expertise is in Urological Cancer. He has special interest in high precision radiotherapy procedures such as Image Guided Radiotherapy, SBRT and Adaptive Radiotherapy. Dr. Murthy did his training in the field of Radiation Oncology from Tata Memorial Hospital and The Royal Marsden NHS Foundation Hospital, London . He also undertook a Diploma in Epidemiology and Biostatistics from the London School of Health and Tropical Medicine. He has over 180 publications in peer reviewed international journals, some of which have had global impact on clinical practice (e.g POP RT trial, JCO 2021) Dr Murthy is the Convenor of Uro Oncology at Tata Hospital and currently running several investigator initiated clinical trials including randomised controlled trials in prostate and bladder cancer and is a part of international co-operative groups in GU Oncology. The main areas of interest within GU oncology are high risk prostate cancer, SBRT for prostate and kidney cancer, Brachytherapy and adjuvant radiotherapy in penile cancers, bladder preservation and adjuvant radiotherapy in bladder cancer.

Dr. Werutsky is the Chairman of Latin American Cooperative Oncology Group (LACOG) and Medical Oncologist of the Breast Cancer Program, Hospital Moinhos de Vento, Porto Alegre Brazil. He is the member representative of LACOG in the Breast International Group (BIG), Belgium and SWOG Cancer Research Network, US. Werutsky is member of the breast cancer Faculty of the European Society of Medical Oncology (ESMO). Former medical research fellow at the European Organisation for Research and Treatment of Cancer (EORTC) 2008-2011 working in the breast and gastrointestinal cancer groups. Also, past fellow of the Flims workshop on cancer research (EORTC – NCI - AACR), Flims, Switzerland and of the ESMO translational research unit visit, Charité – Universitätsmedizin Berlin, Berlin, Germany. Graduated in Medicine at Pontifícia Universidade Católica do Rio Grande do Sul (2003), specialization in Internal Medicine (2006) and Medical Oncology (2008) at Hospital São Lucas PUCRS, Porto Alegre, Brazil and PhD (2021) in Medicine at Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil. He is member of the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO) and Sociedade Brasileira de Oncologia Clínica (SBOC). Areas of interest are breast cancer research, collaborative groups, drug development, and methods in clinical trials.

Ms. Carranza has more than 12 years of nursing experience in internal medicine and oncology. After completing her education as a nurse practitioner at the University of Miami School of Nursing, she accepted a position in the Phase 1 Experimental Therapeutics Clinic at Sylvester Comprehensive Cancer Center over four years ago. Lucia helps oversee the care of phase 1 and phase 2 patients with various solid tumor malignancies including lung, kidney, and pancreatic tumors. Lucia is a certified oncology nurse practitioner and a sub-investigator on over 30 clinical trials.

Gayle Jameson is a Nurse Practitioner who has cared for adults living with cancer for more than 40 years. She is certified as an Advanced Oncology Nurse (AOCN) and is especially interested in the care of patients with pancreatic cancer, early cancer drug development and symptom management.

In her role as Clinical Investigator at the Oncology Clinical Trials Department, HonorHealth Research Institute (HRI) in Scottsdale, Arizona, she has been Principal Investigator (PI) on multiple phase I, II, and investigator-initiated studies and Sub-investigator on more than 100 phase I and II anti-tumor clinical trials. She incorporates translational science in clinical trial designs by working with bench science colleagues at Translational Genomics Institute (TGEN), and as a member of the SU2C Pancreatic Cancer Dream Team. Gayle also was the site Principal Investigator on an international study that led to the approval of Onivyde™ plus 5FU and leucovorin for patients with metastatic pancreatic cancer. She published a study in JAMA Oncology 2020 that demonstrated significant improvement in the overall survival in patients with advanced pancreatic cancer. Gayle has presented her work nationally and internationally. As a pioneer of the role of an NP as a Clinical Investigator in early Cancer Drug Development, she served as Founder and Co-Director of the “Inaugural Oncology Nurse Practitioner Clinical Investigator Intensive Course,” a collaborative project of HRI and City of Hope, held at HonorHealth in 2018 and repeated in 2020. Gayle has also been honored as a recipient of the Oncology Nursing Society’s 2019 Lifetime Achievement Award, and the 2020 Luminary Award in GI Cancers by The Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown Lombardi Comprehensive Cancer Center.

