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

  • 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

      Watch Session
    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 10:15
  • How better engage HCPs and patient through digital tools ?

      Watch Session   Presentation
    Stefania Alvino

    Stefania Alvino Omnichannel Marketing Manager & Digital Orchestrator
    Daiichi Sankyo Italia S.p.A

  • 10:40
  • How the World Health Organization’s International Clinical Trials Registry Platform (ICTRP) is improving research transparency globally.

      Watch Session   Presentation
    Ghassan Karam

    Ghassan Karam Project Manager
    World Health Organization

  • 11:05
  • 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
      Watch Session
    Floris Morang

    Floris Morang Director of Business Development
    Castor

    Iain Little

    Iain Little Team Head IRT Management
    Novartis

Patient Recruitment & Site Selection

  • 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
      Watch Session   Presentation
    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
  • True Global Diversity in our Trials: Africa is Ready

      Watch Session
    Shalom Lloyd

    Shalom Lloyd Co-Founder & Chief Strategy Officer
    eMQT

    Tina Barton

    Tina Barton Chief Operating Officer
    eMQT

  • 13:25
  • 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
      Watch Session
    Nawab Qizilbash

    Nawab Qizilbash Clinical Epidemiologist & Head of OXON
    OXON Epidemiology

  • 13:50
  • Medical Affairs and Clinical Operations collaborating on Clinical Trial Optimization

      Watch Session   Presentation
    Eva Gallagher

    Eva Gallagher Vice President, Head of Medical Affairs
    Agios Pharmaceuticals

  • 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
    • Utilize wider use of the innovative statistical and Machine Learning techniques to provide more accurate data-driven forecasting and centralized monitoring of patient recruitment
      Watch Session
    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

    Vladimir Anisimov

    Vladimir Anisimov Principal Data Scientist, Data Science, Center for Design & Analysis
    Amgen

    Carole Scrafton

    Carole Scrafton Patient & Health Advocate
    FibroFlutters

    Lauren Bataille

    Lauren Bataille Head, Digital Medical Capabilities
    Novartis

    Obiageli  Onwusaka

    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
      Watch Session   Presentation
    Dex Bilkic

    Dex Bilkic Senior Manager, Site Engagement
    Bayer

Patient Centricity & Patient Engagement

  • 15:35
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

         

  • 15:50
  • Integrating the Patient Voice into Medical Product Development: Opportunities and Applications for the Use of Patient Experience Data

      Watch Session   Presentation
    Jessica Abel

    Jessica Abel Director, Patient Experience Data Policy and Best Practices
    Abbvie

  • 16:15
  • Patient Engagement in Clinical Development - A look at what the UK are doing to bring patients to the forefront of study design

      Watch Session   Presentation
    Alex Hammond

    Alex Hammond Business Development Manager
    NIHR Clinical Research Network

    Kim Down

    Kim Down Business Development Manager
    National Institute of Health and Care Research (NIHR)

  • 16:40
  • 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
      Watch Session   Presentation
    Behtash Bahador

    Behtash Bahador Director, Health Literacy
    CISCRP

  • 17:05
  • 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
      Watch Session
    Carole Scrafton

    Carole Scrafton Patient & Health Advocate
    FibroFlutters

    Hayley Chapman

    Hayley Chapman Senior Program Director
    The Synergist

  • 17:30
  • Quality by Design - what you need to know

    • When/where is it needed
    • What is QbD
    • How to implement
      Watch Session   Presentation
    William Lawton

    William Lawton Consultant
    Risk Based Approach Ltd

  • 17:55
  • Panel discussion: The patient's perspective: why their voice is so important in clinical research

      Watch Session
    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

    Melissa Penn

    Melissa Penn Director, Patient Engagement R&D
    Bayer

    Jost Leemhuis

    Jost Leemhuis Safety Science Partner and Global Business Lead
    Roche

  • 18:25
  • Chairperson’s closing remarks

      Watch Session
    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 18:30
  • Networking - Catch-up with your peers in social lounge


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

  • 09:40
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 09:50
  • Chairperson’s opening remarks

      Watch Session
    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 10:00
  • 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

      Watch Session   Presentation
    Domenico Merante

    Domenico Merante Clinical Research Lead TA Orphan-Nephrology
    CSL Vifor

Decentralized Clinical Trials

  • 10:30
  • Patient centric trials to increase Diversity and generate more patient care relevant outcomes from RCTs

      Watch Session   Presentation
    Michael Zaiac

    Michael Zaiac Head of Medical Affairs Oncology Region Europe
    Novartis

  • 11:00
  • Evidence derived from RWD through the application of research methods

      Watch Session   Presentation
    Mohamed Sharaf

    Mohamed Sharaf EMEA Senior Medical Advisor
    Janssen Europe, Middle East & Africa

  • 11:55
  • Global Clinical Development – Complex Generics

      Watch Session   Presentation
    Siddharth Chachad

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

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

     

                

Quality, Compliance & Risk Management

  • 13:05
  • 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
      Watch Session   Presentation
    Mireille (Zerola) Lovejoy

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

  • 13:55
  • 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.
      Watch Session
    Shawntel Swannack

    Shawntel Swannack Director, Central Monitoring and Data Analytics
    GSK

Outsourcing & Clinical Trials

  • 14:20
    • Manage Phase I studies during pandemic
    • Site resource situation in Early Phase and Sponsor/CRO demands
    • How can Sponsor and CRO decrease demand on healthy volunteers and site resources
      Watch Session   Presentation
    Jan Schmejkal

    Jan Schmejkal Associate Director, Global Trial Leader
    The Janssen Pharmaceutical Companies of Johnson & Johnson

  • 14:45
  • Panel Discussion - A collaborative clinical ecosystem: How to effectively manage partnerships with all Stakeholders including Patients, Sites, CROs, Sponsors and Regulators.

      Watch Session
    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

    Oscar Segurado

    Oscar Segurado Chief Medical Officer
    ASC Therapeutics

    Katie Madden

    Katie Madden Senior Manager, Digital and Process Optimization
    GSK

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

     

         

Clinical Data & Tech Driven Clinical Trials

  • 15:40
  • FDA draft guidance on 'Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

      Watch Session   Presentation
    Benoit Marchal

    Benoit Marchal Chief Digital Trust Officer
    Partners for Patients

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

      Watch Session   Presentation
    Maria Palombini

    Maria Palombini Leader, Healthcare Life Sciences Practice
    IEEE Standards Association

  • 16:30
  • Statistics and Data Science in the Research and Development (R&D) department of a pharmaceutical company

      Watch Session   Presentation
    Meritxell Falques Casanovas

    Meritxell Falques Casanovas Head of Global Statistics
    Almirall

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

      Watch Session
    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

    Bhupathy Alagiriswamy

    Bhupathy Alagiriswamy Director
    Credence Clinical Solutions Ltd

    Jessica Riggleman

    Jessica Riggleman Sr. Director, Clinical and Regulatory Affairs
    Mydecine Innovations Group

    Siddhant Ekale

    Siddhant Ekale Enterprise Architect – Clinical Data Management

  • 17:25
  • Decentralized Clinical Trials and Patient Centricity: Spotlight on Rare Diseases

    • Uses & challenges for Blockchain in Clinical Trials
    • Storing all types of data safely and securely
    • Better Clinical Trials Quality
      Watch Session   Presentation
    Oscar Segurado

    Oscar Segurado Chief Medical Officer
    ASC Therapeutics

  • 17:50
  • Chairperson’s closing remarks

      Watch Session
    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT


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