REAL WORLD EVIDENCE IN ADAPTIVE CLINICAL

TRIAL DESIGNPOLICY CONFERENCE | 17 SEPTEMBER 2014, BRUSSELS

09:00 Real world data: the impact on research and policy

▪ Peteris Zilgalvis, Head of Unit, eHealth and Well Being, DG Connect, European Commission ▪ Nathalie Seigneuret, Senior Scientific Project Manager, Innovative Medicines Initiative (IMI) ▪ Sarah Garner, Associate Director R&D, NICE (Project Director for Adaptive Licensing, CASMI) ▪ Hans-Peter Dauben, Head German Agency for HTA, DIMDII ▪ Chris Chinn, VP and Head of Health Investment Evidence, GSK

10:15 Showcasing the best practice in data capture and usage

▪ Tim Williams, Head of Research, Clinical Practice Research Datalink, MHRA ▪ Brian Rothman, Medical Director Informatics, Vanderbilt University ▪ Joel Haspel, Director Strategy & Business Development EMEA, Oracle Health Sciences ▪ John Crawford, Healthcare Industry Leader, IBM Europe ▪ Peeter Ross, Project Expert Regional Telemedicine Forum, Estonia

11:30 Coffee Break

11:45 Real time monitoring and enhancing the patient practitioner relationship

▪ Richard Torbett, Chief Economist, EFPIA ▪ Mohammad Al-Ubaydli, CEO, Patients Know Best ▪ Jack Bowman, CEO, Handle My Health ▪ Simon Gabe, Consultant Gastroenterologist, St Mark’s Hospital, Harrow UK ▪ Leo Exter, Director, WeStartup

13:00 Networking Lunch

AGENDA

Topics to be discussed:

• How real world evidence facilitates adaptive trial design• eHealth systems working today that showcase the best practice in data capture• mHealth platforms being successfully used for real time monitoring and enhancing the patient practitioner

relationship

MANAGING PATIENT DATA 100% OF THE TIME TO SPEED DEVELOPMENT

This Vital Transformation round table has been organised in partnership with:

REAL WORLD EVIDENCE IN ADAPTIVE CLINICAL TRIAL DESIGN

17 SEPTEMBER 2014, BRUSSELS

PANEL: THE IMPACT ON RESEARCH AND POLICY

Previously, he was Head of the Unit, Infectious Diseases and Public Health in the Health Research Directorate. Until 2010, he was Head of the Governance and Ethics Unit, Directorate Science, Economy and Society at DG Research, European Commission. From 1997 to 2005, he was Deputy Head of the Bioethics Department of the Council of Europe, in its Directorate General of Legal Affairs. In addition, he has held various positions in the Latvian civil service (Ministry of Foreign Affairs, Environment). He was Senior Environmental Law Advisor to the World Bank/Russian Federation Environmental Management Project and was Regional Environmental Specialist for the Baltic Countries at the World Bank. P. Zilgalvis studied political science (cum laude) at the University of California, Los Angeles.

Peteris ZilgalvisHead of Unit, eHealth and Well Being, DG Connect, European Commission

In his current role within GlaxoSmithKline R&D’s Value Evidence and Outcomes group, Chris leads on establishing corporate strategy on the use of Real World Data over the lifecycle of medicines across the company. Chris is also the Coordinator of the newly launched IMI GetReal consortium “Incorporating real-life clinical data into drug development”. Chris graduated from Oxford University with a degree in Biochemistry in 1989. He qualified as a chartered accountant with Ernst & Young in London in 1992 and subsequently joined SmithKline Beecham. In 1997 Chris completed a MSc in Health Economics at City University, London and joined SB’s global health economics group. Chris moved to Eli Lilly’s European Health Outcomes group in 2000. He was Head of Health Outcomes for the UK from 2003 to 2005 providing technical support for a wide range of product launches and the submissions to NICE and SMC. He was appointed Head of Lilly’s European Health Outcomes group in 2006 and joined GlaxoSmithKline in March 2010.

