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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
  • Lori Abrams - Vice President, Patient Advocacy & Clinical Research Diversity, WCG, USA
  • Lisa Shafe - Programme Leader, pRED, Roche Products Ltd, UK
  • Ruma Bhagat - Principal Science Leader, Health Equity and Population Science, Genentech, USA
  • Stephen Keith - Senior Medical Director, Medical and Scientific Management, Syneos Health, USA
10:00 - 10:5050 mins
Impact of COVID-19
PANEL: How much are Pharma Companies Tackling Diversity Issues?
  • Tina Barton - Chief Operating Officer, eMQT
  • Lori Abrams - Vice President, Patient Advocacy & Clinical Research Diversity, WCG, USA
  • Lisa Shafe - Programme Leader, pRED, Roche Products Ltd, UK
  • Ruma Bhagat - Principal Science Leader, Health Equity and Population Science, Genentech, USA
  • Stephen Keith - Senior Medical Director, Medical and Scientific Management, Syneos Health, USA
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 - CGP-Training and Consulting, (former Head ZKS-UW/H, Witten/Herdecke University, Germany, former Head Clinical Operations Grunenthal, Germany; former Head Clinical Research Central Europe Novo Nordisk), Germany
10:00 - 10:2525 mins
Operations
Spotlight Presentation:
    10:00 - 10:2525 mins
    Decentralized Trials
    LEGAL LANDSCAPE: Decentralized Trials from a Legal Point of View
    • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
    10:00 - 10:2525 mins
    Decentralized Trials & Technology
    Spotlight Presentation: Best Practices for Global DCT Adoption
    • John Reites - CEO, THREAD, USA
    10:25 - 10:5025 mins
    Patient Engagement & Recruitment
    Spotlight Presentation: Keys to Successful Global Clinical Trial Technology Implementation
    • Courtney Valeo - Sr. Principal Consultant, Greenphire, USA
    • Elisa Toma - Founder and CEO, CTA Focus, Greenphire, Romania
    10:25 - 10:5025 mins
    Operations
    Spotlight Presentation: Keys to Successful Global Clinical Trial Technology Implementation
    • Courtney Valeo - Sr. Principal Consultant, Greenphire, USA
    • Elisa Toma - Founder and CEO, CTA Focus, Greenphire, Romania
    10:25 - 10:5025 mins
    Decentralized Trials
    Spotlight Presentation: Bringing Pediatric DCTs to Europe and Beyond: How New Tools Promote Patient Engagement and Protocol Compliance
      10:25 - 10:5025 mins
      Decentralized Trials & Technology
      Technology Implementation of BlockChain
      • Kristina Livitckaia - R&D Project Manager, Centre for Research and Technological Development (CERTH), Greece
      10:50 - 11:3040 mins
      LIVE Virtual Showcase Hub Networking Clinical Tours
        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
        Impact of COVID-19
        Chasing a Pandemic: Overcoming Obstacles in Clinical Trial Operations
        • Stephanie Gonzalez - VP, Head of Biotech Operations, EMEA, Parexel, USA
        11:30 - 12:2050 mins
        Patient Engagement & Recruitment
        PANEL: 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 - Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen R&D, Spain
        • Mike Wenger - Vice President of Patient Engagement, Informa Pharma Intelligence
        • Alun Bedding - Global Head Methods Collaboration and Outreach Enabling Platform, Roche, UK
        • Yolanda Barbachano - Leading Senior Statistical Assessor, Medicines and HealthCare Products Regulatory Agency (MHRA), UK
        • Zachary Smith - Senior Research Analyst, Tufts University School of Medicine, USA
        11:30 - 12:2050 mins
        Operations
        PANEL: 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 - Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen R&D, Spain
        • Mike Wenger - Vice President of Patient Engagement, Informa Pharma Intelligence
        • Alun Bedding - Global Head Methods Collaboration and Outreach Enabling Platform, Roche, UK
        • Yolanda Barbachano - Leading Senior Statistical Assessor, Medicines and HealthCare Products Regulatory Agency (MHRA), UK
        • Zachary Smith - Senior Research Analyst, Tufts University School of Medicine, USA
        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 - Senior Vice President, Scientific & Clinical Affairs, Global Center of Excellence for Decentralized Clinical Trials, ICON
        • Alexandre Malouvier - Director Commercial & Strategic Healthcare & Technology Partnerships, ICON, France
        11:55 - 12:2025 mins
        Partnerships and Outsourcing
        The Role of FSP in The Future of Clinical Trial Delivery
        • Chris Baker - EVP, Global Head Parexel FSP, Parexel International, USA
        11:55 - 12:2025 mins
        Impact of COVID-19
        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: Umotif
        • Bruce Hellman - CEO, Umotif
        11:55 - 12:2025 mins
        Decentralized Trials & Technology
        Panel: PharmaLedger: Blockchain Driven Clinical Trials in the Healthcare Industry
        • Miguel Gaspar - Project Operations Manager, Hospital do Espírito Santo de Évora, E.P.E, Portugal
        • Xenia Beltran - Lead Coordinator and Project Manager, PharmaLedger, Spain
        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, TriRadial Solutions, France
        12:20 - 12:4525 mins
        Impact of COVID-19
        Spotlight Presentation: Explore the Impact of Covid-19 on Clinical Development with Real World Insights and Leading Perspectives
