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Leading Insights For The Whole Clinical Trials Community

Overcoming The Big Challenges Together

Project Management, Patient Centricity, Clinical Trials Of The Future, The Drug Development Operating Environment, Virtual Trials, Wearables And The Digital Revolution

Clinical Trials Europe Opening Plenary

Day 1: 19th November 2019
14.00 - 16.10
14:00 - 14:40 - Change as an opportunity - Better project management of your clinical trials

With the ever-faster pace of clinical research, many organisations are facing a crisis of complexity. This session will look at the very latest university research on how complexity can be not only harnessed but even used as a competitive advantage. A fun and fast-moving session by a Master Storyteller.

  • Dealing with Complexity
  • Increasing the Pace
  • Managing the Stakeholders
  • Leading the Teams
  • Mindsets for Success

Stephen Carver, Senior Lecturer in Change Project and Programme Management, Cranfield University

14:40 - 15:20 - PATIENT STORY: Frankie’s Journey: A parents perspective on their son who has Dravets who went on a clinical trial
  • Who is Frankie?
  • What is Dravet Syndrome?
  • Why we trialled Fenfluramine?
  • Initial Drug trial enrolment
  • During the Placebo Process
  • The Outcome and how this has changed our life

Stacey Williamson, mum to Frankie who has the rare genetic disease Dravets syndrome. 

15.20-16.10 - PANEL: Trials of the future

Phil Hammond, Doctor, Journalist, Broadcaster, Campaigner and Comedian

Christian Born Djurhuus, Vice President, Head of Digital Transformation, Global Development, Novo Nordisk A/S, Denmark

Lode de Wulf, Chief Patient Officer, Servier

Donna Graham, Honorary Consultant in Medical Oncology, Experimental Cancer Medicine Team (ECMT), The University of Manchester, UK

Richard Stephens, Chair of the National Cancer Research Institute's Consumer Forum, National Cancer Research Institute’s Consumer Forum (NCRI), UK

Diane Driver, Head Program Delivery, Development & Medical (Patient Value) Practices, UCB, UK

Clinical Trials Europe Day 2 Plenary

Day 2: 20th November 2019
16:00 - 18:30
16:00 - 16:30 - Mapping the drug development operating environment’s future state
  • Assessing the changing structure and nature of global drug development activity
  • Anticipating the maturation of the patient engagement movement and where its impact will be most notable
  • Tracking the convergence of clinical research and clinical care
  • Projecting the rapidly evolving role of data and analytics to support development planning and decision-making

Kenneth Getz, Senior Reseach Fellow, Tufts Center for the Study of Drug Development, Tufts University

16:30 - 17:00 - Regulatory - where we are with Digital Health Technology and Decentralized Clinical Trials?

Regulatory Challenges using Digital health technologies, Sensors and Wearables for Clinical trials

  • Why are regulators interested in digital health technologies, biosensor and wearable data?
  • How do we approach the reliability, the relevance and the risks of biosensor and wearable data?
  • Required records- what makes sense? Sorting out raw data, source data, algorithms and analyses

Where we are with Decentralized clinical trials?

  • Decentralized clinical trials- what’s new and what’s old?
  • How can we responsibly incorporate local health care providers in the clinical trial enterprise?
  • Technology, real world data and their limitations in decentralized clinical trial.

Leonard Sacks, Associate Director for Clinical Methodology in the Office off Medical Policy, FDA - Center for Drug Evaluation and Research (CDER)

17:00 - 17:40 - PANEL: The digital revolution – Are science and technology advancing at such a rapid rate Clinical Development is unable to keep up?

Christian Born Djurhuus, Vice President, Head of Digital Transformation, Global Development, Novo Nordisk A/S, Denmark

Leonard Sacks, Associate Director for Clinical Methodology in the Office off Medical Policy, FDA - Center for Drug Evaluation and Research (CDER)

Rasmus Hogreffe, Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark

Adama Ibrahim, Associate Director, POC, Global Clinical Operations, Women in Innovation UK, Biogen, UK

Kai Langel, Director, Janssen Clinical Innovation (JCI), Janssen, Spain

17.40 - 17.50 - Lifetime Achievement Presentation

The Clinical Trials Europe Lifetime Achievement Award in association with MD Group recognises such pioneers and we are currently taking nominations for the 2019 award to be presented at Partnerships in Clinical Trials Europe this November in Barcelona.

17:50 - 18:30 - Info Inspirational Talk: Keep Moving – Adventures with Parkinson’s disease

Being diagnosed with Parkinson’s disease at the age of 36, has had a profound and life changing effect on Alex. Overcoming adversity, dealing with diagnosis, travel adventure, danger and facing the future In a world of perpetual change.

Alex Flynn, Adventurer, Speaker, Writer, UK