Ms. Maroccia is a Clinical Research Nursing Manager for Sylvester's northern network locations. She has been a member of the Clinical Research Services Department for over three years. Prior to her current position, she was an Oncology Research Nurse within Sylvester Clinical Research Services who specialized in areas such as Gynecology, Thoracic, Head and Neck, and Precison Medicine. She started her nursing career as a Medical Surgical Registered Nurse at the Johns Hopkins Hospital and eventually transitioned to a nursing role in Radiation Oncology, which is where she discovered her passion for clinical research.

Dr. Sicre is originally from Miami, FL, and attended Nova Southeastern University, where he earned his MBA in management and PharmD in 2021. He then completed his PGY-1 and PGY-2 in Oncology at the University of Miami Sylvester Cancer Center and now works as a Clinical Research Pharmacist for the Investigational Drug Service Pharmacy at Sylvester. He has experience in providing exceptional clinical care to research patients, executing pharmacy-driven study starts up in phase I/II/III, investigational drug accountability, chemotherapeutic drug monitoring, and toxicity management.

Mr. Agar is a Clinical Research Data Specialist (CRDS) for the Leukemia Site Disease Group at Sylvester Comprehensive Cancer Center. He grew up in Spokane, Washington, and has always been interested in life sciences. He moved to Seattle to pursue a Bachelor of Science in Chemistry, then moved to Florida to take on new challenges and experience different cultures, ideas, and activities. He is thankful and excited to work at the forefront of cancer research, learn all about clinical research, and continue on this path of helping others. He hopes to learn from and serve our community even more in the years to come.

Ms. Morissette was born and raised in the St. John, U.S. Virgin Islands. She earned a Bachelor of Science in Biology from Lynn University in South Florida, where she actively participated in campus life as a new student ambassador, held leadership roles in a sorority, and achieved academic honors. A summer spent researching chimpanzees at a zoo ignited her passion for scientific research. Seeking more impactful research opportunities, she moved to Miami in 2022 and joined the University of Miami Health System as a Clinical Research Coordinator. Since then, she has grown her expertise, contributing to both the Leukemia team and the Classical Benign Hematology team. She is currently pursuing a Master of Science in Microbiology & Cell Science (Medical Microbiology & Biochemistry) online at the University of Florida. With certifications in Advanced Clinical Research Associate (ACRAC), Good Clinical Practice (GCP), and various safety protocols, she is dedicated to advancing medical research ethically and efficiently.

Elissa Dawkins is the Senior Manager for Education and Training in Clinical Research Services at the Sylvester Comprehensive Cancer Center. She serves an integral role in onboarding all new hires, and the development of competency-based, clinical research training for both clinical staff and principal investigators to increase their understanding of implementing clinical research, as well as the guidelines that go along with the conduct of research. Elissa also serves as Part-time and Adjunct faculty at various universities, and provides qualitative, quantitative, and statistical consultations for PhD students, residents, and trainees. She's published articles in preventive cardiology, geriatrics, and cancer research, and serves as a contributing author, guest editor, and reviewer for various journals such as SVOA Medical Research, American Journal of Preventive Cardiology, American Journal of Managed Care, etc.

With over a decade of clinical research experience and as an Advanced Practice Provider (APP), Christopher Otero is a respected figure in healthcare. Christopher Otero has contributed to research across stem cell, endocrinology, oncology, and beyond, playing a pivotal role in designing and managing clinical trials while ensuring top-notch patient care.

Christopher Otero possesses a profound understanding of research methodologies and regulatory requirements, having led teams and fostered collaborations to address healthcare challenges. As a Clinical Research Professional, he engages on the education and training of several sub-investigators involved in clinical research studies in both In-patient and Out-patient setting.

