April 13th – 15th, 2015

dia The DIA EuroMeeting 2015 is unique in presenting a microcosm of the entire drug development process ranging from the policy environment to market uptake and regulation.  It attracts attendees & exhibitors from all stages of the value chain, ranging from those conducting original R&D to the patients benefiting from innovation.

Theme 9 – Big Data, Mobile Health
Theme Leaders:
Luca Pani
, Director General, Italian Medicines Agency (AIFA), Italy
Duane Schulthess, Managing Director, Vital Transformation, Belgium

Harnessing Big Data to make better, quicker medical decisions is a logical development. However, this demands a delicate balance between individual patient rights and the wider public good. This theme explores how to reconcile these issues to maximise the benefits offered by harnessing available health data. How can Big Data improve patient outcomes and accelerate clinical development? What are the implications of data ownership, and what will be the role of social media in healthcare?

Session EM0901 | Tuesday, 14 April | 09:00-10:30
There is a wide agreement that system-wide electronic health records and electronic heath management systems have the potential to fundamentally change the way we currently evaluate new therapies and manage treatment pathways. However, many institutions and governments are leery of proceeding, aware of the many failed and expensive EHR system implementations that have gone wrong and not delivered their expected results. This session will feature and demonstrate several successful ‘best in breed’ eHealth platforms that focus on divergent parts of the healthcare value chain to harness medical data for improved decision making, efficiency gains, and better patient outcomes.

jillianoderkirkSession Chair
Jillian Odenkirk, Senior Analyst, Organisation for Economic Cooperation and Development (OECD)
Brian1Brian Rothman, Medical Director Informatics, Vanderbilt University Medical Center, USA
“A Road Map for New Care Models in the 21st Century”
TimWilliams-sqTim Williams, Head of Research, MHRA Clinical Practice Reseach Datalink, UK
“Using National Health Records to Speed up Development”
georgina-evansGeorgina Evans, Industry Manager, Farr Institute of Health Informatics Research
“eHealth UK”


Session EM0903 | Tuesday, 14 April, 14:00-15:30
Bakul Patel, who heads the FDA’s initiatives on Mobile Health (mHealth) strategy, describes their potential as “taking care of patients 100% of the time”. While many governments and healthcare systems are focused on large-scale national and regional health IT projects, mHeatlh is a catchas-catch-can of Angry Birds disruptive innovation that can fundamentally change the way manage patient care an outcomes. This session will investigate how companies, governments and industry are addressing
the challenges and opportunities of mHealth, and are integrating it into strategy and policy.

sten-stovall-sqSession Chair
Sten Stovall, The Pink Sheet, European Bureau Chief, Informa Business Intelligence, UK
matthew-stummMatthew Stumm, Corporate Promotion and Lead Generation, BBK Worldwide, USA
“mHealth for Patient Recruitment in Global Clinical Trials”
john-eaglesham-sqJohn Eaglesham, Chief Executive, Advanced Digital Institute
“Integrating mHealth Into National Healthcare Decision Making”
gene-dantsker-sqGene Dantsker, Director, Business Development, Qualcomm Life, USA
“Connected, Continuous & Coordinated: How mobile delivers connected therapies that improve outcomes & powers business models”

Session EM0904 | Tuesday, 14 April, 16:00-17:30
Big Data world is invading the field of life sciences. Research organisations, pharma companies as well as policy makers should be prepared to manage this enormous amount of information and all the knowledge changes that will be derived from it at a global level. This approach can lead to a better and more accurate definition of several diseases and to the development of monitoring activities and targeted responses.

“From the world to a water pump”: this is the story of John Snow who mapped all the cases of typhus fever in the 19th century using the London city map. He could find that the center of the epidemic was indeed in a water pump and was able to stop it. Since then Big Data analysis became more sophisticated and as people are sharing more and more information future scenarios are even now hard to imagine…

lucapaniSession Chair
Luca Pani, Director General, Italian Medicines Agency (AIFA)
candida-fratazzi-sqCandida Fratazzi, President, Boston Biotech Clinical Research, USA
“Simplifying Clinical Research and Cost-Effective Trials in the Era of Big Data”
izabelle-dezegher-sqIsabelle de Zegher, Worldwide Director, Clinical Data Standards, PAREXEL informatics, Belgium
“Metadata Management at the Core of “Big Data Management””
dinesh-singhDinesh Singh, Senior Manager- Business Consulting, Cognizant Technology Solutions, UK
“Big Data Analytics Revolutionising the Real-Life Evidence Journey across the Pharma Value Chain – Challenges and opportunities”
valentine-mantua-sqValentina Mantua, European Assessment Office, Italian Medicines Agency (AIFA), Italy

