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Key Sessions

Amelia Hursey

CASE STUDY: How Parkinson’s UK are supporting participation; shared learning from the charity sector

Parkinson’s UK

Nov 29
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08:30 - 08:50

Morning Coffee and Networking

08:50 - 09:00

Opening remarks from the chairperson

Showing of Streams
10:30 - 11:20

Morning Break

Showing of Streams
13:30 - 15:00

Lunch

Showing of Streams
16:30 - 16:35
End of Conference

End of Conference

08:30 - 08:50 20 mins
Morning Coffee and Networking
08:50 - 09:00 10 mins
Opening remarks from the chairperson
09:00 - 09:30 30 mins
STREAM 7: Patient Recruitment & Retention
CASE STUDY: Running a program to build a patient community for data sharing (in-trial) and to pick up screen failures for future enrolment, very innovative and running for 12 months now in 3 regions
  • Caroline Feys - Clinical Innovation Leader, Janssen, Belgium
more
09:00 - 09:30 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
CASE STUDY: Patient Reported Outcomes and beyond: A Self-Service setup
  • Angelo Trotta - Connected Health Solutions & Operations, Janssen, Belgium
more
  • How we currently deploy ePRO and mobile apps within clinical trials
  • Challenges we’re facing with ePRO and mobile apps
  • Self-Service model for ePRO and beyond: pilot setup
  • How can we effectively scale up
  • Unified support model
09:00 - 09:30 30 mins
STREAM 9: Regulatory Updates
Update from Stakeholder regarding Landscape of regulatory changes affecting Clinical trials
more
  • The impact of the ICH E6R2 a year after implementation
  • Clinical trial regulation – are we ready for 2019?
  • The impact of the GDPR on patient data
  • The effect of Brexit
09:00 - 09:30 30 mins
STREAM 10: Artificial Intelligence
Big Data, Artificial Intelligence and Robots and what does it mean and what impact it will have?
more
  • Use of AI in clinical research and what does it mean?
  • Primary focus of all pharma is data 
  • New CEO at Novartis- focussed on big data and what we can do with that?
  • Predictive analytics and machine learning- predict where we may have problems with a clinical trials
  • Artificial intelligence - Anticipate what is going on with your trial
  • Tapas – looks for the data in the past and actual- what Novartis is doing- predict what is coming on, where are we? Predict issue with the site? Look into the future?
  • Artificial intelligence and robots and how affect the industry
  • AI- how they affect day to day work?
  • How find best patients- exclusion
  • Best recruitment strategies
  • Bigger picture - AI and its impact on protocol design, patient recruitment and faster clinical trials
  • Lots of processes that we do they are really manual- and they are repetitive- machines could do with them
  • AI- a machine that compares everything to everything
  • There are machines being used- IBM Watson is being used with ICON- looking at network of patients and filter and highlight best candidates for a trial
  • Robots - the rest of the world are scared, what is the possible influence on our jobs and are we really as safe as we think we should be.  What is the CRA of the future?
  •  
  • Robotics and human robotics
  • Is he doing anything in clinical trial arena?
  • Related to healthcare

Artificial Intelligence and Big Data - how the tools are built? 

