The Global Clinical Trials Connect 2024 will provide a platform to discuss on the futuristic advancements in clinical trials and clinical research. This multidisciplinary program involves broad participation of people from clinical trials community from around the globe who are focused on learning more about clinical research, clinical trials planning and management.
The Pharma and Bio-Tech companies are consistently evolving and new clinical studies, technologies and advancements in care and treatments have augmented the efficiency and at the same time the complexity of clinical trials has increased, with tests being carried out in a highly structured and closely coordinated manner. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry.
This conference intends to focus on the global health and clinical trials around the world. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based monitoring, clinical auditing & financial planning and other significant topics that play a key role in clinical trials will be addressed along with innovative sessions on new technologies, effective and quality collaborations.
This program will certainly educate health care scientists on trial design, operations, organizing trials, research computing, regulatory aspects, report on clinical trials and gain a better knowledge of the implications of clinical trials in prevention, diagnosis, clinical trial-related ethics and disease treatments.
The summit will facilitate an invaluable networking opportunities with decision makers and focus on real case studies, insightful presentations and round tables.
It gives us a great pleasure in welcoming you to the Global Clinical Trials Connect 2024.
KEY HIGHLIGHTS
- Patient Recruitment and Site Selection
- Innovative trial designs
- Partnership & Collaboration - Sponsors, CROs, Sites and External Vendors
- Patient-centric clinical trials
- Making Patient Engagement a Reality
- New innovations in Patient Recruitment planning and execution on a clinical trial
- Outsourcing strategies and models
- Electronic Clinical Outcome Assessment and Electronic Patient Reported Outcome
- Streamlined IRT development process
- Pharmacovigilance & Clinical Trials
- Post-Clinical Trial closed communities
- How to future-proof your clinical operations
- Diversity and Inclusion in Clinical Trials
- Implementing Risk-Based Monitoring
- Streamlining R&D and lower costs in clinical trials
- Adaptive Trial Model
- Clinical Trial Auditing
- Real World Clinical Trial Strategies
- Data Quality & Technology
- Clinical Data Strategy & Analytics
- Electronic Data Capture (EDC) Systems
- Decentralised Clinical Trials
- Clinical Technology and Driving Innovation
- M-Health, Wearable and Consumer Technology
- Big-Data, IoT and Artificial Intelligence in Clinical trials
- Blockchain technology for improving clinical research quality
Agenda
Tuesday - 28th May 2024
08:00 - Registration & Refreshments
Kick off your conference experience by checking in at our registration desk. Collect your event materials and enjoy a selection of refreshments. It's the perfect time to mingle with fellow attendees and set the tone for an engaging and informative event
08:50 - Welcome Address & Chairperson’s opening remarks
Begin your conference journey with a warm welcome from our esteemed Chairperson
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
09:00 - Growing trends in clinical trials: Agility, Sustainability, Diversity and Predictability
Cem Asma Cem Asma Team Agility Lead
Novartis
09:25 - Integrating Blockchain into clinical research
Jose Manuel Cervera Grau Jose Manuel Cervera Grau Executive Director
Eli Lilly
09:50 - Digital Transformation of Clinical Trials: Innovative Protocol Design and Strategic Approaches
Haneen Njoum Haneen Njoum Senior Data Scientist
Sanofi
10:15 - Sustainability by Design in Clinical Trials - Why sustainability matters for patients and for business resilience
Carly Santer Carly Santer Strategic Initiatives Project Leader & Sustainability Activator
Bayer
10:40 - Business Card Exchange with Morning Coffee/Tea & Discussion
10:50 - Forging Successful Global Research Partnership in Southeast Asia - Universiti Malaya Medical Centre's Experience
Prof. Dr. Ho Gwo Fuang Prof. Dr. Ho Gwo Fuang Consultant clinical oncologist
Clinical Investigation Centre, UMMC
Patient Recruitment & Site Selection
11:20 - Site Selection Excellence: Matching Capabilities to Trial Needs
Criteria for selecting sites with the right patient demographics and technological capabilities.
The benefits of site and investigator networks to streamline multi-site trials.
