Beijing esubmission Packages

Transcription

1 Single Day Event Beijing esubmission Packages 8th July 2016 Park Plaza Beijing Science Park Beijing 2016 PhUSE Single Day Event 1

2 Your guide to the day Introduction Agenda Time Title and Speaker 09:00 09:10 Welcome and Opening Remarks Tony Guo, Head of LDS, BARDS-AP, MSD China R&D 09:10 10:00 FDA ectd Overview from a Programmer s Perspective Cindy Song, Sanofi US Welcome to Beijing 10:00 10:45 SDTM Theory & Application Jinghui Lv, Covance 10:45 11:00 Morning Break 11:00 11:45 New Features in Define.xml 2.0 and Steps for SDTM Define File Generation Yuan Wang, FMD K&L Inc. 11:45 12:30 ADaM: Data Preparation, Reporting Programs and ADRG Jianyong Tong, MSD China R&D 12:30 13:30 Lunch 13:30 14:00 OSI (or BIMO) Deliverables for FDA NDA Filing Michael Lai, Sanofi China R&D 14:00 14:45 Drug Development and esubmission for PMDA Filing Fan Zhang, Sanofi China R&D 14:45 15:30 esubmission Challenges for CFDA NDA Filing Victor Wu, Data Science Express 15:30 15:45 Afternoon Break 15:45 16:30 Therapeutic Area (TA) Specific Requirements in FDA Filing Huadan Li, MSD China R&D 16:30 17:00 Panel Discussion Yazhong Deng, Guowei Wu, All Speakers 17:00 17:10 Closing Remarks Yazhong Deng Huadan Li MSD China R&D Eric Liao Sanofi China R&D Dear Single Day Event Attendees, On behalf of the PhUSE Beijing SDE Committee, we would like to welcome you all to the PhUSE Single Day Event in Beijing, China. This is the first time that we have held an SDE in Beijing. Since its inception in 2005, PhUSE has been focused on organising events of interest in the pharmaceutical industry; and since 2013, the PhUSE China Working Group has focused on organising events in Shanghai. The theme of this Beijing SDE will focus on esubmission package preparation. esubmission is becoming essential for major regulatory submissions including the FDA, EMA and PMDA. Beginning May 5, 2017, submission types NDA, ANDA, BLA and master files must be submitted to the FDA in ectd format. This will be a big challenge for all pharmaceutical companies. During this event, experts from pharmaceutical companies and CROs will share their experiences during preparation of ectds via case studies, including regulatory requirements, submission strategies and process, technical document preparation, etc. We would like to thank our sponsors FMD, Bioknow and DAP for their great support to this SDE. This event would not have been possible without the effort of the Organizing Committee, and we would like to thank them also for all their contributions. Additional thanks for the great support from Sarvesh Singh, PhUSE Asia Events Director, and the PhUSE global team, who have provided great guidance and support to make the first SDE in Beijing happen. We wish to extend our gratitude and welcome to all organisers, participants and sponsors of this event. We hope you will all enjoy and gain insight from it. As usual, your feedback is important to us. We will review any comments or suggestions you make with great interest and will try to action them for future events. Many thanks for your participation. Best regards, PhUSE Beijing SDE Committee Sarvesh Singh PhUSE Asia Events Director 2 PhUSE Single Day Event Beijing 2016 Beijing 2016 PhUSE Single Day Event 3