In his current role as Clinical Research APP Manager, Christopher Otero continues to drive healthcare innovation, bridging the gap between research and practice. Christopher Otero dedication to improving patient outcomes and shaping the future of healthcare with a focus in Clinical Research is unwavering .

Ms. Carranza has more than 12 years of nursing experience in internal medicine and oncology. After completing her education as a nurse practitioner at the University of Miami School of Nursing, she accepted a position in the Phase 1 Experimental Therapeutics Clinic at Sylvester Comprehensive Cancer Center over four years ago. Lucia helps oversee the care of phase 1 and phase 2 patients with various solid tumor malignancies including lung, kidney, and pancreatic tumors. Lucia is a certified oncology nurse practitioner and a sub-investigator on over 30 clinical trials.

Gayle Jameson is a Nurse Practitioner who has cared for adults living with cancer for more than 40 years. She is certified as an Advanced Oncology Nurse (AOCN) and is especially interested in the care of patients with pancreatic cancer, early cancer drug development and symptom management.

In her role as Clinical Investigator at the Oncology Clinical Trials Department, HonorHealth Research Institute (HRI) in Scottsdale, Arizona, she has been Principal Investigator (PI) on multiple phase I, II, and investigator-initiated studies and Sub-investigator on more than 100 phase I and II anti-tumor clinical trials. She incorporates translational science in clinical trial designs by working with bench science colleagues at Translational Genomics Institute (TGEN), and as a member of the SU2C Pancreatic Cancer Dream Team. Gayle also was the site Principal Investigator on an international study that led to the approval of Onivyde™ plus 5FU and leucovorin for patients with metastatic pancreatic cancer. She published a study in JAMA Oncology 2020 that demonstrated significant improvement in the overall survival in patients with advanced pancreatic cancer. Gayle has presented her work nationally and internationally. As a pioneer of the role of an NP as a Clinical Investigator in early Cancer Drug Development, she served as Founder and Co-Director of the “Inaugural Oncology Nurse Practitioner Clinical Investigator Intensive Course,” a collaborative project of HRI and City of Hope, held at HonorHealth in 2018 and repeated in 2020. Gayle has also been honored as a recipient of the Oncology Nursing Society’s 2019 Lifetime Achievement Award, and the 2020 Luminary Award in GI Cancers by The Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown Lombardi Comprehensive Cancer Center.

Ms. Maroccia is a Clinical Research Nursing Manager for Sylvester's northern network locations. She has been a member of the Clinical Research Services Department for over three years. Prior to her current position, she was an Oncology Research Nurse within Sylvester Clinical Research Services who specialized in areas such as Gynecology, Thoracic, Head and Neck, and Precison Medicine. She started her nursing career as a Medical Surgical Registered Nurse at the Johns Hopkins Hospital and eventually transitioned to a nursing role in Radiation Oncology, which is where she discovered her passion for clinical research.

Dr. Sicre is originally from Miami, FL, and attended Nova Southeastern University, where he earned his MBA in management and PharmD in 2021. He then completed his PGY-1 and PGY-2 in Oncology at the University of Miami Sylvester Cancer Center and now works as a Clinical Research Pharmacist for the Investigational Drug Service Pharmacy at Sylvester. He has experience in providing exceptional clinical care to research patients, executing pharmacy-driven study starts up in phase I/II/III, investigational drug accountability, chemotherapeutic drug monitoring, and toxicity management.

Mr. Agar is a Clinical Research Data Specialist (CRDS) for the Leukemia Site Disease Group at Sylvester Comprehensive Cancer Center. He grew up in Spokane, Washington, and has always been interested in life sciences. He moved to Seattle to pursue a Bachelor of Science in Chemistry, then moved to Florida to take on new challenges and experience different cultures, ideas, and activities. He is thankful and excited to work at the forefront of cancer research, learn all about clinical research, and continue on this path of helping others. He hopes to learn from and serve our community even more in the years to come.