Chris ChinnVP and Head of Health Investment Evidence,GSK

Dr. Hans-Peter Dauben, born in Moenchengladbach, Germany, is a civil servant at the German Institution for Medical Documentation and Information (DIMDI), Cologne, Germany, an institution within the scope of the Federal Ministry of Health. After finalizing his training as a cardiac surgeon at the University of Duesseldorf, Germany, he moved to DIMDI to establish the German Agency for HTA at DIMDI on behalf of the federal ministry in 2000 and to develop a structure to access HTA information, set priorities in HTA and monitor new technology developments to establish a broad consensus on HTA in Germany. The experiences of information systems developments lead to the nomination of Dr. Dauben as the national representative for information system development at the European medicine agency (EMEA) in London, UK.

Hans-Peter DaubenHead, German Agency for HTA, DIMDII

Prof. Sarah Garner PhD, BPharm is a pharmacist specialising in Health Technology Assessment (HTA). Sarah is the Associate Director for R&D at the UK’s National Institute for Health and Clinical Excellence (NICE) and is responsible for the planning and delivery of NICE’s R&D agenda relating to methodology and clinical research.Sarah is also Project Director for Adaptive Licensing at the newly formed Centre for the Advancement of Sustainable Medical Innovation, a partnership between the University of Oxford and UCL. In 2010-11 Sarah was a Harkness Fellow in Healthcare Policy and Practice in the United States. Her research examined the impact of comparative effectiveness research and HTA on innovation.

Sarah GarnerAssociate Director, Research and Development, National Institutes of Clinical Excellence

REAL WORLD EVIDENCE IN ADAPTIVE CLINICAL TRIAL DESIGN

17 SEPTEMBER 2014, BRUSSELS

PANEL: BEST PRACTICE IN DATA CAPTURE AND USAGE

Nathalie Seigneuret is a Senior Scientific Project Manager at IMI (Innovative Medicines Initiative) responsible for the coordination and management of projects within the scientific team and for regulatory support and interactions with EMA & FDA. Before joining IMI in 2011, she was a scientific administrator at the European Medicines Agency (EMA, London). Over 15 years at the EMA, her responsibilities included management of the centralised procedures and other activities related to the evaluation of marketing authorisation applications (mostly in relation to anti-infectives) and the implementation of the EU Paediatric Regulation at the Agency level. Nathalie Seigneuret is a state-certified Doctor in Pharmacy and holds a Post-Graduate degree in International Development and Drug Registration. During her studies she gained experience in pharmaceutical industry through traineeships.

Nathalie SeigneuretSenior Scientific Project Manager, Innovative Medicines Initiative (IMI)

John is jointly responsible for IBM’s Healthcare business in Europe, the Middle East and Africa. He is a member of several healthcare IT industry groups, including COCIR, vContinua Health Alliance and Intellect . He represents IBM on the industry Team Steering Group of epSOS, an EU project to enable cross -border digital health services. He is often invited to provide expert commentary about developments in eHealth, and has spoken at many conferences including EuroPACS, MIR, ECR, TTeC, pHealth, World of Health IT, the BCS Healthcare Computing Conference, the Danish eHealth Observatory , and the Global eHealth Forum. He has presented on the evolution of eHealth at the INSEAD Business School, Fontainebleau, and he provides briefings on IBM’s healthcare business and eHealth to the press and analysts.

John CrawfordHealthcare Industry Leader,IBM Europe

Joel leads the overall healthcare strategy and business development in EMEA, working across the Oracle Health Sciences Global Business Unit strategy, alliance, sales, consulting and solution consulting teams as well as the extended technology, applications and Industry Business Unit groups. Leveraging his 25 years of consulting and IT experience, of which 14 have been exclusively focused on healthcare, Joel works closely with the Oracle Health Sciences Network, Enterprise Health Analytics, Translational Research Center and Health Information Exchange product strategy team. Prior to joining Oracle in 2011 he served as CEO of Sentient Health, an innovative supply chain and analytics software provider with customers in Europe and Asia. The company was acquired in 2011.

Joel HaspelDirector Strategy & Business Development EMEA, Oracle Health Sciences

Peeter Ross is a senior research scientist in Tallinn University of Technology (TUT). He also serves as an e-health expert at Estonian E-Health Foundation and holds radiologists position in East Tallinn Central Hospital (ETCH). He is a founder and CEO of radiology and e-health consulting company SMIS International Ltd. Dr. Ross has previously worked as a Director of R&D in ETCH, been a member of the supervisory board of the Estonian E-Health Foundation and Estonian Health Insurance Fund. Peeter is responsible for research and teaching of healthcare innovation and use of digital applications in health domain. He has participated actively in designing and implementation of Estonian nation-wide Electronic Health Record system. He has also been involved in several EU funded eHealth projects.

