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Tuesday, June 21 • 2:00pm - 3:00pm
#250: Patients as Central Partners in COA Design

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-571-L04-P ; CME 1.00; RN 1.00

Co-designing with representative patient populations can enable the selection of COAs/PROs that are most relevant to patients and care givers. Participants will learn the background, reasoning, and technical process for bringing patients into drug development.Attendees will attend a panel discussion with FDA and Industry discussing where in the process patient engagement strategies assisted in shaping selection and implementation.

Learning Objectives

Discuss relevance of core COAs/PROSs to patient/caregivers of different ages, disease stages, demographics, and patient populations differentially impacted by social determinants of health ; Describe a process which enables adaptation of existing or creation of novel core COAs/PROs to align with disease state progression and innovation as well as potentially shifting patient perspectives.

Chair

Terrell Baptiste, MBA

Speaker

Conversations are Happening Whether you are There or Not: Using Social Media to Develop Meaningful Clinical Endpoints
Bill Byrom, PhD

FDA Update
Michelle Campbell, PhD

Patients as Central Partners in COA Design: Looking Beyond Semi-Structured Interviews
Denise Globe, MHS, PhD

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
Ji Li, MD, PhD


Speakers
TB

Terrell Baptiste

Associate Director, Regulatory Policy and Intelligence, Gilead Sciences, Inc., United States
Terrell Baptiste, Regulatory Policy and Intelligence, Gilead Sciences represents the Regulatory Affairs and Development organization to support and advise regulatory strategies that leverage innovative regulatory programs. He has a track record of successfully forging collaborations... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
Michelle Campbell is the Sr. Clinical Analyst 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). Previously, Dr. Campbell was a reviewer... Read More →
avatar for Denise Globe

Denise Globe

Head, HEOR, Gilead Sciences, Inc., United States
Denise Globe has 30 years of experience in health care with a focus on quantitative policy research and direct research experiences in disease management including the outcomes, process, financing and delivery of care. A particular focus has been on assessing the impact of disease... Read More →
avatar for Ji Li

Ji Li

Reviewer, Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Ji Li is a primary reviewer at the Division of Clinical Outcome Assessment at the U.S. FDA. Dr. Li reviews the use of clinical outcome assessments in IND/NDA/BLA applications that are intended to support labeling claims of medical product development programs. Dr. Li also reviews... Read More →

Tuesday June 21, 2022 2:00pm - 3:00pm CDT
Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum