Shanghai (Nov 12 - Nov 13, 2021)

Application Development & Technical Techniques Coder's Corner Data Validation & Management Data Standards/CDISC and Regulatory Submission

Data Visualization and Graphics Management and Career Development Statistics & R

Application Development & Technical Techniques

AD03. Data De-identification of Demographic Detail in Adult and Pediatric Study
Huan Lu, Sanofi Aventis

AD08. Risk of Re-identification Assessment
Lanlan Peng, Sanofi Aventis

AD11. Auto-annotation in SDTM aCRF Using R Package and SAS
Teresa Tang, Merck

AD13. A Tool to Combine TFL Outputs
Jason Wang,Yashan Zhou, WuXi Clinical

AD14. Development of Integrated Statistical Computing Platform (iSCP) Based on Intelligent Apps
Zhiping Yan, Dizal

AD20. Title/footnote Auto Extraction from TLG shell to Program Tracker
Jiapeng He, Tingting Zeng, BeiGene, Beijing

AD32. A Submission Package Translation Toolkit by SAS and Excel VBA
Shijia Wang, Tigermed Co., Ltd.

AD35. CRF Chinese Translation – Mask Plan
Chunpeng Zhao, Liming Xie, Chunling Xu, BeiGene

AD40. Automation for CRF Annotation and Bookmark Generation via Python
Peng Wang, Yiqun Wang, Cstone Pharmaceuticals

AD42. Essential project management skill for solving potential risks of electronic study data submission to PMDA
Manabu Uehara, Takashi Kitahara, Novartis

AD44. ISPP, an Integrated Statistical Programming Platform to systematically manage study programing environment, program, output, log, lst and more
Jinling Li, BeiGene

AD45. AUTOMATING SAS EG INTEGRATION TECHNOLOGIES VIA EXCEL VBA
Xiaoyang Yu, Anheart Therapeutics(Hangzhou) Co.,Ltd.

AD49. An Approach to Generate Define.xml for Submission in China Based on Python
Siyi Li, Sanofi Aventis

AD61. Leveraging Python Streamlit to do project management
Zhiwei Luo, Pfizer (China) Research and Development Co.,Ltd. China

AD67. SDTM ARTs - a CRF-Driven SDTM Automation Tool for Generating aCRF, SDTM Mapping Specification and Programs
Haiqiang Luo, Kaiying Li, Xiaoyi Niu, Xiaoxia Zhou, Hengrui Pharma, Guangzhou, China

AD72. Using R Shiny to Explore Clinical Trial Data
Yaoxian Yuan, Jiaying Wu, CStone Pharmaceuticals (Suzhou) Co., Ltd

AD75. Automated Process from aCRF to ADRG for SAS programming with Python and VBA
Weineng Zhou, Parexel International, Shanghai, China

AD101. Multi-study programming – a best practice outline
Simon Purkess, Matt Metherell, PHASTAR, London, UK

Coder's Corner

CC04. TFLS TITLE CHECK TOOL
Beixin Lu, BeiGene Co., Ltd.

CC15. How to Translate RTF Documents
Jundong Ma, Zhiping Yan, Dizal Pharma, Shanghai, China

CC26. Surviving Left Truncation: Number at Risk Calculation for a Specific Timepoint Using SAS
Rolland Luo,Lihua Wu, Sanofi Aventis

CC53. A SAS Macro to Generate Customized Patient Profile Output Simply
Mingyue Zhu, Everest Clinical Research

CC65. Customize EXCEL Output
Hui Liu, Jiangsu Hengrui Pharmaceuticals Co.,Ltd., Guang Zhou

CC73. Float-point number and encode in SAS
Weineng Zhou, Parexel International, Shanghai, China

CC76. Estimating Binomial Proportion Confidence Interval with Zero Frequency Response using FREQ Procedure
Linga Reddy Baddam, Syneos Health®, Hyderabad, India

CC81. The Hidden Influence of Program Structure in the SAS DATA Step
Xiangyu Song, Laekna Therapeutics

Data Validation & Management (DM)

DM16. Quality Management of Critical Data from eDevice in Decentralized Clinical Trial
Yueqing Wang, Binqi Ye, Boehringer-Ingelheim, Co. Ltd

DM18. Don’t Panic: A Data Manager’s Guide to SDTM
Lanjin Jin, Boehringer-Ingelheim, Co. Ltd

DM23. Implementation of Data Cut-Off in Analysis of Oncology Clinical Trials
Shang Shi, Weibin Cai, Zhiping Yan, Dizal Pharma, Beijing, China

Data Standards/CDISC and Regulatory Submission

DS07. A Customizable Conformance Check Tool Design
Dan Li, Merck; Haiping Yu, dMed Biopharmaceutical Co., Ltd.