Peeter RossProject Expert, Regional Telemedicine Forum, Estonia

REAL WORLD EVIDENCE IN ADAPTIVE CLINICAL TRIAL DESIGN

17 SEPTEMBER 2014, BRUSSELS

PANEL: REAL TIME MONITORING AND ENHANCING THE PATIENT PRACTITIONER RELATIONSHIP

Brian Rothman, MD, is Assistant Professor of Anesthesiology and Medical Director of Perioperative Informatics at Vanderbilt University Medical Center. Dr. Rothman received his medical degree from the University of Cincinnati and completed his residency at The Johns Hopkins Hospital. He serves on the Committee for Electronic Media and Information Technology for the American Society of Anesthesiologists and on the Board of Directors for the American Association of Clinical Directors and the Society for Technology in Anesthesia (STA). His research in mobile perioperative information management systems received the Innovation and Clinical Application of Technology awards at the 2010 STA Annual Meeting. Dr. Rothman’s current work focuses on further enhancing a robust electronic medical record with decision support, as well as automated process monitoring and controls.

Brian RothmanMedical Director Informatics,Vanderbilt University

Richard Torbett is Chief Economist at EFPIA. He is responsible for economic analysis as well as EFPIA’s relations with international economic institutions, notably the so-called Troika – the International Monetary Fund, the European Commission’s DG Economic and Financial Affairs (ECFIN) and the European Central Bank. Richard’s current work focuses on the relationship between Health and Economic Growth.

Richard TorbettChief Economist,EFPIA

Mohammad is founder and CEO of Patients Know Best and has over 15 years of experience in medical software. He trained as a physician at the University of Cambridge; worked as a staff scientist at the National Institutes of Health; and was a management consultant to US hospitals at The Advisory Board Company. He is the author of seven books, including Personal health records: A guide for clinicians and Streamlining Hospital-Patient Communication: Developing High Impact Patient Portals. He is also an honorary senior research associate at UCL medical school for his research on patient-controlled medical records. In 2012 he was elected an Ashoka Fellow as a social entrepreneur for the contributions he has made to patient care.

Mohammad Al-UbaydliCEO, Patients Know Best

By approaching every project with vigour, Jack has developed everything from patient centred systems to medicine adherence programs to multi-system integrations and much more! At HandleMyHealth, Jack works to develop a medication compliance and quality of life support system for more personalized medicine and more effective treatment.

Jack BowmanCEO, Handle My Health

REAL WORLD EVIDENCE IN ADAPTIVE CLINICAL TRIAL DESIGN

17 SEPTEMBER 2014, BRUSSELS

Leo is co-founder and Partner in HealthStartup http://healthstartup.eu, an international network of healthcare experts, patients, web and mobile entrepreneurs, Pharma and IT corporates, policy makers and investors. HealthStartup organizes high-level conferences and creates brand-new digital health startups with events like http://hackforhealth.be. Leo is also founder of http://westartup.eu, network of over 4,000 entrepreneurs worldwide, and organizer of a multitude of events for startups like Bizcamp http://bizcamp.be/ and Startup Weekend. He managed the Microsoft Innovation Center’s Boostcamp startup acceleration program. Leo’s career began with marketing roles at The Coca-Cola Company in Moscow and Brussels.

Leo ExterDirector, WeStartup

Simon Gabe is a Consultant Gastroenterologist at St Mark’s Hospital in Harrow. St Mark’s has a National and International reputation in disorders of the gastrointestinal tract, especially inflammatory bowel disease, nutrition and intestinal failure, endoscopy and complex surgery. He Co-Chairs the supra-regionally funded Intestinal Failure service, one of two centers in the UK funded to provide this service. He was appointed as Senior Lecturer at St Mark’s and Imperial College in 2000. Since 2005 this has become an NHS appointment. His MD thesis was on intestinal permeability in critical illness and he also has an MSc in Clinical Nutrition. Dr Gabe has a wide clinical experience in dealing with complex inflammatory bowel disease, especially with fistula development as well as intestinal failure, clinical nutrition and home parenteral nutrition.

