• 08:30
• 

• Registration & Refreshments

• 09:20
• 

• Chairperson's opening remarks

  ---

  

  Nancy Meyerson-Hess Former Head, Clinical Operations and Compliance
  Grunenthal

• 09:30
• 

• Strategies for globalization in clinical trials

  • Connecting the developed and the developing nations
  • Dealing with differences owing to culture and ethnicity
  • Role of CROs and third party stakeholders

• 10:00
• 

• Innovative trial designs to save time and cost without compromising on the efficiency

  • Strategies & Methods for flexible design trials
  • The Adoption and Impact of Adaptive Trial Designs
  • Preclinical environment and trial designs Opportunities and Limitations

  ---

  

  Catherine O'connor Associate Director of Medical Affairs
  MSD

• 10:30
• 

• Morning Coffee/Tea & Networking

• 10:50
• 

• Case Study: The role of surrogate markers in (cardiovascular) drug development

  The session will highlight the importance of surrogate markers in general for drug development and in the field of cardiovascular research in particular. Following aspects will be covered in the presentation:

  
  
  • Inform / de-risk phase III
  • Proof of Concept
  • Enrich patient population
  • Label enhancement

  ---

  

  Marc Ditmarsch Former Country Medical Director
  Astrazeneca

Patient Recruitment & Site Selection

• 11:20
• 

• Efficient and Effective clinical trial recruitment planning

  • New approach to strategic recruitment planning
  • Co-operation with all relevant stakeholders
  • Data-driven approach to maximize engagement and support
  • Recruitment performance monitoring and evaluation plan
  • Patient-Centric Enrolments Planning and Engagement

• 11:50
• 

• Monitoring and Quality Assurance in site selection and patient recruitment to optimize clinical trials

  • Site pre-assessment and selection
  • Ensure patient protection and to deliver high quality data
  • Quality assurance can at times be difficult as regulatory requirements, standards and access to care differ globally – How are we going to handle this?

  ---

  

  Ana Herradon Virseda Associate Director, Monitoring Manager
  Bristol-Myers Squibb

• 12:20
• 

• Networking & Luncheon

• 13:10
• 

• Sponsor centric to Patient centric framework - Improving patient recruitment & enhancing their involvement

  • Patient recruitment and engagement tools
  • Challenges and Barriers – How to overcome it?
  • New models will have to emerge to support data sharing while protecting patient privacy
  • How to tackle the lack of regulatory guidance?

  ---

  

  Devaki Nair Clinical Lead for Clinical Biochemistry and HOD - Director SAS Centre for Cardiac Biomarkers
  NHS

• 13:40
• 

• Effective patient recruitment and retention in clinical trials

  • What will persuade and impact the patient?
  • Is there anything pharma can provide for a trial member that will increase the value of participation?
  • The aim of patient-driven clinical trials is to diminish the burden of participation by making the participant journey as convenient and pleasant as possible
  • Utilize fitting procedures and techniques to limit dropouts without, in any capacity, constraining a patient to remain in the study

  ---

  

  Kylie Gyertson Head of Cancer Clinical Trials
  UCLH

• 14:10
• 

• Panel discussion: Novel approaches to streamline site selection and reduce delay in recruitment to ensure success

  • Discover sites with a demonstrated track record of good execution in trials
  • Study and site staff with solid certifications to expand the likelihood of powerful enrolment and an effective trial.
  • Factors such as disease prevalence rates, treatment practices, regulatory requirements and statistical considerations must be considered
  • Access to subject population with the required eligibility criteria
  • Network within industries

  ---

  

  Nancy Meyerson-Hess Former Head, Clinical Operations and Compliance
  Grunenthal

Patient Centricity & Patient Engagement

• 14:40
• 

• Making Patient Engagement a Reality

  • Current trends & challenges
  • Understanding of the patient and the trial journey
  • Improving data quality and ensure safety & efficacy
  • Engaging and retaining existing patients
  • Improving patient centricity of the trials
  • Integrating technology and communication to enhance transparency

  ---

  

  Daniel De Schryver Patient Engagement & Advocacy Lead, EMEA
  Janssen Pharmaceutical

• 15:10
• 

• Afternoon Tea/Coffee

• 15:30
• 

• Case study: Embedding a patient-centric approach to clinical trial design

  • Examine learning points from multiple studies engaging patients at the protocol design stage
  • Understand the importance of the independent intermediary
  • Analyse the outcomes - evidencing the impact of earlier involvement

  ---

  

  Gareth Powell Business Development Officer
  NIHR

• 16:00
• 

• Aspects of Informed Consent and Vulnerable Patients in Clinical Trials in the Digital Age

  ---

  

  Maria Kuthning Global Clinical Operations Lead
  MARIA KUTHNING Global Clinical Operations Lead Boehringer Ingelheim

• 16:30
• 

• Gain Insight to PatientCentric Remote Trial Conduct

  • Patient-centric remote trials trial setting
  • Customization of clinical trials
  • Simplify trial participation.
  • Modern technology for collecting clinical data
  • Direct Data Capture (DDC)
  • Experiences from current trials, challenges and benefits

  ---

  

  Bodo Lutz Global Quality & Risk Management and Data Integrity QA
  Novartis

• 17:00
• 

• Interactive Breakout Discussions:

  All the participants will have a great opportunity to discuss and explore a selection of most interesting topics discussed during the conference in small groups with their industry colleagues in an informal setting.

   

  Each table will nominate a head who will summarise the discussion and questions posed. The group members are given equal rights to share and learn from each other's experiences to discover an actionable solution on the discussed topic.

