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

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


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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
45+
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

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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 10:10 am to
11:20 am

Phase I clinical trial design and statistics

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

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Mario Sznol, MD
Professor of Medicine; Leader, Clinical Research Team, Skin And Kidney Cancer Program; Co-Leader, Cancer Immunology, Yale Cancer Center

time iconSeptember 5, 2025 11:20 am to
12:30 pm

Phase II clinical trial design and statistics

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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

time iconSeptember 5, 2025 12:30 pm to
01:00 pm

Panel: Bench-to-bedside translation

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

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

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Mario Sznol, MD
Professor of Medicine; Leader, Clinical Research Team, Skin And Kidney Cancer Program; Co-Leader, Cancer Immunology, Yale Cancer Center

time iconSeptember 12, 2025 10:00 am to
11:15 am

Phase III and non-interventional trial design and statistics

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Mitchell Machtay, MD
Endowed Chair in Cancer Clinical Research; Associate Dean for Cancer Clinical Research; Associate Director for Clinical Research, Penn State Cancer Institute

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Chen Hu, PhD, MS
Associate Professor of Oncology, Johns Hopkins School of Medicine

time iconSeptember 12, 2025 11:15 am to
12:00 pm

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 12, 2025 12:15 pm to
01:00 pm

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

time iconSeptember 19, 2025 10:00 am to
10:45 am

What it means to be a PI

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

time iconSeptember 19, 2025 10:45 am to
11:30 am

Addressing catchment area populations in recruitment and retention

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Estelamari Rodriguez, MD, MPH
Assistant Director for Diversity, Equity, and Inclusion, University of Miami Sylvester Comprehensive Cancer Center

time iconSeptember 19, 2025 11:30 am to
12:15 pm

Crafting a successful LOI

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

time iconSeptember 19, 2025 12:15 pm to
01:00 pm

Incorporating biomarkers into your clinical trial

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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

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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

time iconSeptember 19, 2025 11:00 am to
12:00 pm

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

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Nicole McCullough, MS
Director of Clinical Research Operations & Regulatory Support, University of Miami Sylvester Comprehensive Cancer Center

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Kenia Viamonte, MA
Director of Human Subject Research, University of Miami Sylvester Comprehensive Cancer Center

time iconSeptember 19, 2025 12:00 pm to
01:00 pm

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

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Kath Connolly, MA
Director of Human Subject Research, University of Miami Sylvester Comprehensive Cancer Center

time iconSeptember 26, 2025 10:00 am to
10:45 am

Liquid biopsies in correlative studies

time iconSeptember 26, 2025 10:45 am to
11:30 am

Protocol approval from start to finish

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

time iconSeptember 26, 2025 11:30 am to
12:15 pm

Special session: International clinical trial infrastructure

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Aisha Mustapha, MBBS, MS
Senior Lecturer; Consultant Obstetrician Gynecologist, Ahmadu Bello University Teaching Hospital

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Stephane Supiot, MD, PhD
Professor, Université de Nantes

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

Panel: Collaboration with industry

time iconSeptember 26, 2025 10:00 am to
01:00 pm

Community engagement in clinical research

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Erin Kobetz, PhD, MPH
Chief Health Equity Officer, University of Miami Sylvester Comprehensive Cancer Center

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

time iconOctober 3, 2025 10:00 am to
10:45 am

Patient-reported outcomes in clinical trials

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

time iconOctober 3, 2025 10:45 am to
11:30 am

The Road to Regulatory Approval

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

time iconOctober 3, 2025 11:30 am to
12:15 pm

Interacting with the FDA

time iconOctober 3, 2025 12:15 pm to
01:00 pm

NCI clinical trial funding mechanisms

time iconOctober 10, 2025 10:00 am to
10:45 am

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

time iconOctober 10, 2025 10:45 am to
11:30 am

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

time iconOctober 10, 2025 11:30 am to
12:15 pm

The ethics of AI in clinical research

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

time iconOctober 10, 2025 12:15 pm to
01:00 pm

Panel: Considerations for AI in clinical research

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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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Alyssa Vanderbeek, MS
Senior Product Manager, Unlearn.AI

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

time iconOctober 10, 2025 10:00 am to
11:00 am

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

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Carolyn Raski,MS, CGC
Genetic Counselor, Ann & Robert H. Lurie Children's Hospital of Chicago

Our Speakers

Juan Alderuccio, MD

Associate Professor of MedicineUniversity of Miami Sylvester Comprehensive Cancer Center

