Tuesday, September 12, 2023
Pre-Workshop: Fundamentals of Global Cancer Drug Development
8:50 AM(EST)
OPENING OF PRE WORKSHOP EDUCATIONAL SESSION
AAADV Program Committee: H. Kim Lyerly (Duke University)
9:00 AM(EST)
Plenary Session A: Overcoming the hazards of survival analysis - PFS, RFS, HR, RMST, and CSO
Session Chairperson: Martin Stockler (University of Sydney)
- Martin Stockeler (University of Sydney) Time to event analysis in oncology
- Elizabeth Eisenhauer (Queens University) Progression-free survival in advanced cancer
- Ian Tannock (University of Toronto) Relapse-free survival and adjuvant therapy
- Ludovic Trinquart (Tufts Univeristy) Use and abuse of hazard ratios in oncology
- Mahesh (Max) Parmar, (MRC CTU UCL) Restricted mean survival time in oncology
- Bishal Gyawali (Queens, Kingston, ON) Time for Common Sense in Oncology
- Panel Discussion
12:00 PM(EST)
Break
12:30 PM(EST)
Plenary Session B: STATISTICAL DESIGN AND ANALYSIS
Session Chairpersons: Thomas Fleming (University of Washington, Seattle) and Lisa McShane (National Cancer Institute)
- Thomas Fleming (University of Washington, Seattle) Subset analysis
- John H. Powers (George Washington University) Surrogate biomarkers/endpoints
- Amylou C. Dueck (Mayo Clinic) Patient reported outcomes for assessing benefits & harms in cancer treatment and prevention trials.
- Panel Discussion
3:30 PM(EST)
END
Wednesday, September 13, 2023
9:00am (EST)
Plenary Session #1: Detecting cancer precursors: The changing landscape of early detection of cancer/cancer precursors
Session Chairperson: Gwen Nichols, (Leukemia and Lymphoma Society)
- Gwen Nichols (Leukemia & Lymphoma Society) Introduction
- Eric Klein (GRAIL) Multicancer early detection diagnostic tests (MCED)
- Lachelle Weeks (Dana Farber Cancer Institute) Science and testing possibilities for clonal hematopoiesis of indeterminate potential (CHIP)
- Irene Ghobrial (Dana Farber Cancer Institute) Early natural history of myeloma: from MGUS on
- Jacques Mascaro (AstraZeneca) Regulatory challenges in early detection and prevention of cancer
- Panel Discussion
- Jeffrey Venstrom (GRAIL) Invited discussant
11:00am (EST)
Plenary Session #2: The utility and success of multi-center basket trials in cancer drug development:
Session Chairperson: Richard Schilsky (University of Chicago)
- Rich Schilsky (University of Chicago): Targeted Agent and Profiling Utilization Registry (TAPUR)
- Emile E. Voest (Netherlands Cancer Institute): Netherlands Drug Rediscovery Protocol (DRUP)
- Janet Dancey (Canadian Clinical Trials Group): Canadian Profling and Targeted Agent Utilization Trial (CAPTUR)
- Panel Discussion
- Scott Patterson (Gilead) Invited Discussant
- Tania Szado (Genetech) Invited Discussant
- Deo Ruhangaza (Butaro Cancer Center, Rwanda) Invited Discussant
1:00pm (EST) Wednesday, September 13
Break
1:30pm (EST)
Plenary Session #3: The development of precision medicine in LMIC:
Session Chairpersons: Bob Li, (Memorial Sloan Kettering Cancer Center), Katherine Van Loon (UCSF)
- Aminu Umar-Sadiq (Nigeria Sovereign Investment Authority) Investing in Cancer Centers of Excellence in Nigeria (NLCC)
- Jennifer Dent (BioVentures) The Cancer Clinical Trial Landscape in Africa and through AC3T
- Abasi Ene-Obong (Syndicate Bio) Genomic testing in LMIC
- Panel Discussion
- Chitkala Kalidas (Bayer) Invited Discussant
- Adedayo Joseph (NLCC) Invited Discussant
3:30pm (EST) Wednesday, September 13
End
Thursday, September 14th, 2023
9:00am (EST)
Keynote: The White House Cancer Moonshot
9:25am (EST)
Discussion- Cancer Prevention Opportunities in 2023
10:00am (EST)
Plenary Session #3: Carcinogenesis and the emerging science of precision prevention
Session Chairperson: Philip E. Castle (Divison of Cancer Prevention, National Cancer Institute (DCP-NCI)
- Ludmil Alexandrov (University of California, San Diego): The genomic landscape of human precancer
- Sudhir Srivastava (National Cancer Institute): The Biology of Precancer
- Mary “Nora” Disis (University of Washington, Seattle): Immunoprevention
- Panel Discussion
12:00pm (EST)
Keynote: Drug development for cancer prevention: opportunities and challenges.