Assessing and improving site performance through training and support in patient recruitment strategies.
Dex Bilkic Dex Bilkic Director, Alliance Management
AstraZeneca
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?
12:20 - Advanced Analytic Technologies for Patient Recruitment Planning and Trial Optimization
Volodymyr Anisimov Volodymyr Anisimov Data Science Associate Director, Data Science, Centre for Design & Analysis
Amgen
12:50 - Luncheon & Networking - Explore, Engage with Your Peers, and Connect at Our Exhibitor Booths
13:30 - 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?
14:00 - Patient-Centric Approaches to Site Selection and Recruitment
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
Mohammed Naja Mohammed Naja Associate Director North Region, Clinical Site Management
Abbott
14:30 - Panel discussion: Critical Success Factors while Planning for Site Selection and Patient Recruitment
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 Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
Volodymyr Anisimov Volodymyr Anisimov Data Science Associate Director, Data Science, Centre for Design & Analysis
Amgen
Patient Centricity & Patient Engagement
15:00 - EU-PEARL: An EU patient-centric clinical trial platform
Nadir Ammour Nadir Ammour Global Lead, Clinical Innovation & External Partnership
Sanofi
15:30 - Recharge with Tea or Coffee While Networking
15:50 - Patient Engagement in Clinical Development - A look at what the UK are doing to bring patients to the forefront of study design
Alex Hammond Alex Hammond Business Development Manager
NIHR
16:20 - Patient Involvement and Patient Reported Outcomes. Does it make a difference?
Regine Buffels Regine Buffels Principal Global Medical Affairs Director
Hoffmann-La Roche
16:50 - Panel Discussion: The Future of Patient-Centricity in Clinical Trials - Embedding a patient-centric approach to clinical trial design
How to integrate patient feedback into clinical trial design effectively.
The role of digital health technologies in enhancing patient engagement and experience.
Strategies for maintaining communication and trust with participants throughout the trial.
The impact of patient-centric approaches on trial outcomes and drug development timelines.
Ethical considerations and data privacy in a patient-centered model.
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
Nadir Ammour Nadir Ammour Global Lead, Clinical Innovation & External Partnership
Sanofi
Sophie Wintrich Sophie Wintrich Chief Executive
MDS UK Patient Support Group
17:20 - The Role of Investigator-Initiated Trials in Leveraging Real-World Evidence
Viraj Rajadhyaksha Viraj Rajadhyaksha Area Medical Director
AstraZeneca
17:50 - Interactive Breakout Round Table Discussion
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.
Table 1 - Revolutionizing Patient Recruitment: Strategies for Today’s Digital World
Exploring the intersection of digital marketing, social media, and patient advocacy in enhancing recruitment efficiency.
Table 2 - Mastering the Art of Site Selection: Balancing Technology, Geography, and Patient Access
Delving into the criteria and tools that can optimize site selection for diverse and technologically advanced clinical trials.
Table 3 - Harnessing Data Science: The New Frontier in Trial Design and Real-World Evidence
Discussing the transformative potential of big data analytics, AI, and real-world evidence in the design and execution of clinical trials.
Table 4 - The Evolving Landscape of Clinical Trial Regulations: Global Perspectives and Harmonization
Navigating the complexities of international regulatory environments and striving for a harmonized approach to global clinical trials.
Table 5- Patient-Centricity in Clinical Trials: More Than Just a Buzzword?
Evaluating the real-world application of patient-centric approaches in trial design, conduct, and outcomes.
Table 6- Innovation in Trial Monitoring and Quality Assurance: Risk-Based Approaches and Beyond
Examining the latest methodologies in risk-based monitoring, quality by design, and the role of clinical auditing in ensuring trial integrity.
18:20 - Chairperson’s Closing Remark
18:30 - Networking Drinks Session - Unwind with Evening Drinks and Engaging Conversations
Wednesday - 29th May 2024
08:30 - Registration & Refreshments
Start the second day of the conference by checking in and grabbing a morning refreshment. It’s a great opportunity to re-engage with peers, discuss the previous day’s insights, and prepare for another day of learning and networking.
