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Keyword Search Criteria: oncology returned 44 record(s)
Sunday, 07/29/2018
Statistical Development in Addressing Delayed Treatment Effect or Crossing Survival Curves in Immuno-Oncology Clinical Trials
Huyuan Yang, Takeda Oncology Pharmaceutical
2:20 PM

Cure Survival Data in Oncology Studies
Shih-Yuan Lee, Takeda
2:35 PM

Statistical Evaluation of Oncology Drug Trial Portfolios and the Potential for Inappropriate Regulatory Approval: a Simulation Study
Renee Gennarelli, Memorial Sloan Kettering Cancer Center; Peter Bach, Memorial Sloan Kettering Cancer Center; Mithat Gonen, Memorial Sloan Kettering Cancer Center
3:20 PM

A Case Study on Model Based Meta-Analysis (MBMA) for Drug Development Decisions
Guohui Liu, Takeda Pharmaceuticals Inc ; Zhaoyang Teng, Takeda pharmaceuticals international, Co; Zhaowei Hua, Takeda Pharmaceuticals International Co.; Neeraj Gupta, Takeda pharmaceuticals international, Co; Richard Labotka, Takeda pharmaceuticals international, Co
3:35 PM

Sample Size and Power Calculation for Immuno-Oncology Clinical Trials
Binbing Yu, MedImmune, Inc.; Dongyue FU, MedImmune, Inc.; Hefei (Harry) Yang, MedImmune, Inc.
4:20 PM

Case Studies of Non-Proportional Hazards in Oncology and Hematology Trials
Jingjing Ye, FDA
4:45 PM

Monday, 07/30/2018
Challenges in Oncology: Pragmatic Trials Using Real-World Evidence
Zhe Zhang, Pfizer


Comparison of Methods for Predicting High-Cost Patients Captured Within the Oncology Care Model (OCM): a Simulation Study
Jung-Yi Lin, Icahn School of Medicine at Mount Sinai; Wei Zhang, UALR; Mark Liu, Mount Sinai Health System; Mark Sanderson, Mount Sinai Health System; Luis Isola, Mount Sinai Health System; Madhu Mazumdar, Icahn School of Medicine at Mount Sinai; Liangyuan Hu, Icahn School of Medicine at Mount Sinai


A Bayesian Logistic Model with Covariate to Identify Optimal Dose for Heterogeneous Population in Phase I Oncology Trial
Xin Wei, Celgene Corporation; Michael Branson, celgene corporation
8:50 AM

Comparison of Methods for Predicting High-Cost Patients Captured Within the Oncology Care Model (OCM): a Simulation Study
Jung-Yi Lin, Icahn School of Medicine at Mount Sinai; Wei Zhang, UALR; Mark Liu, Mount Sinai Health System; Mark Sanderson, Mount Sinai Health System; Luis Isola, Mount Sinai Health System; Madhu Mazumdar, Icahn School of Medicine at Mount Sinai; Liangyuan Hu, Icahn School of Medicine at Mount Sinai
9:10 AM

Practical Considerations on the Challenges to the Design and Analysis of Immuno-Oncology Trials
Yabing Mai, AbbVie, Inc; Yue Shentu, Merck and Co Inc
11:50 AM

An Application of 2-In-1 Adaptive Phase 2/3 Design for Expedited Oncology Drug Development
Xinqun (Maggie) Chen, Merck & Co., Inc.; Linda Sun, Merck & Co., Inc.; Cong Chen, Merck & Co.
2:05 PM

A Meta-Analysis to Indirectly Compare Experimental Drugs Across Multiple Indications Using a Bayesian Hierarchical Model
Ji Lin, Eli Lilly; Jingyi Liu, Eli Lilly; Zachary Thomas, Eli Lilly; Yumin Zhao, Eli Lilly & Co.; Mythili Koneru, Eli Lilly
2:05 PM

