DIA Europe 2019: Full Schedule

10:45 CET

#S0701: Digital Disruptors: What Do We Mean?

Component Type: Session

There is a huge opportunity for significant change in Clinical research, by embracing Digital Approaches such as mHealth, wearables, Patient Apps, remote monitoring, siteless trials, digital therapies, EHR integration. What will this disruption mean and how can we harness the potential of digital for better healthcare?

Chair

Jonathan Palmer

Speaker

Panel Discussion
Isabelle M de Zegher, DrMed, MD, MS, MSc

Panel Discussion
Chris Walker, MSc

Panel Discussion
Jeremy Wyatt, MBA

Speakers

Isabelle de Zegher

Vice President, PAREXEL Informatics

Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →

Chris Walker

Vice President, European Head of Regulatory Affairs, Amgen Ltd

Chris Walker (MSc RA & BSc Hons), is Head of Regulatory Affairs for Europe for Amgen and Head of the UK R&D sites.. Chris is chair of the Digital Health Taskforce at EFPIA, a member of the Innovation BSC & Regulatory Strategy Groups. Chris leads the regulatory strategy team for Amgen’s... Read More →

Jonathan Palmer

Senior Director, Product Strategy, Digital Trials, Oracle Health Sciences

Jonathan leads Product Strategy for Digital Trials within Oracle’s Health Sciences Global Business Unit. He is responsible for defining, and delivering, new innovative Digital/mHealth solutions. He has spent over 20 years within Oracle’s Clinical Trial business teams delivering... Read More →

Jeremy Wyatt

CEO, ActiGraph, United States

Jeremy Wyatt is the CEO of ActiGraph, a leading provider of motion-sensing wearable technology solutions for pharmaceutical and academic research. With two decades of embedded hardware systems development and related cloud technology expertise, Jeremy has a uniquely well-rounded perspective... Read More →

Wednesday February 6, 2019 10:45 - 11:45 CET
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

07 Digital Disruptors, Session

Featured Topics Data and Data Standards
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12:00 CET

#S0702: Blockchain in Healthcare and Pharma

Component Type: Session

Blockchain is the one of the most talked about technologies of 2017. With the potential exceeding any other to revolutionize the healthcare industry, it is crucial to first understand the nature of blockchain technology, to distinguish the hype from the reality and then to see real-world case studies of how blockchain, combined with other technology such as AI, will be applied to healthcare systems.

Chair

Pascal Bouquet, MSc

Speaker

Panel Discussion
Disa Lee Choun, MBA, RPh

Panel Discussion
Andy Bushell, PhD, MBA

Panel Discussion
Nikolai Constantin Brun

Speakers

Pascal Bouquet

Global Head of Technology, Architecture and Digital for the Drug Development, Novartis

Senior technologist and Enterprise Digital Architect, Pascal has more than 20 years of experience leading global IT organizations, building high performing teams, managing Enterprise Architecture teams, leading digital innovation and delivering large scale, global programs. He joined... Read More →

Nikolai Brun

Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics, Danish Medicines Agency, Denmark

Background and experience in the clinical field and afterward in research and devel-opment of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years with a long list of publications in high-impact journals. 4 years as Director of Division responsible for Medical Evaluation... Read More →

Andy Bushell

CEO, OoNiDa, Oonida

Andy has 30+ years experience in discovery, development and commercialization of medicines worldwide. Keynote speaker on Innovation, Universal Health, Non-communicable disease and Digital Advances. Currently Global Program Head for Novartis Pharma AG and President/founding CEO of... Read More →

Disa Lee Choun

Head of Innovation, Global Clinical Services and Operations, UCB Celltech

Disa has years of experience working in technology and innovation especially in the pharmaceutical industry. In her current role as Director Head of Innovation within the Global Clinical Sciences & Operations at UCB, she is responsible for evaluating and piloting innovative solutions... Read More →

Wednesday February 6, 2019 12:00 - 13:15 CET
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

07 Digital Disruptors, Session

Featured Topics Data and Data Standards
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15:15 CET

#S0703: The Digital Transformation of Clinical Trials and its Regulatory Implications – What are the Challenges?