Simon GabeConsultant Gastroenterologist,St Mark’s Hospital, Harrow UK

Dr. Tim Williams is a Head of Research within the formed Clinical Practice Research Datalink (CPRD) within the Medicines and Healthcare products Regulatory Agency (MHRA). He has an MSc in Epidemiology from London School of Hygiene and Tropical Medicine and PhD in biomedical computing from the University of Leeds. He has worked in the healthcare data field for over 17 years both in academia and within government. As the programme manager for the research group he has oversight of a wide range of projects but his main area of research involves work into observational healthcare data quality and the application of large observational databases to novel areas including Clinical Trial feasibility and delivery.

Tim WilliamsHead of Research,Clinical Practice Research Datalink (CPRD)

Duane is the Managing Director of Vital Transformation. He regularly consults to National health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He is a regular speaker at many leading international conferences including the European Health Forum Gastein, London Genetics, DIA, and the Royal College of Physicians. Mr. Schulthess has also collaborated with Professor Henry Chesbrough in establishing the European Innovation Forum and is a member of the advisory board of Health Policy and Technology. Duane was the EMEA Head of Corporate Development of The Wall Street Journal. He was also, for five years, the Commercial Director of Science|Business, establishing and building their successful Brussels consultancy practice.

Duane SchulthessManaging Director, Vital Transformation

MODERATION

REAL WORLD EVIDENCE IN ADAPTIVE CLINICAL TRIAL DESIGN

17 SEPTEMBER 2014, BRUSSELS

PARTICIPANTS

The team at Vital Transformation understands the implications of new medical procedures and technologies. We measure their impact on current clinical practices in close collaboration with health care professionals, researchers, and regulators. The research findings of Vital Transformation have been presented at conferences

sponsored by The Royal College of Physicians, The European Commission, The British Embassy – Belgium, London Genetics, The European Science Foundation, The European Microelectronics Summit, and others.

Our clients include many of the world’s leading health care organisations.

WHAT IS THE IMPACT OF NEW TECHNOLOGY ON THE DELIVERY OF HEALTH CARE?

Name Organisation

Mohammad Al-Ubaydli Patients Know Best

Jessamy Baird Lilly

Jack Bowman Handle My Health

Chris Chinn GSK

Magda Chlebus EFPIA

Constance Colin CPME

John Crawford IBM

Jelena Curac Croatian Health Insurance Fund

Hans-Peter Dauben DIMDI

Joaquin de Santos Novartis

Cristina DeJoncheere UCB

Leo Exter WeStartup

Simon Gabe St Marks Hospital

Heike Galbraith Pfizer

Sarah Garner National Institute for Health and Care Excellence (NICE), UK

Daniel Gassul Vital Transformation

Susana Getman US Mission to the EU

Shahid Hanif ABPI

Joel Haspel Oracle

Xavier Honaechea UCB

Denis Horgan EAPM

Brodie Houlette Vital Transformation

Name Organisation

Walter Janssens Federal Agency for Medicines and Health Products, Belgium

Jake Lebiecki Pfizer

Luc Maes COCIR

Nuala Moran Vital Transformation

Petra Naster Vital Transformation

Dee O'Sullivan myhealthapps.net

Ray Pinto Microsoft

Raquel Resendes EFPIA

Peeter Ross Estonia Health

Brian Rothman Vanderbilt University

Philip Rye EFPIA

Benjamin Sarda Orange Healthcare

Duane Schulthess Vital Transformation

Nathalie Seigneuret Innovative Medicines Initiative (IMI)

Richard Torbett EFPIA

Marcel van Drunen Dell

Bart Vannieuwenhuyse J&J

Gergely Vertes UCB

Tim Williams CPRD

Gianluca Zia Caretek

Peteris Zilgalvis DG Connect, European Commission

For more inforation, visit vitaltransformation.com.

REAL WORLD EVIDENCE IN ADAPTIVE CLINICAL TRIAL DESIGN

17 SEPTEMBER 2014, BRUSSELS

vitaltransformation.com