Extension of Bayesian Logistic Regression Model (BLRM) for Dose Timing Selection in Oncology Phase I Combination Studies
Yiyun Zhang, Novartis; Nigel Yateman, Novartis; Fang Xiang, Novartis; Lan Yi, Novartis; Kapildeb Sen, Novartis; Beat Neuenschwander, Novartis
2:05 PM

Does Phase 2 PFS or ORR Predict Phase 3 OS?
Russell Reeve, Quintiles
2:50 PM

A Simulation-Based Comparison Study About Different Methods Adjusting for the Bias of Treatment Non-Adherence
Jia Jia, AbbVie; Ying Zhang, Penn State College of Medicine; Jane Qian, Abbvie
3:20 PM

Tuesday, 07/31/2018
Determination of Optimal Cut-Off Points for Biomarkers in Oncology Research
Shu-Pang Huang, Bristol-Myers Squibb Co.; Tian Chen, Bristol-Myers Squibb Co.; Ye Feng, Bristol-Myers Squibb Co.; Ming Zhou, Bristol-Myers Squibb Company; Ramachandran Suresh, Bristol-Myers Squibb Co.


Safety Data Presentations in USPIs: Methodological Considerations
Adam Boyd, Array BioPharma Inc; Michael Pickard, Array BioPharma Inc


Relationship Between ORR, PFS and OS in Patients Treated with Anti-PD1/PDL1 Therapies
Jiabu Ye, AstraZeneca; Pralay Mukhopadhyay, Astrazeneca; Xiang Ji, AstraZeneca


Complexity of Implementing Sample Size Re-Estimation (SSR) in Oncology Trials
Alicia Zhang, Amgen; Yuqi Chen, Amgen; Chris Holland, Amgen
8:35 AM

Benefit Cost Ratio Analysis in Oncology Drug Development: Single Arm Vs RCT
Thomas Jemielita, Merck & Co.; Cong Chen, Merck & Co.
9:15 AM

Design Considerations in Clinical Trials with Cure Rate Survival Data: a Case Study in Oncology
Grace Liu, Johnson & Johnson; Steven Sun, J&J; Tzu-min Yhe, janssen pharmaceuticals; Tianmeng Lyu, University of Minnesota; Rao Sudhakar, janssen pharmaceuticals; Bruce Xue, Johnson & Johnson China
9:20 AM

Relationship Between ORR, PFS and OS in Patients Treated with Anti-PD1/PDL1 Therapies
Jiabu Ye, AstraZeneca; Pralay Mukhopadhyay, Astrazeneca; Xiang Ji, AstraZeneca
9:45 AM

Basket Trials Design and Analysis in Non-Oncology Therapeutical Areas
Binbing Yu, MedImmune/AstraZeneca; Jingjing Chen, Takeda Pharmaceuticals; Dewei She, MedImmune/AstraZeneca; Jianliang Zhang, Medimmune, LLC
9:50 AM

Limitations of Progression Free Survival as a Surrogate Marker for Overall Survival in Oncology Trials
Robin Mogg, Merck Research Laboratories; Yiwei Zhang, Merck Research Laboratories
11:15 AM

Developing Genomic Biomarker to Guide Personalized Patient Management in Oncology: Validity and Utility of Clinical Diagnostic Applications
Michael Crager, Genomic Health; Ruixiao Lu, Genomic Health, Inc.
11:25 AM

Modeling Overall Survival Under Immuno-Oncology Therapies with Long-Term Survival Models
Junshui Ma, Merck & Co., Inc.; Keaven Anderson, Merck & Co., Inc.
11:35 AM

Biomarker-Defined Subgroup Selection Adaptive Design for Phase III Confirmatory Trial
Rui Tang, Shire; Xiaoye Ma, University of Minnesota; Hui Yang, Amgen Inc.
11:50 AM

Dose Finding Model Selection in Oncology Combination Therapy
Lixia Pei, Janssen Pharmaceuticals ; Yichen Guo, Harvard University; Kevin Liu, Janssen Pharmaceuticals
2:20 PM