- Introduction: H. Kim Lyerly (Duke University)
- Speaker: Dr. Susan Galbraith (AstraZenca)
- Discussion
12:30pm (EST)
Plenary Session #5: Case studies in cancer prevention Successes and pitfalls
Session Chairperson: Renzo Canetta (Independent Consultant)
- John Schiller (National Cancer Institute): HPV vaccines for cervical and other cancers
- David M. Miller (Harvard University): Nicotinamide for skin cancer after transplant
- Seema Khan (Northwestern University): Tamoxifen for breast cancer
- Andrew Chan (Harvard University): Celecoxib and Aspirin For colorectal adenomatous polyps
- Ian Thompson (National Cancer Institute): Dutasteride/finasteride for prostate cancer prevention
- Panel Discussion
2:30pm (EST)
Plenary Session #6: Regulatory pathways for next generation prevention agents:
Session Chairperson: Robert H. Shoemaker (National Cancer Institute, Divison of Cancer Prevention)
- Steven Reed (HDT Bio): mRNA vaccines in cancer prevention
- Zelanna Goldberg (Replicate Bioscience): Self replicating mRNA vaccines preventing resistance
- Brian Cholewa (National Cancer Institute, Divison of Cancer Prevention): Regulatory pathways
- Shizuko Sei (National Cancer Institute, Divison of Cancer Prevention): NCI-DCP activities in cancer prevention
- Panel Discussion
4:30pm (EST) Thursday, September 14
End
Friday, September 15th, 2023
8:50am (EST)
OPENING OF SESSION
Speaker: H. Kim Lyerly (Duke University)
9:00am (EST)
Satellite #4: Clinical trial design/analysis for global drug development
Session Chairperson: Lisa McShane (National Cancer Institute)
- Lisa McShane (National Cancer Institute): Clinical trial designs to evaluate liquid biopsy-guided therapy
- Marco Bonetti, Bernard Cole, Richard Gelber: Exploring treatment-effect heterogeneity using continuous biomarkers: the STEPP approach
- John Simes (University of Sydney) Design and analysis issues evaluating biomarkers in cancer clinical trials
- Panel Discussion
Track A
11:00am (EST)
Session Chairperson: Jian Wang (AstraZeneca)
1:00pm (EST) Friday, September 15
Break
1:30am (EST)
Satellite #3: Pediatric Neuroncology and Childhood Cancer Data Initiative
Session Chairperson: David Arons (National Brain Tumor Society)
- Chitkala Kalidas (Bayer): A global pediatric neuro oncololgy newwork
- Kristin Schroeder (Duke University): Tanzania and Duke pilot in global pediatric neuro-oncology
- Parvati Dev (Open Health Systems Laboratories): Information systems supporting a pediatric neuro-oncology
- Ken Buetow (Arizona State University) Digital Twin
- Greg Reaman (National Cancer Institute): Childhood Cancer Data Initiative
- Panel Discussion / QA
3:30pm (EST) Friday, September 15
End
Track B
11:00am (EST)
Satellite #5 Panel: Use of Regulatory Headwinds to Manage Towards Properly Enrolled Clinical Trials
Session Chairperson: Terrel Baptiste (Gilead)
- Stacey Bledsoe (Gilead): Head of Clinical Trial Diversity, Gilead
- Binita Patel (Bayer): Clinical Operations, Diversity Lead, Bayer
- Barbara Bierer (MRCT Center): Center Director
- Shaalan Beg (Science37): Vice-President
- Panel Discussion
- Chitkala Kalidas (Bayer)– Invited Discussant
- Patricia Keegan (TopAllianceBio)– Invited Discussant
1:00pm (EST) Friday, September 15
Break
1:30pm (EST)
Satellite #6: Access to care following screening and prevention trials
Session Chairperson: Michelle Treagar (National Breast Cancer Coalition)
- Derek Raghavan (Levine Cancer Center): Screening for lung cancer
- Eduardo Vilar-Sanchez (MD Anderson): Lynch Syndrome Vaccines
- Panel Discussion
- Philip E. Castle (National Cancer Institute)- Invited Discussant
- Jeffrey Levi (George Washington University)– Invited Discussant
- Jennifer Berzock- Invited Discussant
- Christine Carpenter- Invited Discussant
3:30pm (EST) Friday, September 15
End
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