Registration is opening soon
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
Panel Discussion:
Industry Perspective on Clinical Trials in Sub-Saharan Africa
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Introduction of Session: Global Drug Development1:00PM - 1:05PM
Moderators: Jaap Verweij & Jennifer Dent
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Multi-national clinical research in cancer1:05PM
Speaker: Denis Lacombe (EORTC)
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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)
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 PM – 1:00 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