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Wednesday, June 19 • 1:15pm - 2:15pm
#348: Challenges and Solutions to Building the Right Patient-Centered Evidence to Support Fit-For-Purpose Sensor-Based Outcomes

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-651-L04-P; CME 1.00; RN 1.00

Challenge areas for developing patient-centered sensor-based outcomes (SBOs) will be identified, along with solutions and key considerations using real-world examples of SBO development.

Learning Objectives

Describe key challenges to leveraging the patient-focused drug development (PFDD) guidance series to develop fit-for-purpose, patient-centered sensor-based outcomes (SBOs, eg, wearables) to support medical product development and decision making; Identify potential solutions to inform development of fit-for-purpose, patient-centered SBOs.

Chair

Katelyn R Keyloun, PharmD, MS

Speaker

Sensor-Based Outcome Measure Development: Challenge Areas for Concept Elicitation and Interpretation of Endpoints
Bill Byrom, PhD

FDA Update
Michelle Campbell, PhD


Speakers
KK

Katelyn Keyloun

Director, R&D Digital and Data Strategy, AbbVie, United States
Kate has spent the last 10 years in the HEOR space, supporting evidence generation and the intersection of Patient Centered Outcomes Research and Digital Health. She started her career researching a cure for malaria, which fostered her strong desire to study medicine and gain a 360... Read More →
avatar for Bill Byrom

Bill Byrom

Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
avatar for Michelle Campbell

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Workshop |   03: Data-Tech, Workshop