DS09. SAS Macro Solution for NMPA Submission Data Validation Rules
Ting Sun and Jipian He, dMed

DS33. Consideration and Solutions of Garbled Codes in Multiple Languages Projects
Yi Lu, Shijia Wang, Tigermed Co., Ltd.

DS36. SDTM Annotated CRF Digitalization
Chunpeng Zhao, Mijun Hu, Jiapeng He and Aide Zhou, BeiGene

DS46. Annotated CRF Submission to NMPA for Foreign Database
Shan Wan, Sanofi, Chengdu, China

DS47. Challenges and solutions for e-data submission to NMPA under new regulation
Grace Sun, Astrazeneca

DS51. Coding Data Translation Automation
Chunling Xu, Quting Zhang, Yankun Zhang, Yang Song, BeiGene (Beijing) Co., Ltd.

DS83. How to present exposure data nicely in the SDTM?
Manxi Chen, Everest Clinical Research

DS102. A case of mistaken ID: reimagining rescreenings and reenrollments
Matt Metherell, PHASTAR, London

Data Visualization and Graphics

DV05. Review Response Data with an R Shiny App
Hengwei Liu, Hengrui USA

DV22. SAS Macro to Derive Integrated PET+CT Response in FDG-avid Lymphoma per Lugano 2014
Jia Xu, Wenxiao Zhou, Xiaotong Li, Ziwen Tan, BeiGene Co., Ltd.

DV30. Visualization to detect risks of clinical data in Risk-Based Quality Management
Haitao Xu, Siyi Ma, Xilin Luo, Tigermed Co., Ltd.

DV39. Utilizing Plotly in R to Review Clinical Data with Interactive Plots
Kailu Song, Beigene (Beijing) Co., Ltd.

DV68. Visualization of Oncology Data from Interactive Dashboards
Jie Yue, Harbour BioMed

Management and Career Development

MA70. New Opportunities and Challenges for Statistical Programming Job Position in China Bio-Pharma
Xin Wang, Yu Cheng, Beijing Fosun Pharmaceutical Research and Development Co., Ltd.

Statistics & R

SR31. JSON Data in R
Peng Li, Sanofi Aventis

SR38. A novel insight into confirmed Best Overall Response per RECIST 1.1
Shuangbin Ji, CR Medicon, Nanjing, China

SR41. Number of Events Estimation using R step by step
Chunyan He, Ark Biosciences Inc.; Liyan Zhao, Changchun University of Technology

SR52. Being Therapeutic Area Coach for Programmers: Taking RECIST 1.1 Training as An Example
Han Wang, Jiaqi Wang, Beigene (Beijing) Co., Ltd.

SR55. Statistical considerations in a case study disrupted by COVID-19 pandemic
Kun Li, Jiangsu Hengrui Pharmaceutical Co., Ltd.

SR57. BIP: A Powerful Biomarker Interactive Profiler based on R Shiny APP
Miao Yu, Chun Yi, BeiGene Co., Ltd.

SR66. BRAT: An R-Shiny Application on Block Randomization Allocation Process for Animal Experiments in Clinical Research Area
Shuo Zhang, Chun Yi, BeiGene Co., Ltd.

SR78. The Application of Reference-Scaled Average Bioequivalence in Bioequivalence Analysis with Highly Variable Drug
Chuying Dai, CR Medicon, Nanjing, China

SR79. Interactive web widgets and applications in R
Changming Yang, BeiGene

We are pleased to announce our Special Presentations.

