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Legend: Boston Convention & Exhibition Center = CC, Westin Boston Waterfront = W, Seaport Boston Hotel = S
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.

Activity Number

Title

Sponsor(s)

Type

Location


CE_03C
Analysis of Clinical Trials: Theory and Applications ASA
Biopharmaceutical Section
Professional Development Continuing Education Course Sat, 8/2
8:30 AM to 5:00 PM

Room: CC-160B
 

13
* Statistical Challenges for Cancer Clinical Trials Biopharmaceutical Section
Statistics Without Borders
International Indian Statistical Association
Topic Contributed Papers Sun, 8/3
2:00 PM to 3:50 PM

Room: CC-257B
 

21
* Patient Monitoring and Adaptive Intervention in Clinical Quality Improvement Biopharmaceutical Section
Topic Contributed Papers Sun, 8/3
2:00 PM to 3:50 PM

Room: CC-254B
 

30
* Adaptive Designs for Early Phase Studies Biopharmaceutical Section
Contributed Papers Sun, 8/3
2:00 PM to 3:50 PM

Room: CC-254A
 

31
* Power and Sample Size Biopharmaceutical Section
Contributed Papers Sun, 8/3
2:00 PM to 3:50 PM

Room: CC-258C
 

46
* ! Data-Monitoring Committees: Do They Have Role in Post-Marketing Approval Commitments? Biopharmaceutical Section
Section on Medical Devices and Diagnostics
Scientific and Public Affairs Advisory Committee
Invited Papers Sun, 8/3
4:00 PM to 5:50 PM

Room: CC-258A
 

63
* ! Missing Data in Safety Evaluation and Observational Studies Biopharmaceutical Section
Topic Contributed Papers Sun, 8/3
4:00 PM to 5:50 PM

Room: CC-260
 

66
* ! Enrollment and Event Projection in Clinical Trials Social Statistics Section
Biopharmaceutical Section
Topic Contributed Papers Sun, 8/3
4:00 PM to 5:50 PM

Room: CC-157B
 

72
* Biomarkers and Endpoint Validation 1 Biopharmaceutical Section
Contributed Papers Sun, 8/3
4:00 PM to 5:50 PM

Room: CC-208
 

73
* Randomization and Covariate Adjustment Biopharmaceutical Section
Contributed Papers Sun, 8/3
4:00 PM to 5:50 PM

Room: CC-209
 

210653
Biopharmaceutical Section Executive Committee Meeting Biopharmaceutical Section
Other Cmte/Business Mon, 8/4
7:30 AM to 12:00 PM

Room: S-Seaport Ballroom C
 

113
Go/No-Go: The Practice for Developing Best-in-Class Product from Statistical Perspective Biopharmaceutical Section
Topic Contributed Papers Mon, 8/4
8:30 AM to 10:20 AM

Room: CC-257B
 

114
* ! Statistical Issues in Process Validation of Pharmaceutical Products Biopharmaceutical Section
Section on Physical and Engineering Sciences
Topic Contributed Papers Mon, 8/4
8:30 AM to 10:20 AM

Room: CC-257A
 

127
* Bayesian Designs in Clinical Trials Biopharmaceutical Section
International Society for Bayesian Analysis (ISBA)
Contributed Papers Mon, 8/4
8:30 AM to 10:20 AM

Room: CC-258C
 

128
* Statistical Methods for Early Stopping and Go/No-Go Decision Biopharmaceutical Section
Contributed Papers Mon, 8/4
8:30 AM to 10:20 AM

Room: CC-258B
 

CE_14C
Design and Analysis of Noninferiority Trials ASA
Biopharmaceutical Section
Professional Development Continuing Education Course Mon, 8/4
8:30 AM to 5:00 PM

Room: CC-162AB
 

149
* ! Global Development of Biopharmaceutical Products: Past, Present and Future Biopharmaceutical Section
Section on Medical Devices and Diagnostics
Invited Papers Mon, 8/4
10:30 AM to 12:20 PM

Room: CC-257B
 

157
* ! Impact of Statistics on Imaging Studies in Drug Development Biopharmaceutical Section
Section on Statistics in Imaging
Topic Contributed Papers Mon, 8/4
10:30 AM to 12:20 PM

Room: CC-213
 

167
Speed Session #2: Topics in Biopharmaceutical Research and Statistical Programming and Analysis, Part 1 Section for Statistical Programmers and Analysts
Biopharmaceutical Section
Contributed Speed Mon, 8/4
10:30 AM to 12:20 PM

Room: CC-255
 

172
* Statistical Methods in Oncology Trials Biopharmaceutical Section
Contributed Papers Mon, 8/4
10:30 AM to 12:20 PM

Room: CC-259A
 

173
* Biopharmaceutical Section Student Paper Competition Biopharmaceutical Section
Contributed Papers Mon, 8/4
10:30 AM to 12:20 PM

Room: CC-260
 

217
* The Role of Statisticians in Risk-Based Monitoring and Fraud Detection in Clinical Trials Biopharmaceutical Section
Topic Contributed Papers Mon, 8/4
2:00 PM to 3:50 PM

