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Tuesday, June 25 • 2:00pm - 3:15pm
#261: Patient Experience Data: How Could this Data Enhance Decision-Making at Different Stages of Medical Product Development?

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Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-613-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will provide an opportunity for key stakeholders to discuss examples of various types of patient experience data, and how this data could potentially inform decision-making at different stages of medical product development.

Learning Objectives

Define patient experience data; Describe types of patient experience data that could inform medical product development; Discuss how patient experience data can inform decision making at different stages of medical product development.

Chair

Meghana Chalasani, MHA

Speaker

FDA Perspective
Michelle Campbell, PhD

Panelist
Elizabeth Hart, MD

Panelist
Isabelle Lousada, MA

Panelist
Kristina Bowyer, LPN



Speakers
avatar for Kristina Bowyer

Kristina Bowyer

Vice President, Patient Centric Drug Development, Ionis Pharmaceuticals
Kristina Bowyer is the Executive Director of Patient Advocacy & Engagement at Ionis Pharmaceuticals. Kristina has worked at Ionis for over 26 years and has spent the last seven years successfully building Ionis’ internal patient engagement program to ensure that the patient perspective... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, DNP, OND, CDER, FDA
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes for the Division of Neurology Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a... Read More →
avatar for Meghana Chalasani

Meghana Chalasani

Lead, Science Strategies, Office of New Drugs, CDER, FDA
Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused... Read More →
avatar for Isabelle Lousada

Isabelle Lousada

Chief Executive Officer and President, Amyloidosis Research Consortium
As a former patient, Lousada has spent 20 years dedicated to patient advocacy, accelerating drug development, and promoting awareness of rare diseases. Lousada founded the Amyloidosis Research Consortium (ARC) in 2015 to address the critical needs in clinical trials and related research... Read More →
avatar for Elizabeth Hart

Elizabeth Hart

Branch Chief, General Medicine 1, OTAT, CBER, FDA
Dr. Elizabeth Hart is the Branch Chief of General Medicine 1 in the Office of Tissue and Advanced Therapies in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). She completed her undergraduate medical training at the University of Pennsylvania... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient Engagement, Forum |   03: Data-Data Standards, Forum