Ms. Morissette was born and raised in the St. John, U.S. Virgin Islands. She earned a Bachelor of Science in Biology from Lynn University in South Florida, where she actively participated in campus life as a new student ambassador, held leadership roles in a sorority, and achieved academic honors. A summer spent researching chimpanzees at a zoo ignited her passion for scientific research. Seeking more impactful research opportunities, she moved to Miami in 2022 and joined the University of Miami Health System as a Clinical Research Coordinator. Since then, she has grown her expertise, contributing to both the Leukemia team and the Classical Benign Hematology team. She is currently pursuing a Master of Science in Microbiology & Cell Science (Medical Microbiology & Biochemistry) online at the University of Florida. With certifications in Advanced Clinical Research Associate (ACRAC), Good Clinical Practice (GCP), and various safety protocols, she is dedicated to advancing medical research ethically and efficiently.

Ms. Varela has been a passionate clinical trials professional for more than 16 years, including more than 10 in oncology. As Director of Research Nursing, she supervises 2 Research Nurse Managers and over 40 Clinical Research Nurses at Sylvester. Prior to this position, she managed the Gynecology Oncology Research Portfolio. Ms. Varela started her career as an assistant coordinator, then became a research coordinator and a research nurse. She has worked in private practice, hospital setting, and an academic center. She is certified in research and is also a Oncology Nurse.

Dr. Sekeres earned a medical degree and a master's degree in clinical epidemiology from the University of Pennsylvania School of Medicine, then completed his post-graduate training at Harvard University, finishing an internal medicine residency at Massachusetts General Hospital and a fellowship in hematology-oncology at the Dana-Farber Cancer Institute in Boston. He is chair of the medical advisory board of the Aplastic Anemia and Myelodysplastic Syndrome (MDS) International Foundation and formerly chaired the Oncologic Drugs Advisory Committee of the F.D.A.

Dr. Sekeres is a member of the American Society of Hematology, where he serves on the Executive Committee and chairs the Committee on Communications. His research focuses on patients with MDS and older adults with acute myeloid leukemia, and he has been the national and international primary study investigator on dozens of phase I, II, and III trials. He is the author or co-author of over 450 manuscripts and 650 abstracts. He was the inaugural editor-in-chief of the ASH Clinical News magazine; he is on the editorial board of several journals; has written 100 essays for The New York Times, The Washington Post, Huffington Post, Slate, and The Hill, among others; and has authored 8 books, including ""When Blood Breaks Down: Life Lessons from Leukemia"" (The MIT Press 2020) and ""Drugs and the FDA: Safety, Efficacy, and the Public's Trust"" (The MIT Press 2022).

Dr. Shah is a medical oncologist on the breast, gynecologic, and supportive oncology team within the Office of Oncologic Diseases at the FDA. She completed her internal medicine residency at Vanderbilt University Medical Center and her medical oncology fellowship at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, including one year as chief fellow. She also obtained a master’s degree in health sciences through the Johns Hopkins Bloomberg School of Public Health. Her interests include improving palliative and supportive care for patients with cancer, and she maintains a supportive oncology clinic at Johns Hopkins.

Dr. Kazandjian received his medical degree from Boston University School of Medicine and was subsequently commissioned as an officer in the U.S. Air Force Medical Corps. He completed an internal medicine residency at Wilford Hall Medical Center and remained on faculty as an active-duty physician, attending internist, assistant professor, and researcher. After six years of active duty (including a stint in support of Operation Iraqi Freedom), he continued his training at the National Institutes of Health and completed fellowships in medical oncology and hematology. Dr. Kazandjian subsequently remained at the NCI Intramural Research Program as a physician-scientist, clinical researcher, and head of the Myeloma Program in the Lymphoid Malignancies Branch. Additionally, he had a dual-appointment with the FDA Oncology Center of Excellence, where he served as Associate Director of the FDA-NCI Clinical Investigator Program and has had a lead role on a number of drug approvals.

As a clinician and researcher, Dr. Kazandjian focuses on multiple myeloma and its precursor conditions, monoclonal gammopathy of unknown significance (MGUS) and smoldering myeloma. His research interests lie in developing modern and novel laboratory techniques, including next-generation sequencing to advance monitoring of minimal residual disease. He has authored numerous articles in the peer-reviewed literature. 

