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Key Sessions

Caroline Feys

CASE STUDY: Informing and empowering patients by providing access to their data and new research opportunities.

Janssen, Belgium

Angelo Trotta

CASE STUDY: Patient Reported Outcomes and beyond: A Self-Service setup

Janssen, Pharmaceutical Companies of Johnson & Johnson, Belgium

Alain Bindels

How can design thinking transform the Pharma Industry?

Roche, Switzerland

Amelia Hursey

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

Parkinson’s UK

Ms Joana Claverol

CASE STUDY: Paediatrics Trials – what are their experiences?

Barcelona Children’s Hospital Sant Joan de Déu, Spain

Begonya Nafria Escalera

Engagement of young people across Europe to improve paediatric clinical trials

Hospital Sant Joan de Déu, Spain

Katrin Haeverans

CASE STUDY: Collaborative studies and platform studies – changing the scope of clinical research

Deputy Head| Director Risk Management and Central Monitoring, TA lead oncology heme and ED/CP

Daniel Prieto- Alhambra

Big Health Data –Insights you can generate from routine data sources.. if you still “haven’t found what you are looking for

Oxford University, UK

Nov 29
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08:30 - 08:50

Morning Coffee and Networking

Showing of Streams
10:30 - 11:20

Morning Break

Showing of Streams
13:30 - 15:00

Lunch

Showing of Streams
17:30 - 17:35
End of Conference Day Three

End of Conference Day Three

08:30 - 08:50 20 mins
Morning Coffee and Networking
08:50 - 09:00 10 mins
STREAM 7: Patient Recruitment & Retention
Opening remarks from the chairperson
08:50 - 09:00 10 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
Opening remarks from the chairperson
08:50 - 09:00 10 mins
STREAM 9: Regulatory Updates
Opening remarks from the chairperson
08:50 - 09:00 10 mins
STREAM 10: Artificial Intelligence
Opening remarks from the chairperson
08:50 - 09:00 10 mins
EARLY CLINICAL DEVELOPMENT
Chairperson's Opening Remarks
09:00 - 09:30 30 mins
STREAM 7: Patient Recruitment & Retention
CASE STUDY: Informing and empowering patients by providing access to their data and new research opportunities.
  • Caroline Feys - Clinical Innovation Leader, Janssen, Belgium
more

Research indicates that patients want access to their data, also while they are participating in a clinical trial. But why would patients really need access to their health data, after all, aren’t their investigators the ones who truly need to be in the know? Under older healthcare models that may have been true, but the healthcare industry transitions into patient-centred care models and patients want to be empowered with their own health data. Janssen Clinical Innovations (JCI) has developed the Janssen Global Trial Community in which we want to empower patient by providing access to their data, study information, feedback moments and new research opportunities to foster engagement and to create a long-term partnership build on transparency, trust and awareness.

