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 Bristol Meyers Squibb- BMS)
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Beat AML and PedAL10:05-10:25 AM
Speaker: Gwen Nichols (Leukemia and Lymphoma Society- 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 (FOCR) -
NCI-MATCH10:45-11:05 AM
Speaker: James Ford (Stanford)
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: Gideon Blumenthal (Merck)
12:00 –12:30 PM (EST)
Lunch Break
Panel Discussion:
A Perspective on International/Global Clinical Trials in Oncology
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Introduction of Session: Global Drug Development12:30PM - 12:35PM
Moderators: Jaap Verweij (Cancer Drug Development Forum-CDDF) & Jennifer Dent (BIO Ventures for Global Health-BVGH)
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Multi-national clinical research in cancer12:35PM
Speaker: Denis Lacombe (European Organization for Research and Treatment of Cancer- EORTC)
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Planning for representative populations in international clinical development programmes1:05 PM
Fergus Sweeney (CDDF)
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The development of precision medicine in LMIC: India, a case study1:35 PM
Ravi Prakash Mahajan (Apollo), Eric Stahlberg (MD Anderson), Chitkala Kalidas (Bayer)
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Discussion- Regulatory Perspective2:05 PM
Discussion Moderator: Jaap Verweij (CDDF)
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Cancer clinical research opportunities in LMICs – an NCI perspective2:45 PM
Satish Gopal (Director, National Cancer Institute Center for Global Health)
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Nigeria’s vision of becoming a clinical trial hub and innovation ecosystem3:15 PM
Lola Adeyemi (Special Advisor to the Minister of Education), Nigeria on Research
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Expanding clinical trials and access in Africa3:45 PM
Jennifer Dent (BVGH)
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Discussion4:15 PM
Discussion Moderators: Jennifer Dent Invited discussants: Osa Isele (Amgen), Craig Tendler (former J&J), Chitkala Kalidas (Bayer), Satish Gopal (NCI)
5:00 PM (EST)
End
Thursday, May 15, 2025
7:30-9AM (EST)
Breakfast
9:00 AM (EST)
Developing and Implementing Complex Biomarkers to Guide Cancer Treatment
Moderator: Richard Schilsky (University of Chicago)
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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 targets10:10 AM
Eric Walk (Path.AI)
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AI-informed digital pathology to predict homologous recombination deficiency10:30 AM
Ludmil Alexandrov (University of California, San Diego- UCSD)
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Discussion11:30 AM
Discussion Moderator: Richard Schilsky (University of Chicago)
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 (Univ of Washington)
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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 (Patient Advocate)
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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 Perspective2:30 PM
Discussion Moderator: Harpreet Singh (Precision for Medicine)