Wednesday - 21st September 2022 (Time Zone - BST)

  • 09:30
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 09:40
  • Chairperson’s opening remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 09:50
  • Transforming the Way We Do Clinical Trials: Pragmatic Trials Combined with EHR Enabled Services


    Mats Sundgren

    Mats Sundgren Director Health Informatics
    AstraZeneca

  • 10:15
  • Novel approaches in Clinical Trial Design to Improve Efficiency of Research

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

     

    For sponsorship opportunities please contact: [email protected] or call +44 (0) 207 096 0786

  • 10:40
  • Learnings from a Fully Decentralized Trial in Oncology and a Hybrid Decentralized in Autism

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

    Thomas Wiese

    Thomas Wiese Principal Medical Director, Clinical Expert Team Leader
    Roche

  • 11:05
  • How the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) is improving research transparency globally.


    Ghassan Karam

    Ghassan Karam Project Manager
    World Health Organization

Patient Recruitment & Site Selection

  • 11:30
  • How Digital recruitment is changing the face of clinical trials


    Livia Dixon

    Livia Dixon Director Digital Recruitment Strategist
    Novartis

  • 11:55
  • 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

    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
  • 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?

     

    For sponsorship opportunities please contact: [email protected] or call +44 (0) 207 096 0786

  • 13:25
  • Feasibility in clinical trials

    • Importance of conducting feasibility
    • The stages of clinical trial feasibility
    • Feasibility challenges

    Dex Bilkic

    Dex Bilkic Manager, Study Start-up, Patient Recruitment and Outsourced Studies
    Bayer

  • 13:50
  • How can clinical research be truly patient centric?

     

    The Journey of Bringing the Voice of Patients and Sites into End-to-End Clinical Development


    Bert Santy

    Bert Santy Patient and Site Engagement Lead
    Boehringer Ingelheim

  • 14:15
  • 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

    Dex Bilkic

    Dex Bilkic Manager, Study Start-up, Patient Recruitment and Outsourced Studies
    Bayer

    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 14:40
  • Harnessing the power of Deep Site Data and AI to advance clinical trials - Gain insights that would not be possible with traditional approaches

Patient Centricity & Patient Engagement

  • 15:05
  • Bringing the patient voice in the design of clinical trials and how patient engagement/inclusiveness must be planned and implemented throughout the lifecycle of clinical development


    Lea-Isabelle Proulx

    Lea-Isabelle Proulx Patient Voice Partner
    Roche

  • 15:30
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

         

  • 15:50
  • Consent Transformation: a Requirement for Digitization of Trials


    Brenda Yanak

    Brenda Yanak Vice President, Global Biospecimen & Imaging Management
    Bristol-Myers Squibb

  • 16:15
  • What are the benefits of using multi stakeholder approaches, in research, from the patient perspective


    Carole Scrafton

    Carole Scrafton Patient & Health Advocate
    FibroFlutters

  • 16:40
  • Global Clinical Development – Complex Generics


    Siddharth Chachad

    Siddharth Chachad Executive Vice President & Head - Global Clinical Management
    Dr. Reddy's Laboratories

  • 17:05
  • Panel discussion: The patient's perspective: why their voice is so important in clinical research


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

    Mary Lynne Van Poelgeest-Pomfret

    Mary Lynne Van Poelgeest-Pomfret International patient advocate
    World Federation for Incontinent Patients - WFIP

  • 17:30
  • 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.

     

    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

  • 18:00
  • Chairperson’s closing remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 18:10
  • Networking - Catch-up with your peers in social lounge


Thursday - 22nd September 2022 (Time Zone - BST)

  • 09:30
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 09:40
  • Chairperson’s opening remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 09:50
  • Topic TBC


    Rebecca Jackson

    Rebecca Jackson Sr. Mgr. Clinical R&D Innovation & Novel Modalities IT
    Janssen Pharmaceutical

  • 10:15
  • Enrolment and retention in clinical studies before and during Covid-19 pandemic: clinical challenges and new opportunities. A case report from a phase 3 clinical program in fibromyalgia


    Domenico Merante

    Domenico Merante Global Clinical Development TA Lead Nephrology and Orphan Disease Area
    Vifor Pharma

