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2 - 4 November 2021
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DAY TWO - GMT (Greenwich Mean Time)

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DAY TWO - GMT (Greenwich Mean Time)

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09:55 - 10:005 mins
Welcome to Day Two
  • Louisa Maitland - Conference Director, Informa
10:00 - 10:5050 mins
Partnerships and Outsourcing
PANEL: How much are Pharma Companies Tackling Diversity Issues?
  • Tina Barton - Chief Operating Officer, eMQT
10:00 - 10:5050 mins
Covid-19 Learnings
PANEL: How much are Pharma Companies Tackling Diversity Issues?
  • Tina Barton - Chief Operating Officer, eMQT
10:00 - 10:2525 mins
Patient Engagement & Recruitment
How to Motivate Patients to Participate in Clinical Trials and to Cooperate to Obtain Reliable Data
  • Wolfgang Eglmeier - Head Centre for Clinical Studies, Witten/Herdecke University
10:00 - 10:2525 mins
Operations
Spotlight Presentation:
    10:00 - 10:2525 mins
    Decentralized Trials
    LEGAL LANDSCAPE: Decentralized Trials from a legal point of views
    • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
    10:00 - 10:2525 mins
    Decentralized Trials & Technology
    Spotlight Presentation:
      10:25 - 10:5025 mins
      Patient Engagement & Recruitment
      Spotlight Presentation:
        10:25 - 10:5025 mins
        Operations
        EU Clinical Trial Regulation - Impact on Clinical Research in Europe
        • Beatrix Friedeberg - Executive Director, Global Regulatory Affairs & Strategy, Amgen, EFPIA CREG member
        10:25 - 10:5025 mins
        Decentralized Trials
        Spotlight Presentation:
          10:25 - 10:5025 mins
          Decentralized Trials & Technology
          Technology Implementation of BlockChain
            10:50 - 11:3040 mins
            LIVE Virtual Showcase Hub Networking Tech Tours Roundtables
              11:30 - 11:5525 mins
              Partnerships and Outsourcing
              Ensuring Diversity – Experiences of Running Trials in Sub-Saharan Africa
              • Tina Barton - Chief Operating Officer, eMQT
              • Shalom Lloyd - Co-Founder and Chief Strategy Officer, eMQT
              11:30 - 11:5525 mins
              Covid-19 Learnings
              Managing Study-Start-up in a Pandemic
                11:30 - 12:2050 mins
                Patient Engagement & Recruitment
                PANEL A: Increasing Efficiency and Reducing Cycle-Times in Drug Development: Multi-Stakeholder Views on the Topic
                • Lada Leyens - Global Regulatory lead - Clinical Trial Innovation and Digital Health, Roche
                • Kai Langel - Director, Janssen Clinical Innovation (JCI), Janssen-Cilag GmbH, Johnson & Johnson, Belgium
                11:30 - 12:2050 mins
                Operations
                PANEL A: Increasing Efficiency and Reducing Cycle-Times in Drug Development: Multi-Stakeholder Views on the Topic
                • Lada Leyens - Global Regulatory lead - Clinical Trial Innovation and Digital Health, Roche
                • Kai Langel - Director, Janssen Clinical Innovation (JCI), Janssen-Cilag GmbH, Johnson & Johnson, Belgium
                11:30 - 11:5525 mins
                Decentralized Trials
                INVESTIGATOR: Challenges during the Pandemic for Investigators and Experiences with Decentralized Trials
                • Roman Fishchuk - CEO, Clinical Trials Unit, Central City Clinical Hospital of Ivano-Frankivsk City Council
                11:30 - 11:5525 mins
                Decentralized Trials & Technology
                Optimizing Efficiencies in Clinical Research and Data Management by Implementing Technology-enhanced Decentralized Clinical Trials as a Care Option for Patients
                • Isaac Rodriguez-Chavez, PhD, MHSc, MSc - Senior Vice President, Scientific & Clinical Affairs, Global Center of Excellence for Decentralized Clinical Trials, PRA Health Sciences
                • Alexandre Malouvier - Scientific Affairs Director, Real World Solutions, PRA Health Sciences, France
                11:55 - 12:2025 mins
                Partnerships and Outsourcing
                FSP
                  11:55 - 12:2025 mins
                  Covid-19 Learnings
                  Learnings from Running a Nationally Prioritised COVID-19 Trial
                  • Stephen Nabarro - Head of Clinical Operations and Data Management, Cancer Research UK Centre for Drug Development
                  11:55 - 12:2025 mins
