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September 5, 2025
September 12, 2025
September 19, 2025

September 26, 2025
October 3, 2025
October 10, 2025


Registration coming soon. While you wait, catch up with 2024 course content.
All recordings and materials are available.
2024 Course Access

About the Course

This course was designed to provide physicians and others involved in developing and managing clinical trials with key information to foster better clinical trial design, advance a program of clinical research, and ultimately improve patient care. Participants will learn basic research concepts and principles that underlie the design and day-to-day conduct of cancer clinical trials.

1200+
participants
35+
Speakers
25+
Sessions
6
Days
0
Travel

Agenda

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AGENDA


time iconSeptember 5, 2025 10:00 am to
10:10 am

Welcome and opening remarks

September 5, 2025 10:00 - 10:10 EST

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Alan Pollack, MD, PhD
Course Director; Professor of Radiation Oncology, University of Miami Sylvester Comprehensive Cancer Center

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Vaughn Edelson, MPH, MPA
Course Co-Director, University of Miami Sylvester Comprehensive Cancer Center

time iconSeptember 5, 2025 10:05 am to
11:15 am

Phase I clinical trial design and statistics

September 5, 2025 10:05 - 11:15 EST

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Cody Chiuzan, PhD
Associate Professor, Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health

time iconSeptember 5, 2025 11:15 am to
12:30 pm

Phase II clinical trial design and statistics

September 5, 2025 11:15 - 12:30 EST

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Juan Alderuccio, MD
Associate Professor of Medicine, University of Miami Sylvester Comprehensive Cancer Center

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Mi-Ok Kim, PhD
Director, Biostatistics Core, UCSF Helen Diller Family Comprehensive Cancer Center

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00:00:00

Panel: Bench to bedside translation

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Hudson Santos, PhD, RN, FABMR, FAAN
Dean of Nursing and Health Studies; Professor and Dolores J. Chambreau Endowed Chair in Nursing, University of Miami Sylvester Comprehensive Cancer Center

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Sophia George, PhD
Professor of Obstetrics, Gynecology, & Reproductive Sciences, University of Miami Sylvester Comprehensive Cancer Center

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Michael Paidas, MD
Professor and Chair of Obstetrics, Gynecology and Reproductive Sciences, University of Miami Sylvester Comprehensive Cancer Center

time iconSeptember 12, 2025 10:00 am to
11:20 am

Phase III and non-interventional trial design and statistics

September 12, 2025 10:00 - 11:15 EST

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00:00:00

Advancing oncology through theranostics: Innovations in targeted drug development

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Aman Chauhan, MD
Associate Professor of Clinical Medicine, Medical Oncology, University of Miami Sylvester Comprehensive Cancer Center

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00:00:00

Sequential trials case study: STAMPEDE

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Nicholas James, MBBS, PhD
Professor of Prostate and Bladder Cancer Research, Institute of Cancer Research, the Royal Marsden Hospital in London

time iconSeptember 19, 2025 10:00 am to
10:50 am

What it means to be a PI

September 19, 2025 10:00 - 10:45 EST

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Marijo Bilusic, MD, PhD
Professor of Medicine, University of Miami Sylvester Comprehensive Cancer Center

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00:00:00

Addressing catchment area populations in recruitment and retention

time iconOctober 11, 2024 11:30 am to
12:15 pm

Crafting a successful LOI

September 19, 2025 11:30 - 12:15 EST

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Macarena de la Fuente, MD
Associate Professor of Neurology, University of Miami Sylvester Comprehensive Cancer Center

time iconSeptember 27, 2024 10:45 am to
11:30 am

Incorporating biomarkers into your clinical trial

September 19, 2025 10:45 - 11:30 EST

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Nina Lukinova, PhD
PhD, Program Director, Cancer Diagnosis Program, National Cancer Institute

time iconSeptember 19, 2025 10:00 am to
11:00 am

Roles and Responsibilities of the Study Team

September 19, 2025 10:00 - 11:00 EST

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Lucia Carranza, MSN, APRN, AOCNP
Phase I Oncology Nurse Practitioner, University of Miami Sylvester Comprehensive Cancer Center

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Gayle Jameson, MSN, ACNP-BC, AOCN
Nurse Practitioner; Associate Clinical Investigator, HonorHealth Research Institute

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Esperanza Bas, PhD
Clinical Research Pharmacist, University of Miami Sylvester Comprehensive Cancer Center

