Melvin Munsaka of Takeda Global Research & Development, Workshop Publicity Chair, and Wherly Hoffman of Elan, Workshop Chair
The Midwest Biopharmaceutical Statistics Workshop (MBSW) will be held at Ball State University’s alumni center in Muncie, Indiana, May 23–25. This year’s theme is “Beyond Statistics: Delivery Is Key!”
The workshop will begin with a half-day short course covering adaptive clinical trial design taught by Shein-Chung Chow of the Duke University School of Medicine.
Plenary sessions will take place in the afternoon. Speakers are Abraham Wyner of the University of Pennsylvania, Blakeley McShane of Northwestern University, and Keith Baggerly of The University of Texas MD Anderson Cancer Center. Wyner and McShane will give a talk titled “A Statistical Analysis of Multiple Temperature Proxies: Are Reconstructions of Surface Temperatures Over the Last 1,000 Years Reliable?” Baggerly’s talk is titled “Case Studies in Forensic Bioinformatics: The Need for Simple Tests in High-Throughput Biology.”
The workshop will have four parallel tracks, with sessions on May 24 and 25. The clinical track, organized by Chito Hernandez of Elan, will focus on statistical perspectives on current challenges in drug development and feature sessions on controversies in active-controlled clinical trial designs, evaluating product safety profile, and predictive biomarkers and oncology trials.
The discovery/pre-clinical track, organized by Steven Novick of GlaxoSmithKline, will include sessions on drug attrition rate reduction, statistical considerations in immunogenicity testing, and bioassay and bioprocess comparability analysis.
The post-approval track, organized by Doug Faries of Eli Lilly, will feature sessions on addressing uncontrolled confounding, advanced bias adjustment techniques, and personalized medicine.
The nonclinical track, organized by Bill Pikounis of Johnson & Johnson, will revolve around product advancement through statistics and include sessions on univariate and multivariate process monitoring, statistical mitigation of out-of-specification/out-of-trend in a quality-by-design world, and delivery of content uniformity.
Additional opportunities to meet speakers and network will take place at the mixer, social hour, and banquet. Sastry Pantula, 2010 ASA president, will deliver the banquet speech, titled “Surfing the Data Waves.”
Contributed posters are being accepted on any biopharmaceutical statistical topic until April 18. Students are especially encouraged to participate. To help financially, limited scholarships are available to students, with preference given to those who present posters. The best student poster, as judged by a committee including past workshop chairs, will receive the Charles Sampson Award, named in honor of a founder and guiding force behind MBSW.
Questions may be addressed to Melvin Munsaka at mmunsaka@tgrd.com, Wherly Hoffman at wherly.hoffman@elan.com, or Mir Masoom Ali at mali@bsu.edu.
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