                  Decentralized Trials
                  Spotlight Presentation:
                    11:55 - 12:2025 mins
                    Decentralized Trials & Technology
                    CASE STUDY: Industry Leader- Novartis: BlockChain
                      12:20 - 12:4525 mins
                      Partnerships and Outsourcing
                      JOINT PRESENTATION: Supporting an Emerging Biopharma in Setting up Fit For Purpose Vendor Oversight
                      • Alexandra Kemmer-Brueck - Senior Director Clinical Operations, BioNTech
                      • Raphaele Mary - Global Alliance Integration Lead, Proptimum Consulting
                      12:20 - 12:4525 mins
                      Covid-19 Learnings
                      Spotlight Presentation:
                        12:20 - 12:4525 mins
                        Patient Engagement & Recruitment
                        Practicalities of Applying the PFMD How-to Guides to Encourage Patient Engagement and the Clinical Trial Information Network
                        • Nicholas Brooke - Founder and Executive Director of The Synergist, PFMD (Patient Focused Medicines Development) and The Synergist
                        12:20 - 12:4525 mins
                        Operations
                        Spotlight Presentation:
                          12:20 - 13:1050 mins
                          Decentralized Trials
                          PANEL: Strategy for Decentralized Trials from Different Stakeholders Perspectives
                          • Roman Fishchuk - CEO, Clinical Trials Unit, Central City Clinical Hospital of Ivano-Frankivsk City Council
                          • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
                          • Adam Hardin - Director, Digital Health, Clinical Technology & Innovation, Development, Gilead
                          12:20 - 13:1050 mins
                          Decentralized Trials & Technology
                          PANEL: Strategy for Decentralized Trials from Different Stakeholders Perspectives
                          • Roman Fishchuk - CEO, Clinical Trials Unit, Central City Clinical Hospital of Ivano-Frankivsk City Council
                          • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
                          • Adam Hardin - Director, Digital Health, Clinical Technology & Innovation, Development, Gilead
                          12:45 - 13:0520 mins
                          Partnerships and Outsourcing
                          Spotlight Presentation:
                            12:45 - 13:1025 mins
                            Covid-19 Learnings
                            Insights on Remote Clinical Team Experience and Productivity During the Pandemic
                            • Maria Florez - Senior Research Analyst, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
                            12:45 - 13:1025 mins
                            Patient Engagement & Recruitment
                            Spotlight Presentation:
                              12:45 - 13:1025 mins
                              Operations
                              Practical Perspective - EU Clinical Trial Regulation- How is this being Addressed and What we can Expect
                              • Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
                              13:10 - 14:0050 mins
                              LIVE Virtual Showcase Hub Networking Tech Tours Roundtables
                                14:00 - 14:5050 mins
                                Partnerships and Outsourcing
                                PANEL: David and Goliath – Is There Still a Place for Small to Mid-sized CROs in Today’s Complex Clinical Trial Arena?
                                • Anna Matranga - Managing Director, AMC Alliances & Consulting, France
                                • Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
                                • Beatrix Friedeberg - Executive Director, Global Regulatory Affairs & Strategy, Amgen, EFPIA CREG member
                                • Stephen Walker - Alliance Management Director , Strategic Enablement, R&D | Global Medicines Development, Clinical Operations, AstraZeneca
                                14:00 - 14:5050 mins
                                Covid-19 Learnings
                                PANEL: David and Goliath – Is There Still a Place for Small to Mid-sized CROs in Today’s Complex Clinical Trial Arena?
