Short Course- Thursday at 9:00 AM EDT
Title: Adaptive sequential designs: Benefits, Challenges, and the Best Practices to Win Regulatory Approval
Presenters: Ping Gao, Innovatio Statistics and Weidong Zhang, Sana Biotechnology

Abstract:
Adaptive sequential designs (ASD) have gained popularity over the last few decades in drug development due to its efficiency, flexibility and improved probability of success for clinical trials. In this short course, concepts and theoretical background will be first introduced to facilitate better understanding the merit of ASDs. Great details will be focused on solving practical issues on how to implement the ASDs in both randomized controlled trials and single arm studies . We propose a structured, comprehensive strategy that can help achieve adequate power and cost-effective sample size in trial design when there is great uncertainty about the true effect size. We also discuss expanding and applying sample size re-estimation to Simon’s design. Demonstrations will be performed using the R/Shinny based software DACT (the Design and Analysis for Clinical Trials). Attendees will be granted to access to DACT for training purpose.

Bios:
Dr. Ping Gao has worked for more than 20 years working at the FDA/CDER and in the pharmaceutical industry. He has worked in various therapeutic area including : Rare diseases , oncology ,,Cardiovascular, Infectious disease, Pain
Management, Medical device, Dermatology, Central Nervous System, Hypertension, Hemostasis, Dental, Arthritis, pulmonary diseases. His research interest includes: non-inferiority, adaptive sequential designs, adaptive sequential designs for phase 2/3 seamless combination, adaptive sequential design for multiple comparisons, adaptive design for phase 2 single arm oncology trials, and phase 1 oncology dose escalation.

Dr. Weidong Zhang is a Vice President, Head of Biometrics at Sana Biotechnology, where he oversees statistical and programming activities in support of clinical design, data analysis and clinical development strategy. Prior to Sana, Dr. Zhang worked for Jounce Therapeutics as Vice President, head of Biostatistics and Programming supporting clinical development in immuno-oncology. Prior to Jounce, he worker for Pfizer as a Senior Director Biostatistics with increased
responsibilities in clinical development in Oncology, Immunology and Inflammation, Rare Disease and Translational Oncology. Prior to joining Pfizer, he worked for Sanofi Oncology providing statistical support to early clinical trials and translational oncology. Dr. Zhang’s research interests focus on developing new statistical methods in clinical development and translational study. He is passionate about teaching and has taught short courses on innovative clinical design at numerous conferences and workshops. Dr. Zhang obtained his PhD degree in Statistical Genetics and MS degree in Statistics both from the University of Wisconsin-Madison.