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DISS2024 Program

Join Duke University School of Medicine along with several industry and non-profit partners for 3 days of in-depth training.

Wednesday, April 3, 2024

7:30 – 8:30am BreakfastServed in the Trinity Pre-Function
8:30 – 11:45am
Short CourseC1AI/ML for Clinical Trials and Humanized AI for Future HealthcareMark Chang, PhD
Short CourseC2Dose Optimization in Drug DevelopmentYing Yuan, PhD
Short CourseC3The DOOR is Open: Pragmatic Benefit:Risk Evaluation Using Outcomes to Analyze Patients
Rather than Pa-tients to Analyze Outcomes
Toshimitsu Hamasaki, PhD
Scott Evans, PhD
Daniel Rubin, PhD
11:45 – 1:30pm

LunchServed in the Trinity Pre-Function
1:30 – 4:45pm
Short CourseC4Adaptive Platform Trials: From Concept to CompletionJoe Marion, PhD
Elizabeth Lorenzi, PhD
Lindsay Berry, PhD
Short CourseC5Statistical Challenges in the Evaluation of Surrogate Endpoints in OncologyBie Verbist, PhD
Wim Van der Elst, PhD

Thursday, April 4, 2024 

7:30 – 8:30amContinental BreakfastServed in the University Ballroom
8:30 – 9:00amOpening RemarksWelcome
Opening Remarks by Mary E. Klotman, MD; Dean, School of Medicine
DISS Partner Remarks by Fang Chen, PhD; SAS & Ralph DeMasi, PhD; ViiV Healthcare
Shein-Chung Chow (Duke)
Xiaofei Wang (Duke)
9:00 – 10:00amKeynote IChanges in the Drug Development and Regulatory Landscape: Evolutions and RevolutionsShein-Chung Chow (Duke)
Xiaofei Wang (Duke)
10:00 – 10:15amBreak
10:15 – 11:30am SessionS1AUse of RWD to Generate RWE in Regulatory Decision-MakingHerbert Pang (Genentech)
SessionS1BJoint Modeling of Longitudinal Endpoints in Clinical TrialSudhakar Rao (Janssen)
Xiang Li (Johnson & Johnson)
Qing Xu (Taiho Oncology)
SessionS1CBayes or Not Bayes, Is This The Question?Anastasia Ivanova (UNC)
11:30 – 1:30pmLunch & Poster Session Served in the University BallroomHwanhee Hong (Duke)
1:30 – 2:15pm SessionS2AEstimands for Clinical TrialHuiman Barnhart (Duke)
Laine Thomas (Duke)
SessionS2BBayesian Methods to Borrow Information in Rare Disease TrialsYing Yuan (University of Texas MD Anderson Cancer Center)
Yong Zang (Indiana University)
SessionS2CDose Optimization in Drug DevelopmentVictoria Chang (JBS | BeiGene)
2:15 – 2:30pmBreak
2:30 – 4:30pm SessionS3ACovariate Adjustment in Randomized Clinical TrialsRakhi Kilaru (PPD, Part of Thermo Fisher Scientific)
SessionS3BNovel Methods for Multiple and Hierarchical Outcomes in Clinical TrialsDavid Yanez (Duke)
SessionS3CPoster Lightning TalksHwanhee Hong (Duke)
5:30 – 7:00pm Social MixerEmpire BallroomDISS2024 – Celebrating a DecadeShein-Chung Chow (Duke)
Xiaofei Wang (Duke)

Friday, April 5, 2024 

7:30 – 8:30amContinental BreakfastServed in the University Ballroom
8:30 – 9:00amOpening Remarks Welcome
Poster Award Presentations by Hwanhee Hong, PhD; Duke
DISS Partner Remarks
Xiaofei Wang (Duke)
Shein-Chung Chow (Duke)
Hwanhee Hong (Duke)
9:00 – 10:00amKeynote IIThe Power of AI, Data Sciences, and Technology in Drug DevelopmentXiaofei Wang (Duke)
Shein-Chung Chow (Duke)
10:00 – 10:15amBreak
10:15 – 11:30amSessionS4A Causal Inference Methods to Estimate Treatment Effects in Clinical TrialsSudhakar Rao (Janssen)
Xiang Li (Johnson & Johnson)
SessionS4BStatistical Innovation in the Application of ctDNA in Oncology Drug DevelopmentShibing Deng (Pfizer)
SessionS4C Bridging Early Insights for Enhanced Oncology Decision-MakingMiaomiao Ge (Boehringer Ingelheim)
Wenqiong Xue (Boehringer Ingelheim)
11:30 – 1:00pm Lunch / BreakServed in the University Ballroom
11:45 – 1:00pmSession / Lunch EventS5AHonoring Professor Shein-Chung Chow’s 40 years of Contributions to Statistical and Regulatory SciencesMark Chang (Boston University)
Herbert Pang (Genentech)
Xiaofei Wang (Duke)
1:00 – 3:00pmSessionS6A Advancing Dose Optimization: Innovations and PracticesYing Yuan (University of Texas MD Anderson Cancer Center)
SessionS6B Statistical Significance, Clinical Meaningfulness, and Regulatory Consideration for Rare Disease Drugs’ Approval – Examples SharingYeh-Fong Chen (FDA)
Huan Wang (FDA/CDER)
SessionS6C Statistical Innovation in Biosimilar and Bioequivalence StudiesFairouz Makhlouf (FDA)
Shein-Chung Chow (Duke)