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Hyatt Regency Bethesda

Oct 29, 2019 12:00 PM - Oct 30, 2019 4:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Master Protocol Workshop

Session 5: Multi-Company, Adaptive Platform Trials, and Integrated Research Platforms: Clinical Research of the Future

Session Chair(s)

Daniel  Millar, MBA

Daniel Millar, MBA

Senior Director, Strategic Business Transformation

Johnson & Johnson, United States

Scott  Berry, PhD

Scott Berry, PhD

President and Senior Statistical Scientist

Berry Consultants LLC, United States

Master protocols offer substantial opportunities to achieve efficiencies in clinical development both operationally and inferentially. Maximizing these benefits and delivering on the promise of patient-centric R&D, requires going beyond the capability of any one company or organization to ensure patients have the best opportunity to participate in a trial that may benefit them and promising therapies or futile endeavors can be identified quickly, allowing reallocation of scare resources to a more fruitful direction. This section will provide updates on a multi-company, public-private partnership, adaptive platform trial, IMI EPAD (European Prevention of Alzheimer's Dementia Consortium), including learnings related to trial design, stakeholder collaboration, and the business model for sustainability.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the benefits, challenges, and critical success factors for designing and implementing multi-company platform trials
  • Identify relevant case studies of prior work and opportunities on the horizon
  • Identify the stakeholder landscape and how diverse stakeholder

Speaker(s)

Kristy  Draper, PhD

Speaker

Kristy Draper, PhD

The University of Edinburgh, United Kingdom

Global Trial Lead for European Prevention of Alzheimer's Dementia Consortium

Saira  Ramasastry, MS, MSc

Speaker

Saira Ramasastry, MS, MSc

Life Sciences Advisory, United States

Partner

Esther  Arevalo, MS, MSc

Overview of IMI EU-PEARL

Esther Arevalo, MS, MSc

Vall d'Hebron Institute of Research (VHIR), Spain

EU-PEARL Project Management Strategy Unit

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