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, Pharmaceutical Companies of Johnson & Johnson, 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
Clinical trial cost and time savings using robotics and cognitive analytics
more
  • Case study on the use of automation in house to free up resources and save time and money
  • Can robotics offer the possibility to accelerate the whole clinical trial process?
  • Specifically, the use of robotics in site initiation and contract negotiation
09:00 - 09:30 30 mins
EARLY CLINICAL DEVELOPMENT
CASE STUDY: NIMA – Advancing Science and Drug Development through Public – Private Collaborations
  • Anja Hijzen - Associate Director Clinical Scientist, Janssen, Pharmaceutical Companies of Johnson & Johnson, 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
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
The role of Patient Reported Outcomes (PROs) and Quality of Life Measures in trials and clinical practice
  • Galina Velikova - Professor of Psycho-social and Medical Oncology, University of Leeds, UK
more
  • Monitoring of patients’ physical and psychological problems during and after cancer treatment is essential in modern oncology practice.  Traditional clinical methods can be supplemented by Patient-Reported Outcome (PROs) measures. The potential role of PROs is recognized and endorsed by national and international practice guidelines.
  • This presentation will first provide a brief historical overview and define the terms used in the field, such as health status, health-related quality of life, patient-reported outcomes, clinical outcomes.
  • The second part will give examples of cancer clinical trials where QOL data provided important extra information for patients and oncologists.
  • The third part will focus on using PROs in clinical practice to monitor symptoms and side-effects during cancer treatment. There is increasing research evidence that using PROs in individual patient care in oncology is beneficial to patients, supporting communication, achieving better symptom control, and possibly better survival. A brief overview of this evidence will be provided, followed by an example of our experience in Leeds, UK of online monitoring of toxicity during cancer chemotherapy using patient self-reported side-effects integrated with the electronic patient records (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice- eRAPID research program funded by the National Institute for Health Research). The values and challenges of PROs integration in routine oncology practice will be discussed.
09:30 - 10:00 30 mins
STREAM 9: Regulatory Updates
Strategies to prepare of Clinical Trial Regulation
  • Dr. med Uwe Gudat - Head of Clinical Safety & Pharmacovigilance, Fresenius Kabi SwissBioSim GmbH, Switzerland
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
Identifying the right mix of RPA & human oversight
more
  • What level of automation of RPA is right?
  • What will lead the best ROI for both large pharma and smaller biotech
  • What is the optimal path for implementing automation in house?
09:30 - 10:00 30 mins
EARLY CLINICAL DEVELOPMENT
Facilitating collaboration between industry & academia in the discovery & development of new medicines: A Cancer Research UK Perspective
  • Nigel Blackburn - Drug Development Director, Cancer Research
more
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
Spotlight session
  • Martine Dehlinger-Kremer - Vice President, Global Medical and Regulatory Affairs, SynteractHCR, UK
more
10:00 - 10:30 30 mins
STREAM 10: Artificial Intelligence
Artificial Intelligence in Clinical Trials Automation
  • Vitthal Gouri - Director, Clinical Solutions, ArisGlobal, UK
more
  • What automation?
  • Approach to automation in clinical trials
  • Technology(AI) adoption for clinical trials automation
  • Automation planning and implementation
  • Regulatory prospective of automation in clinical trials
  • Conclusion
10:00 - 10:30 30 mins
EARLY CLINICAL DEVELOPMENT
Spotlight session
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
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
Clinical Trials in emerging regions
  • Nancy Meyerson-Hess - Head Clinical Operations & Compliance, Gruenthal
more
11:20 - 11:50 30 mins
STREAM 10: Artificial Intelligence
Patient engagement and recruitment advances
more
  • Feedback on the use of the technology to improve patient engagement and recruitment
  • How can it also be used to identify the best protocols and sites for clinical trials?
  • Other ways the technology can be used to optimise the clinical trial process
11:20 - 11:50 30 mins
EARLY CLINICAL DEVELOPMENT
PANEL DISCUSSION: Outsourcing early clinical trials
  • Nigel Blackburn - Drug Development Director, Cancer Research
  • Anja Hijzen - Associate Director Clinical Scientist, Janssen, Pharmaceutical Companies of Johnson & Johnson, Belgium
more
  • Are clinical CROs really focused on the early phases?
  • Experiences and challenges with outsourcing to CROs in the early phase
  • CROs vs. academic institutions
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
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 10: Artificial Intelligence
