Patient-Focused Drug Development Meeting

10:00 a.m. – 10:05 a.m. Welcome & Opening Remarks

Lisa Gable, FARE CEO

10:05 a.m. – 10:15 a.m. FDA Remarks

Ronald Rabin, MD
Chief, Laboratory of Immunobiochemistry
Division of Bacterial, Parasitic and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

10:15 a.m. – 10:25 a.m. Background on Food Allergies and Treatment Options

Linda Herbert, PhD
Assistant Professor in the Division of Psychology and Behavioral Health
Children’s National Hospital

10:25 a.m. – 10:35 a.m. Meeting Overview

James Valentine, Moderator
Associate, Hyman, Phelps, & McNamara PC

10:35 a.m. – 11:10 a.m. Topic 1 Panel: Symptoms and Daily Impacts of Food Allergy

11:10 a.m. – 12:10 p.m. Large-Group Facilitated Discussion on Topic 1

Discussion questions:

1. 1. What was your journey to food allergy diagnosis (length of time to diagnosis, misdiagnosis experience, barriers and burdens in the process, uncertainties?)
   2. How does having a food allergy impact your daily life and mental health?
   3. What are the biggest challenges of having a food allergy?
   4. Let’s talk specifically about adult-onset food allergy: What have been the specific challenges of developing food allergy in adulthood? How does this compare to those with childhood-onset food allergy?
   5. How has having a food allergy affected the nutrition you are receiving from your food?
   6. How has access to food allergy safe foods, or lack thereof, impacted your daily life?
   7. How does having multiple allergies impact you?
   8. How do you manage top nine allergies compared to non-top nine allergies? Are their complications that exist? Are there differences with peanut allergy compared with other top nine?

12:10 p.m. – 12:15 p.m. Morning Recap

Eleanor Garrow-Holding, FAACT CEO

12:15 p.m. – 1:15 p.m. Lunch

1:15 p.m. – 1:20 p.m. Afternoon Welcome

James Valentine

1:20 p.m. – 1:55 p.m. Topic 2 Panel: Patients’ Perspectives on Prevention and Treatments for Food Allergy

1:55 p.m. – 2:55 p.m. Large-Group Facilitated Discussion on Topic 2

Discussion questions:

• 1. Are you currently undergoing treatment for your food allergy? Please share your experience.
  2. For those who have undergone treatment: What are the most significant downsides to current treatment options, and how do they affect your daily life?
  3. For those who have not undergone treatment: What challenges or barriers to treatment have you encountered?
  4. What challenges or barriers to epinephrine access have you encountered?
  5. As a parent, what strategies have you introduced to attempt to prevent your child from developing a food allergy?
  6. Question for those with food allergy: What specific things would you look for in an ideal treatment for your food allergy? Logistics of the treatment but also the ultimate outcome desired?
  7. Question for caregivers: How does this differ from what you are looking for in an ideal food allergy treatment and management strategy for your child?
  8. What obstacles are you willing to endure during treatment?

2:55 p.m. – 3:00 p.m. Afternoon Recap

Tonya Winders, AAN CEO

3:00 p.m. – 3:10 p.m. Summary of Meeting

Larry Bauer, Facilitator
Senior Regulatory Drug Expert, Hyman, Phelps, & McNamara PC

3:10 p.m. – 3:15 p.m. Closing Remarks

Kenny Mendez, AAFA CEO