   

  Round Table 1: Innovation in Clinical Trials - Digital Approaches

   

  Round Table 2: Patient Centricity

   

  Round Table 3: Globalization and Country Specifics

   

  Round Table 4: Recruitment Challenges - Patients and Sites

   

  Round Table 5: Changing Clinical Trials - What needs to be addressed

   

  Round Table 6: Patient Retention

• 17:30
• 

• Chairperson’s closing remarks

  ---

  

  Nancy Meyerson-Hess Former Head, Clinical Operations and Compliance
  Grunenthal

• 17:40
• 

• Networking Drinks Session

• 08:30
• 

• Registration & Refreshments

• 08:50
• 

• Chairperson's opening remarks

Outsourcing and Partnerships in Clinical Trials

• 09:00
• 

• Weighing and evaluating the outsourcing approach that is right for you

  • Flexible, and easy to implement model
  • Creating an effective strategy to decide when to outsource
  • Analysing the key risk factors your CRO might bring and how to tackle them

• 09:30
• 

• Establishing quality partnerships between sponsors And CROs

  • Having a shared vision in sponsor–vendor relationships
  • Involving the CRO in the project design and planning
  • Decide on the Quality Agreement and CRO Oversight Plan upfront

  ---

  

  Pawel Wojcik Associate Director Study Management
  Astrazeneca

• 10:00
• 

• Efficient means of vendor oversight when it comes to metrics, deliverables and quality

  • Monitoring outsourced clinical trials
  • Managing Continuous & Real-Time Collaboration
  • Both sponsor and CRO must invest time in defining goals, anticipating issues and measuring results

  ---

  

  Veronique Freund Head of Clinical External Parties Quality Management
  Sanofi

• 10:30
• 

• Morning Coffee/Tea & Discussion

• 10:50
• 

• Establishing quality partnerships between sponsor and CROs

  ---

  

  Tamzin Blagbrough Sourcing consultant
  Eli Lilly

• 11:20
• 

• A key factor in vendor Selection - The role of the CRO in advancing patient-centric clinical trial approaches

  ---

  

  Ellen Van Vijnckt Head Start Up & Admin Team Country Clinical Operations
  Roche

• 11:50
• 

• Panel Discussion - A collaborative clinical ecosystem: How to effectively manage partnerships with all Stakeholders including Patients, Sites,CROs, Sponsors and Regulators.

  • Managing continuous & real-time collaboration
  • How transparency will lead to industrywide collaboration
  • Both sponsor and CRO must invest time in defining goals, anticipating issues and measuring results.
  • Considering what patient centricity factors your CRO brings in

  ---

  

  Karen Hue Director, Quality Assurance
  AIMMUNE THERAPEUTICS

  

  Sol Yates Associate Director Regulatory Affairs Development
  Grunenthal

  

  Maria Palombini Director, Communities & Initiatives Development, Life Sciences
  IEEE Standards Association

• 12:20
• 

• Networking & Luncheon

Quality, Compliance and Risk Management

• 13:10
• 

• Adapting QA to ensure that we move quality to the front of all processes using auditing and internal compliance management

  ---

  

  Karen Hue Director, Quality Assurance
  AIMMUNE THERAPEUTICS

• 13:40
• 

• Inspection readiness, inspections and audits preparation and CAPA management

  ---

  

  Edyta Zbirog-Lukawska Central Europe Quality And Compliance Specialist
  Roche

• 14:10
• 

• Implementing risk proportionate approaches in clinical trials - moving towards risk-based monitoring

  • Observing exercises and methodologies ought to be chosen to be proportionate to the risks identified within a trial.
  • Risk-based monitoring needs an effective and adaptable technology platform with analytics, which are combined with monitoring to assess, manage and mitigate risk

Clinical Data and Tech Driven Trials

• 14:40
• 

• Advances in Predictive Analytic Modelling of Clinical Trails Operations

  • Innovative trial designs
  • Patient Recruitment and Site selection
  • Implementing Risk Based Monitoring

  ---

  

  Vladimir Anisimov Principal Data Scientist
  Amgen

• 15:10
• 

• Afternoon Tea/Coffee

• 15:30
• 

• Interpretation and Impact of Real-World Clinical Data

  • Strategies for better decision-making
  • High-level models and simulations compelled by data will allow elimination of risky trials
  • The potential of real world data in clinical research goes past patient identification and patient recruitment

• 16:00
• 

• Clinical trials in the era of digitization - the impact of smart innovations in clinical research

  • Rethinking the R&D Clinical Process
  • Patient-Centred Innovation in Clinical Trials
  • New trial designs and analysis methods
  • Discovering and validating sequential,personalized decision-making strategies
  • An Integrated Business Model – Using technology to streamline processes

  ---

  

  Maria Palombini Director, Communities & Initiatives Development, Life Sciences
  IEEE Standards Association

• 16:30
• 

• Describing the landscape in the pharma and healthcare settings,exploring the areas where Blockchain could be used and presenting two detailed use cases

  • Patient Data Access/Transparency) to support future development and implementation for an upcoming proof of concept.
  • Drug Supply Chain using Smart Contracts

  ---

  

  Adama Ibrahim Associate Director, Global Clinical Operations
  Biogen

• 17:00
• 

• Novel techniques- Techdriven clinical trials

  • Effectively using Technology is enabling patient centricity
  • How to implement mobile technology and make it work in clinical trials
  • Does consumer technology devices used in clinical trials?
  • IoT in digital transformation of clinical trials

• 17:30
• 

• Chairperson’s closing remarks