                                • Anna Matranga - Managing Director, AMC Alliances & Consulting, France
                                • Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
                                • Beatrix Friedeberg - Executive Director, Global Regulatory Affairs & Strategy, Amgen, EFPIA CREG member
                                • Stephen Walker - Alliance Management Director , Strategic Enablement, R&D | Global Medicines Development, Clinical Operations, AstraZeneca
                                14:00 - 14:2525 mins
                                Patient Engagement & Recruitment
                                Spotlight Presentation:
                                  14:00 - 14:2525 mins
                                  Operations
                                  The Rapidly Changing Regulatory Landscape for Clinical Trials
                                  • Julianne Hull - CEO, WenStar Enterprizes
                                  14:00 - 14:2525 mins
                                  Decentralized Trials
                                  Spotlight Presentation:
                                    14:00 - 14:2525 mins
                                    Decentralized Trials & Technology
                                    Emerging Best Practices for Decentralized Clinical Trials – An Update from the Clinical Trials Transformation Initiative
                                    • Leanne Madre - Acting Executive Director, Clinical Trials Transformation Initiative (CTTI)
                                    14:25 - 14:5025 mins
                                    Patient Engagement & Recruitment
                                    Leveraging TransCelerate’s Patient-Centric Tools in Today’s Modern World to Improve the Overall Patient Experience
                                    • Peter Schaeffer - Clinical Platforms and Sciences Third Party Resourcing Analytics Director, GlaxoSmithKline
                                    14:25 - 14:5025 mins
                                    Operations
                                    Spotlight Presentation:
                                      14:25 - 14:5025 mins
                                      Decentralized Trials
                                      Expanding the Universe of Data Used to Inform Drug Development
                                      • Robert Westphal - Digital Innovation Manager, Bayer
                                      14:25 - 14:5025 mins
                                      Decentralized Trials & Technology
                                      Bench to Market in Record Time with Decentralized Technology
                                      • Anthony Costello, - Vice President Mobile Health, Medidata
                                      • Lisa Moneymaker - SVP Clinical Operations Technologies, Medidata
                                      14:50 - 15:1525 mins
                                      Partnerships and Outsourcing
                                      Spotlight Presentation:
                                        14:50 - 15:1525 mins
                                        Covid-19 Learnings
                                        Unmasking the Secrets to Recruitment Success for Moderna’s COVID-19 Trial Team
                                        • Mike Wenger - Vice President of Patient Engagement, Informa Pharma Intelligence
                                        14:50 - 15:4050 mins
                                        Patient Engagement & Recruitment
                                        PANEL: How Companies Ensure Patient Engagement is a Reality
                                        • Nancy Meyerson-Hess - Consultant Clinical Research, Chief Compliance & Regulatory Officer, eMQT
                                        • Jimmy Bechtel - Vice President, Site Engagement, Society For Clinical Research Sites (SCRS), USA
                                        • Karlin Schroeder - Associate Vice President, Community Engagement, Parkinson’s Foundation
                                        • Begonya Nafria Escalera - Patient Engagement in Research Coordinator, Barcelona Children’s Hospital Sant Joan de Déu, Spain
                                        14:50 - 15:4050 mins
                                        Operations
                                        PANEL: How Companies Ensure Patient Engagement is a Reality
                                        • Nancy Meyerson-Hess - Consultant Clinical Research, Chief Compliance & Regulatory Officer, eMQT
                                        • Jimmy Bechtel - Vice President, Site Engagement, Society For Clinical Research Sites (SCRS), USA
                                        • Karlin Schroeder - Associate Vice President, Community Engagement, Parkinson’s Foundation
                                        • Begonya Nafria Escalera - Patient Engagement in Research Coordinator, Barcelona Children’s Hospital Sant Joan de Déu, Spain
                                        14:50 - 15:1525 mins
                                        Decentralized Trials
                                        CASE STUDY: Early Phase - How make Trials more Virtual and more Patient Centric?
                                        • Lisa Shafe - Strategy, Portfolio & Clinical Operations,Pharma Research & Early Development (pRED), Roche Innovation Centre
                                        14:50 - 15:1525 mins
                                        Decentralized Trials & Technology
                                        CASE STUDY: Early Phase - How make Trials more Virtual and more Patient Centric?