Intelligent digital advertising tactics for accelerating clinical trial recruitment
more
  • Case study on the use of digital advertising platforms in patient recruitment
  • Targeting candidates based on key inclusion/exclusion criteria
  •  How this could offer the opportunity to reach previously untapped pools of
11:50 - 12:20 30 mins
EARLY CLINICAL DEVELOPMENT
Application of digital technologies into early phase
more
  • A practical overview of the potential role and benefits of digital technologies in early phase clinical trials
  • Exploring how digital technologies can aid data collection and benefit study design
  • The limitations of digital biomarkers in phase 1 environments and how to use them as effectively as possible
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
  • Dmitry Manuilov - Head of Clinical Development, MYR GmbH, Germany
  • Divya Chadha Manek - Head of Business Development and Marketing (commercial), NIHR, UK
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
Quality Risk Management - impact from ICHH E6R2 Guideline
  • A Representative from Merck - -, Merck, UK
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 10: Artificial Intelligence
Achieving improved patient centricity and engagement with the use of AI – Opportunities and Limitations
more
  • Is there an opportunity to effectively and efficiently use ambient listening devices?
  • How can AI and machine learning be leveraged
  • Detection of adverse events?
  • The use of NLP and other strategies for analysis?
12:20 - 13:00 40 mins
EARLY CLINICAL DEVELOPMENT
Role of PK/PD Modeling in supporting design of FIH-trials of high risk molecules
  • Youssef Hijazi - Expert Clinical Pharmacokinetics,, Sanofi
more
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
Spotlight presentation
more
13:00 - 13:30 30 mins
STREAM 10: Artificial Intelligence
Innovation Den
13:00 - 13:30 30 mins
EARLY CLINICAL DEVELOPMENT
Spotlight session
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, Deputy Head| Director Risk Management and Central Monitoring, TA lead oncology heme and ED/CP
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
CASE STUDY: Inspectors experience’s on GDPR and ICHH E6R2
15:00 - 16:00 60 mins
EARLY CLINICAL DEVELOPMENT
Early phase study design for novel modalities and biosimilars: bispecifics, cell and gene therapies, biosimilars
more
  • How to use the MABEL (Minimum Anticipated Biology Effect Level) approach to PK modelling for novel modalities such as biologics
  • Understanding the unique challenges associated with novel modalities and how to overcome these through effective early phase study design
  • Case examples of effectively reducing risk when bringing novel molecules into humans for the first time
  • Understanding current regulations and requirements for early phase clinical trials of biosimilars and bioequivalents
  • Practical case examples of the understanding and efficiently applying the unique requirements for early phase trials of biosimilars
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
Patient data under GDPR
  • Kristof Van Quathem - Special Counsel, Covington & Burling LLP, Belgium
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?
15:30 - 16:00 30 mins
STREAM 10: Artificial Intelligence
Making all data machine learnable
more
  • Leveraging data for machine learning projects
  • Implementing robust data standards
  • Analysing big data using machine learning algorithms
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
16:00 - 16:30 30 mins
STREAM 10: Artificial Intelligence
Using AI to generate and test novel hypotheses – increasing efficient and accuracy of clinical trial processes
more
  • How machine learning can be used to analyse complex data sets
  • The use of programs to generate and test novel hypotheses more efficiently than traditional processes – thus enabling much faster and more accurate clinical trial periods
16:00 - 16:30 30 mins
EARLY CLINICAL DEVELOPMENT
Applying seamless early phase study design concepts from oncology
more
  • Applying seamless trial design for early clinical development from clinical studies focused on oncology treatments
  • An outline of how seamless studies could reduce costs and timescales of early development
  • Discussing how and when seamless study designs can be applied to early phases trials for diseases other than oncology
  • Exploring the current regulatory view on seamless studies
16:30 - 16:35 5 mins
STREAM 8: Real World Evidence, Paediatrics, Trial Design & Big Data
End of Conference
16:30 - 16:35 5 mins
STREAM 9: Regulatory Updates
End of Conference
16:30 - 16:35 5 mins
STREAM 10: Artificial Intelligence
End of Conference
16:30 - 17:30 60 mins
EARLY CLINICAL DEVELOPMENT
Early phase clinical trials for rare diseases and oncology
more
  • Understanding and overcoming patient enrolment issues in early phase development for rare diseases and oncology
  • How to define endpoints for rare diseases with complex biomarkers
  • How to design an early phase study with the unique challenges of oncology such as having no placebo control
17:30 - 17:35 5 mins
End of Conference Day Three