Dr. Shah is a medical oncologist on the breast, gynecologic, and supportive oncology team within the Office of Oncologic Diseases at the FDA. She completed her internal medicine residency at Vanderbilt University Medical Center and her medical oncology fellowship at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, including one year as chief fellow. She also obtained a master’s degree in health sciences through the Johns Hopkins Bloomberg School of Public Health. Her interests include improving palliative and supportive care for patients with cancer, and she maintains a supportive oncology clinic at Johns Hopkins.

Dr. Sekeres earned a medical degree and a master's degree in clinical epidemiology from the University of Pennsylvania School of Medicine, then completed his post-graduate training at Harvard University, finishing an internal medicine residency at Massachusetts General Hospital and a fellowship in hematology-oncology at the Dana-Farber Cancer Institute in Boston. He is chair of the medical advisory board of the Aplastic Anemia and Myelodysplastic Syndrome (MDS) International Foundation and formerly chaired the Oncologic Drugs Advisory Committee of the F.D.A.

Dr. Sekeres is a member of the American Society of Hematology, where he serves on the Executive Committee and chairs the Committee on Communications. His research focuses on patients with MDS and older adults with acute myeloid leukemia, and he has been the national and international primary study investigator on dozens of phase I, II, and III trials. He is the author or co-author of over 450 manuscripts and 650 abstracts. He was the inaugural editor-in-chief of the ASH Clinical News magazine; he is on the editorial board of several journals; has written 100 essays for The New York Times, The Washington Post, Huffington Post, Slate, and The Hill, among others; and has authored 8 books, including ""When Blood Breaks Down: Life Lessons from Leukemia"" (The MIT Press 2020) and ""Drugs and the FDA: Safety, Efficacy, and the Public's Trust"" (The MIT Press 2022).

Dr. Kazandjian received his medical degree from Boston University School of Medicine and was subsequently commissioned as an officer in the U.S. Air Force Medical Corps. He completed an internal medicine residency at Wilford Hall Medical Center and remained on faculty as an active-duty physician, attending internist, assistant professor, and researcher. After six years of active duty (including a stint in support of Operation Iraqi Freedom), he continued his training at the National Institutes of Health and completed fellowships in medical oncology and hematology. Dr. Kazandjian subsequently remained at the NCI Intramural Research Program as a physician-scientist, clinical researcher, and head of the Myeloma Program in the Lymphoid Malignancies Branch. Additionally, he had a dual-appointment with the FDA Oncology Center of Excellence, where he served as Associate Director of the FDA-NCI Clinical Investigator Program and has had a lead role on a number of drug approvals.

As a clinician and researcher, Dr. Kazandjian focuses on multiple myeloma and its precursor conditions, monoclonal gammopathy of unknown significance (MGUS) and smoldering myeloma. His research interests lie in developing modern and novel laboratory techniques, including next-generation sequencing to advance monitoring of minimal residual disease. He has authored numerous articles in the peer-reviewed literature. 

Dr. Hough has PhD in Chemistry and MBA in Strategy from The University of Alabama. During her time as an undergraduate researcher, she synthesized compounds that resulted in her first patent application, which was granted and licensed to a Fortune 50 company. Experiencing the transition of her invention from the lab to marketplace sparked her interest in Technology Transfer. She started as Venture Development Associate at The University of Alabama’s Office for Technology Transfer where she streamlined the invention disclosure process. This resulted in promotion to Assistant Director.

Then, she joined TreMonti Consulting, LLC, an innovation and technology transfer consultancy. Whitney worked with 20+ clients where she performed all duties related to technology transfer and innovation management including managing of financials/royalty distributions, database management, and contract/license negotiation. Next, she was recruited by Procter & Gamble to be the Program Leader for their new Oral Care Monograph Reform program. This position integrated information from all functions to successfully communicate and submit an application to the FDA. She also served as Technical Readiness Leader for several front-end innovation projects, thereby ensuring all tasks were on time for product graduation from R&D. In June 2023, she joined University of Miami as Director of Technology Transfer.

