Plans Under Way for 37th Annual Midwest Biopharmaceutical Statistics Workshop
Melvin S. Munsaka of Takeda Global Research & Development, Workshop Publicity Chair, and Steven Novick of GlaxoSmithKline, Workshop Chair
The following individuals have made vital contributions to the success of the workshop:
- Cindy Lee of Eli Lilly, Co-Registrar
- Yun-Fei Chen of Eli Lilly, Co-Registrar
- Yonggang Zhao of Skyview Pharma Services, Treasurer
- Ying Grace Li of Eli Lilly, Treasurer
- Dale Umbach, Local Arrangements Chair
- Fangyi Zhao of Eli Lilly, Outgoing Poster Session Chair
- Bill Pikounis of Johnson and Johnson, Past Poster Session Chair, Webmaster, and Social Feeds
- Charles Sampson of Eli Lilly (retired)
- Mir Masoom Ali of Ball State University (retired)
- Stan Young of CGStat
- Jeff Hofer of Eli Lilly
- Jackie Reisner of PPD
Additionally, we would like to acknowledge the contributions of the session chairs and speakers, all of whom are listed on the website.
The 37th Midwest Biopharmaceutical Statistics Workshop (MBSW), with the theme “Modern Perspectives: Model Selection and Validation,” will be held at Ball State University in Muncie, Indiana, May 19–21 at the alumni center.
The workshop will begin with two half-day short courses—Network-Based Analysis of High-Throughput Omics Data by Steven Ma of Yale University and An Introduction to Data-Driven Treatment Regimes by Eric Laber of North Carolina State University—before moving into the afternoon plenary session. Plenary speakers are Marianthi Markatou of SUNY – Buffalo, who will discuss lessons learned from the OMOP and Sentinel experiments, and C. Glenn Begley (independent consultant), who will discuss validation in drug development.
As usual, 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 at least two hours in length with 3–5 speakers. Speakers have time to discuss topics in more detail than at many conferences, and participants will have many opportunities to ask questions and participate in discussions. Additionally, speakers from the FDA and other governmental agencies will be invited to give presentations.
The theme of the Clinical track, organized by David Manner of Eli Lilly, is “Modern statistical methodologies for analyzing clinical trials … This is not your father’s analysis.” This track will include sessions of historical control data in clinical trials, Bayesian analyses of safety data, and novel subgroup identification methods.
The Discovery/Pre-clinical track, organized by Ray Liu of Takeda, will focus on translation research—theoretical, practical, and regulatory perspectives.
The theme of the Health Outcomes and Observational Research track, organized by Jie Cheng of GlaxoSmithKline, is “The statistical elements you need for success in health outcome studies.” It will include sessions on methodological developments for indirect treatment comparisons and network meta-analyses and personalized medicine for observational data.
The Chemistry, Manufacturing, and Controls track, organized by Brad Evans of Pfizer Inc., has the theme “Data, analysis, and beyond—that is, we do more than number crunching” and will include sessions on dissolution, statistical influence/regulatory, and biosimilars.
A student-focused session organized by Yun-Fei Chen and Brian Millen of Eli Lilly and Cathie Spino of the University of Michigan will be part of the workshop again.
Additional opportunities to meet speakers and network will take place during the Monday evening mixer and Tuesday social hour and banquet. Kaiser Fung from Vimeo will discuss his book, Numbersense: How to Use Big Data to Your Advantage.
Contributed posters are being accepted for the poster session, held on Tuesday, with Ying (Grace) Li of Eli Lilly serving as the chair. The poster session theme is “From theories to applications: Great opportunities being a statistician in the pharmaceutical industry.” Posters will be considered on any biopharmaceutical statistical topic. Abstracts must be submitted by April 11. Visit the website for details.
Students are especially encouraged to participate in the MBSW activities. To help financially, limited scholarships are available 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 this series of workshops. Students or faculty sponsors interested in applying for scholarships should visit the workshop website or contact Ying Grace Li at li_ying_grace@lilly.com for details.
MBSW was co-founded by Charles B. Sampson and Mir Masoom Ali and is co-sponsored by the Biopharmaceutical Section. MBSW, which was founded as a conference to meet the needs of U.S. pharmaceutical industry statisticians in the Midwest, has remained in Muncie, but welcomes attendees from across the United States and around the world.
Questions not addressed on the website can be sent to Melvin Munsaka, publicity chair, at melvin.munsaka@takeda.com; Steven Novick, workshop chair, at chair@mbswonline.com; or Dale Umbach, local arrangements chair, at dumbach@bsu.edu.
Updates about MBSW are being posted on:
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