08:50 - Welcome Address & Chairperson’s opening remarks
Start the second day with insightful remarks from our Chairperson
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
The Rise of Decentralized Clinical Trials
09:00 - Clinical Trials in the Era of Digitization - The Impact of Smart Innovations in Clinical Research
Linus Kao Linus Kao Senior Expert Decentralized Clinical Trial (DCT)
Novartis
09:25 - Clinical trial decentralisation: why it matters?
The challenges of decentralisation for clinical trials
How to ensure appropriate standards and protocols in a decentralised clinical trial environment
Potential barriers to the adoption of decentralised clinical trials and how to overcome them
Nikita Sharma Nikita Sharma Global Clinical Sciences & Operations Innovation Manager
UCB
09:50 - Increasing diversity in clinical trials in the UK: Results from a nationally representative survey
Rebecca West Rebecca West Associate Director leading Global Health
Ipsos
10:15 - Personalized Clinical Trials Framework: Considerations for implementation from a patient centricity perspective
Sophie Wintrich Sophie Wintrich Chief Executive
MDS UK Patient Support Group
10:40 - Business Card Exchange with Morning Coffee/Tea & Discussion
Clinical Data & Tech Driven Clinical Trials
10:55 - Harnessing Real-World Data for Enhanced Clinical Trial Efficiency and Effectiveness
Natalia M. Monteiro Natalia M. Monteiro Senior Project Manager & RTE
Roche
11:20 - Improving clinical data management (CDM) and statistics to meet new regulatory requirements
Integrating end-to-end clinical data management to manage data disruption
Centralized Statistical Monitoring to Improve the Quality of Clinical Data
Analysing the data constantly to evaluate and adjust the monitoring strategy as required
Mohamed Sharaf Mohamed Sharaf EMEA Regional Senior Medical Advisor (Immunology)
Janssen Europe, Middle East & Africa
11:40 - 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
12:00 - Quality considerations for the use of Real World Evidence in clinical development
Andrew Gray Andrew Gray Director, Global Regulatory and R&D Policy
Amgen
12:25 - 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
Meelis Lootus Meelis Lootus Member of IEEE Novel Biomarkers for Decentralised Clinical Trials Working Group
IEEE
12:50 - Luncheon & Networking - Explore, Engage with Your Peers, and Connect at Our Exhibitor Booths
13:30 - Panel Discussion: Leveraging Big Data and AI in the Era of Tech-Driven Clinical Trials: Opportunities and Ethical Dilemmas
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
Meelis Lootus Meelis Lootus Member of IEEE Novel Biomarkers for Decentralised Clinical Trials Working Group
IEEE
Tina Barton Tina Barton Chief Operating Officer
eMQT
Outsourcing & Clinical Trials
14:00 - 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
Craig Elliott Craig Elliott Director Strategic Alliance and Sourcing
Merck
14:30 - Strategic Outsourcing in Digital Health: Enhancing Data Quality through Supplier Partnerships
Monitoring outsourced clinical trials
Managing Continuous & Real-Time Collaboration
Both sponsor and CRO must invest time in defining goals, anticipating issues and measuring results.
Jennifer Eyerman Jennifer Eyerman Clinical Trial Partner, Expert Chapter, pRED
Roche
15:00 - Africa’s role in reducing clinical delays
Tina Barton Tina Barton Chief Operating Officer
eMQT
Shalom Lloyd Shalom Lloyd Co-Founder & Chief Strategy Officer
eMQT
15:30 - Recharge with Tea or Coffee While Networking
15:50 - Topic TBC
Jordi Ferrer Jordi Ferrer Clinical Development Director
Merck
Quality, Compliance & Risk Management
16:20 - 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.
Mireille Lovejoy Mireille Lovejoy Director, Clinical Risk Management and Process Excellence
GE Healthcare
16:50 - Quality as a Catalyst: Accelerating development with RBQM
Paula Walker Paula Walker Global Head of Risk Based Quality Management
Roche
17:20 - Panel Discussion - Breaking Silos, Building Bridges: Fostering Collaborative Ecosystems in Clinical Research
Exploring the dynamics and benefits of partnerships between biotech firms, pharma, academia, and healthcare providers.