3 Speakers and abstracts Speakers and abstracts 09:10 10:00 11:00 11:45 FDA ectd Overview from a Programmer s Perspective New Features in Define.xml 2.0 and Steps for SDTM Define File Generation Cindy Song Sanofi US The FDA has placed increasing requirements regarding electronic submissions. It is important for sponsors and healthcare professionals to understand these requirements and prepare esubmission packages accordingly. This paper gives a brief overview of an FDA esubmission from a programmer s perspective what the requirements are and how to prepare for an esubmission package. The content and structure of a typical ectd package will be presented, including the annotated CRF, SAS transport files, Study Data Reviewer s Guide and Analysis Data Reviewer s Guide. 10:00 10:45 SDTM Theory & Application Cindy Song is a director, programming group head of the biostatistics and programming department at Sanofi, a leading global pharmaceutical company. She has been with the company for 11 years, with more than 10 years at the company s Bridgewater, New Jersey site; last December, she was relocated to their Beijing site. Prior to Sanofi, Cindy was with Merck s clinical biostatistics department for 10 years. During her 21 years of clinical programming experience, Cindy has developed a broad interest in programming technologies and processes, as well as knowledge in clinical studies and regulatory standards. Yuan Wang FMD K&L Inc. According to the latest FDA guidance documents (Study Data Specifications v2.0, Common Data Standards Issues Document v1.1), a critical component of data submission is the define file. Compared to the define.xml 1.0 (CRT-DDS) package, there are many new features in define.xml 2.0 such as flexible definition of Value Level Metadata, codelist with link to CDISC/NCI Controlled Terminology code, improved handling of comments, etc. These traits will make certain that the data and related attributes are clearly and easily accessible. Here, we just give you a comparison between define.xml 1.0 and define.xml 2.0 about the specific features and illustrate a detailed process of SDTM define.xml 2.0 generation based on prepared source data sets and specifications. Some internal macro tools should be used during the creation. Yuan Wang has been a SAS programmer at Nanjing Fountain Medical Development LTD. for almost four years. She received her bachelor's degree in pharmacy from Nanjing University of Technology in This is her second presentation at a SAS conference; the first was at PharmaSUG 2015 China. Yuan currently lives in Nanjing and is engaged in SDTM, ADaM and TLG programming work. Jinghui Lv Covance The FDA recognises the investment made by sponsors over the past decade to develop the expertise and infrastructure to utilise Clinical Data Interchange Standards Consortium (CDISC) standards for study data. The submission of standardised study data enhances a reviewer s ability to more fully understand and characterise the efficacy and safety of a medical product. The Prescription Drug User Fee Act (PDUFA V) Performance Goals state that the FDA will develop guidance for industry on the use of CDISC data standards for the electronic submission of study data in applications. In the near future, the FDA will publish guidance that will require study data in conformance with CDISC standards. This presentation will generally discuss SDTM theory & application: how to standardise our data from the start; how to annotate CRF with SDTM variables by SAS macro; how to learn SDTM IG systematically; how to write SDTM specification; and what we should pay more attention to when we do SDTM programming. This presentation will provide you some ideas. Jinghui Lv is a statistical programming supervisor at Covance. She has been working in the pharmaceutical industry as a statistical programmer for more than seven years, and has six years experience working for global CROs such as Quintiles and Covance. 11:45 12:30 ADaM: Data Preparation, Reporting Programs and ADRG Jianyong Tong MSD China R&D This preparation of analysis packages is recommended as an important part of a standards-compliant clinical study data submission. The FDA has very strict rules and regulations regarding analysis packages, and the FDA has provided sufficient reference documents to guide us with this request. This presentation introduces the contents of analysis packages, how to prepare analysis packages, and the specific pay-attention-points when we prepare the analysis packages based on guidance and working experiences. Jianyong Tong began his programmer career at KendleWit, Beijing, China and worked there from 2010 to He has been working at MSD R&D (China) Co., Ltd. as a Senior Scientist, Statistical Programming since He has a master s degree in public health and over six years of industry experience. At MSD China R&D, he transferred his solid programming skills to support clinical trials in different therapeutic areas where he had gained plenty of experience, especially in infectious diseases. 4 PhUSE Single Day Event Beijing 2016 Beijing 2016 PhUSE Single Day Event 5

