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Spire

Nov 08, 2018 12:45 PM - Nov 09, 2018 4:00 PM

750 First Street NE, Washington, DC 20002

Master Protocol Workshop

Session 4: Collaboration with Stakeholders

Session Chair(s)

Abby  Bronson, MBA

Abby Bronson, MBA

Vice President, Patient Advocacy and External Innovation

Edgewise Therapeutics, United States

Daniel  Millar, MBA

Daniel Millar, MBA

Senior Director, Strategic Business Transformation

Johnson & Johnson, United States

Master protocols promise transformational efficiencies for drug developers while addressing shortcomings of traditional clinical trials which leave clinical trial patients underserved and society waiting for new therapies despite considerable investment. This session explores the importance of stakeholder collaboration to enable evolving the clinical development paradigm and realizing the promised benefits of master protocols. Examples will highlight where stakeholders’ interests align well and where potential tensions must be managed actively through collaboration

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the collaborations required to successfully design, fund, and execute a master protocol
  • Establish a master protocol consortium and understand opportunities and challenges
  • Collaborate with regulators on innovative clinical development approaches

    Speaker(s)

    Abby  Bronson, MBA

    Collaborations with Stakeholders

    Abby Bronson, MBA

    Edgewise Therapeutics, United States

    Vice President, Patient Advocacy and External Innovation

    Victoria  Manax Rutson, MD

    Collaboration with Stakeholders

    Victoria Manax Rutson, MD

    Pancreatic Cancer Action Network, United States

    Chief Medical Officer

    Amy  Burd, PhD

    Who is LLS

    Amy Burd, PhD

    Eilean Therapeutics, United States

    Chief Scientific Officer

    Gideon M.  Blumenthal, MD

    Master Protocols: @FDAOncology View

    Gideon M. Blumenthal, MD

    Merck & Co., Inc., United States

    Vice President Clinical Development Oncology

    Daniel  Millar, MBA

    Daniel Millar, MBA

    Daniel Millar, MBA

    Johnson & Johnson, United States

    Senior Director, Strategic Business Transformation

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