Registration and Lunch

Networking Session: Trainees & Future Opportunities

Mentors: Brian Van Tine, Bassel El-Rayes, David Hong, Jaydira del Rivero, MD, Raymond Wadlow, MD

11:30 – 12:30 p.m.

Opening Remarks

Nagla Abdel Karmin, MD

12:30 – 12:35 p.m.

Session I: Patients’ Advocates for Phase I Studies

Stephanie Van Bebber

Jaydira del Rivero

12:35 – 1:20 p.m.

• Patients Story: “Patient who Went Through a Phase I Study”

TBD – patient name coming soon

12:35 – 12:40 p.m.

• Life with Cancer

Jennifer Bires

12:40 – 12:50 p.m.

• GO2 Foundation

Andrew Cuplick

12:50 – 1:00 p.m.

• The White Ribbon Foundation

Christ Draft

1:00 – 1:10 p.m.

• Lungevity

Andrea Ferris

1:10 – 1:20 p.m.

Break with Exhibitors

Atrium

1:20 – 1:40 p.m.

Session II: Multidisciplinary Impact of Pharmacy and Nutrition in Phase I Programs

Session Chair: Ishwaria Subbiah, MD

1:40 – 2:20 p.m.

• PKs: The Vital Players in Phase I Trials, Navigating Safety to Innovation

Doug Figg, PharmD

1:40 – 1:50 p.m.

• Maximize Potential, Minimize Risk with Strategic Drug-Drug Interactions (DDI) in Phase I Trials

Safae Chouraichi, PharmD

Simona Armanca, PharmD

1:50 – 2:00 p.m.

• Nourishing Hope: Empowering Phase I Oncology Trials Through Targeted Nutritional Support

Pamela Brandt, DO

2:00 – 2:10 p.m.

• The Impact of Personalized Nutrition Approach in Cancer Patients

Lauren Fay, RD-AP, CSO, CNSC

2:10 - 2:20 p.m.

• Panel Discussion

2:20 – 2:30 p.m.

Session III: Coordination of Phase I Studies

Teja Poosarla, MD

2:30 – 3:30 p.m.

The Unique Management of Phase I Programs

Ludimila Cavalcante, MD

2:30 – 2:40 p.m.

• Aspirations of Current Phase I Team Members

David Hong, MD

2:40 – 2:50 p.m.

• Study Start Up & Expedited Processes

Glenn Hanna, MD

2:50 – 3:00 p.m.

• Optimizing Communication between Phase I team members

Margret Kamel

3:00 – 3:10 p.m.

• Panel Discussion

3:10 – 3:20 p.m.

Break with Exhibitors

Atrium

3:20 – 3:40 p.m.

Session IV: Revolutionizing Clinical Trials with Precision Oncology: A Game Changer in Cancer Treatment

Session Chair: Michael Pishvaian, MD, PhD

3:40 – 4:30 p.m.

• Incorporating Targeted Therapies in Drug Development

Johnathan Ries, MD

3:40 – 3:50 p.m.

• K-RAS Mutations in GI Oncology

Nilo Azad, MD

3:50 – 4:00 p.m.

• Mechanisms of Resistance to K-RAS Inhibitors

Andy Aguirre, PhD

4:00 – 4:10 p.m.

• Biomarkers in SCLC

Triparna Sen, PhD

4:10 – 4:20 p.m.

• Panel Discussion

4:20 – 4:30 p.m.

• Reception & Networking: Curate the Perfect Melody with Our Diverse Models

Atrium

4:30 – 5:30 p.m.

Session V: Evolving Landscapes from Industry

Nagla Abdel Karmin, MD

Vivek Subbiah, MD

5:30 – 6:30 p.m.

Mechanisms of Resistance ADC’s

Olivier Rixe, MD

5:30 – 5:40 p.m.

Equity in Early Drug Development

Leora Horn, MD; Astra Zeneca

5:40 – 5:50 p.m.

• Incorporation of Germline Testing, Testing Panels

Lisa Macera, PhD; Tempus

5:50 – 6:00 p.m.

• gRED/EON Program-Global Program

TBD

6:00 – 6:10 p.m.

• Panel Discussion

Nabeel Chehab, MD, Michelle Bowman, Stephanie Gilliard; BMS, Joe Lee, MD, Exelixis

6:10 – 6:20 p.m.

Registration and Breakfast with Exhibitors

Atrium

7:00 – 8:00 a.m.

Session VI: Building Strong Foundation, Embrace Safety Excellence with Multidisciplinary Phase I Programs

Stephen Medlin MD

Germame H. Ajebo, MD

8:00 – 8:50 a.m.

• Harnessing IO Toxicity Management in Phase I Studies

Elad Sharon, MD

8:00 – 8:10 a.m.

• The Role of BiTEs in SCLC

Carl Gay, MD

8:10 – 8:20 a.m.

• Management of Concomitant Radiation Therapy Adverse Events While Incorporating Novel Agents

Christopher Johnson, MD

8:20 – 8:30 a.m.

Panel Discussion

Question: CART Management Teams from Drug Development to Possible Real Time Utilization

8:30 – 8:40 a.m.

Session VII: Update on NCI-Sponsored Early Trial Program

Session Chair:

Joshua Reuss, MD

Speaker: Rabih Said, MD, MPH

8:40 – 8:50 a.m.

Session VIII: Multidisciplinary Approaches within Evolving Therapies

Kei Suzuki, MD, Amin Benyounes, MD, & Melissa Yacur, MD

8:40 – 8:50 a.m.

