Operating Systems and Version Control Basel, Switzerland 4th November 2015

Transcription

1 Operating Systems and Version Control Basel, Switzerland 4th November 2015 Switzerland SDE

2 Agenda Welcome Time Title and Speaker 08:45-09:30 Registration 09:30-09:40 Welcome Bill Bird, Actelion Pharmaceuticals Ltd 09:40-10:30 Moving the Clinical Analytical Environment into the Cloud Stijn Rogiers, SAS 10:30-11:00 Coffee Break 11:00-12:00 Approaching Version Control Magnus Mengelbier, Limelogic 12:00-13:30 Lunch 13:30-13:45 PhUSE News Beate Hientzsch, PhUSE 13:45-14:45 To Version or Not (When) to Version Joel Hoffman, Sycamore Informatics 14:45-15:15 Coffee Break 15:15-16:15 Dimensions of Standards Versioning: from Variables and Terms to Program Code Dimitri Kutsenko, Entimo 16:15-16:45 GPS: Our Version-controlled Environment Pros & Cons Kamila Duniec and Nigel Montgomery, Novartis 16:45-17:00 Closing Bill Bird, Actelion Pharmaceuticals Ltd 17:00 Meeting Ends Dear Single Day Event Attendee, It is our great pleasure to welcome you to this event. For the seventh year, we are running a series of Single Day Events across Europe: Frankfurt (Germany), Copenhagen (Denmark), Paris (France), Basel (Switzerland) and London (UK) are our destinations this year. We are hoping that you will find these events beneficial in both their content and structure. They give a great opportunity to network and meet colleagues from other companies during the year while waiting for the main conference, which will take place in Vienna (October, 11th -14th) this year. In addition to our EU Single Day Events, six SDEs will be organised in the US, four in India, two in China, and following the successful inaugural meeting in 2014 a second event in Japan. It would be highly appreciated if you could let your colleagues in other regions know about the upcoming events. More details are available on the PhUSE website. The vast majority of brand-new presentations demonstrates the energy of our community, and also ensures that you receive new information Kath and I have been very fortunate this year to work with a very experienced sub-committee who have brought a lot of motivation and energy to our small team. Our thanks also go to the various companies that are supporting these events and provide us with high standard locations and catering facilities to fully enjoy. This year we have chosen to go back to not only providing the SDE brochure in hard copy at the events, but also in electronic format. This provides consistency between the events in both quality and format though the electronic option allows you to get the agenda ahead of the event to better plan your day and also will help us to promote the event. Also you will notice that this year again a vast majority of presentations will be never seen before presentations. This demonstrates the energy of our community but also ensures that you receive new information. A big Thank You! to all our presenters for dedicating time and effort for the success of these events. As usual your feedback is key to us. We want to deliver the best events possible and 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, Adie & Kathryn PhUSE EU Single Day Event Chair Orgainisers 2015 Adrienne Bonwick Eisai Kathryn Wright Cmed 2 Switzerland SDE 2015 Switzerland SDE

