Externally-Led Patient-Focused Drug Development Meeting
Patient Voices Driving the Future of HDFN Care
Maternal Alloimmunization & Hemolytic Disease of the Fetus and Newborn
You’re Invited!
Monday, July 20th, 2026
10:00AM to 3:30PM
Washington Plaza Hotel (with virtual access)
10 Thomas Cir NW
Washington, DC 20005
What Are Externally-Led Patient-Focused Drug Development (EL-PFDD) Meetings?
Externally-Led Patient-Focused Drug Development (EL-PFDD) meetings are special gatherings created to bring the real-world experiences and voices of patients and caregivers directly to the center of decision-making about new treatments and research.
Established by the U.S. Food and Drug Administration (FDA), the Patient-Focused Drug Development (PFDD) initiative aims to ensure the concerns, needs, and priorities of people living with serious medical conditions—Maternal Alloimmunization and HDFN—are understood by FDA, product developers, clinicians, and academic researchers and used to guide the development and evaluation of new therapies.
Why Attend?
The EL-PFDD meeting is all about patient voices
This meeting is for families who have experienced maternal alloimmunization or hemolytic disease of the fetus and newborn (HDFN), including patients, parents, caregivers, and loved ones. By attending, you will hear first-hand stories from other families and have the opportunity to share your own experience.
These patient perspectives will be heard by the people shaping future research and care.
Who Should Participate?
This meeting is designed for anyone with lived experience of maternal alloimmunization or HDFN.
Participants may include:
Patients currently navigating maternal alloimmunization
Parents of babies affected by HDFN
Families who have experienced fetal loss or complications
Caregivers and loved ones who supported someone through this diagnosis
Every story helps create a clearer picture of what families experience.
Who Will Be Listening?
The experiences shared during the meeting will help inform leaders working to improve care and develop future therapies.
Stakeholders may include:
The U.S. Food and Drug Administration (FDA)
Researchers studying maternal alloimmunization and HDFN
Clinicians who care for high-risk pregnancies and newborns
Pharmaceutical and biotechnology companies
Patient advocacy organizations
Why Your Voice Matters
Maternal alloimmunization and HDFN are rare and often misunderstood conditions.
By sharing your experience, you can help:
Highlight challenges families face during pregnancy and after birth
Identify gaps in current care and treatment options
Guide future research priorities
Improve awareness among clinicians and researchers
Patient experiences are essential to shaping better care and future therapies.
How You Can Get Involved
There are several ways to participate in the EL-PFDD meeting.
Attend the meeting and listen to patient panels
Share your personal experience during public comment
Participate in patient surveys or listening sessions
Help spread awareness in the community
Learn More
Want to learn more about the EL-PFDD meeting and how to participate?
For additional information, please contact
stephanie@HDFN.org
Submit Your Comments Early
Submit a comment below on the topics we will be discussing in advance of the EL-PFDD meeting. Comments should be submitted individually.
The comments collected may be shared during the MAF EL-PFDD and may also be used in the final Voice of the Patient report (with identifying information removed).
Topic 1: Health Effects and Daily Impacts of Maternal
Alloimmunization and HDFN
- Of all the symptoms, experiences, and challenges related to maternal
alloimmunization and HDFN, which 1–3 had the most significant impact on your
life, pregnancy, or family? - Are there specific activities or parts of pregnancy, birth, or early parenthood that
you could not experience as fully as you would have liked because of
alloimmunization or HDFN? - As it relates to your experience with alloimmunization and HDFN, what did a good
day look like? What did a difficult day look like? - How have your condition, care experience, and its impact changed over time, during
one pregnancy or across multiple pregnancies? - What worried you most during your pregnancy and your baby’s care journey?
Topic 2: Current Approaches to Treatment and Care
- What types of monitoring, treatments, or interventions did you receive during
pregnancy and after birth to help manage alloimmunization and HDFN? - How did your treatment regimen or care plan change over time, and why?
- How well did your monitoring and treatments address the most significant
challenges you faced or improve your pregnancy and your baby’s outcomes? - What were the most significant downsides or burdens associated with your care and
treatments? - Short of a complete cure, what would an ideal treatment or approach to managing
alloimmunization and HDFN look like?
Sponsors & Supporters
We are deeply grateful to the organizations helping make the Maternal Alloimmunization & HDFN EL-PFDD meeting possible. Their support helps ensure that the voices of patients and families are heard by the researchers, clinicians, and policymakers working to improve care and develop future therapies.
Help Support the EL-PFDD Meeting
Your donation helps support patient participation, meeting logistics, and the development of the final Voice of the Patient report. Every gift helps bring family experiences forward so clinicians, researchers, FDA and industry partners can better understand the real burden of maternal alloimmunization and HDFN.