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Advancing Patient Science Workshop


Session 5: Multi-Stakeholder Perspectives on the Value and Future of Patient-Reported Outcomes (PROs) in Clinical Trials

Session Chair(s)

Thomas  Morel, DrSc

Thomas Morel, DrSc

  • Director, Patient-Centred Outcomes Research
  • UCB Biopharma, Belgium
Session 5: Multi-Stakeholder Perspectives on the Value and Future of Patient-Reported Outcomes (PROs) in Clinical Trials

Speaker(s)

Roger  Wilson

PROs from a Patient Perspective

Roger Wilson

  • Patient Representative
  • Sarcoma UK, United Kingdom
Melanie Jane Calvert, PhD

PROs from a Trialist Perspective

Melanie Jane Calvert, PhD

  • Professor of Outcomes Methodology, Director of the Centre for PROs Research
  • University of Birmingham, United Kingdom
Daniel  O'Connor, DrMed, PhD, MS

PROs from a Regulatory Science Perspective

Daniel O'Connor, DrMed, PhD, MS

  • Medical Assessor
  • Medicines and Healthcare products Regulatory Agency, United Kingdom
Pavel Petrov Balabanov, MD, PhD

PROs from a Regulatory Science Perspective – focus on Neurology

Pavel Petrov Balabanov, MD, PhD

  • Head of Therapies for Neurological and Psychiatric Disorders
  • European Medicines Agency, Netherlands
Caridad  Pontes

PROs from an HTA Perspective

Caridad Pontes

  • Head, Pharmacotherapeutic Harmonization
  • Catalan Health System, Spain
Antoine  Regnault, PhD, MS

PROs from an Outcomes Measurement Perspective

Antoine Regnault, PhD, MS

  • Global Lead - Statistics
  • Modus Outcomes, France
Thomas  Keeley, PhD, MSc

PROs from the Pharmaceutical Industry Perspective

Thomas Keeley, PhD, MSc

  • Director, Patient Centred Outcomes
  • GlaxoSmithKline, United Kingdom
Michelle  Campbell, PhD

Panel discussion with Q&A, including additional participation

Michelle Campbell, PhD

  • Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
  • FDA, United States