Component Type: Session

Digital technology and novel approaches to clinical trial conduct have the potential to simplify the clinical trial process to become more patient-centric. What are the regulatory challenges and hopefully solutions for using these tools in clinical trials of the future?

Chair

Mireille Muller, DrSc, PhD, MSc

Speaker

Challenges Using Digital Tools in Clinical Research
Nitharna Sivarajah

FDA View
David Martin, MD, MPH

The Importance of Software and Apps in Healthcare – Regulatory Considerations
Maria Isabel Manley, LLM

Speakers

Marie Manley

Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP, United Kingdom

Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts... Read More →

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA

David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →

Mireille Muller

Regulatory Policy & Intelligence Director, Novartis Pharma AG, Switzerland

Mireille Muller Ph.D. has over 20 years of experience in regulatory affairs at the global level, including policy, benefit-risk research, drug development focused in clinical research. Special interest in early development, scientific advice, and technology-enabled clinical trials... Read More →

Nitharna Sivarajah

Pharmacovigilance Information Coordinator - Direct Reporting lead, Medicines and Healthcare products Regulatory Agency

Nitharna graduated in Natural Sciences at the University of Cambridge. She joined the Medicines and Healthcare products Regulatory Agency (MHRA) in 2015 and swiftly built her knowledge in pharmacovigilance across a range of roles, from case processing to signal management. As a Pharmacovigilance... Read More →

Wednesday February 6, 2019 15:15 - 16:15 CET
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

07 Digital Disruptors, Session

Featured Topics Data and Data Standards
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16:45 CET

#S0704: Digital Innovation is Revolutionising All Aspects of Trial Execution: Opportunities and Requirements

Component Type: Session

Digital innovation is a key enabler in the drive to modernise clinical trials and make them faster, better and different. Technology promises to bring efficiency to our processes, insights for planning, richer information on interventions being studied, and new paradigms to simplify trial participation. How do we leverage these new approaches to gain efficiencies, increase the quality of clinical research and remain in compliance with current regulatory requirements and thinking?

Chair

Bill Byrom, PhD

Speaker

Virtual Trials
Scott Askin

TransCelerate's Common Protocol Template: Overview and Implementation Case Studies
Mitzi Allred, PhD

Endpoints Using Wearables: How Do I Know Data Will Be Accepted?
Bill Byrom, PhD

Speakers

Mitzi Allred

Director, Clinical Operations, Merck & Co., Inc., United States

Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse... Read More →

Scott Askin

Digital Solutions Director, Novartis

Scott Askin, a Digital Solutions Director with Novartis, plays a leading role in many of the company’s digital projects such as eSource (electronic Source), electronic Informed Consent (eICF/eConsent) and Decentralized Clinical Trials. He has ~20 years of industry experience, from... Read More →

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health

Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →

Wednesday February 6, 2019 16:45 - 18:00 CET
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

07 Digital Disruptors, Session

Featured Topics Data and Data Standards
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09:15 CET

#S0705: Can We Improve Patient Experience with Digitisation – Part 1: Patient Information

Component Type: Session

Patients expect to take greater accountability for their health, are researching symptoms and taking greater control of the treatment of their disease. Timely access to reliable information in a format that is suitable for patients in the 21st century will transform communication with patients in the healthcare setting.

Chair

Valdo Arnera, DrMed, MD

Speaker

How eConsent will Support Study Oversight and Future Enhancement of Informed Consent
Mika Lindroos, MSc

Towards an Electronic Patient Information Leaflet – Industry Experience with the Belgian Pilot
Koen Nauwelaerts, PharmD, PhD, MBA

Speakers

Valdo Arnera

General Manager, Europe, ERT

An MD by training, Valdo has 30+ years of experience in the pharma industry. After having practiced medicine, he started in the industry as a clinical pharmacologist at Ciba-Geigy. He then founded the 1st European Central Clinical Lab for clinical trials, SciCor (now Covance Central... Read More →

Mika Lindroos

Director, Product Management, eConsent, Signant Health

Mika Lindroos is the Director of Product Management and an eConsent expert at Signant Health, and he says he is most at home where technology meets humanity. With over 25 years of experience in software product management in the global environment, Mika’s breadth of experience spans... Read More →

Koen Nauwelaerts

Head Regulatory Affairs and Quality Belgium Luxemburg, Bayer

Koen Nauwelaerts studies pharmaceutical sciences at Leuven University in Belgium and obtained a PhD at the same university. Before joining Bayer he worked in Quality and regulatory affairs functions in the pharmaceutical industry.