Session EM0906 | Wednesday, 15 April, 11:00-12:30
As information becomes increasingly democratised, the barriers between confidential data and public information are becoming increasingly blurred. There are many examples of patients sharing information on clinical research, promising new therapies, and locations of trials, but where does this cross a line into impacting the impartiality of the research and regulatory process? How can policy makers, patients, practitioners and researchers harness social media tools for better stakeholder engagement, while not impacting the need for some health information to remain confidential as part of the research process?

Alastair-Kent-newSession Chair
Alastair Kent, Director General, Genetic Alliance UK
iftyIfty Ahmed, Managing Director, Pow Health, UK
“PowHealth: Using Social Media Tools to Change the Nature of Research”
NicolaBedlington Nicola Bedlington, Executive Director, European Patient’s Forum, Belgium
“The EPF’s View of Social Media”
 CarolyneHaynesCarolyn Hynes, Head of Global Regulatory Intelligence, GlaxoSmithKline, UK
“Perspectives on Stakeholder Engagement in Regulatory Intelligence Activities”

Session EM0907 | Wednesday, 15 April, 14:00-15:30
Who has the right to use patient data, and who gets to decide how it’s used? The European Parliament in March of 2014 overwhelmingly voted for a data protection policy that could limit the use of existing health databases without an opt-in by patients, but the US has an approach to data that allows institutions to harness their captured medical information as long as that usage falls within established confidentiality guidelines. What are the implications if health data is not allowed to be harnessed as easily in Europe as it is in the US and increasingly, Asia? What is the correct path forward to make sure data is harnessed to provide the best patient outcomes, but confidentiality is preserved?

This session will include four 15 minute presentations on patient data and an open discussion of the impact of data usage and policy

Duane-sqSession Chair
Duane Schulthess, Managing Director, Vital Transformation, Belgium
john-parkinsonJohn Parkinson, Leeds University, UK
“Harnessing Patient Data to Develop New Therapies”
bettina_ryllBettina Ryll, Founder, Melanoma Patient Network Europe; Uppsala University
“Who owns my data? Data protection when faced with a terminal illness”
Nathalie_sqNathalie Kayadjanian, Senior Scientific Officer, Science Europe
“EU Health Data and Research”
ruxandra-DraghiaRuxandra Draghia-Akli, Director Health Directorate DG Research, European Commission
“Balancing the Need for Data Protection and Securing the Public Good”

Session EM0908 | Wednesday, 15 April, 16:00-17:30
After nearly a decade of discussion, analysis and development, Medicine’s Adaptive Pathways to Patients (MAPPs) is beginning to see acceptance from regulators, industry and payers with the first live adaptive pilot project under the guidance of the European Medicine’s Agency (EMA) in 2014. A key plank of adaptive licensing is the ability to harness data in real time to measure and capture an expanding evidence base. What are the current frontiers and best practices of real world evidence, and how it incorporate into new clinical pathways and accelerated decision making while insuring data quality and security?

chris chinnSQSession Chair
Chris Chinn, VP and Head of Health Investment Evidence, GSK; Project Coordinator IMI GETREAL
Jonathan_Cave-sqJonathan Cave, Department of Economics, University of Warwick
“Harnessing Real World Evidence”
liesl-leary-2-sqLiesl Leary, Director, Social Intelligence & Solutions, SDL, UK
“Optimising Patient-Centricity through Multilingual Social Intelligence”
Duane-sqDuane Schulthess, Managing Director, Vital Transformation
“Opt-in, Opt-out, & Patient Led Databases. Better Patient Outcomes, Faster and Cheaper”
see full programme DIA Euromeeting 2015: http://www.diahome.org/en/Flagship-Meetings/EuroMeeting2015/Meeting-Program.aspx