4 Speakers and abstracts Speakers and abstracts 13:30 14:00 14:45 15:30 OSI (or BIMO) Deliverables for FDA NDA Filing esubmission Challenges for CFDA NDA Filing Michael Lai Sanofi China R&D 14:00 14:45 Fan Zhang Sanofi China R&D The FDA s Bioresearch Monitoring (BIMO) program of drugs is managed by the FDA s Office of Scientific Investigations (OSI), which consists of three main parts (Part I, II and III). Sponsors are asked to provide the details of site-level information according to the guidance issued by the Center for Drug Evaluation and Research (CDER), to help the OSI to identify sites for on-site inspection. In this presentation, the background of BIMO (OSI) will be introduced, followed by details of the BIMO package requirements, which will focus on biostatistics and programming deliverables. Examples/sharing will also be provided. Drug Development and esubmission for PMDA Filing First, we will highlight the differences between Japan CTD and global CTD, with some examples, before explaining several specific requirements, AE parts and Module We will then introduce audit and inspection in Japan, including commonly checked points and examples. Finally, we will look at Japanspecific requirements for esubmission. There will be comparison between FDA and PMDA requirements, including ADaM, programs, validation rule, split data set and resize of variable length, and mention of timelines, notifications, guides released for industry and other considerations. Michael Lai is a statistical programming manager at Sanofi, with nine years industry experience. He heads a team that provides programming support for oncology phase I to IV trials. Prior to his career at Sanofi, Michael was a statistical programmer at KendleWit, a CRO in Beijing. Michael has focused his programming on oncology studies since Fan Zhang is an associate manager of statistical programming at Sanofi, with more than eight years industry experience. She heads a team that provides programming services for Japanese phase I to IV trials. Prior to her career at Sanofi, Fan was a statistical programmer at Venturepharm, a local CRO in Beijing. Fan has focused her programming on Japanese studies since 2010, including in oncology, diabetes, cardiovascular and vaccines therapeutic areas. Victor Wu Data Science Express Current status, challenge and solution of data submission in China: 1 Current status a. There must be data standardisation, otherwise it is not possible for the CDE to do real data review and statistical review. b. The CFDA organised a group of experts to discuss whether to create China data submission standards or to use existing CDISC standards. The final agreement was to use CDISC standards, in order to remain consistent with global standards. c. The CFDA has delegated C3C to form data standardisation-specific Working Groups (including CDASH, SDTM, ADaM, CT and TCM), to translate, localise CDISC standards, and to propagate, train and spread; 2 Challenge a. Technical: language issue such as CT; date format; people (sub-race); traditional Chinese medicine b. Capability of implementation: local companies lack of knowledge and experience c. Policy from regulatory agencies; 3 Solution a. Technical: Working Group is working on data submission proposal and China implementation guide, and organising training b. Capability: i. Company level: to realise the importance of data standards, which will improve quality and efficiency, not just meet regulatory needs ii. Hire experienced people and provide training iii. Turn to external experts: to leverage knowledge and experience, to simplify implementation through process, templates and tools c. Regulatory agencies need to be more aggressive: Japan is a good example. CDISC Authorised SDTM Instructor; Vice Chair of China CDISC Coordinating Committee (C3C); co-founder of Beijing Data Science Express Consulting Co., Ltd. Dr. Wu has over 10 years experience in biometrics and 8 years in CDISC standards implementation (including CDASH, SDTM and ADaM). He is highly proficient in clinical study, from protocol/statistical design, CRF development, SDTM mapping, programming for analysis data sets and tables, listings, figures to submission packages, as well as in process optimisation and coaching biostatisticians and SAS programmers. Victor has greatly contributed to the review of the Chinese version of CDISC standards documents and coordinating CDISC activities in China. 6 PhUSE Single Day Event Beijing 2016 Beijing 2016 PhUSE Single Day Event 7

5 Speakers and abstracts Upcoming events 15:45 16:30 Topics for CFDA (Therapeutic Area (TA) Specific Requirements in FDA Filing) Huadan Li MSD China R&D Two data standards initiatives of CDER, FDA Therapeutic Area (TA) Data Standards Efficacy Requirements and Analysis Requirements are estimated to be completed by the end of 2016 which may impact future FDA NDA/ BLA submissions. In fact, the Hepatitis C Virus (HCV) area, the resistance data standards pilot has been completed. This paper gives a brief overview of FDA TA data standards through FDA-required efficacy and resistance data standards requirements in HCV studies. Huadan Li is a senior programming manager at BARDS-AP at MSD China R&D, with ten years industry experience. He leads a programming team which provides wide programming support for global and regional late-phase studies, focusing on infectious diseases and vaccines TAs. Prior to his career at MSD, Huadan was a programming team leader at Sanofi China R&D. Looking Forward July USA SDE Deerfield, IL July 21st India SDE Trivandrum July 30th August USA SDE Frenchtown, NJ August 4th Japan SDE Tokyo August 4th October PhUSE Annual Conference Barcelona, Spain October 9th 12th November China SDE Shanghai November 4th USA SDE Durham, NC November 10th December India SDE Mumbai December 3rd Scan for China web chat and to follow our PhUSE SDE activities 8 PhUSE Single Day Event Beijing 2016 Beijing 2016 PhUSE Single Day Event 9

6 Thanks Contributors Thank you to all our contributors for their generous support Thank you to our gold sponsor klserv.com 10 PhUSE Single Day Event Beijing 2016 Beijing 2016 PhUSE Single Day Event 11

7 Annual Conference Barcelona 2016 Fast Track to Approval: Speed and Efficiency 9th 12th October Princesa Sofia Gran Hotel, Barcelona Conference Chair Åsa Carlsheimer, Trialbee Conference Co-Chair Jules van der Zalm, OCS Consulting For more information visit the PhUSE website phuse.eu/annual-conference.aspx 12 PhUSE Single Day Event Beijing 2016