The Biopharmaceutical Section welcomes everyone to 2014 JSM in Boston!

This year we will be celebrating the 175th anniversary of ASA at JSM. Our section has many activities on the program starting with its continuing education program. We are offering three full day short courses at JSM. On Saturday (Aug 2nd) of the JSM, Alexei Dmitrenko, Jeff Maca (both of Quintiles) and Devan Mehrotra (Merck) will give a short course on Analysis of Clinical Trials: Theory and Applications. On Monday (Aug 4th) of the JSM, Brian Wiens (Alcon Labs) will teach his class on the Design and Analysis of Non-inferiority Trials. On Tuesday (Aug 5th) of JSM, Dr. Richard Simon from National Cancer Institute will present a short course on Genomic Clinical Trials and Predictive Medicine.

In addition, we will have 6 invited sessions, 22 sponsored topic contributed sessions, and 26 contributed sessions! I will highlight a few to entice you to join us and strongly advise that you go to the ASA website ( and check out the program now on-line.

Sunday at JSM (Aug 3rd)
2:00PM Statistical Challenges for Cancer Clinical Trials Organizer: Sudhakar Rao, Janssen pharmaceutical
4:00PM Data Monitoring Committees - Do they have role in Post-Marketing Approval Commitments? Organizer: Vipin Arora, AbbVie, Inc

Monday at JSM (Aug 4th)
8:30 AM Go/No-Go: the practice for developing best-in-class product from statistical perspective Organizer: Xuan Liu, AbbVie
10:30 AM Global development of biopharmaceutical products: past, present and future
Organizer: Bo Yang, AbbVie
10:30 AM Biopharmaceutical Section Student Paper Competition Chair: Richard McNally, Covance
2:00PM The Role of Statisticians in Risk-Based Monitoring and Fraud Detection in Clinical Trials Organizer: Richard C. Zink, JMP Life Sciences, SAS Institute

Tuesday at JSM (Aug 5th)
8:30 AM Statisticians' Contributions to Public Health Achievements of the 20th Century Organizer: Christy Chuang-Stein, Pfizer Inc
10:30AM Impact of missing data on trial success and approval of potentially efficacious therapies Organizer: Abdul J Sankoh, Vertex Pharmaceuticals
2:00PM Impacts of emerging global clinical trials transparency initiatives Organizer: Theodore Lystig, Medtronic, Inc.

Wednesday at JSM (Aug 6th)
8:30 AM Statistical planning of an adaptive design in early phase trials Organizer: Bo Huang, Pfizer Inc.
10:30AM Approaches for Benefit-Risk Assessment in Clinical Development Decision-Making Organizer: Weili He, Merck & Co., Inc.
2:00PM Innovative Designs in Vaccine Clinical Trials Organizer: Robert D. Small, Sanofi Pasteur

Thursday at JSM (Aug 7th)
8:30 AM Design and analysis of large outcomes trials Organizer(s): Charlie Cao, Takeda Development Center Americas, Inc.
10:30 AM Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence Organizer(s): Byron Jones, Novartis Pharma AG

Many of the contributed submissions are excellent so we urge you not to skip these. The poster sessions: these are great if you like having a one on one discussion with the authors. This year we also have a hybrid kind of presentation, the SPEED session (like speed-dating…. only better). In the SPEED session, you get to hear a short 5 minute talk on each presentation with 20 such talks in a session. In the following session, you get to talk with the authors and enjoy some refreshments. In addition, our section will sponsor 1 roundtable discussion sessions on Wednesday. Please check out the details and registration information on the JSM website.

Of course, while you tell your boss that you are coming for all the intellectual stimulation, I urge section members to attend our reception and business meeting on Aug 5th (Tuesday). Check the program for the time and place. Please come and be engaged!

Submissions are now being accepted for the 2014 Biopharm Student Paper Awards

Submissions are now being accepted for the 2014 Biopharmaceutical Student Paper Awards. These awards ($1000 for first place, $600 for 2nd, $400 for 3rd ) are presented annually during the Biopharmaceutical Section open business meeting held at the 2014 Joint Statistical Meetings in Boston. Winners will present their paper during in one of the contributed paper sessions at JSM and are encouraged to attend the section’s business meeting to receive their award in person.

See details at:

Congratulations to the winners of Biopharm Section 2013 JSM best contributed poster award

1 - Li Wang and Weihua Tang, Bristol-Myers Squibb
Meta Analysis for All-cause Death for Apixaban vs. Placebo Or Control in SPAF Trials

2 - Jianing Di, Xin Zhao, Daniel Wang, Ming Lu, and Michael Krams, Janssen Research & Development
Assessing the Cumulative Exposure Response in Alzheimer Disease Studies

3 - Kelly H. Zou, Ching-Ray Yu, Ye Tan, and Martin O. Carlsson, Pfizer Inc.
Comparative Effectiveness Research Using Meta-Analysis to Evaluate and Summarize Diagnostic Accuracy

What's New


Biopharm Report Winter 2014


Karen Price - Bayesian Statistics

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