        • Jim Bush - Vice President, Medical at Labcorp, Clinical Pharmacology Services, Labcorp Drug Development, UK
        12:20 - 12:4525 mins
        Patient Engagement & Recruitment
        Development and Application of the PFMD How-to Guides to Encourage Patient Engagement
        • Nicole Wicki - Program Manager, The Synergist and PFMD (Patient Focused Medicines Development), Switzerland
        12:20 - 12:4525 mins
        Operations
        Spotlight Presentation: Supplies Controls and Patient Centricity in DCT - Challenges in Clinical Trials
        • Neta Bendelac - Senior Director of Strategy, 4G Clinical, Israel
        12:20 - 13:1050 mins
        Decentralized Trials
        PANEL: Strategy for Decentralized Trials from Different Stakeholders Perspectives
        • Matt Bryant - Head of Technology & Innovation Global Development and Clinical Operations, Gilead
        • Roman Fishchuk - CEO, Clinical Trials Unit, Central City Clinical Hospital of Ivano-Frankivsk City Council
        • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
        • Elizabeth Theogaraj - Global Regulatory Lead, Roche
        • Isaac Rodriguez-Chavez - Senior Vice President, Scientific & Clinical Affairs, Global Center of Excellence for Decentralized Clinical Trials, ICON
        12:20 - 13:1050 mins
        Decentralized Trials & Technology
        PANEL: Strategy for Decentralized Trials from Different Stakeholders Perspectives
        • Matt Bryant - Head of Technology & Innovation Global Development and Clinical Operations, Gilead
        • Roman Fishchuk - CEO, Clinical Trials Unit, Central City Clinical Hospital of Ivano-Frankivsk City Council
        • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
        • Elizabeth Theogaraj - Global Regulatory Lead, Roche
        • Isaac Rodriguez-Chavez - Senior Vice President, Scientific & Clinical Affairs, Global Center of Excellence for Decentralized Clinical Trials, ICON
        12:45 - 13:1025 mins
        Partnerships and Outsourcing
        Spotlight Presentation: What a Difference a Partnership Can Make!
        • Barbara Buls - Executive Manager Clinical Operations, SGS Health Science, Belgium
        • Jelle Klein - Associate Medical Director, SGS Health Science, Belgium
        12:45 - 13:1025 mins
        Impact of COVID-19
        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: Diversity and Inclusion: Practical Considerations to Implement into Trial Designs Today
        • Ben Quartley - VP Feasibility, Patient recruitment and Engagement, Labcorp Drug Development, UK
        12:45 - 13:1025 mins
        Operations
        Practical Perspective - EU Clinical Trial Regulation- How is this being Addressed and What we can Expect
          13:10 - 13:3525 mins
          Partnerships and Outsourcing
          LIVE Virtual Showcase Hub Networking Clinical Tours
            13:10 - 13:3525 mins
            Impact of COVID-19
            LIVE Virtual Showcase Hub Networking Clinical Tours
              13:10 - 13:3525 mins
              Patient Engagement & Recruitment
              LIVE Virtual Showcase Hub Networking Clinical Tours
                13:10 - 13:3525 mins
                Operations
                LIVE Virtual Showcase Hub Networking Clinical Tours
                  13:10 - 13:3525 mins
                  Decentralized Trials
                  LIVE Virtual Showcase Hub Networking Tech Tours Roundtables
                    13:10 - 13:3525 mins
                    Decentralized Trials & Technology
                    LIVE Virtual Showcase Hub Networking Tech Tours Roundtables
                      13:35 - 14:0025 mins
                      Partnerships and Outsourcing
                      Spotlight Presentation: Acceleration of Clinical Research with Focused Sample Management
                      • Markus Albertini - General Manager & Director of European Regional Services,, Azenta Life Sciences, Germany
                      13:35 - 14:0025 mins
                      Decentralized Trials
                      Spotlight Presentation: Navigating Regulatory Pathways and Requirements for Decentralized Clinical Trials in Europe
                      • Silvia Chia - Senior Director Regulatory Affairs, Medical Affairs, Science 37, UK
                      13:35 - 14:0025 mins
                      Decentralized Trials & Technology
                      Spotlight Presentation:The Dimensions of Risk Associated with DCT’s
                      • John Hall - SVP, Business Development, CluePoints, UK
                      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
                      • Michael Zoerer - Senior Group Leader, Clinical Operations, AOP Orphan Pharmaceuticals AG
                      14:00 - 14:5050 mins
                      Impact of COVID-19
                      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
                      • Michael Zoerer - Senior Group Leader, Clinical Operations, AOP Orphan Pharmaceuticals AG
                      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
                        Emerging Best Practices for Decentralized Clinical Trials – An Update from the Clinical Trials Transformation Initiative
                        • Lindsay Kehoe - Project Manager, Clinical Trials Transformation Initiative (CTTI), USA
                        14:00 - 14:2525 mins
                        Decentralized Trials & Technology
                        Emerging Best Practices for Decentralized Clinical Trials – An Update from the Clinical Trials Transformation Initiative
