Challenges and Innovations in Pharmaceutical Products Development Focus of Duke Symposium

About 250 people attended the Duke-Industry Statistics Symposium October 22–23 at the Trent Semans Center on the Duke University Campus. The annual symposium—organized by the department of biostatistics and bioinformatics in the Duke University School of Medicine—was established to promote research and collaboration among colleagues from industry, academia, and regulatory agencies and explore challenging issues and recent advances related to the pharmaceutical/clinical development of drugs and devices.

This year’s theme was “Challenges and Innovations in Pharmaceutical Products Development.” The first day led with the following half-day short courses that covered critical topics in clinical research:

• Adaptive Clinical Trial Design – Case Studies (Shiowjen Lee, FDA; Annie Lin, FDA)
• Analytical Similarity Assessment in Biosimilar Studies (Yi Tsong, FDA; Shein-Chung Chow, Duke)
• Phase II Clinical Trial Design and Dose Finding (Naitee Ting, Boehringer-Ingelheim)
• Biomarker Utilities in Adaptive Trials (Mark Chang, AMAG Pharmaceuticals)

The short courses attracted participants from both industry and academia.

Liz DeLong, chair of the department of biostatistics and bioinformatics at Duke, and Rene Kubiak, head of U.S. statistics at Boehringer-Ingelheim, opened the Friday session with welcoming remarks. Yi Tsong from the FDA’s Center for Drug Evaluation and Research gave the keynote address, titled “Duality of Significance Tests and Confidence Intervals in Drug Development.” This was followed by nine parallel sessions that offered 30 invited presentations on topics including advanced survival analysis, Bayesian noninferiority trials, bioequivalence and biosimilars, data-monitoring committees, dose finding and selection in clinical phase, enrichment design for clinical trials, randomized concentration-controlled trials, and subgrouping analysis.

The symposium also attracted a number of posters from industry and academia. Prizes for best posters were awarded to Hyang Kim from PAREXEL and Laine Thomas, Tongrong Wang, and Meng Chen from Duke University.