Melvin S. Munsaka of Takeda Global Research & Development, Workshop Publicity Chair, and Douglas E. Faries of Eli Lilly, Workshop Chair

The Midwest Biopharmaceutical Statistics Workshop (MBSW) will be hosted by Ball State University in Muncie, Indiana, from May 21–23 for the 35th consecutive year. MBSW, co founded by Charles B. Sampson and Mir Masoom Ali, was created to meet the needs of U.S. pharmaceutical industry statisticians in the Midwest, but continues to welcome attendees from across the country and around the world.

The 2012 workshop, which will be held at the Alumni Center of Ball State University, will begin with three half-day short courses, including Comparative Effectiveness Using Observational Research by Thomas Love, High-Dimensional Data and Non-Negative Matrix Factorization by Paul Fogel, and Prevention and Treatment of Missing Data by Craig Mallinckrodt.

The theme for the workshop is “Strategic Use of Statistical Thinking.” The Monday afternoon plenary session speakers are Lee Wilkinson, who will give a talk titled “Expert Systems and Statistical Graphics,” and Lisa LaVange, who will present “Select Regulatory Statistical Challenges.”

The workshop will have four parallel tracks with sessions on Tuesday and Wednesday. The four tracks are Clinical; Discovery/Pre-Clinical; Chemistry, Manufacturing, and Controls; and Health Outcomes and Observational Research. Each track will have three sessions on Tuesday morning, Tuesday afternoon, and Wednesday morning. Each session will be at least two hours in length, with 3–5 speakers in any session. Speakers have more time to discuss topics in detail than is typically given at many conferences, and participants will have ample opportunity to ask questions and participate in discussions. Various sessions will include multiple speakers from industry and academia. Additionally, speakers from the U.S. Food and Drug Administration (FDA) and other governmental agencies will be invited to give presentations.

The Clinical track, organized by Yili Pritchett of Abbott, will focus on decisionmaking at critical stages of pipeline advancement, recent development in multiple endpoints, and joint modeling for survival data. The Discovery/Pre-Clinical track, organized by Steven Novick of GlaxoSmithKline, will focus on working toward success in translational medicine, enhancing HTS compound progression through multivariate analysis, and statistical principles in analysis of messy data to advance scientific discovery. The Health Outcomes and Observational Research track, organized by Gerhardt Pohl of Eli Lilly, will feature sessions on simulations in economic modeling of health care resource use, issues in observational research, and patient-reported outcomes. The Chemistry, Manufacturing, and Controls track, organized by Brad Evans of Pfizer, will focus on statistical contributions to stability studies and release limits, the new FDA process validation guidance, and bioassay development, implementation, and challenges within the pharmaceutical industry.

Additional opportunities to meet speakers and network will be afforded at the Monday evening mixer and the Tuesday social hour, followed by the banquet with Russell Lyons of Indiana University. He will give a talk titled “Fat Chance: Adventures in Debunking.”

Contributed posters are being accepted for the poster session on Tuesday, which will take place over the lunch hour and be chaired by Paul Berg of Eli Lilly. Posters will be considered on any biopharmaceutical statistical topic. Abstracts must be submitted by April 20. Details will be provided on the website.

Students are especially encouraged to participate in the MBSW activities. To help financially, limited scholarships are available to students to offset travel costs, with preference given to students 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 the workshops. Students or faculty sponsors interested in applying for scholarships should visit the website for information or contact Berg at pberg@lilly.com.

General questions about cost and housing will be available on the website. For more information, contact Publicity Chair Melvin Munsaka at melvin.munsaka@takeda.com, Workshop Chair Douglas Faries at faries_douglas_e@lilly.com, or Local Arrangements chairs Mir Masoom Ali at mali@bsu.edu and Dale Umbach at dumbach@bsu.edu.