  • In Clinical we are seeing more machines, what is the regulatory status of them?
  • Quality of data is better- as don’t get stressed as come to clinic
  • Collect so much data- have huge quantity of data
  • What are you looking for? Take ages to analyse, money to store data.
  • Have better technology, quality for data is better, never replace the people and thinking behind people.
  • Regulators concerns of AI 
09:30 - 10:00 30 mins
STREAM 7: Patient Recruitment & Retention
Patient engagement - what is it and how do we make sure we are doing it right?"
  • Russell Wheeler - Trustee, Leber's Hereditary Optic Neuropathy Society (LHON Society), UK
more
  • Patient engagement - defining the undefinable
  • Best practice in implementation of patient engagement
  • Early evidence and reasons to be optimistic
09:30 - 10:00 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
Patient-centred research using electronic Patient-Reported-Outcome Measures in daily practice and clinical trials
  • Galina Velikova - Professor of Psycho-social and Medical Oncology, University of Leeds, UK
more
09:30 - 10:00 30 mins
STREAM 9: Regulatory Updates
Strategies to prepare of Clinical Trial Regulation
more
  • The impact of the CTR on industry
  • Preparation required by industry to be ready for implementation in 2019
  • Changes needed to clinical trial studies and strategies to implement these requirements
09:30 - 10:00 30 mins
STREAM 10: Artificial Intelligence
PANEL: Artificial intelligence- topic to be confirmed
10:00 - 10:30 30 mins
STREAM 7: Patient Recruitment & Retention
Sponsored Speaking - Bracket
more
10:00 - 10:30 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
Sponsored Speaking Slot - Real World Evidence – PRA
more
10:00 - 10:30 30 mins
STREAM 9: Regulatory Updates
Member State feedback on CTR readiness:
  • Martine Dehlinger-Kremer - Vice President, Global Medical and Regulatory Affairs, SynteractHCR, UK
more
  • Update on Clinical Trial Regulation Portal
  • Providing timelines and the status of the CTR Portal
  • The requirements of industry to use the regulation portal
  • Expectations of the CTF portal by the 2019 deadline
10:00 - 10:30 30 mins
STREAM 10: Artificial Intelligence
SPEX: ArisGlobal
more
10:30 - 11:20 50 mins
Morning Break
11:20 - 11:50 30 mins
STREAM 7: Patient Recruitment & Retention
CASE STUDY: How Parkinson’s UK are supporting participation; shared learning from the charity sector
  • Amelia Hursey - Senior Research Participation Officer, Parkinson’s UK
more
  • Why we are supporting participation
  • Our Research Support Network
  • Our Patient and Public Involvement initiative to improve research
  • The Take Part Hub
  • How we can and do work with partners to help increase participation
  • How you can work with us
11:20 - 11:50 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
JOINT CASE STUDY: Paediatrics Trials – what are their experiences?
  • Ms Joana Claverol - Clinical Research Unit Manager, Barcelona Children’s Hospital Sant Joan de Déu, Spain
more
11:20 - 11:50 30 mins
STREAM 9: Regulatory Updates
CASE STUDY: Sponsors responsibility for vendor oversight – impact from ICH E6R2 Guideline
  • Geoff Taylor - Director, Clinical Quality Assurance,, Eisai Product Creation Systems, UK
more
  • Need for new processes for vendor selection and oversight, including delegated activities.  
  • Who has overall responsibility, who needs to be involved and how does this work from a QA perspective?
  • Introducing risk management into vendor oversight, what is the best mechanism for doing this?
  • What might regulators expect under ICH GCP R2?
  • How to effectively implement and document vendor oversight
11:50 - 12:20 30 mins
STREAM 7: Patient Recruitment & Retention
CASE STUDY: Using primary care electronic medical records to identify study subjects in clinical trials of biomarkers
  • Frank Sullivan - Director of Research, University of St Andrews, UK
more
  • Recruitment to trials often fails
  • Studies within a trial (SWATs) are needed – but difficult
  • EMRs enable more Precision recruitment- e.g. 12K patients recruited to ECLS
  • Feasibility platforms e.g. SHARE and Patient Reported data (Tablet study)
  • Use tools to see what sites are applicable
  • Using epidemiological data- computer science and stats to optimise inclusion/exclusion criteria
11:50 - 12:20 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
Engagement of young people across Europe to improve paediatric clinical trials
  • Begonya Nafria Escalera - Patient Advocacy Manager in Research, Hospital Sant Joan de Déu, Spain
more
  • Paediatric clinical trials landscape for the upcoming years
  • Young advocates can have a voice and involvement along the lifecycle of medicines
  • Standardization of the young advocates participation in clinical trials needs to be a gold standard
  • Good practices about the involvement of young people along the lifecycle of medicines
11:50 - 12:20 30 mins
STREAM 9: Regulatory Updates
Quality Risk Management - impact from ICHH E6R2 Guideline
more
  • Do risk management and unclear how to do that?
  • Quality management, quality improvement and quality by design
  • Encourage the diversity in study design and doing a proper holistic quality approach – design and management of study
  • Outline the changes and then the impact of the changes- what’s going on?
  • Exploring the impact on day to day we work
  • Relationship with sponsor and CRO- where does it lead us?
  • What’s the change for the future?
12:20 - 13:00 40 mins
STREAM 7: Patient Recruitment & Retention
PANEL: What are the reasons and motivations for persons to participate in trials and how to achieve patient engagement?
  • Sammy Ainsworth - Patient Research, Ambassador, UK
