October 22-23, 2015
Trent Semans Center, Duke University, Durham, NC
The program book can be downloaded here.
The pdf files for some invited talks can be found here.
The pdf files of poster session can be found here.
The symposium is organized by the Department of Biostatistics and Bioinformatics, Duke University School of Medicine and co-sponsored by Abbvie, Boehringer-Ingelheim, Parexel, Quintiles and SAS. It was established to promote research and collaboration among colleagues from industry, academia, and regulatory agencies to discuss challenging issues and recent advances related to the clinical development of drugs and devices. The symposium theme this year is “Challenges and Innovations in Pharmaceutical Products Development”.
The keynote speech will be given by Dr Yi Tsong from FDA on “Duality of significance tests and confidence intervals in drug development”.
Day 1 (October 22) events will include 4 short (1/2 day) courses on critical topics in clinical research: 1) Adaptive Clinical Trial Design – Case Studies (Shiowjen Lee, FDA; Annie Lin, FDA); 2) Analytical Similarity Assessment in Biosimilar Studies (Yi Tsong, FDA; Shein-Chung Chow, Duke); 3) Phase II Clinical Trial Design and Dose Finding (Naitee Ting, Boehringer-Ingelheim); and 4) Biomarker Utilities in Adaptive Trials (Mark Chang, AMAG Pharmaceuticals).
Day 2 (October 23) will include the keynote speech, nine parallel sessions and a poster session. The topics of the parallel sessions are: Bioequivalence and Biosimilars, Bayesian Non-Inferiority Trials, Data Monitoring Committees, Randomized Concentration-Controlled Trials, Subgrouping Analysis, Biosimilars II, Advanced Survival Analysis, Enrichment Design for Clinical Trials, and Dose Finding and Selection in Clinical Phase.
The Department is pleased to recognize the following sponsors for this event: Abbvie, Boehringer-Ingelheim, Parexel, Quintiles and SAS.
