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Master Protocol Workshop


Session 6: COVID-19 Learnings: Research Done Differently

Session Chair(s)

Daniel  Millar, MBA

Daniel Millar, MBA

  • Senior Director, Strategic Business Transformation Quantitative Sciences
  • Janssen Research & Development, United States
The value of Master Protocols has become understood and accepted through unprecedented multi-stakeholder response to the COVID-19 pandemic. Over 300 clinical studies were set up in record time, including several Master Protocols for both therapeutics and vaccines. Suddenly, the ability to form productive consortia became a critical path challenge to implement quantitative innovations provided by Master Protocols. This session will focus on the underlying trends transforming Master Protocol studies and clinical research.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify the role of Master Protocols in COVID-19 therapeutic and vaccine development
  • Identify recent developments in stakeholders’ attitudes and perceptions of Master Protocol studies
  • Identify factors that will influence the successful design and implementation of Master Protocol studies

Speaker(s)

Lennie  Derde, MD, PhD

Speaker

Lennie Derde, MD, PhD

  • Intensivist and Clinician Researcher
  • UMC Utrecht, Netherlands
Janice  Chang

Catalyzing Innovation Through Collaboration

Janice Chang

  • Chief Operating Officer
  • TransCelerate Biopharma Inc., United States
Lisa  LaVange, PhD

Speaker

Lisa LaVange, PhD

  • Professor and Chair, Department of Biostatistics
  • University of North Carolina At Chapel Hill, United States
Tobias  Mielke, PhD

When Time Matters Most: Converting a Traditional Study into a Master Protocol in One Week

Tobias Mielke, PhD

  • Janssen Pharmaceutical
  • Scientific Director, Germany