                        • Lindsay Kehoe - Project Manager, Clinical Trials Transformation Initiative (CTTI), USA
                        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
                        • Joachim Lövin - eTrials Senior System Supporter, Novo Nordisk, Denmark
                        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
                          Spotlight Presentation: Smarter, Safer Trials, From Anywhere: The Medidata Decentralized Clinical Trials (DCT) Program
                          • Anthony Costello - CEO, Patient Cloud, Medidata, USA
                          • Lisa Moneymaker - SVP Clinical Operations Technologies, Medidata
                          14:50 - 15:1525 mins
                          Partnerships and Outsourcing
                          Spotlight Presentation: 7 Steps to Maximise the Effectiveness of Your CRO Partnership
                          • Katell Bernois - Director of Statistical Consulting, Alira Health, France
                          • Paula Yates - Senior Director, Biostatistics & Data Management, CROS NT, UK
                          14:50 - 15:1525 mins
                          Impact of COVID-19
                          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
                          • Lorna Allen - PPI Co-ordinator, Cystic Fibrosis Trust
                          • Nicole Wicki - Program Manager, The Synergist and PFMD (Patient Focused Medicines Development), Switzerland
                          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
                          • Lorna Allen - PPI Co-ordinator, Cystic Fibrosis Trust
                          • Nicole Wicki - Program Manager, The Synergist and PFMD (Patient Focused Medicines Development), Switzerland
                          14:50 - 15:1525 mins
                          Decentralized Trials
                          Early Phase - How to Make Trials More Virtual and More Patient Centric?
                          • Lisa Shafe - Programme Leader, pRED, Roche Products Ltd, UK
                          14:50 - 15:1525 mins
                          Decentralized Trials & Technology
                          Early Phase - How to Make Trials More Virtual and More Patient Centric?
                          • Lisa Shafe - Programme Leader, pRED, Roche Products Ltd, UK
                          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
                          Impact of COVID-19
                          Spotlight Presentation: The Shifting Landscape: How the Pandemic is Driving Demand for Cloud-Based Platforms and Services
                          • Dave Davidson - Director, Business Development North America, Philips HealthSuite, USA
                          • John Enderle - AVP, Cognizant Business & Technology, USA
                          15:15 - 15:4025 mins
                          Decentralized Trials
                          Experiences of using Decentralized Trials concepts in Early Phase Development
                          • Vanessa Spaldin - Clinical Project Management Advisor, Neuroscience, Clinical Pharmacology, Eli Lilly and Company Limited
                          15:15 - 15:4025 mins
                          Decentralized Trials & Technology
                          Experiences of using Decentralized Trials concepts in Early Phase Development
                          • 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
                          Impact of COVID-19
                          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, Germany
                          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
                          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 - Founder & CEO, Castor EDC
                          • Lisa Shafe - Programme Leader, pRED, Roche Products Ltd, UK
                          • Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited, UK
                          • Vanessa Spaldin - Clinical Project Management Advisor, Neuroscience, Clinical Pharmacology, Eli Lilly and Company Limited
                          • Todd Greenwood - Senior Director of Outcomes,, ZS | Medullan, USA
                          15:40 - 16:0525 mins
                          Decentralized Trials & Technology
                          PANEL: Decentralized Clinical Trials to Support Early Clinical Development
                          • Derk Arts - Founder & CEO, Castor EDC
                          • Lisa Shafe - Programme Leader, pRED, Roche Products Ltd, UK
                          • Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited, UK
                          • Vanessa Spaldin - Clinical Project Management Advisor, Neuroscience, Clinical Pharmacology, Eli Lilly and Company Limited
                          • Todd Greenwood - Senior Director of Outcomes,, ZS | Medullan, USA
                          16:05 - 16:3025 mins
                          Partnerships and Outsourcing
                          CRO Sponsorship Relationships
                          • Tamzin Blagbrough - Clinical Functional Consultant, Exploratory Medicine and Pharmacology, Eli Lilly and Company Limited, UK
                          16:05 - 16:3025 mins
                          Impact of COVID-19
                          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
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