Room: CC-257B
 

222
* ! Showcasing the Application of Bayesian Methods in Drug Development via Case Studies Biopharmaceutical Section
International Society for Bayesian Analysis (ISBA)
Topic Contributed Papers Mon, 8/4
2:00 PM to 3:50 PM

Room: CC-254A
 

233
* Meta-Analysis in Biopharmaceutical Research Biopharmaceutical Section
Contributed Papers Mon, 8/4
2:00 PM to 3:50 PM

Room: CC-254B
 

234
* Subgroup Analysis and Biomarkers Biopharmaceutical Section
Contributed Papers Mon, 8/4
2:00 PM to 3:50 PM

Room: CC-258C
 

245
Speed Session #2: Topics in Biopharmaceutical Statistics and Programming and Analysis, Part 2 Biopharmaceutical Section
Section for Statistical Programmers and Analysts
Contributed Poster Presentations Mon, 8/4
2:00 PM to 2:45 PM

Room: CC-Exhibit Hall B2
 

269
* ! Statisticians' Contributions to Public Health Achievements of the 20th Century Biopharmaceutical Section
Scientific and Public Affairs Advisory Committee
ASA 175th Anniversary Steering Committee
Committee on ASA Archives and Historical Materials
Invited Papers Tue, 8/5
8:30 AM to 10:20 AM

Room: CC-151A
 

277
* ! Designs and Analyses of Studies with Small Sample Sizes Biopharmaceutical Section
Topic Contributed Papers Tue, 8/5
8:30 AM to 10:20 AM

Room: CC-153A
 

280
* ! Learning to Use and Love Analysis Data Standards Biopharmaceutical Section
Education Workgroup on Undergraduate Curriculum Guidelines
Topic Contributed Papers Tue, 8/5
8:30 AM to 10:20 AM

Room: CC-153C
 

293
* Dose Finding, Dose Range, and Oncology Trials Biopharmaceutical Section
Contributed Papers Tue, 8/5
8:30 AM to 10:20 AM

Room: CC-151B
 

305
* Statistical Issues in Drug Development and Labeling Biopharmaceutical Section
Contributed Papers Tue, 8/5
8:30 AM to 10:20 AM

Room: CC-156C
 

CE_22C
Genomic Clinical Trials and Predictive Medicine ASA
Biopharmaceutical Section
Professional Development Continuing Education Course Tue, 8/5
8:30 AM to 5:00 PM

Room: CC-162AB
 

319
* Impact of Missing Data on Trial Success and Approval of Potentially Efficacious Therapies Biopharmaceutical Section
Topic Contributed Papers Tue, 8/5
10:30 AM to 12:20 PM

Room: CC-156A
 

330
* Advancing Oncology Drug Development Using Biomarker and Surrogate Endpoints Biopharmaceutical Section
Topic Contributed Papers Tue, 8/5
10:30 AM to 12:20 PM

Room: CC-156C
 

331
Speed Session #5: Topics in Nonparametric and Biopharmaceutical Statistics, Part 1 Biopharmaceutical Section
Section on Nonparametric Statistics
Contributed Speed Tue, 8/5
10:30 AM to 12:20 PM

Room: CC-255
 

335
* Assessing Biosimilar and Equivalence Biopharmaceutical Section
Contributed Papers Tue, 8/5
10:30 AM to 12:20 PM

Room: CC-153B
 

336
* Modeling in Longitudinal Analysis Biopharmaceutical Section
Contributed Papers Tue, 8/5
10:30 AM to 12:20 PM

Room: CC-157C
 

350
Contributed Oral Poster Presentations: Biopharmaceutical Section Biopharmaceutical Section
Contributed Poster Presentations Tue, 8/5
10:30 AM to 12:20 PM

Room: CC-Exhibit Hall B2
 

377
* ! Optimizing Drug Development Programs and Portfolios: Beyond Adaptive Design Biopharmaceutical Section
Topic Contributed Papers Tue, 8/5
2:00 PM to 3:50 PM

Room: CC-252B
 

385
* ! Impacts of Emerging Global Clinical Trials Transparency Initiatives Biopharmaceutical Section
Section on Medical Devices and Diagnostics
Topic Contributed Papers Tue, 8/5
2:00 PM to 3:50 PM

Room: CC-251
 

394
* Innovative Clinical Trial Design and Analysis Methods Biopharmaceutical Section
Contributed Papers Tue, 8/5
2:00 PM to 3:50 PM

Room: CC-258A
 

395
* Missing Data Methods 1 Biopharmaceutical Section
Contributed Papers Tue, 8/5
2:00 PM to 3:50 PM

Room: CC-258B
 

409
Speed Session #5: Topics in Nonparametric and Biopharmaceutical Statistics, Part 2 Section on Nonparametric Statistics
Biopharmaceutical Section
Contributed Poster Presentations Tue, 8/5
2:00 PM to 2:45 PM

Room: CC-Exhibit Hall B2
 

210702
Biopharmaceutical Section Business Meeting Biopharmaceutical Section
Other Cmte/Business Tue, 8/5
5:30 PM to 7:00 PM