  • Ben Cromarty - North Yorkshire AIDS Action (NYAA), UK Community Advisory Board (UK-CAB), Medical Research Council Clinical Trials Unit at University College London Patient and Public Involvement Group, UK
  • Svilen Konov - Director, SEVT Ltd, UK
  • Ms Kate O’Brien - Senior Research Nurse, Freelance Site Consultant, UK
  • Richard Stephens - Chair of the National Cancer Research Institute's Consumer Forum, NCRI, UK
more
  • Increased involvement of patients in clinical trials for the trial design - How do we innovate clinical trials to include input from patients?
  • How to reach patient groups? Different aspects?
  • Improve the trial design – e.g. provide childcare for trial participants, compensation, travel costs, global differences, should patients receive financial compensation? A controversial area
  • Patient receives good clinical care already, why would they want to undertake a new medication trial? Why enter a clinical trial with a new substance if already have a good standard of care- how to attract? What would be the motivation?
  • How to make trials more attractive to patients?
  • Flexibility have home care visits- nurses to send to home
  • Better understanding of the gap between what patients expect and what drs are delivering when it comes into information of clinical trials
  • What can patients contribute to the trial design / development of trial protocols?
  • How can they be actively involved in all levels of the trial (including steering committees etc)
12:20 - 13:00 40 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
PANEL: Now, next and future for clinical trial design?
  • Roland Rich - Operations Expert, DevQA, Novartis, France
more
  • How virtual can we go?
  • Looking at all the different trial options- advantages and disadvantages
  • Why we do it and the benefits of platform studies?
12:20 - 13:00 40 mins
STREAM 9: Regulatory Updates
CASE STUDY: Inspectors experience’s on GDPR and ICHH E6R2
more
  • A sponsor/inspector case study of how they have built a risk management plan
  • How implement a risk management plan including best practices for communication with CRO
  • Inspector feedback on experiences of GDPR checks
  • Valuable insight on how industry is expected to handle patient and trial data
13:00 - 13:30 30 mins
STREAM 7: Patient Recruitment & Retention
Sponsored Speaking Slot to Fill
13:00 - 13:30 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
Sponsored Speaking Slot - Real World Evidence – Covance
more
13:00 - 13:30 30 mins
STREAM 9: Regulatory Updates
Spex presentation TO FILL
13:30 - 15:00 90 mins
Lunch
15:00 - 16:00 60 mins
STREAM 7: Patient Recruitment & Retention
Please go to stream 8, 9 or 10
15:00 - 15:30 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
CASE STUDY: Collaborative studies and platform studies – changing the scope of clinical research
  • Katrin Haeverans - Clinical Scientist and External Affairs Director, Janssen Research and Development, Belgium
more
  • The sad truth about Alzheimer’s Dementia
  • EPAD (Early Prevention of Alzheimer’s Disease)– A New Era for Performing Prevention studies using a platform approach
  • EPAD Consortium joining forces - Framework and Scene setting
  • Building a Platform
  • What are the operational challenges?
  • What is the added value for pharma companies?
15:00 - 15:30 30 mins
STREAM 9: Regulatory Updates
Patient data under GDPR
more
  • How we protect patient data?
  • Understanding the requirements of collected images such as chest X-Rays. Do we need to remove their name?
  • What does it mean for clinical research consent? Will people able to consent to certain parts of the trial?
15:00 - 15:30 30 mins
STREAM 10: Artificial Intelligence
CASE STUDY: NIMA – Advancing Science and Drug Development through Public – Private Collaborations
  • Anja Hijzen - Associate Director Clinical Scientist, Janssen Research and Development, Belgium
  • Maarten Timmers - Director, Clinical Research Manager - Experimental Medicine, Ambassador of the European Health Parliament – Commission Prevention and Self-care Janssen Research and Development, Janssen, Belgium
more
  • Preclinical and Clinical Component
  • Clinical Focus on Phase 1b/2 studies
  • Main focus on advancing science / leveraging into clinical development strategies
  • What are the operational challenges and opportunities
15:30 - 16:00 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
Big Health Data –Insights you can generate from routine data sources.. if you still “haven’t found what you are looking for
  • Daniel Prieto- Alhambra - Associate Professor & NIHR Clinician Scientist, Oxford University, UK
more
  • Start here: Data discovery, what is out there? Their Pros and Cons
  • First steps: big health data to inform patient recruitment
  • Letting go for a while: Routine data linkage for long-term follow-up in trials
  • The aftermath: Big healthcare data for post-marketing drug and device surveillance
15:30 - 16:00 30 mins
STREAM 9: Regulatory Updates
Case study: Preparation to get GDPR compliance
more
  • Strategies to get GDPR compliance
  • Assessing what data needs to be held and how to do so safely
  • Best practices to control and store data  
  • Understanding the requirements on how to delete data securely
16:00 - 16:30 30 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
Technology enablement and wealth of data
  • Roland Rich - Operations Expert, DevQA, Novartis, France
more
16:00 - 16:30 30 mins
STREAM 9: Regulatory Updates
Panel discussions: Interaction with Industry and Member states on the landscape of regulatory compliance
more
  • The impact of Brexit on the regulatory landscape
  • The long term effect of the GDPR and ICH
  • Preparations needed for the CTR
16:30 - 16:35 5 mins
End of Conference