3 Welcome to Basel Speakers and s Dear Single Day Event Attendee, May we extend a warm welcome to you for the PhUSE Single Day Event (SDE) Switzerland The event will be hosted at Actelion Pharmaceuticals Ltd, in the exciting architecture that is our head office, and will provide an opportunity for meeting colleagues from Actelion Pharmaceuticals Ltd and hearing presentations and networking with colleagues from both local and international companies. This year s SDE has the theme Operating Systems and Version Control as, while we all work in different environments with different standard tools, we are all affected by our use of the operating system and the requirement for version control. We have invited a broad spectrum of presenters from both local and international companies who will share their thoughts, ideas and experience on how to get the most out of both version control and the operating systems, with technical solutions, tips, tricks, theories and practical examples behind its use. The first part of the day looks at how SAS can be used with the cloud to bring the operating system and version control usage up to date with the virtual world. After a coffee break, we will be presented with how to approach using version control to get the most from it. During lunch, you will have plenty of time for networking with your colleagues, in the main building outside the conference room, where lunch and coffee will be provided. After lunch we will be discussing why we actually use version control and when/if it should be used. During the last part of the day, you will have insights into and examples of how a commercial system implements version control, along with examples from users of these systems. We would like to thank our sponsors Actelion Pharmaceuticals Ltd, Sycamore Informatics and the SAS Institute for their support of this Single Day Event in Basel. While we all work in different environments with different standard tools, we are all affected by our use of the operating system and version control One of the aims of the SDE is to stimulate discussion, knowledge-sharing and networking, so your contribution in terms of questions and comments throughout the day will be key to the success of this event. We hope you will enjoy the day, learn from each other and get to know some new people. Best regards, Bill Bird & Jerome Milotti Basel Single Day Event Chair 2015 Bill Bird Actelion Pharmaceuticals Ltd Jerome Milotti Actelion Pharmaceuticals Ltd 09:40-10:30 Moving the Clinical Analytical Environment into the Cloud Stijn Rogiers, SAS The first-generation statistical computing environments were developed in-house, hosted on different operating systems such as Windows or UNIX and installed within the boundaries of a local office or company-wide network. Some required functionalities were absent or not granular enough, however, such as lack of access control to the clinical data, an audit history and version control. Companies have tried to overcome these unmet needs, e.g. by implementing bespoke version control systems or using open-source version control systems like git or CVS. These readily available systems are made for specific purposes only and although often functionally rich and detailed, are less transparent and miss other requirements expected from a clinically validated and collaborative environment. SAS has developed the SAS Life Science Analytics Framework (formerly named SAS Drug Development) with a built-in version control system, object-level access control and a rich authoring and execution environment. The SAS Life Science Analytics Framework contains an audit history for recorded user actions in the system. The system is validated as expected for clinical systems that contain submission-grade data and is hosted in a private highly secured cloud. It has been designed to be accessible for all user roles in a clinical development group of a sponsor or CRO/partner. Finally, the system is easily extensible, can be integrated with other systems and aligned to custom business processes and workflows used in the organisation. During this presentation, we will focus on the programming and versioning engine in SAS Life Science Analytics Framework that allow programmers to collaborate and deliver high-quality statistical programs, data and results. We will also talk about the evolution of clinical analytics from a centralised to a distributed collaborative environment. The need for sharing information for collaborative research requires not only a cloud-based approach but one where a variety of sharing, security and access models must be supported. Biographies Stijn graduated 15 years ago as a programmer/analyst and started his career at SGS Life Sciences. After five years at SGS, he moved to Tibotec R&D (Johnson & Johnson) where he first acted as an electronic data capture expert and later transitioned into a clinical data architect role. After several years at J&J, he received the opportunity to start a new adventure as an expat for one and a half years in India (Bangalore). In 2010, J&J decided to change the way data management worked, and he came back to Belgium to be part of the global core team driving this new future (project HERMES). He also led the clinical data architect team for the infectious diseases & vaccines therapeutic area. After the implementation of the first two phases of project HERMES, he picked up the role of Platform Domain Lead, in which he coordinated and successfully implemented a new platform facilitating the new processes and organisational structure for J&J data management. Later on, he was also actively involved in getting the J&J Quantitative Sciences organisation in the same environment. In 2013, he graduated with the Dean s List Award from a twoyear Executive MBA at Antwerp Management School; and by mid-2014, he had transitioned into the clinical trial innovation group working on e-meds, developing an integrated medication & adherence management platform. Earlier this year, he decided to take on a new opportunity and join SAS Institute as Senior Industry Consultant for Life Sciences and Healthcare (EMEA/AP). 4 Switzerland SDE 2015 Switzerland SDE

4 Speakers and s 11:00-12:00 Approaching Version Control Magnus Mengelbier, Limelogic 13:45-14:45 To Version or Not (When) to Version Joel Hoffman, Sycamore Informatics The ability to maintain versions of items is more common than we fully realise, whether it is through a formal version control strategy or process, or simple user behaviour. There exist a multitude of applications, software, solutions and other integrated environments that allow a formal version control process, each with varying degrees of freedom or interpretation. Practical approaches are considered, as we discuss the different paths available to evolve and subsequently adopt a version control strategy, which may involve legacies, team culture, regulatory requirements and tools as key drivers to organisation initiatives. Biography Magnus Mengelbier has been working within the pharmaceutical, biotech, advertising and IT industry for nearly 20 years. He is currently the founder and a director of Limelogic. He continues to be involved with project management, programming and process development roles, which has provided a broad background in clinical trials, regulatory requirements, process development, project management, system design and programming. He is a keen advocate of simple uses of programming skills and technology and a frequent participant of PhUSE, SAS Global Forum and other programming forums. Managing and effectively using versions is central to the biopharmaceutical research and business process, as we continuously receive, integrate, analyse and report the data with a set of programs and specifications that are also changing to meet changing data and evolving reporting requirements. If not tracked, finding which version of what was used and when can require significant effort and cause delays in responding to regulatory questions. We propose that a more complete definition for version is the name, location, date time and owner of the files that, collectively, are the specifications, source, parameters, programs and output used for decision-making and regulatory filings. After making the case for this definition, we will go on to suggest that to be efficient and effective, systems must be ubiquitously available, seamless and transparent to the user in order for the collection and storage of the information to be automatic, complete and robust. Biography Joel is an implementer of clinical data systems and has been working with clinical data since his post-doc (1985) in medical informatics analysing premature infants cry, to delivering Pfizer Research s first CANDA and initial analysis and reporting systems, to delivering pharmacokinetic and clinical study management systems, to deploying the first versions of a statistical analysis environment. Joel is currently head of services at Sycamore Informatics, provisioning its metadata repository, statistical analysis environment and clinical data repository. We will illustrate how tracking and keeping the versions of data, programs and outputs can be used to automate business processes, meet regulatory requirements and simplify reporting. Use cases showing the value of implementing this definition for (1) managing CRO sponsor data, (2) analysis and reporting deliverables, and (3) interactions with regulatory agencies will be presented. 6 Switzerland SDE 2015 Switzerland SDE