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Guillermo Perez, BA
Clinical Research Data Specialist, University of Miami Sylvester Comprehensive Cancer Center

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00:00:00

Navigating the regulatory gamut: From study start up to post approval monitoring

time icon to
00:00:00

Talking to lay people about clinical trials

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Matthew Schlumbrecht, MD, MPH
Professor of Clinical Obstetrics, Gynecology, and Reproductive Sciences; Vice Chair of Global and Community Health, University of Miami Sylvester Comprehensive Cancer Center

time iconSeptember 26, 2025 12:15 pm to
01:00 pm

Special session: International clinical trial infrastructure

September 26, 2025 12:15 - 13:00 EST

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00:00:00

Protocol approval from start to finish

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Craig Moskowitz, MD
Physician-in-Chief, University of Miami Sylvester Comprehensive Cancer Center

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00:00:00

Community-engaged research

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Denise Vidot, PhD
Associate Professor; Director, Community and Stakeholder Engagement, University of Miami Sylvester Comprehensive Cancer Center

time iconOctober 4, 2024 10:00 am to
11:05 am

The Road to Regulatory Approval

October 3, 2025 10:00 - 11:00 EST

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Mikkael Sekeres, MD
Professor and Chief of Hematology, University of Miami Sylvester Comprehensive Cancer Center

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00:00:00

Patient-reported outcomes in clinical research

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Ruben Mesa,MD
Executive Director, Atrium Health Wake Forest Baptist Comprehensive Cancer Center

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00:00:00

TrialGPT: Matching patients to clinical trials with large language models

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Charalampos (Harris) Floudas, MD, DMSc, MS
Associate Research Physician, Center for Immuno-Oncology, Center for Cancer Research, National Cancer Institute

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00:00:00

Digital twins in clinical trials: How they work and how they don’t

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Alyssa Vanderbeek, MS
Senior Product Manager, Unlearn.AI

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00:00:00

The ethics of AI in clinical research

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Louis Voigt, MD
Intensivist; Ethics Committee Chair, Memorial Sloan Kettering Cancer Center

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00:00:00

Dungeons and Drug Approvals: An immersive experience in the clinical trials and tribulations of obtaining FDA approval of new treatments

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Farrah Jackson, MS, CCRP
Clinical Research Coordinator and Program Manager, Cincinnati Children's Hospital Medical Center

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Leanne Hagen, MS, CGC
Genetic Counselo, Cincinnati Children's Hospital Medical Center

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Sarah Chadwell, MS, CGC
Medical Strategic Account Director, Sanofi

Our Speakers

Sean Agar, BS

Clinical Research Data SpecialistUniversity of Miami Sylvester Comprehensive Cancer Center

Juan Alderuccio, MD

Associate Professor of MedicineUniversity of Miami Sylvester Comprehensive Cancer Center

Marijo Bilusic, MD, PhD

Professor of MedicineUniversity of Miami Sylvester Comprehensive Cancer Center

Cody Chiuzan, PhD

Associate Professor, Institute of Health System ScienceFeinstein Institutes for Medical Research, Northwell Health

Lucia Carranza, MSN, APRN, AOCNP

Phase I Oncology Nurse PractitionerUniversity of Miami Sylvester Comprehensive Cancer Center

Elissa Dawkins, PhD, MS

Sr. Manager, Education and Training, Clinical Research ServicesUniversity of Miami Sylvester Comprehensive Cancer Center

Macarena de la Fuente, MD

Associate Professor of Neurology Co-Chair, Neuro-Oncology Site Disease Group; Program Director, Neuro-Oncology Fellowship; Neuro-Oncology Clinical Service LeaderUniversity of Miami Sylvester Comprehensive Cancer Center

Jeremy Deni, PharmD, BCPS

Clinical Research PharmacistUniversity of Miami Sylvester Comprehensive Cancer Center

Jose Garcia, MBA

Director, Regulatory SupportUniversity of Miami Sylvester Comprehensive Cancer Center

Kenneth Goodman, PhD

Professor of Medicine; Founder and Director, Institute for Bioethics & Health PolicyUniversity of Miami Sylvester Comprehensive Cancer Center

Emma Hall, PhD

Professor of Oncology Trials; Co-Director, Cancer Research UK-funded Clinical Trials and Statistics UnitThe Institute of Cancer Research, United Kingdom

