CERSI Collaborators: Joey Mattingly, PharmD, MBA, PhD, C. Daniel Mullins, PhD, Hillary Edwards, MPH

FDA Collaborators: Karen Jackler, MPH, Sarah Stothers, RN, MSN, MPH, Christine Lee, PharmD, PhD, RDML Richardae Araojo, PharmD, MS

CERSI Subcontractors: National Health Council: Elisabeth Oehrlein, PhD, Eleanor Perfetto, PhD

Project Start Date: January 2021

Regulatory Science Challenge

FDA patient engagement activities encourage patients and caregivers to share information with FDA about how they experience a disease or a condition, their experience with current treatments, treatment preferences, unmet needs, and how they weigh the benefits and risks of existing and future treatments. Hearing from many diverse groups including, but not limited to, those representing different ethnicities, races, ages, abilities and areas of the United States, can help FDA better understand patient experiences and unmet needs. Understanding patient experiences and unmet needs can help FDA better incorporate the patient’s voice into drug development and evaluation.

Project Description and Goals

This project will increase understanding of how race and ethnicity, gender, geography, age, primary language, education level, and income influences how, when, and why patients engage with the Center for Biologics Evaluation and Research (CBER) on the topic of therapies to treat food allergy and their preferred methods to engage. The project team will review current research and activities related to patient engagement in food allergy therapies and conduct interviews with a diverse group of people with food allergies and their caregivers, and with those in food allergy organizations to identify challenges and preferred methods for patients and caregivers to engage with CBER. CBER will use the information gained to more meaningfully engage with diverse populations about food allergy and to help develop a patient-engagement framework that could be used in CBER’s other therapeutic areas.