Room: S-Plaza Ballroom C
 

422
Biopharmaceutical Section A.M. Roundtable Discussion (Fee Event) Biopharmaceutical Section
Roundtables AM Roundtable Discussion Wed, 8/6
7:00 AM to 8:15 AM

Room: CC-Ballroom West
 

429
* ! Statistical Planning of an Adaptive Design in Early Phase Trials Biopharmaceutical Section
Invited Papers Wed, 8/6
8:30 AM to 10:20 AM

Room: CC-260
 

443
* Sequential Monitoring in Late-Stage Clinical Trials Biopharmaceutical Section
Topic Contributed Papers Wed, 8/6
8:30 AM to 10:20 AM

Room: CC-258A
 

458
* Sample Size Determination and Mid-Course Adjustment Biopharmaceutical Section
Contributed Papers Wed, 8/6
8:30 AM to 10:20 AM

Room: CC-254A
 

459
* Multiplicity Adjustment Methods 1 Biopharmaceutical Section
Contributed Papers Wed, 8/6
8:30 AM to 10:20 AM

Room: CC-257B
 

484
* ! Bayesian Methods in Global Clinical Trials: An Era of Synthesizing Evidence Biopharmaceutical Section
International Society for Bayesian Analysis (ISBA)
International Indian Statistical Association
Topic Contributed Papers Wed, 8/6
10:30 AM to 12:20 PM

Room: CC-252B
 

492
* ! Approaches for Benefit-Risk Assessment in Clinical Development Decisionmaking Biopharmaceutical Section
Topic Contributed Papers Wed, 8/6
10:30 AM to 12:20 PM

Room: CC-254B
 

500
* Noninferiority and Equivalence Trials Biopharmaceutical Section
Contributed Papers Wed, 8/6
10:30 AM to 12:20 PM

Room: CC-258B
 

501
* Methods for Safety, Quality, and Benefit-Risk Biopharmaceutical Section
Contributed Papers Wed, 8/6
10:30 AM to 12:20 PM

Room: CC-251
 

522
Biopharmaceutical Section P.M. Roundtable Discussion (Fee Event) Biopharmaceutical Section
Roundtables PM Roundtable Discussion Wed, 8/6
12:30 PM to 1:50 PM

Room: CC-Ballroom West
 

534
* ! Innovative Designs in Vaccine Clinical Trials Biopharmaceutical Section
Invited Papers Wed, 8/6
2:00 PM to 3:50 PM

Room: CC-258A
 

546
* ! Recent Advances in Covariate-Adaptive Randomization in Clinical Trials: Statistical, Operational, and Regulatory Aspects Biopharmaceutical Section
Topic Contributed Papers Wed, 8/6
2:00 PM to 3:50 PM

Room: CC-252A
 

563
* Multiplicity Adjustment Methods 2 Biopharmaceutical Section
Contributed Papers Wed, 8/6
2:00 PM to 3:50 PM

Room: CC-259A
 

564
* Modeling, Simulations, Predictions, and Pro for Labeling Biopharmaceutical Section
Contributed Papers Wed, 8/6
2:00 PM to 3:50 PM

Room: CC-257A
 

591
! Clinical Trials: Innovative Design and Analysis Ideas for Improving Efficiency Biopharmaceutical Section
Topic Contributed Papers Thu, 8/7
8:30 AM to 10:20 AM

Room: CC-258A
 

592
* Design and Analysis of Large Outcomes Trials Biopharmaceutical Section
Topic Contributed Papers Thu, 8/7
8:30 AM to 10:20 AM

Room: CC-254B
 

605
* Adaptive Designs for Clinical Trials and Observational Studies Biopharmaceutical Section
Contributed Papers Thu, 8/7
8:30 AM to 10:20 AM

Room: CC-254A
 

606
* Biomarkers and Endpoint Validation 2 Biopharmaceutical Section
Contributed Papers Thu, 8/7
8:30 AM to 10:20 AM

Room: CC-252B
 

625
* Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies Based on the Totality of Evidence Biopharmaceutical Section
Invited Papers Thu, 8/7
10:30 AM to 12:20 PM

Room: CC-260
 

631
* ! Evidential Approaches to Multiplicity of Hypothesis Testing Biopharmaceutical Section
Topic Contributed Papers Thu, 8/7
10:30 AM to 12:20 PM

Room: CC-254A
 

632
* Biomarkers in Clinical Trials and the Regulatory Environment Biopharmaceutical Section
Topic Contributed Papers Thu, 8/7
10:30 AM to 12:20 PM

Room: CC-254B
 

646
* Missing Data Methods 2 Biopharmaceutical Section
Contributed Papers Thu, 8/7
10:30 AM to 12:20 PM

Room: CC-252B
 

657
* Analysis of Cut Point and Correlated Data Biopharmaceutical Section
Contributed Papers Thu, 8/7
10:30 AM to 12:20 PM

Room: CC-257B
 
  • A * preceding a session name means that the session is an applied session.
  • A ! preceding a session name means that the session reflects the JSM meeting theme.



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