Thursday February 7, 2019 09:15 - 10:15 CET
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

07 Digital Disruptors, Session

Featured Topics Data and Data Standards
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10:45 CET

#S0706: Can We Improve Patient Experience with Digitisation – Part 2: Digital Devices

Component Type: Session

Digital devices are increasingly used in clinical trial execution – and certainly around Phase 4 studies. While these enable remote trials and collection of new clinical end points, they do not always take into account the view of the patient (e.g., patient comfort) and may not therefore enhance compliance. Listen to concrete examples on how to improve patient experience and retention.

Chair

Valdo Arnera, DrMed, MD

Speaker

Medical Devices and mHealth - Bridging Trial and Health Care and Putting Patients at the Center of Clinical Research
Bruce Hellman, MBA

Deploying a Digital Platform Optimising Patient Monitoring, Compliance and Retention – Uses Cases
Julia Lakeland

Validating Digital Mobility Outcomes as Clinical Endpoints – Easier Said than Done?
Beatrix Vereijken, PhD, MSc

Speakers

Valdo Arnera

General Manager, Europe, ERT

Bruce Hellman

CEO and Co-founder, uMotif

Bruce is the CEO of uMotif and co-founded the company in 2012. He and his team have developed the leading platform for real-world and observational research – a modern data capture platform that patients love to use. Bruce began his career working in clinical trials at British Biotech... Read More →

Julia Lakeland

Senior Director,Sensor Solutions, Parexel, United Kingdom

Julia is a Product Director at PAREXEL who is passionate about improving the patient experience within the Clinical Trial. She has 20 years experience in industry and plays a key role in identifying and understanding market problems, managing the product portfolio life cycle and leading... Read More →

Beatrix Vereijken

Professor, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology

Beatrix Vereijken is Professor in Medicine/Movement Science at the Norwegian University of Science and Technology in Trondheim, Norway. She has a PhD in Human Movement Science and a Master degree in Experimental Psychology, both from the Netherlands. She has long-standing expertise... Read More →

Thursday February 7, 2019 10:45 - 11:45 CET
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

07 Digital Disruptors, Session

Featured Topics Data and Data Standards
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12:00 CET

#S0707: Preparing the Way for a Learning Healthcare Ecosystem

Component Type: Session

A learning healthcare system will connect available health data from multiple sources and ensure feedback from this data is used to enhance future medicine development, improve use of medicines and enhance the overall health of European citizens. Hear from those helping to advance the improvement of this ecosystem.

Chair

Emma Du Four, MBA

Speaker

Vision for a Learning Healthcare Ecosystem –– Signature Digital Health Initiatives: How They Fit Together as Enablers to Each Other
Thomas Metcalfe, MBA

Panel Discussion
Elena Bonfiglioli

Panel Discussion
Magda Chlebus, MA

Speakers

Elena Bonfiglioli

Managing Director, Health and Life Sciences, Microsoft

Magda Chlebus

Executive Director Science Policy & Regulatory Affairs, EFPIA

Magda Chlebus is Executive Director Science Policy & Regulatory Affairs at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D-based pharmaceutical industry in Europe.Magda and her team are in charge of following policy and legislative... Read More →

Emma Du Four

Head of International Regulatory Policy, Abbvie

Emma Du Four has extensive global experience in the biopharmaceutical industry encompassing product development, clinical trials, real world evidence, paediatric medicines, biotherapeutics, devices, pharmacovigilance, policy and strategy development. Emma currently serves as Head... Read More →

Thomas Metcalfe

Data Policy Leader, Personalised Healthcare, F. Hoffmann-La Roche

Tom Metcalfe graduated in Biochem from King's in London and has an MBA from the Open University. He currently works as a Data Policy Leader in Roche Pharma's Personalised Healthcare Centre of Excellence. Prior to that he worked for Roche as a Strategic Innovation Leader in Global... Read More →

Thursday February 7, 2019 12:00 - 13:15 CET
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

07 Digital Disruptors, Session

Featured Topics Data and Data Standards
Tags Session