Decentralized Clinical Trials

  • 10:40
  • Exploring Decentralised and Virtual trials, with pilot studies and challenges encountered


    Michael Zaiac

    Michael Zaiac Head of Medical Affairs Oncology Region Europe
    Novartis

  • 11:05
  • Optimizing your Decentralized Clinical Trials with Real-World Data

     

    For sponsorship opportunities please contact: [email protected] or call +44 (0) 207 096 0786

  • 11:30
  • Setting up Your Decentralised Trial for Success

    • New business model based on the Technological advances and research activities integrated seamlessly into clinical trials
    • Developing custom made contracts by third-party vendors, CROs and sponsors for modern clinical trials

    Angel Soubhie

    Angel Soubhie Head clinical trial scientists - Medical Director
    Bayer

Outsourcing & Clinical Trials

  • 11:55
  • A key factor in vendor Selection - The role of the CRO in advancing patientcentric clinical trial approaches


    Jan Schmejkal

    Jan Schmejkal Associate Director, Clinical Project Lead
    Alexion Pharmaceuticals, Inc

  • 12:20
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                

  • 13:00
  • Panel Discussion - A collaborative clinical ecosystem: How to effectively manage partnerships with all Stakeholders including Patients, Sites, CROs, Sponsors and Regulators.


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

    Sonia Houston Pichardo

    Sonia Houston Pichardo Business Lead of MyStudyWindow
    Boehringer Ingelheim

Quality, Compliance & Risk Management

  • 13:30
  • The effectiveness of new generation analytics models in RBM

    • Centralized monitoring can characterize key risk classifications and pointers from all clinical and operational source data available.
    • To evaluate risks to site performance, subject safety and data quality using Data and Analytics
    • Differentiating the relative risks between sites and subjects using the new age analytics models.

    Shawntel Swannack

    Shawntel Swannack Director, Central Monitoring and Data Analytics
    GSK

  • 13:55
  • Navigating and applying risk based approaches in clinical trials


    Laura Galuchie

    Laura Galuchie Senior Director & TransCelerate Program Lead
    Merck

  • 14:20
  • Are we obsessed with Quality Tolerance Limits?

    • Choosing QTL Parameters wisely
    • Are you asking the right questions when considering the application of Quality Tolerance Limits (QTL)?
    • Controlling risk within diagnostic clinical studies

    Mireille (Zerola) Lovejoy

    Mireille (Zerola) Lovejoy Director of Clinical Risk Management
    GE Healthcare

Clinical Data & Tech Driven Clinical Trials

  • 14:55
  • FDA draft guidance on 'Digital Health Technologies for Remote Data Acquisition in Clinical Investigations


    Benoit Marchal

    Benoit Marchal Senior IT Project Manager (PMP)
    F. Hoffmann-La Roche AG

  • 15:20
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

         

  • 15:40
  • 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

    Mohamed Sharaf

    Mohamed Sharaf EMEA Medical Program Lead (Immunology)
    Janssen Europe, Middle East & Africa (EMEA)

  • 16:05
  • Making Decentralizing Clinical Trials Pragmatic with AI and Wearables


    Maria Palombini

    Maria Palombini Leader, Healthcare Life Sciences Practice
    IEEE Standards Association

  • 16:30
  • Leverage AI to create value in Clinical Trials

  • 16:55
  • Panel Discussion: The Future of Clinical Trials - The Role of Advanced Analytics and Artificial Intelligence


    Mohamed Sharaf

    Mohamed Sharaf EMEA Medical Program Lead (Immunology)
    Janssen Europe, Middle East & Africa (EMEA)

    Bhupathy Alagiriswamy

    Bhupathy Alagiriswamy Director
    Credence Clinical Solutions Ltd

    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 17:25
  • Novel techniques- Tech-driven 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

     

    Speaker TBC - Slot booked for Gavion Technolgoies

  • 17:50
  • Integrating Blockchain into clinical research

    • Uses & challenges for Blockchain in Clinical Trials
    • Storing all types of data safely and securely
    • Better Clinical Trials Quality

  • 18:15
  • Chairperson’s closing remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT


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