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DISS2024 Program

Wednesday, April 3, 2024

TimeEvent#RoomTitleInstructors
7:30 – 8:30am BreakfastTrinity Pre-FunctionContinental breakfast buffet
8:30 – 11:45am
Short CourseC1Trinity CAI/ML for Clinical Trials and Humanized AI for Future HealthcareMark Chang, PhD
Short CourseC2Trustees 1/2Dose Optimization in Drug DevelopmentYing Yuan, PhD
Short CourseC3Trinity A/BThe DOOR is Open: Pragmatic Benefit:Risk Evaluation Using Outcomes to Analyze Patients Rather than Patients to Analyze OutcomesToshimitsu Hamasaki, PhD
Scott Evans, PhD
Daniel Rubin, PhD
11:45 – 1:30pm

LunchTrinity Pre-FunctionBoxed lunch selected during registration
1:30 – 4:45pm
Short CourseC4Trustees 1/2Adaptive Platform Trials: From Concept to CompletionJoe Marion, PhD
Elizabeth Lorenzi, PhD
Lindsay Berry, PhD
Short CourseC5Trinity CStatistical Challenges in the Evaluation of Surrogate Endpoints in OncologyBie Verbist, PhD
Wim Van der Elst, PhD

Thursday, April 4, 2024 

TimeEvent#RoomTitleOrganizers
7:30 – 8:30amContinental BreakfastUniversity BallroomContinental breakfast buffet
8:30 – 9:00amOpening RemarksUniversity BallroomWelcome
Opening Remarks by Mary E. Klotman, MD; Dean, School of Medicine
DISS Organizing Committee Remarks by Wanjie Sun, PhD; FDA
Shein-Chung Chow (Duke)
Xiaofei Wang (Duke)
9:00 – 10:00amKeynote IUniversity BallroomChanges in the Drug Development and Regulatory Landscape: Evolutions and RevolutionsShein-Chung Chow (Duke)
Xiaofei Wang (Duke)
10:00 – 10:15amBreak
10:15 – 11:30am SessionS1ATrinity DUse of RWD to Generate RWE in Regulatory Decision-MakingHerbert Pang (Genentech)
SessionS1BTrinity A/BJoint Modeling of Longitudinal Endpoints in Clinical TrialSudhakar Rao (Janssen)
Xiang Li (Johnson & Johnson)
Qing Xu (Taiho Oncology)
SessionS1CTrustees 1/2Bayes or Not Bayes, Is This The Question?Anastasia Ivanova (UNC)
11:30 – 1:30pmLunch & Poster Session University BallroomBoxed lunch selected during registration
2024 Poster Session
Hwanhee Hong (Duke)
1:30 – 2:45pm SessionS2ATrinity DEstimands for Clinical TrialHuiman Barnhart (Duke)
Laine Thomas (Duke)
SessionS2BTrustees 1/2Bayesian Methods to Borrow Information in Rare Disease TrialsYing Yuan (University of Texas MD Anderson Cancer Center)
Yong Zang (Indiana University)
SessionS2CTrinity A/BDose Optimization in Drug DevelopmentVictoria Chang (JBS | BeiGene)
2:45 – 3:00pmBreak
3:00 – 5:00pm SessionS3ATrustees 1/2Covariate Adjustment in Randomized Clinical TrialsRakhi Kilaru (PPD, Part of Thermo Fisher Scientific)
SessionS3BTrinity A/BNovel Methods for Multiple and Hierarchical Outcomes in Clinical TrialsDavid Yanez (Duke)
SessionS3CTrinity DPoster Lightning TalksHwanhee Hong (Duke)
5:30 – 7:00pm Social MixerRegistration requiredEmpire BallroomDISS2024 – Celebrating a DecadeShein-Chung Chow (Duke)
Xiaofei Wang (Duke)

Friday, April 5, 2024 

TimeEvent#RoomTitleOrganizers
7:30 – 8:30amContinental BreakfastUniversity BallroomContinental breakfast buffet
8:30 – 9:00amOpening Remarks University BallroomWelcome
Poster Award Presentations by Hwanhee Hong, PhD; Duke
DISS Organizing Committee Remarks by Rui (Sammi) Tang, PhD; Servier
Xiaofei Wang (Duke)
Shein-Chung Chow (Duke)
9:00 – 10:00amKeynote IIUniversity BallroomThe Power of AI, Data Sciences, and Technology in Drug DevelopmentXiaofei Wang (Duke)
Shein-Chung Chow (Duke)
10:00 – 10:15amBreak
10:15 – 11:30amSessionS4ATrinity A/B Causal Inference Methods to Estimate Treatment Effects in Clinical TrialsSudhakar Rao (Janssen)
Xiang Li (Johnson & Johnson)
SessionS4BTrinity DStatistical Innovation in the Application of ctDNA in Oncology Drug DevelopmentShibing Deng (Pfizer)
SessionS4CTrustees 1/2 Bridging Early Insights for Enhanced Oncology Decision-MakingMiaomiao Ge (Boehringer Ingelheim)
Wenqiong Xue (Boehringer Ingelheim)
11:30 – 1:00pm Lunch / BreakUniversity BallroomBoxed lunch selected during registration
11:45 – 1:00pmSession / Lunch EventS5AUniversity BallroomHonoring 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 – 3:00pmSessionS6ATrinity A/B Advancing Dose Optimization: Innovations and PracticesVictoria Chang (JBS | BeiGene)
SessionS6BTrinity D Statistical Significance, Clinical Meaningfulness, and Regulatory Consideration for Rare Disease Drugs’ Approval – Examples SharingYeh-Fong Chen (FDA)
Huan Wang (FDA/CDER)
SessionS6CTrustees 1/2 Statistical Innovation in Biosimilar and Bioequivalence StudiesFairouz Makhlouf (FDA)
Shein-Chung Chow (Duke)