5 Speakers and s 15:15-16:15 Dimensions of Standards Versioning: from Variables and Terms to Program Code Dimitri Kutsenko, Entimo 16:15-16:45 GPS: Our Version-controlled Environment Pros & Cons Kamila Duniec and Nigel Montgomery, Novartis Versioning is a very ambiguous term, with different facets and meanings depending on the industry and company where it is used. The goal of this presentation is to illuminate the versioning concept(s), with the focus on standards governance in life sciences organisations. After defining the term and narrowing down the scope, the presenter will guide the participants through the end-to-end chain of standards from protocol elements through variables (e.g. CDISC, CDASH, SDTM, ADaM) or terms to programming code, and provide specifics and versioning options for the described artifacts. The metadata repository entimice DARE MDR shall be used, among other tools, as the source for examples of how version-related issues in the end-to-end standards governance can be solved. Biography Dimitri is responsible for Global Sales, Marketing and Global Alliances at Entimo. He oversees implementation of Entimo s products, in particular metadata repositories, across the partner network. In the past, Dimitri has initiated and led in strategically important, groundbreaking projects which set new standards in clinical R&D processes. Dimitri has more than 10 years of experience in standards governance and implementation of standards in the pharmaceutical industry. He has in-depth expertise of various clinical and pre-clinical data models including CDISC BRIDG, ODM, CDASH, SDTM, ADaM, terminology, and reporting standards. Education MBA, Dipl. Kaufmann; Majors: Strategic Management, Statistics. Freie Universität Berlin. BA, MA; Majors: Language Sciences, Interpreting, Translating. Minsk State Linguistic University. Global Programming and Statistical Environment (GPS) is the Novartis system providing tools for data analysis and reporting. There are people using it at any one time across more than eight geographical locations. GPS is accessible via Citrix and consists of ClearCase, SAS and other applications for code, data and output viewing and editing. Rational ClearCase is an IBM product, which provides a graphical user interface to file management, version control of the files, record of file history, as well as information on file dependencies. At Novartis, we are versioning all the files (SAS programs and macros, source and analysis data, and reports). The advantages of applying version control to all the files includes full traceability of every file under version control, which is related to GCP compliance (21 CFR Part 11), as well as the ability to reproduce any version of any output from any version of a SAS program and any version of the data. Such flexibility and capacity, however, come at a cost. With over 3,000 GPS accounts and hundreds of projects, we are experiencing performance issues. Furthermore, complexity of the system has led to a heavy business process, and a need for a greater training and support infrastructure and resources. There is no industry standard with regards to the scope of what needs to be version-controlled. At Novartis, we are exploring the alternatives and system structures which reduce the need to version control. Also, an industry-wide discussion has begun in order to understand the regulatory and business requirements for the most suitable reporting system. Biographies Nigel Montgomery After graduating with a BSc Honours in Mathematics, Statistics and Computing, Nigel has gone on to work in SAS for almost 15 years, working with CROs, the insurance industry and, now, large pharma in various different roles and responsibilities. Nigel is currently a project programmer within the integrated hospital care therapeutic area at Novartis in Basel. Kamila Duniec Kamila Duniec joined the pharmaceutical industry in 2006 after completing a PhD in Molecular Neurobiology. During this time, Kamila worked as a SAS programmer and/or lead programmer on clinical programming projects leading to regulatory submissions. Kamila also has experience of running clinical trials as a senior clinical manager. Currently, she is part of the Novartis Programming Excellence group, responsible for several initiatives related to the programming and reporting system, quality and processes, as well as training development. She is also leading the implementation of a project management methodology (Agile/Scrum). 8 Switzerland SDE 2015 Switzerland SDE

6 Cloud Software to Automate Processes, Increase Efficiency & Lower Costs in Clinical Research Notes Manage metadata standards as a blueprint for accelerated traceable well-governed collaboration. Intelligent mappings relate your standards to the different representations for data collection, reporting, and analysis. Centralize, secure, store, share and deliver your clinical trial operational and study data. Sophisticated versioning and traceability ensures that the lineage, integrity and provenance of data are always available. Automate the highly complex, collaborative and mostly manual practices in clinical trials biostatistics and programming. Advanced data access controls and task management tools enforce process and save time. 10 Switzerland SDE 2015 Switzerland SDE

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 12 For more Switzerland information SDE visit 2015 the PhUSE website phuse.eu/annual-conference.aspx