Wednesday, May 14, 2025
9:00 AM (EST)
Keynote Speaker
Robert Califf, Former Commissioner, US Food and Drug Administration
10:00 AM (EST)
What did we learn from trials of different agents from different companies: what's next?
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Introduction10:05am
Moderator: Renzo Canetta, former BMS
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Beat AML and PedAL10:05-10:25 AM
Speaker: Gwen Nichols, LLS
Setting: Hematologic malignancies in adults and children
Sponsor: The Leukemia and Lymphoma Society (LLS) -
Lung-MAP10:25-10:45 AM
Speaker: Roy Herbst, Yale
Setting: Non-small cell lung cancer
Sponsor: The Foundation of NIH (FNIH) and Friends of Cancer Research -
NCI-MATCH10:45-11:05 AM
Speaker: TBD
Setting: Solid tumors and lymphomas
Sponsor: National Cancer Institute (NCI) -
TAPUR11:05-11:25 AM
Speaker: Rich Schilsky, University of Chicago
Setting: Solid tumors, myeloma, B-cell lymphomas
Sponsor: American Society of Cancer Research (ASCO) -
Critical Panel Review and Discussion11:25AM-12:00PM
Title: From signal identification to future standard of care combinations: a suitable regulatory pathway?
Moderator: Eric Rubin, former Merck
12:00 –1:00 PM (EST)
Lunch Break
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Global Drug Development AAADV- CDDF1:00PM - 1:05PM
Moderators: Jaap Verweij, CDDF, Jennifer Dent- BIO Ventures for Global Health Multi-national clinical research in cancer
Speaker: Denis Lacombe, EORTC -
Designing clinical trials that with representative populations1:30 PM
Fergus Sweeney, former EMA
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Regional variation in standard of care; Acceptable endpoints, etc.2:00 PM
Filip Josephson, EMA (invited)
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Discussion- Regulatory Perspective2:30 PM
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Nigeria’s vision of becoming a clinical trial hub and innovation ecosystem3:00 PM
Lola Adeyemi, Special Advisor to the Minister of Education, Nigeria on Research (invited)
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Expanding clinical trials and access in Africa3:30 PM
Osa Eisele, Executive Director, Head of Representation in Clinical Research (RISE), Amgen (invited)
Panel Discussion- Industry Perspective on Clinical Trials in Sub-Saharan Africa 4:00 PM
Moderators: Jennifer Dent and Jaap Verweij
Invited Speakers:
Hal Barron – ex Genentech
Osa Eisele – Amgen
LaShell Robinson – Takeda
Craig Tendler – Prior J&J
Bob Li – AstraZeneca
4:10 PM (EST)
End
Thursday, May 15, 2025
9:00 AM (EST)
Developing and Implementing Complex Biomarkers to Guide Cancer Treatment
Moderator: Richard Schilsky
...
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Role of AI in Cancer Drug and Biomarker Development9:05 AM
Olivier Elemento, Weill Cornell
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Network analysis to identify novel biomarkers/targets9:30 AM
Andrea Califano, Columbia University
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Clinical application of transcriptomics in precision oncology9:50 AM
Funda Meric-Bernstam, MD Anderson
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Digital pathology to identify actionable molecular targets9:50 AM 10:10 AM
Eric Walk, Path.AI
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AI-informed digital pathology to predict homologous recombination deficiency10:10 AM 10:20 AM
Ludmil Alexandrov, UCSD
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Discussion- Suggested Regulatory Perspective11:30 AM
Soma Ghosh, CDRH, U.S. FDA
12:00 –12:30 PM (EST)
Lunch Break
Choosing Proper Primary Endpoints in Registrational Oncology Trials, with Focus on the Indolent Cancer Setting
Moderator: Tom Fleming
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Reliable assessment of efficacy and safety in oncology trials, with focus on indolent cancers1:05 PM
Thomas Fleming, Univ of Washington
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The Importance of evaluating effects on how patients feel and function: A Patient Perspective1:30 PM
Loriana Hernandez
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The development and proper qualification of Patient Reported Outcome2:00 PM
John Powers, George Washington University School of Medicine
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Discussion- Regulatory Perspective Suggested2:30 PM
Paul Kleutz