Under Dr. Kenyon’s leadership, the U Innovation team, including the Office of Technology Transfer and the Wallace H. Coulter Center for Translational Research, has successfully increased the number of licensing agreements and startups emanating from faculty innovations across UM’s 11 schools and colleges. The Launch Pad provides mentoring for emerging student, alumni, and faculty entrepreneurs throughout the University community, and Dr. Kenyon established the 'Cane Angel Network to provide investment opportunities to all startups connected to the university.

Dr. Kenyon and her research team have focused on ways to transplant insulin producing islet cells, in both clinically relevant transplant models and in clinical studies, without the need for life-long anti-rejection drugs. Dr. Kenyon has received research funding from the National Institute of Allergy and Infectious Disease, the National Institute of Diabetes, Digestive and Kidney Diseases, the Juvenile Diabetes Research Foundation International, the Diabetes Research Institute Foundation, and several industry collaborators. She has served as a member of both the National Advisory Allergy and Infectious Disease Council and the NIH Council of Councils. Dr. Kenyon was a scientific advisor to the Food and Drug Administration, spending half her time at the FDA for a year, and has participated in several panels involving islet transplantation and stem cells.

Dr. Kenyon earned her undergraduate degree from Duke University and her PhD from Virginia Commonwealth University, followed by postdoctoral positions at UCLA and the University of Miami. Subsequent to postdoctoral training, Dr. Kenyon was a Senior Scientist and Lab Head at Coulter Corporation, holding positions in both research and product development.

Dr. Heckman-Stoddard received a Doctor of Philosophy degree in Molecular and Cellular Biology at Baylor College of Medicine focusing on the intersection of Rho and IGF signaling in mammary gland development and breast cancer before joining the National Cancer Institute as a Cancer Prevention Fellow. During the fellowship she completed her master's in public health at the Johns Hopkins Bloomberg School of Public Health working with the Institute for Global Tobacco Control and the Evidence-Based Practice Center. During her time at NCI as a fellow, she focused on breast cancer prevention research including preclinical development and early clinical trials.

Dr. Heckman-Stoddard's research focuses on drug development for breast cancer prevention and biomarker development. She is particularly interested in local delivery of agents, alternate dosing strategies, biomarkers of efficacy to reduce the number needed to treat, and targeting of stem cells. She serves as program director for the Early Phase Breast Cancer Prevention Clinical Trials grants portfolio and scientific monitor of early phase breast cancer clinical trials within the NCI Division of Cancer Prevention Early Phase Prevention Consortia. Dr. Heckman-Stoddard is also the NCI lead for an NCI-NIDDK collaboration examining cancer incidence within the Diabetes Prevention Program Outcomes Study a randomized study of metformin, lifestyle intervention, versus placebo.

Dr. de la Fuente is the Neuro-Oncology Clinical Service Leader for the Oncology Service Line and the clinical research chair of the Neuro-Oncology Site Disease Group. She also serves as Chief of the Neuro-Oncology Division in the Department of Neurology at the University of Miami Miller School of Medicine. Through these roles, she oversees the clinical and clinical research programs for Neuro-Oncology.

Her primary research focuses on clinical and translational research in primary human brain tumors with a goal to develop innovative, more effective treatments as well as develop radiographic biomarkers to better assess the efficacy of those treatments. This effort has been conducted along two tracks: 1) optimizing therapy for patients with low- and high-grade glioma using a combined approach of targeted therapies and or immunotherapy, and 2) developing molecular imaging through collaborations with basic research scientists. She has a strong interest in gliomas and metabolic pathway alterations, particularly isocitrate dehydrogenase (IDH) mutations. Her work has been specifically focused on IDH inhibitors for the treatment of IDH mutant gliomas as well as the identification and clinical application of novel radiographic biomarkers for IDH mutant gliomas. She is currently leading and collaborating in multiple active research projects with colleagues from Neurosurgery, Radiology, Medicine, Pediatrics, Medical Physics, and Radiation Oncology. She is a Memorial Sloan Kettering-trained neuro-oncologist serving as principal investigator for several clinical trials, including IISs, as well as collaborations within NIH-funded cooperative groups and industry.