Brandy Heckman-Stoddard, PhD, MPH

Chief, Breast & Gynecologic Cancer Research GroupNational Cancer Institute

Whitney Hough, PhD, MBA

Director of Technology TransferUniversity of Miami Sylvester Comprehensive Cancer Center

Alexia Iasonos, PhD

Attending BiostatisticianMemorial Sloan Kettering Cancer Center

Meredeth Jackson, AGPCNP-BC

Phase I Research APRN - HematologyUniversity of Miami Sylvester Comprehensive Cancer Center

Gayle Jameson, MSN, ACNP-BC, AOCN

Nurse Practitioner; Associate Clinical InvestigatorHonorHealth Research Institute

Dickran Kazandjian, MD

Professor of MedicineUniversity of Miami Sylvester Comprehensive Cancer Center

Norma Sue Kenyon, PhD

Chief Innovation Officer; Vice Provost for InnovationUniversity of Miami Sylvester Comprehensive Cancer Center

Mi-Ok Kim, PhD

Director, Biostatistics CoreUCSF Helen Diller Family Comprehensive Cancer Center

Erin Kobetz, PhD, MPH

Chief Health Equity OfficerUniversity of Miami Sylvester Comprehensive Cancer Center

Quynh-Thu Le, MD

Professor and Chair of Radiation OncologyStanford University

Shaddai Lopez

Director, Clinical Research Services Research Labs & Network SitesUniversity of Miami Sylvester Comprehensive Cancer Center

Nina Lukinova, PhD

Program Director, Cancer Diagnosis ProgramNational Cancer Institute

Jose Lutzky, MD

Professor of Medicine; Director, Clinical Trials Coordinating UnitUniversity of Miami Sylvester Comprehensive Cancer Center

Indranil Mallick, MD, DNB

Radiation OncologistTata Medical Center, Kolkata, India

Marisa Maroccia, MBA, BSN, RN

Manager, Clinical Research NursingUniversity of Miami Sylvester Comprehensive Cancer Center

Jaime Merchan, MD, MMSc

Professor of Medicine; Director, Phase I Program; Co-Leader, Translational and Clinical Oncology Research ProgramUniversity of Miami Sylvester Comprehensive Cancer Center

Christopher Montanez Hernandez, BS

Manager, Research SupportUniversity of Miami Sylvester Comprehensive Cancer Center

Savanna Morrisette, BS, ACRA

Clinical Research CoordinatorUniversity of Miami Sylvester Comprehensive Cancer Center

Gilberto de Lima Lopes, MD, MBA

Professor of and Chief of Medical Oncology; Associate Director, Global OncologyUniversity of Miami Sylvester Comprehensive Cancer Center

Christopher Otero, BSc, MSN AGNP-C

APP Team Manager, Clinical ResearchUniversity of Miami Sylvester Comprehensive Cancer Center

Frank Penedo, PhD

Professor of Psychology; Associate Director for Cancer Survivorship & Translational Behavioral SciencesUniversity of Miami Sylvester Comprehensive Cancer Center

Alan Pollack, MD, PhD

Course Director; Professor of Radiation OncologyUniversity of Miami Sylvester Comprehensive Cancer Center

Estelamari Rodriguez, MD, MPH

Assistant Director for Diversity, Equity, and InclusionUniversity of Miami Sylvester Comprehensive Cancer Center

Mikkael Sekeres, MD

Professor and Chief of HematologyUniversity of Miami Sylvester Comprehensive Cancer Center

Mirat Shah, MD, MHA

Medical OncologistU.S. Food and Drug Administration

Nima Sharifi, MD

Scientific Director, Desai Seth Urology InstituteUniversity of Miami Sylvester Comprehensive Cancer Center

David Sicre, PharmD, MBA

Clinical Research PharmacistUniversity of Miami Sylvester Comprehensive Cancer Center

Leslie Varela, MSN, RN, OCN, CCRC

Director, Research Nursing, Clinical Trials OfficeUniversity of Miami Sylvester Comprehensive Cancer Center

Scott Welford, PhD

Professor of Radiation Oncology; Co-Leader, Tumor Biology Research ProgramUniversity of Miami Sylvester Comprehensive Cancer Center

Gustavo Werutsky, MD, PhD

Executive DirectorLatin American Cooperative Oncology Group (LACOG)

Shuang (George) Zhao, MD

Assistant Professor of Human OncologyUniversity of Wisconsin School of Medicine and Public Health