P-MEDICINE NEWSLETTERISSUE NO 4 2 no 4 • february 2015 no 4 • february contents Editorial 3 Latest Achievements in the p-medicine project 4 How to Ensure GCP-Compliance for p-medicine Tools 6 Predicting Drug Side Effects: Opportunities and Challenges 8 Browse-Directed Search: A Tool for Generating Hypotheses 9 Partners in Depth: Biovista 11 ECRIN and p-medicine 12 ALGA-BC: An interactive empowerment tool for breast cancer patients 14 MyHealthAvatar: A Demonstration of 4d Digital Avatar Infrastructure 15 VPH-Share Makes Impact at VPH2014 in Trondheim 15 Building Policy Recognition for VPH Research 16 p-medicine newsletter 3 editorial by Norbert Graf, p-medicine coordinator We are fast approaching the end of partner Biovista summarizes the platform will remain. The p-medicine our project now with only six more knowledge gained regarding the partners have agreed to support the months to go. The next half-year will close collaboration of p-medicine development of a legal entity called 2015 no 4 • february be focused on finalising an integrated partners and regulatory bodies, such STaRC: Study, Trial and Research scenario demonstrating all aspects as EMA and FDA. More of Biovista’s Centre that will guarantee that our of the project. All our efforts have interesting work on pages 8-11. fantastic work is continued beyond been put forth to develop tangible the lifetime of p-medicine. scenarios that will convince clinicians At the end of the project we have set to use the p-medicine infrastructure up an infrastructure that will facilitate Of course, these excellent results in their research and their clinical personalized medicine in all aspects, are only possible with a terrific practice. including running more patients consortium. It was and still is in prospective clinical trials using a privilege to work with such Now it’s time to look back. During ObTiMA. We have a legal and ethical exceptional partners and friends the project we have established many framework in place. Data, including in our ambitious p-medicine collaborations. Together with VPH- molecular and imaging data, can be project. This has been and will be Share, we held various meetings, securely stored in a data warehouse the guarantee of our success. It is conferences and a summer school. for further exploitation to gain new beyond words to say how proud and Our main joint activities are related knowledge. Access to biobanking is grateful I am for being part of such to security, semantic interoperability provided. Tools and models will be an endeavour. I am convinced that and running the Oncosimulator in place for decision support. The our mission towards personalized in their infrastructure. Once more ALGA questionnaire enhances patient medicine will help patients in the end. VPH-Share gives an update on their empowerment as a central part of latest activities in this newspaper personalized medicine (see also p. (p. 15). Members of p-medicine 14). The Oncosimulator is able to attended many interfacing meetings simulate response to treatment in not only in Europe but around the nephroblastoma, breast cancer and globe to disseminate our goals ALL. and achievements to a widespread audience including clinicians. In Seeing all our achievements, I am one of our deliverables p-medicine convinced that the p-medicine Towards a personalized medicine p-medicine newsletter 4 latest achievements in the p-medicine project – an interview with gordon mcvie Now that the end of the project is tissue and the tumor tissue – put put together and the technical people approaching, we have asked Gordon it all together and come up with a got together to create solutions. no 4 • february 2015 no 4 • february McVie from ecancer to give his series of management proposals. personal view on the most important Also, this requires to be translated The core components which are now achievements of the p-medicine into understandable language for the available for usage are: project. patient and the patient needs to be encouraged to question the doctor • A portal for p-medicine Starting off four years ago with a quite and to take part in an equal way in • A workbench for p-medicine disparate group of skilled people, decision making. That’s what we call • A data warehouse i.e. people working on ontology, patient empowerment.” • An ontology annotator, the clinical people, psychologists, first ontology for psychological bioinformaticians, technicians, etc., medicine that we know of these experts have soon learned How has this idea been trans- • Data translation service to speak the same “language” and lated into a precise p-medicine • Privacy protocols started to work together on the product? • ObTiMA, which is a clinical trials subjects of data integration, legal management system and ethical issues of storage of • Biobank access framework so that data, system biology models, tools, Gordon McVie: “The infrastructure you can look at what rare tissues logistics and new ways of data is based around clinical scenarios, are banked and a number of warehousing. in