Dr. de la Fuente is deeply interested and invested in achieving diversity, equity, and inclusion in the academic medical environment. She currently serves as one of the co-chairs of the Women and Diversity Committee of the Society for Neuro-Oncology and as the Equity Focused Clinical Investigator for University of Miami to North American Star Consortium.

Dr. de la Fuente is the Neuro-Oncology Clinical Service Leader for the Oncology Service Line and the clinical research chair of the Neuro-Oncology Site Disease Group. She also serves as Chief of the Neuro-Oncology Division in the Department of Neurology at the University of Miami Miller School of Medicine. Through these roles, she oversees the clinical and clinical research programs for Neuro-Oncology.

Her primary research focuses on clinical and translational research in primary human brain tumors with a goal to develop innovative, more effective treatments as well as develop radiographic biomarkers to better assess the efficacy of those treatments. This effort has been conducted along two tracks: 1) optimizing therapy for patients with low- and high-grade glioma using a combined approach of targeted therapies and or immunotherapy, and 2) developing molecular imaging through collaborations with basic research scientists. She has a strong interest in gliomas and metabolic pathway alterations, particularly isocitrate dehydrogenase (IDH) mutations. Her work has been specifically focused on IDH inhibitors for the treatment of IDH mutant gliomas as well as the identification and clinical application of novel radiographic biomarkers for IDH mutant gliomas. She is currently leading and collaborating in multiple active research projects with colleagues from Neurosurgery, Radiology, Medicine, Pediatrics, Medical Physics, and Radiation Oncology. She is a Memorial Sloan Kettering-trained neuro-oncologist serving as principal investigator for several clinical trials, including IISs, as well as collaborations within NIH-funded cooperative groups and industry.

Dr. de la Fuente is deeply interested and invested in achieving diversity, equity, and inclusion in the academic medical environment. She currently serves as one of the co-chairs of the Women and Diversity Committee of the Society for Neuro-Oncology and as the Equity Focused Clinical Investigator for University of Miami to North American Star Consortium.

Dr. Heckman-Stoddard received a Doctor of Philosophy degree in Molecular and Cellular Biology at Baylor College of Medicine focusing on the intersection of Rho and IGF signaling in mammary gland development and breast cancer before joining the National Cancer Institute as a Cancer Prevention Fellow. During the fellowship she completed her master's in public health at the Johns Hopkins Bloomberg School of Public Health working with the Institute for Global Tobacco Control and the Evidence-Based Practice Center. During her time at NCI as a fellow, she focused on breast cancer prevention research including preclinical development and early clinical trials.

Dr. Heckman-Stoddard's research focuses on drug development for breast cancer prevention and biomarker development. She is particularly interested in local delivery of agents, alternate dosing strategies, biomarkers of efficacy to reduce the number needed to treat, and targeting of stem cells. She serves as program director for the Early Phase Breast Cancer Prevention Clinical Trials grants portfolio and scientific monitor of early phase breast cancer clinical trials within the NCI Division of Cancer Prevention Early Phase Prevention Consortia. Dr. Heckman-Stoddard is also the NCI lead for an NCI-NIDDK collaboration examining cancer incidence within the Diabetes Prevention Program Outcomes Study a randomized study of metformin, lifestyle intervention, versus placebo.

Dr. Merchan’s research interest is in the development of novel combinatorial strategies to overcome resistance to antiangiogenic and current immunotherapy agents in renal cell and other cancers. His laboratory uses syngeneic and xenograft cancer models of renal cell, breast, and colon cancer. Among the strategies he is investigating are the use of novel recombinant oncolytic viral agents re-designed to target the tumor (immune and non-immune) microenvironment, and dual targeting (stromal-vascular and tumor cells), in combination with novel targeted and cytotoxic agents. Dr. Merchan currently leads the Sylvester Comprehensive Cancer Center’s Phase I Program, the only academic early therapeutics program in South Florida. He also has a track record of moving laboratory-based projects from bench to bedside, leading to innovative early phase trials in renal cell carcinoma and solid tumor patients.