• Unveiling Estimand----Estimand X Data Scientist
  by Leslie Meng, Director of Biostatistics, Boehringer-Ingelheim
  
  
  

  Leslie Meng, BI, China

  ICH E9(R1) is an addendum on Estimands and Sensitivity Analysis in Clinical Trials to the guideline on Statistical Principles for Clinical Trials (ICH E9). ICH E9(R1) proposed a structured framework to strengthen the dialogue between disciplines involved in the formulation of clinical trial objectives, design, conduct, analysis and interpretation, as well as between sponsor and regulator regarding the clinical question of interest that a clinical trial should address. ICH E9(R1) was finalized in Dec 2019, and now it's at step 5 for adoption by each country's health authority. In January 2021, NMPA announced that the adoption of ICH E9(R1) will start in Jan 2022 which means every clinical trial will implement Estimand in the protocol as well as statistical analysis plan. In this talk, the mystery of Estimand will be unveiled, a case sharing will show how the Estimand concept is implemented in the clinical trial and how this impacts on the analyses from statistical programmers' perspective.
  
  
• Data FAIRification: a foundation for accelerating insight generation
  by Shuang Li, Data Scientist, Product Development Data Sciences, Roche
  
  
  

  Shuang Li, Roche

  The reign of data is beginning. To maximize the value of the data that we own, we should pay attention to where we put these data, or the context in which it was generated or acquired, or how it is managed – we are faced with immense time and resource challenges when we try to reuse these data, for filings or for combining into large-scale datasets needed to enable insight generation. We’d like to talk about how we build an E2E engine from FAIRification activities to use of data sets and how to instill a culture of data citizenship to adopt new practices. With the learning-by-doing approach, we develop a fit-for-purpose framework to support the teams to FAIRify incoming data. FAIR data mindset is becoming the new norm to the business from early study planning through Phase III and beyond. FAIR Data Shared becomes the foundation for accelerating and innovating the discovery, development and delivery of more personalized treatments for our patients.
  
  
• An Brief Introduction to Natural Language Processing in Healthcare
  by Xiaohua Li, Lead of science team, Zuoyi Tech
  
  
  

  Xiaohua Li, Zuoyi Tech

  Recently, Natural language processing(NLP) technology which analyzes and represents language has been experiencing a rapid progress due to deep learning and transformer models. Many NLP models and applications have been developed and showed promising achievements in many areas. This talk will start by short introduction to NLP, NLP history and progress in recent years and will expound our research and products in healthcare industry, including medical knowledge graph construction, EHR document understanding, clinical desicion support models, doctor-patient dialogue process optimization and how we apply NLP technology to support top-tier hospitals and clients in China.
  
  

We are pleased to announce our Keynote Presentations.

FDA Study Data Technical Rejection Update by Heather Crandall, FDA Heather Crandall, FDA Study Data Standards listed in the FDA Data Standards Catalog are required for clinical and nonclinical studies that started after December 17, 2016 (for ANDA, NDA and BLA) or December 17, 2017 (for Commercial IND). Through the technical rejection process, FDA can reject an application because of its technical deficiencies, based on the severity of the eCTD validation criteria. FDA has been conducting an analysis on submissions that contain study data that were already received by the Agency to assess conformance rates to Technical Rejection Criteria for Study Data (TRC). This presentation will share the FDA analysis result as well as common errors being noticed as part of this analysis. FDA plans to implement the “Technical Rejection Criteria for Study Data” in 2021 and begin rejecting submissions that do not conform. Heather Crandall has been with the FDA since 2012, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.

Moving at the Speed of Science: Lessons Learned in Response to the Covid-19 Pandemic by Patti Compton/Henry Shen, Pfizer Henry Shen, Pfizer, China In March 2020, the FDA declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic. This presentation will highlight key strategies to accelerate the analysis process to support a COVID-19 EUA as well as lessons learned that may be considered for future programs. Patti Compton is currently the Head of Statistical Programming and Analysis at Pfizer. With over 20 years pharmaceutical academic and industry experience, she has been responsible for leading efforts to build a sustainable framework to optimize statistical reporting including strengthening data reporting environments, quality indicators and data sharing capabilities. Currently she is leading an implementation of a digitized analysis platform with modernized search, integration, and automation/ML to enable simplified workflows and predict risk. Additionally, she is accountable for developing functional sourcing strategies and partnerships and has implemented many development operational expansion efforts within Asia including China, India and Japan. She holds BA and MS degrees from the University of Michigan and Eastern Michigan University. Henry Shen is currently the Head of China Statistical Programming and Analysis Group at Pfizer. The group under his leadership since its inception now has ~250 statistical programmers in both Shanghai and Wuhan, contributing to Pfizer’s global phase 1-4 studies, regulatory submissions / responses, and Scientific and Commercialization Support projects, including the most recent Pfizer’s successful lightspeed launch of mRNA COVID Vaccine. He has led to establish a culture of continuous improvement and innovation in Pfizer China R&D Center with a sharp focus on technical excellence, quality & compliance, talent development and project management. He holds a PhD degree in Statistics from the State University of New York at Buffalo and has over 25 years of pharmaceutical industry experience in both US and China.