• Utilization of Novel Therapies within Neoadjuvant/Adjuvant Multidisciplinary Approaches in NSCLC

Raid Aljumaily, MD

8:50 – 9:00 a.m.

• Redefining Possibilities: Introducing Novel Immunotherapeutic Agents Beyond Ios

Thomas Marron, MD

9:00 – 9:10 a.m.

• Phase I Programs Fit within Multidisciplinary Teams

Nagla Abdel Karim, MD

9:10 – 9:20 a.m.

• Novel Agents Exploration in MRD Positive Colorectal Cancer Post Definitive Surgery and Chemotherapy

Anwar Saeed, MD

9:20 – 9:30 a.m.

Panel Discussion

9:30 – 9:40 a.m.

Break with Exhibitors

Atrium

9:40 – 10:00 a.m.

Session IX: The FDA Perspective on Early Phase Studies

John Deeken, MD

10:00 – 10:40 a.m.

• FDA 1

Nicole Drezner, MD

10:00 – 10:10 a.m.

• FDA 2

Yufan "Frank" Liu

10:10 – 10:20 a.m.

• Pre-Market Dose Optimization

Joseph Gibbons

10:20 – 10:30 a.m.

Panel Discussion

10:30 – 10:40 a.m.

Session X: Mastering the First Step: Essential Tools for Aspiring Clinical Investigators in Phase I Trails

Session Chair: Dr. Chul Kim

10:40 – 11:00 a.m.

• Early Phase Clinical Trials: Concepts, Development and Training During Fellowship

Raymond Wadlow, MD

10:40 – 10:50 a.m.

• Panel Discussion

10:50 – 11:00 a.m.

Session XIV: Debate: Phase I Program as a Stand-Alone Entity vs. Distributed within Individual Disease Groups

Moderator: David Hong, MD

For: Rafeh Naqash, MD

Against: Asrar Al Ahmadi, MD

11:00 – 11:20 a.m.

Lunch with Exhibitors

Atrium

11:20 – 12:30 p.m.

Session XI: Navigating Complexity Phase I Programs Refined, Redefined for Optimal Results

Johnathan Ries, MD

12:30 – 1:45 p.m.

Utilization of Molecular Testing Within Phase I Programs

Stephanie Gaillard, MD

12:30 – 12:40 p.m.

• Phase I Program Model at Sarah Cannon

Vivek Subbiah, MD

12:40 – 12:50 p.m.

• Phase I Program at Washington University

Brian Van Tine MD

12:50 – 1:00 p.m.

• Discover the Key Clues to Phase I Program Model Success

1:00 – 1:10 p.m.

• Future of Experimental Therapeutics Program

Bassel El-Rayes, MD

1:10 – 1:20 p.m.

• Impact of Investigator Initiated Studies on Drug Development

Vamsi Velcheti, MD, MBA, FACP, FCCP

1:20 – 1:30 p.m.

• Panel Discussion

1:30 – 1:45 p.m.

Session XII: Breaking Barriers: Impact of Diversity and Specialized Care of Rare Tumors

Ayham Deeb, MD

Maya Khalil, MD

2:00 – 3:00 p.m.

Increasing Diversity in Clinical Trials to Reduce Health Disparities

Estelamari Rodriguez, MD, MPH

2:00 – 2:10 p.m.

• Collaborative Opportunities from Phase I Programs to Community Practices

TBD

2:10 – 2:20 p.m.

• Bridging Boundaries: Hybrid Decentralization of Phase I Trials

So Yeon Kim, MD

2:20 – 2:30 p.m.

• The Role of Cooperative Groups in Bringing Evolving Therapies to the Next Level

Leslie Randall, MD

2:30 – 2:40 p.m.

• Panel Discussion

2:40 – 2:50 p.m.

Break with Exhibitors

Atrium

2:50 – 3:10 p.m.

Session XIII: Areas of Unmet Needs to be Considered in Future Drug Development in Oncology

Adam Cohen, MD

3:10 – 4:00 p.m.

• Evolving Therapies in Triple Negative Breast Cancer

Teja Poosarla, MD

3:10 – 3:20 p.m.

• Evolving Therapies in Non-Targetable NSCLC; The Treatment Desert

TBD

3:20 – 3:30 p.m.

• Claudin 18.2. What is Next in GI Oncology Evolving Therapies?

Mathew Reilly, MD               

3:30 – 3:40 p.m.

• Evolving Therapeutics in CNS Metastasis

Laura Alder, MD

3:40 – 3:50 p.m.

• Evolving Therapies in Hematologic Malignancies

Aaron Goodman, MD                                                              

3:50 – 4:00 p.m.

• Break

4:00 – 4:15 p.m.

Session XV: Beyond the Numbers: New Perspectives on Measurements of Success

Michael Winkler, MD

4:00 – 5:00 p.m.

Challenges incorporating Artificial Intelligence in early phase Clinical Trials

Heejong Kim, PhD

4:00 – 4:10 p.m.

MRD Assessments

Helio Costa, PhD

4:10 – 4:20 p.m.

• Assessment of Patients on IO Therapies

Ram Subramanian, MD

4:20 – 4:30 p.m.

• RECIST Versus Which of the Measurements Should We Consider for Early Drug Development, Solid Tumors, NET, IO Therapies

Daniel Margolis, MD

4:30 – 4:40 p.m.

• Panel Discussion

4:40 – 4:50 p.m.

• Closing Remarks

Nagla Abdel Karim, MD

4:50 p.m.