Wednesday, April 9, 2025
| Time | Event | Room | Title | Instructors |
|---|---|---|---|---|
| 8:30 – 9:30am | Continental breakfast buffet | Trinity Pre-Function | ||
| 9:30-12:45pm | C1 Short Course | Trinity C | AI/ML Applications Through the Lenses of Statisticians From Regulatory Agency, Industry, and Academia | Paul Schuette (FDA) Chris Harbron (Roche) Yong Chen (UPenn) |
| C2 Short Course | Trustees 1/2 | Statistical Methods for Randomized Clinical Trials with Information Borrowing from External Controls | Xiaofei Wang (Duke) Shu Yang (NCSU) Mingyang Shan (Eli Lilly) |
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| C3 Short Course | Trinity A/B | Quick-thinking, Confident, Communicative, and Collaborative: Fundamentals of Applied Improvisation for (Bio)Statisticians and Data Scientists | Richard C. Zink (JMP Statistical Discovery LLC) | |
| 12:45 – 1:30pm | Lunch | Trinity Pre-Function | ||
| 1:30 – 4:45pm | C4 Short Course | Trinity C | Pediatric Studies with and without Bayesian Borrowing from Adult Studies | James Travis (FDA) Huan Wang (FDA) Fei Wu (FDA) |
| C5 Short Course | Trustees 1/2 | Rare Disease: Regulatory, Statistical Considerations, and Practical Applications | Michelle Zhang (AMMed) Shein-Chung Chow (Duke) |
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| C6 Short Course | Trinity A/B | A Tutorial on Trial Design and Analysis with Hierarchical Endpoints: Methods, Software and Applications in Cardiovascular Diseases | Huiman Barnhart (Duke) Yuliya Lokhnygian (Duke) Roland Matsouaka (Duke) Frank Rockhold (Duke) |
Thursday, April 10, 2025
| Time | Event | Room | Title | Organizers |
|---|---|---|---|---|
| 7:30 – 8:30am | Continental breakfast buffet | University Ballroom | ||
| 8:30 – 9:00am | Opening Remarks | University Ballroom | Welcome Opening Remarks DISS Steering Committee Remarks | Herb Pang (Genentech) Yuan Wu (Duke) Xiaofei Wang (Duke) |
| 9:00 – 10:00am | Keynote I | University Ballroom | Gregory Alexander, PhD; FDA | Wanjie Sun (FDA) |
| 10:00 – 10:15am | Break | |||
| 10:15 – 11:45am | Session – S1A | Trinity A/B | Honoring Dr. Richard Simon | Marlina Nasution (AskBio) Shuyen Ho (Consultant) |
| Session – S1B | Trinity C | Covariate Adjustment in Clinical Trials | Rakhi Kilaru (PPD, Part of Thermo Fisher Scientific) Yeh-Fong Chen (FDA) |
|
| Session – S1C | Trinity D | Statistical Methods in Restricted Mean Survival Time | Kaiyuan Hua (Duke) Hwanhee Hong (Duke) |
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| Session – S1D | Trustees 1/2 | Recent Advances in Computing, Optimization, and Causal Inference for Adaptive Clinical Trials | Brad Carlin (PharmaLex) | |
| 11:30 – 1:30pm | Lunch & Poster Session | University Ballroom | ||
| 1:30 – 3:00pm | Session – S2A | Trinity A/B | Statistical Considerations for Biomarker Real-World Studies Supporting the Launch of ADCs | Shibing Deng (Pfizer) |
| Session – S2B | Trinity C | Quantitative Leadership and Innovation to Accelerate Drug Development: Insights from Leaders in Statistics & Data Science | Charlotte Baidoo (Bristol Myers Squibb) | |
| Session – S2C | Trinity D | Advances in Use of External and Literature Data for Clinical Development and Surveillance: Bayesian, AI/ML and More | Jian Zhu (Servier) Cindy Gao (FDA) |
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| Session – S2D | Trustees 1/2 | Pediatric Drug Development: Emerging Innovations and Future Directions | Jingjing Ye (BeiGene) | |
| 3:00 – 3:15pm | Break | |||
| 3:13 – 5:00pm | Session – S3A | Trinity A/B | Journey to Dose Optimization in Oncology- Challenges and Learning through Designs and Applications | James Rogers (Metrum Research Group) Nicole Li (BeiGene) |
| Session – S3B | Trinity C | Poster Lightening Talks | Roland Matsouaka (Duke) Lisa Wruck (Duke) |
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| Session – S3C | Trinity D | Recent Advances in Statistical Methodology for Biosimilar and Bioequivalence Studies | Fairouz Makhlouf (FDA) | |
| Session – S3D | Trustees 1/2 | Challenges and Opportunities of ML/AL in Drug Development | Zhaoyang Teng (Servier) Wenqiong Xue (BI) Miaomiao Ge (BI) |
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| 5:30 – 7:00pm | Social Mixer – Registration Required | Empire Ballroom | Herb Pang (Genentech) Yuan Wu (Duke) Xiaofei Wang (Duke) |
Friday, April 11, 2025
| Time | Event | Room | Title | Organizers | ||
|---|---|---|---|---|---|---|
| 7:30 – 8:30am | Continental breakfast buffet | University Ballroom | ||||
| 8:30 – 9:00am | Opening Remarks | University Ballroom | Welcome Poster Award Presentations DISS Steering Committee Remarks | Herb Pang (Genentech) Yuan Wu (Duke) Xiaofei Wang (Duke) | ||
| 9:00 – 10:00am | Keynote II | University Ballroom | Haoda Fu, PhD; Amgen | Hong Tian (BeiGene) | ||
| 10:00 – 10:15am | Break | |||||
| 10:15 – 11:45am | Session – S4A | Trinity A/B | Novel Methods for Multiple and Hierarchical Outcomes in Clinical Trials | Roland Matsouaka (Duke) | ||
| Session – S4B | Trinity D | Utility of Digital Twin in Clinical Trial Development | Ethan Cao (Sandoz) Ramin Arani (Sandoz) | |||
| Session – S4C | Trustees 1/2 | Nonclinical Statistics in Regulatory Applications | Yi Tsong (FDA) | |||
| 11:45 – 1:15pm | Lunch / Break | University Ballroom | ||||
| 1:15 – 3:00pm | Session – S5A | Trinity A/B | Bayesian Decision-Making and Dynamic Borrowing: Enhancing Clinical Trial Efficiency | Kevin Gan (ViiV Healthcare) | ||
| Session – S5B | Trinity D | Challenges in Design of CNS Clinical Trials | ||||
| Session – S5C | Trustees 1/2 | S5C – SMARTs and Biomarker-Stratified Designs, Theory Versus Application | Nikki Freeman (Duke) Beibo Zhao (UNC) Anastasi Ivanova (UNC) Inna Perevozskaya (BMS) |
