Melvin S. Munsaka, Takeda Global Research & Development, and Bill Pikounis, Johnson & Johnson
The 36th Midwest Biopharmaceutical Statistics Workshop (MBSW), with the theme “Sharing Statistical Solutions,” will be held at Ball State University in Muncie, Indiana, May 20–22 at the alumni center.
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, Poster Session Chair
Charles Sampson of Eli Lilly (retired), Chair Emeritus
Mir Masoom Ali of Ball State (retired)
Stan Young of CGStat, Workshop Consultant
Jeff Hofer of Eli Lilly, Workshop Consultant
Jackie Reisner of PPD, Workshop Consultant
Wherly Hoffman of Eli Lilly (retired), Workshop Consultant
The workshop will begin with two half-day short courses—Survival Data Models by Terry Therneau of the Mayo Clinic and Handling Informative Censoring by Diane Fairclough of the University of Colorado—before moving into the afternoon plenary session. Plenary speakers are Lee Wilkinson of Advise Analytics/UIC and Frank Harrell of Vanderbilt University. They will discuss expert systems and statistical graphics, among other topics.
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.
The theme of the Clinical track, organized by Bret Musser of Merck, is “Advancing Clinical Trials” and will include sessions on safety in drug development and quantitative methods for decisionmaking.
The Discovery/Pre-clinical track, organized by Steven Novick of GlaxoSmithKline, has the theme “Challenges and Solutions in a Variety of Discovery/Preclinical Statistical Areas.” It will include sessions on current statistical issues in assay development and validation, next generation sequencing and its statistical issues, and reproducible research.
The Health Outcomes and Observational Research track, organized by Gerhardt Pohl of Eli Lilly, has a central theme of “Progressing Observational Research.” It will include sessions on econometric methods in pharmaceutical research, the FDA Sentinel and OMOP initiatives, and methods for missing data.
The Chemistry, Manufacturing, and Controls track—organized by Brad Evans of Pfizer—will include sessions on stability testing beyond ICH Q1E, spec setting, and accelerated testing for biologics. Talks within each session will allow more time for discussion and, ideally, provide opportunities for further collaboration.
A student-focused session organized by Yun-Fei Chen of Eli Lilly and Cathie Spino of the University of Michigan also will be part of the MBSW.
Additional opportunities to meet speakers and network will take place during the Monday evening mixer and Tuesday social hour and banquet. Paul McKenzie of Johnson & Johnson will give a talk titled “Leadership and Career Development” during the banquet.
Contributed posters are being accepted for the poster session, which will be held on Tuesday, with Fangyi Zhao of Eli Lilly serving as the chair. Posters will be considered on any biopharmaceutical statistical topic. Abstracts must be submitted by April 10. See the workshop 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 successful series of workshops. Students or faculty sponsors interested in applying for scholarships should visit the workshop website or contact Fangyi Zhao at zhao_fangyi@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 welcomed 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; Bill Pikounis, 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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