Wednesday - 21st September 2022 (Time Zone - BST) - Virtual Conference
- 09:30
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Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking
- 09:40
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Chairperson’s opening remarks
Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
- 09:50
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Deploying a DCT in Europe – learnings from the IMI Trials@Home Initiative
Rebecca Jackson Sr. Mgr. Clinical R&D Innovation & Novel Modalities IT
Janssen Pharmaceutical
- 10:15
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How better engage HCPs and patient through digital tools ?
Stefania Alvino Omnichannel Marketing Manager & Digital Orchestrator
Daiichi Sankyo Italia S.p.A
- 10:40
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How the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) is improving research transparency globally.
Ghassan Karam Project Manager
World Health Organization
- 11:05
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Building patient-centric early phase clinical trials
- The current state of standardization and reuse of datasets
- The impact of interoperability and reusable data researcher workflow, drug development timelines and patient experience
Floris Morang Director of Business Development
Castor
Iain Little Team Head IRT Management
Novartis
Patient Recruitment & Site Selection
- 11:30
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Situationally Adaptive Trials - Ukraine Crisis
Francis Crawley Executive Director
Good Clinical Practice Alliance - Europe (GCPA)
- 11:55
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Advanced analytic technologies for predictive modelling and optimizing patient recruitment in clinical trials
- Analytic modelling and forecasting patient recruitment
- Optimal operational design, sites/countries selection given costs & time constraints
- Data-driven re-projection and optimal adjustment of recruitment to increase probability to meet target
- Centralized statistical monitoring and detecting unusual data patterns
- Predicting some operational characteristics
Vladimir Anisimov Principal Data Scientist, Data Science, Center for Design & Analysis
Amgen
- 12:20
-
Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)
- 13:00
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True Global Diversity in our Trials: Africa is Ready
Shalom Lloyd Co-Founder & Chief Strategy Officer
eMQT
Tina Barton Chief Operating Officer
eMQT
- 13:25
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Trials and Observational Studies
- How can observational data help RCTs?
- In what situation can real world studies replace RCTs?
- Role of synthetic control arms for one-arm trials
- Data sources
- Case studies
Nawab Qizilbash Clinical Epidemiologist & Head of OXON
OXON Epidemiology
- 13:50
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Medical Affairs and Clinical Operations collaborating on Clinical Trial Optimization
Eva Gallagher Vice President, Head of Medical Affairs
Agios Pharmaceuticals
- 14:15
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Panel discussion: Effective patient recruitment and retention in clinical trials to boost trial success
- 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
- Utilize wider use of the innovative statistical and Machine Learning techniques to provide more accurate data-driven forecasting and centralized monitoring of patient recruitment
Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
Vladimir Anisimov Principal Data Scientist, Data Science, Center for Design & Analysis
Amgen
Carole Scrafton Patient & Health Advocate
FibroFlutters
Lauren Bataille Head, Digital Medical Capabilities
Novartis
Obiageli Onwusaka Director, Biostatistics
ClinFocus
- 14:45
-
Feasibility in clinical trials - the main ingredients
- Importance of conducting feasibility
- The stages of clinical trial feasibility
- Feasibility challenges
Dex Bilkic Senior Manager, Site Engagement
Bayer
Patient Centricity & Patient Engagement
- 15:10
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Bringing the patient voice in the design of clinical trials: why, when and how
Lea Proulx Patient Voice Partner
Roche
- 15:35
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Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)
- 15:50
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Integrating the Patient Voice into Medical Product Development: Opportunities and Applications for the Use of Patient Experience Data
Jessica Abel Director, Patient Experience Data Policy and Best Practices
Abbvie
- 16:15
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Patient Engagement in Clinical Development - A look at what the UK are doing to bring patients to the forefront of study design
Alex Hammond Business Development Manager
NIHR Clinical Research Network
Kim Down Business Development Manager
National Institute of Health and Care Research (NIHR)
- 16:40
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The Integration of Patient-Centricity Across the Lifecycle of Treatment Development
This talk provides a broad view of the rapidly developing landscape of Patient-Centricity in Clinical Research. The audience will learn about a variety of initiatives aimed at improving and accelerating clinical research through collaboration with patients, advocates and their communities.- Explore research measuring and evaluating the "Return on Engagement" financial and efficiency value of Patient Centric activities
- Review key regulatory developments in support of Patient Centered Research
- Gain insights from the largest global survey on patient and public perceptions and experience in clinical research
- Examine concrete examples of Patient Centered Research programs and project
Behtash Bahador Director, Health Literacy
CISCRP
- 17:05
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What are the benefits of using multi stakeholder approaches, in research, from the patient perspective
- Why are multi-stakeholder approaches needed and important?
- Leveraging collaboration to address patients’ needs and challenges
- The impact of multi-stakeholder approaches on reducing patient burden
- Patient experience and perspective taking part in multi-stakeholder initiatives
Carole Scrafton Patient & Health Advocate
FibroFlutters
Hayley Chapman Senior Program Director
The Synergist
- 17:30
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Quality by Design - what you need to know
- When/where is it needed
- What is QbD
- How to implement
William Lawton Consultant
Risk Based Approach Ltd
- 17:55
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Panel discussion: The patient's perspective: why their voice is so important in clinical research
Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
Mary Lynne Van Poelgeest-Pomfret International patient advocate
World Federation for Incontinent Patients - WFIP
Melissa Penn Director, Patient Engagement R&D
Bayer
Jost Leemhuis Safety Science Partner and Global Business Lead
Roche
- 18:25
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Chairperson’s closing remarks
Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
- 18:30
-
Networking - Catch-up with your peers in social lounge
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