Reproducibility of FDG-PET Standardized Uptake Value (SUV) for Use as an Integral Biomarker in Clinical Trials
Brenda Kurland, University of Pittsburgh
3:05 PM

Predicting Cancer Outcomes from Genomics Data
Peter Campbell, Wellcome Trust Sanger Institute
3:20 PM

Wednesday, 08/01/2018
Statistical Models for Longitudinal Analysis of Preclinical Efficacy Screens
William Forrest, Genentech, Inc; Bruno Alicke, Genentech; Oleg Mayba, Genentech; Alice Starr, Genentech


Statistical Models for Longitudinal Analysis of Preclinical Efficacy Screens
William Forrest, Genentech, Inc; Bruno Alicke, Genentech; Oleg Mayba, Genentech; Alice Starr, Genentech
8:45 AM

A Case Study of Adaptive Seamless Design with Subpopulation Selection in Oncology
Rui Qin, Janssen Pharmaceutical R&D
8:55 AM

A Biomarker-Directed Phase 2 Oncology Umbrella Trial to Target Combination Therapy in NSCLC
Hua Ma, Merck; Robin Mogg, Merck Research Laboratories
9:35 AM

Adaptive Multi-Combination Platform Trials in Oncology; Considerations for Study Designs
Stuart Bailey, Novartis Institutes for Biomed Research; Jennifer Gauvin, Novartis
9:55 AM

Improving Dose-Finding for Early Oncology Trials with Monotherapy and Combination Therapy
Zhen Zeng, Merck & Co.; Meihua Wang, Merck & Co.; Victoria Plamadeala Johnson, Merck & Co.; Cong Chen, Merck & Co.
11:15 AM

Adaptive Dose Finding in Oncology Phase I-II Studies with Consideration of Tolerability and Efficacy
Rachael Liu, Takeda Pharmaceuticals ; Ling Wang, Takeda; David Sinclair, Google; Jianchang Lin, Takeda Pharmaceuticals
11:35 AM

Thursday, 08/02/2018
Variational Inference for Proportional Hazards Model with Power Prior in Oncology Studies
Bo Jin, Boston Biomedical Inc.; Yue Chang, Boston Biomedical Inc
8:35 AM

Utilization of Historical Data and Real World Evidence in Clinical Trial Development - Case Studies in Rare Disease and Oncology
Florence H Yong, Pfizer Inc.; Ray Li, Pfizer Inc.; Steven Y Hua, Celgene - Receptos; Jeffery Palmer, Pfizer Inc.; Roberto Bugarini, Pfizer Inc.
8:50 AM

Adaptive Bayesian Interval-Based Oncology Dose Finding Design with Quasi-Continuous Toxicity Model
Dan Zhao, University of Illinois at Chicago; Jian Zhu, Takeda; Eric Westin, ImmunoGen; Ling Wang, Takeda
10:50 AM

Individualized Adaptive Dose-Response Modeling in Multiple Myeloma: Potential to Improve Patient Care
Dean Bottino, Takeda Pharmaceuticals U.S.A.
10:55 AM

Detoxing Toxicity Analysis: Creating Analysis-Ready One-Proc Away ADLB
Ilya Krivelevich, Eisai; Ran Xie, Eisai Inc; Simon Lin, Eisai Inc
11:05 AM

Deriving and Analyzing Endpoints from Electronic Health Record Data: a Case Study from Clinical Oncology
Sandra Griffith, Flatiron Health; Ariel Bourla, Flatiron Health; Bryan Bowser, Flatiron Health ; Geoff Calkins, Flatiron Health; Joe Chang, Flatiron Health; Rebecca Miksad , Flatiron Health ; Brian Segal, Flatiron Health; Elizabeth Sweeney, Flatiron Health ; Erin Williams, Flatiron Health ; Paul You , Flatiron Health ; Amy Abernethy, Flatiron Health
11:15 AM