other words the clinicians started European or in fact international off with the questions and there are biobanks By now a clear picture has evolved three groups of patients being looked • Cloud storage infrastructure and this is what Gordon McVie is at (two groups of pediatric oncology, so that all this data can be talking about in an interview filmed that’s Wilms tumor of the kidney and confidentially kept in the cloud and published by ecancer. leukemia, and an adult cancer, the • A whole series of tools for looking very common breast cancer, were at adverse reactions to drugs taken as a model). • And data mining services What is the idea behind • And last but really not least the p-medicine? A number of clinical scenarios were patient empowerment tools” Gordon McVie: “The idea is that p-medicine will provide a knowledge Video: Gordon McVie sums up the progress discovery platform to manage future clinical research easily for the doctor and understandably for the patient. The entire video is available on ecancer.org and is also prominently featured on the p-medicine website. A patient is now poorly informed about the remarkable progress being made in the whole area of imaging and the whole area of molecular genomics and proteomics and so on. The doctor is bombarded and has sometimes not very much more an idea what to do with all the data than the patient. So the idea would be to put all these masses of data, layers of data, different types together and process it so that the doctor sitting with the patient can press one button and get all the profiles – from the psychological profile to the OBEX profile of the patient’s normal p-medicine newsletter 5 Short CV Gordon McVie Professor Gordon McVie is NCI support, the European New Drug Development widely regarded as a leading Network. international authority in the research and treatment of In the UK he was one of the architects of the Cancer 2015 no 4 • february cancer. Having qualified in the Trials Networks in Scotland, Wales, and England, and 1960ies in science and medicine was a founding member of the National Cancer Research at Edinburgh University, he was Institute appointed Foundation Senior Lecturer at the Cancer Research Professor McVie is the recipient of numerous awards and Campaign oncology unit at the University of Glasgow in has honorary doctorates in science from six universities. 1975. He has served on key committees of AACR and ASCO, and on the boards of the National Cancer Institutes He is currently Senior Consultant to the European Institute of France, Italy, and the Netherlands. He has authored of Oncology, Milan, and is founding editor of ecancer. 350 peer-reviewed articles, and contributed to over 35 org, ecancerpatient.org and ecancerLatinoAmerica- books. online Open Access free websites. His commitment to drug discovery and delivery is He is visiting professor at Kings College London, the evidenced by approximately 240 patents granted to CRC University of Milan and the University of Wales scientists under his leadership, several drugs registered including carboplatin, temozolomide and abiraterone Previously Professor McVie was Chief Executive of the and the foundation of 10 biotechnology companies Cancer Research Campaign (CRC), which, under his based on CRC intellectual property. His clinical interests, aegis, took over seventy molecules from the lab into apart from new drug discovery and chemoprevention, clinical trial. He led CRC into a merger with Imperial are in the management of cancers of the lung, ovary, Cancer Research Fund which formed Cancer Research colon, breast and brain. He is a partner with ecancer in UK, in 2002, and was joint CEO with Sir Paul Nurse. 3 FP7 projects. Throughout the Eighties, he was Clinical Research He was elected as Fellow of the European Association Director at the National Cancer Institute (NCI) of the for Cancer Science in 2014, and has been secretary of Netherlands. As President of EORTC, he set up the the European Alliance for Personalised Medicine in early present Drug Development Group in Brussels, and with 2013. A comprehensive infrastruc- The doctor can now get all of that contact ture has been created. What information thanks to a tool called are the benefits for the exter- ALGA tool and the doctor can Prof. Gordon McVie then frame his language and his ecancermedicalscience nal user of this infrastructure? educational pitch to the psychological print-out.“ +44 7785 325 558 Gordon McVie: “Now we are willing to offer to the outside world data Email warehouse access, access to data What is your personal conclu- Website mining, access to a new tools bar sion at the end of the project? working out what a particular individual patient’s understanding of cancer is, understanding of the Gordon McVie: “We have now got the processes involved in management, lab-clinical interface fixed for I think understanding what sort of the first time in any of these types of educational level would be important projects.” in order to handle the information coming from the doctor.