                                        • Lisa Shafe - Strategy, Portfolio & Clinical Operations,Pharma Research & Early Development (pRED), Roche Innovation Centre
                                        15:15 - 15:4025 mins
                                        Partnerships and Outsourcing
                                        Developing a Data Privacy Framework for the Reuse of Clinical Data for Scientific Research
                                        • Jeppe Guilford Manuel - Principal R&D Data Privacy Specialist, Novo Nordisk
                                        15:15 - 15:4025 mins
                                        Covid-19 Learnings
                                        Spotlight Presentation:
                                          15:15 - 15:4025 mins
                                          Decentralized Trials
                                          CASE STUDY: Experiences of Doing Decentralized Trials in Early Phase Development
                                          • Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited
                                          • Vanessa Spaldin - Clinical Project Management Advisor, Neuroscience, Clinical Pharmacology, Eli Lilly and Company Limited
                                          15:15 - 15:4025 mins
                                          Decentralized Trials & Technology
                                          CASE STUDY: Experiences of Doing Decentralized Trials in Early Phase Development
                                          • Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited
                                          • Vanessa Spaldin - Clinical Project Management Advisor, Neuroscience, Clinical Pharmacology, Eli Lilly and Company Limited
                                          15:40 - 16:0525 mins
                                          Partnerships and Outsourcing
                                          Latest Developments of Data Protection Developments in Clinical Trials
                                          • Kristof Van Quathem - Special Counsel, Covington & Burling LLP, Belgium
                                          15:40 - 16:0525 mins
                                          Covid-19 Learnings
                                          CASE STUDY: COVID-19 Pandemic Triggered Process Changes: Focus Patient Home Supply and Remote Audits and Inspections
                                          • Raquel Benedí - Cluster Head Clinical/PV Quality, Novartis Pharma GmbH
                                          15:40 - 16:0525 mins
                                          Patient Engagement & Recruitment
                                          Future of What Trials will Look Like for Patients
                                          • Luci O'Reilly - CTAP Involvement Coordinator, Cystic Fibrosis Trust
                                          15:40 - 16:0525 mins
                                          Operations
                                          CASE STUDY: Real World Evidence using Non- interventional studies
                                          • Michael Zoerer - Senior Group Leader, Clinical Operations, AOP Orphan Pharmaceuticals AG
                                          15:40 - 16:0525 mins
                                          Decentralized Trials
                                          PANEL: Decentralized Clinical Trials to Support Early Clinical Development
                                          • Derk Arts, PhD - Founder & CEO, Castor EDC
                                          • Lisa Shafe - Strategy, Portfolio & Clinical Operations,Pharma Research & Early Development (pRED), Roche Innovation Centre
                                          • Matt Bryant - Head of Technology & Innovation Global Development and Clinical Operations, Gilead
                                          • Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited
                                          • Vanessa Spaldin - Clinical Project Management Advisor, Neuroscience, Clinical Pharmacology, Eli Lilly and Company Limited
                                          15:40 - 16:0525 mins
                                          Decentralized Trials & Technology
                                          PANEL: Decentralized Clinical Trials to Support Early Clinical Development
                                          • Derk Arts, PhD - Founder & CEO, Castor EDC
                                          • Lisa Shafe - Strategy, Portfolio & Clinical Operations,Pharma Research & Early Development (pRED), Roche Innovation Centre
                                          • Matt Bryant - Head of Technology & Innovation Global Development and Clinical Operations, Gilead
                                          • Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited
                                          • Vanessa Spaldin - Clinical Project Management Advisor, Neuroscience, Clinical Pharmacology, Eli Lilly and Company Limited
                                          16:05 - 16:3025 mins
                                          Partnerships and Outsourcing
                                          CASE STUDY: CRO Sponsorship Relationships
                                          • Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited
                                          • Vanessa Spaldin - Clinical Project Management Advisor, Neuroscience, Clinical Pharmacology, Eli Lilly and Company Limited
                                          16:05 - 16:3025 mins
                                          Covid-19 Learnings
                                          How to use Innovative Clinical Trial Methods to Increase the Efficiency of Drug Development and Allow for Faster Patient Access
                                          • Lada Leyens - Global Regulatory lead - Clinical Trial Innovation and Digital Health, Roche
                                          16:05 - 16:3025 mins
                                          Patient Engagement & Recruitment
                                          The Site Landscape Snapshot: Site Benchmark Data
                                          • Jimmy Bechtel - Vice President, Site Engagement, Society For Clinical Research Sites (SCRS), USA
                                          16:05 - 16:3025 mins
                                          Operations
                                          The Duchenne Parent Project's Model: The Patients Registry
                                          • Marisol Montolio del Olmo - Scientific Director of Duchenne Parent Project, adjunct Professor at the University of Barcelona
                                          16:30 - 17:1040 mins
                                          Networking Activity
                                            17:10 - 17:155 mins
                                            End of Day Two
                                              DAY ONE: MORNING PLENARY
                                              NextDAY THREE
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