Sara Hughes, vice president and head of clinical statistics at GSK, gives opening remarks during the GSK-Duke Workshop.

Shuyen Ho (GSK), Margaret Polinkovsky (GSK), Sara Hughes (GSK), Greg Campbell (FDA) Liz DeLong (Duke), Shein-Chung Chow (Duke), Xiaofei Wang (Duke)

More than 150 GlaxoSmithKline (GSK) employees and Duke faculty and students attended the second Joint GSK-Duke Workshop on Critical Statistical Issues for Drug Development, held at Duke in the Hock Plaza building—home of the Duke Department of Biostatistics and Bioinformatics—September 30.

The program led with a keynote address, “Innovation and Statistics in Clinical Trials,” by Greg Campbell, director of the Division of Biostatistics in Center for Devices and Radiological Health at the U.S. Food and Drug Administration. It was followed by six sessions that offered 18 presentations on Bayesian priors, genetics, benefit-risk, biomarker oncology trials, novel Bayesian approaches, and adaptive trials, in addition to a poster session and Q&A panel.

There were 11 posters from Duke and six from GSK presented at the workshop; four were awarded with prizes.

This year’s workshop solidified the relationship between GSK and Duke that begin with last year’s workshop at GSK’s campus in Research Triangle Park. “Last year felt very much like a first date,” said Sara Hughes, vice president and head of clinical statistics at GSK. “This year, we have moved on to our second date, learning more about each other and what we do, engaging in meaty talks, and provoking new ideas.”

Liz DeLong, chair of the Duke Department of Biostatistics and Bioinformatics, praised the mutual exchange. “This day-long workshop provides an exciting opportunity for us to integrate and partner with those in industry and learn up-to-the-minute information such as we did this morning about the FDA in Greg Campbell’s keynote speech.”