Strategies for involving patients and the public in the research process to ensure studies are aligned with patient needs and societal expectations.
The importance of collaboration in conducting large-scale, multi-national trials, especially in the face of global health crises.
The need for regulatory agencies to work together to streamline approval processes while ensuring patient safety.
Nancy Meyerson-Hess Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
eMQT
Nikita Sharma Nikita Sharma Global Clinical Sciences & Operations Innovation Manager
UCB
17:50 - Chairperson’s Closing Remark
Speakers
Nancy Meyerson-Hess
Chief Compliance and Regulatory Officer
eMQT
Cem Asma
Team Agility Lead
Novartis
Jose Manuel Cervera Grau
Executive Director
Eli Lilly
Haneen Njoum
Senior Data Scientist
Sanofi
Dex Bilkic
Director, Alliance Management
AstraZeneca
Volodymyr Anisimov
Data Science Associate Director, Data Science, Centre for Design & Analysis
Amgen
Prof. Dr. Ho Gwo Fuang
Consultant clinical oncologist
Clinical Investigation Centre, UMMC
Mohammed Naja
Associate Director North Region, Clinical Site Management
Abbott
Nadir Ammour
Global Lead, Clinical Innovation & External Partnership
Sanofi
Regine Buffels
Principal Global Medical Affairs Director
Hoffmann-La Roche
Jordi Ferrer
Clinical Development Director
Merck
Linus Kao
Senior Expert Decentralized Clinical Trial (DCT)
Novartis
Nikita Sharma
Global Clinical Sciences & Operations Innovation Manager
UCB
Natalia M. Monteiro
Senior Project Manager & RTE
Roche
Mohamed Sharaf
EMEA Regional Senior Medical Advisor (Immunology)
Janssen Europe, Middle East & Africa
Meelis Lootus
Member of IEEE Novel Biomarkers for Decentralised Clinical Trials Working Group
IEEE
Jennifer Eyerman
Clinical Trial Partner, Expert Chapter, pRED
Roche
Mireille Lovejoy
Director, Clinical Risk Management and Process Excellence
GE Healthcare
Craig Elliott
Director Strategic Alliance and Sourcing
Merck
Paula Walker
Global Head of Risk Based Quality Management
Roche
Rebecca West
Associate Director leading Global Health
Ipsos
Viraj Rajadhyaksha
Area Medical Director
AstraZeneca
Alex Hammond
Business Development Manager
NIHR
Carly Santer
Strategic Initiatives Project Leader & Sustainability Activator
Bayer
Andrew Gray
Director, Global Regulatory and R&D Policy
Amgen
Sophie Wintrich
Chief Executive
MDS UK Patient Support Group
Tina Barton
Chief Operating Officer
eMQT
Shalom Lloyd
Co-Founder & Chief Strategy Officer
eMQT
Rebecca Jackson
Senior Manager, Clinical R&D Enabling Innovation
The Janssen Pharmaceutical companies of Johnson & Johnson
Miguel Valenzuela
Associate Director Clinical Operations - RBQM+
Alnylam Pharmaceuticals
Who Should Attend
This event is designed for senior-level attendees from various companies including Pharmaceutical, Bio-Tech, Bio-Pharma, CROs, Investigative Sites, Solution provider,s and Government institutions.
Attendees includes VPs, GMs, Directors, Heads and Managers of
- Clinical Trials
- Clinical Study Management
- Clinical Operations
- Clinical Research
- Patient Organizations
- Patient Recruitment
- Outsourcing
- Vendor Management
- Site Management
- Site Monitoring
- Clinical Pharmacology
- Clinical Data Management
- Risk Monitoring
- EDC
- Clinical/Digital Innovation
- Clinical Design/Protocol design/ Strategy makers
- Clinical Research Sites
- CROs and CMOs
- Hospitals/ Associations
- Regulatory affairs
Location
ADDRESS
Hilton London Kensington
179-199 Holland Park Ave
London
W11 4UL
United Kingdom