Esperanza Bas, PhD

Clinical Research PharmacistUniversity of Miami Sylvester Comprehensive Cancer Center

Marijo Bilusic, MD, PhD

Professor of MedicineUniversity of Miami Sylvester Comprehensive Cancer Center

Lucia Carranza, MSN, APRN, AOCNP

Phase I Oncology Nurse PractitionerUniversity of Miami Sylvester Comprehensive Cancer Center

Sarah Chadwell, MS, CGC

Medical Strategic Account DirectorSanofi

Aman Chauhan, MD

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

Cody Chiuzan, PhD

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

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

Vaughn Edelson, MPH, MPA

Course Co-DirectorUniversity of Miami Sylvester Comprehensive Cancer Center

Charalampos (Harris) Floudas, MD, DMSc, MS

Associate Research Physician, Center for Immuno-Oncology, Center for Cancer Research National Cancer Institute

Sophia George, PhD

Professor of Obstetrics, Gynecology, & Reproductive SciencesUniversity of Miami Sylvester Comprehensive Cancer Center

Leanne Hagen, MS, CGC

Genetic Counselo Cincinnati Children's Hospital Medical Center

Chen Hu,PhD, MS

Associate Professor of Oncology Johns Hopkins School of Medicine

Farrah Jackson, MS, CCRP

Clinical Research Coordinator and Program Manager Cincinnati Children's Hospital Medical Center

Nicholas James, MBBS, PhD

Professor of Prostate and Bladder Cancer Research Institute of Cancer Research, the Royal Marsden Hospital in London

Gayle Jameson, MSN, ACNP-BC, AOCN

Nurse Practitioner; Associate Clinical InvestigatorHonorHealth Research Institute

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

Nina Lukinova, PhD

Program Director, Cancer Diagnosis ProgramNational Cancer Institute

Mitchell Machtay, MD

Endowed Chair in Cancer Clinical Research; Associate Dean for Cancer Clinical Research; Associate Director for Clinical Research Penn State Cancer Institute

Nicole McCullough, MS

Director of Clinical Research Operations & Regulatory SupportUniversity of Miami Sylvester Comprehensive Cancer Center

Ruben Mesa, MD

Executive Director Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Craig Moskowitz, MD

Physician-in-ChiefUniversity of Miami Sylvester Comprehensive Cancer Center

Aisha Mustapha, MBBS, MS

Senior Lecturer; Consultant Obstetrician Gynecologist Ahmadu Bello University Teaching Hospital

Laura Ochoa, BSc

Clinical Research CoordinatorUniversity of Miami Sylvester Comprehensive Cancer Center

Michael Paidas, MD

Professor and Chair of Obstetrics, Gynecology and Reproductive SciencesUniversity of Miami Sylvester Comprehensive Cancer Center

Guillermo Perez, BA

Clinical Research Data SpecialistUniversity of Miami Sylvester Comprehensive Cancer Center

Alan Pollack, MD, PhD

Phase 1University of Miami Sylvester Comprehensive Cancer Center

Carolyn Raski, MS, CGC

Genetic Counselor Ann & Robert H. Lurie Children's Hospital of Chicago

Estelamari Rodriguez, MD, MPH

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

Hudson Santos, PhD, RN, FABMR, FAAN

Dean of Nursing and Health Studies; Professor and Dolores J. Chambreau Endowed Chair in NursingUniversity of Miami Sylvester Comprehensive Cancer Center

Matthew Schlumbrecht, MD, MPH

Professor of Clinical Obstetrics, Gynecology, and Reproductive Sciences; Vice Chair of Global and Community HealthUniversity of Miami Sylvester Comprehensive Cancer Center

Mikkael Sekeres, MD

Professor and Chief of HematologyUniversity of Miami Sylvester Comprehensive Cancer Center

Mario Snzol, MD

Professor of Medicine; Leader, Clinical Research Team, Skin And Kidney Cancer Program; Co-Leader, Cancer Immunology Yale Cancer Center

Stephane Supiot, MD, PhD

Professor Université de Nantes

Alyssa Vanderbeek, MS

Senior Product Manager Unlearn.AI

Kenia Viamonte, MA

Director of Human Subject ResearchUniversity of Miami Sylvester Comprehensive Cancer Center

Denise Vidot, PhD

Associate Professor; Director, Community and Stakeholder EngagementUniversity of Miami Sylvester Comprehensive Cancer Center

Louis Voigt, MD

Intensivist; Ethics Committee Chair Memorial Sloan Kettering Cancer Center