Conference Committee

Operations Chair	Dong Guo	Eli Lilly	This email address is being protected from spambots. You need JavaScript enabled to view it.
Academic Chair	Xiaofeng Shi	IPSEN	This email address is being protected from spambots. You need JavaScript enabled to view it.
Webmasters	Wenfang Li	BI	This email address is being protected from spambots. You need JavaScript enabled to view it.
Graphic Designer	Maddy Wilks		This email address is being protected from spambots. You need JavaScript enabled to view it.
Registration/ Sponsorship Coordinator/ Keynote Speaker Coordinator	Margaret Hung	MLW Consulting	This email address is being protected from spambots. You need JavaScript enabled to view it. This email address is being protected from spambots. You need JavaScript enabled to view it.
Registration	Cindy Song	BeiGene	This email address is being protected from spambots. You need JavaScript enabled to view it.
Publication/Registration	Maggie Wang	Pfizer	This email address is being protected from spambots. You need JavaScript enabled to view it.

Section Chairs

Applications Development & Technical Techniques (AD)	Yun Ma	BI	This email address is being protected from spambots. You need JavaScript enabled to view it.
Applications Development & Technical Techniques (AD)	Xin Wang	ClinChoice	This email address is being protected from spambots. You need JavaScript enabled to view it.
Coder’s Corner (CC)	Rowland Hale	Syneos Health	This email address is being protected from spambots. You need JavaScript enabled to view it.
Coder’s Corner (CC)	Yiqian Jiang	Fosun Pharma	This email address is being protected from spambots. You need JavaScript enabled to view it.
Coder’s Corner (CC)	Stanley Wei	Novartis	This email address is being protected from spambots. You need JavaScript enabled to view it.
Data Standards/CDISC and Regulatory Submission (DS)	Mina Chen	AZ	This email address is being protected from spambots. You need JavaScript enabled to view it.
Data Standards/CDISC and Regulatory Submission (DS)	Min Chen	Eli Lilly	This email address is being protected from spambots. You need JavaScript enabled to view it.
Data Validation & Management (DM)	Juan Du	Phastar	This email address is being protected from spambots. You need JavaScript enabled to view it.
Data Validation & Management (DM)	Jie Yao	Novartis	This email address is being protected from spambots. You need JavaScript enabled to view it.
Data Visualization and Graphics (DV)	Kriss Harris	SAS Specialists Ltd	This email address is being protected from spambots. You need JavaScript enabled to view it.
Data Visualization and Graphics (DV)	Sanjay Matange	Retired from SAS Institute	This email address is being protected from spambots. You need JavaScript enabled to view it.
Data Visualization and Graphics (DV)	Gaoyang Li	Happy Life Tech	This email address is being protected from spambots. You need JavaScript enabled to view it.
Data Visualization and Graphics (DV)	Ella Cheng	Fosun Pharma	This email address is being protected from spambots. You need JavaScript enabled to view it.
Hands-On Workshop (HOW)	Maggie Wang	Pfizer	This email address is being protected from spambots. You need JavaScript enabled to view it.
Hands-On Workshop (HOW)	Nancy Ni	JNJ	This email address is being protected from spambots. You need JavaScript enabled to view it.
Management and Career Development (MA)	Hangjun Dai	Cstone	This email address is being protected from spambots. You need JavaScript enabled to view it.
Management and Career Development (MA)	Zhijuan Yu	BeiGene	This email address is being protected from spambots. You need JavaScript enabled to view it.
Posters (PO)	Yiwen Wang	AZ	This email address is being protected from spambots. You need JavaScript enabled to view it.
Statistics & R (SR)	Zhuo Chen	Hutchison	This email address is being protected from spambots. You need JavaScript enabled to view it.
Statistics & R (SR)	Wanqing Li	HengRui	This email address is being protected from spambots. You need JavaScript enabled to view it.