Due to the COVID-19 pandemic and to protect the health of our FSGS patients, this will be a virtual meeting.
Join us on Friday, August 28, 2020 from 9am to 3:30pm online!
We invite anyone who has FSGS, lives with or is interested in FSGS – patients of all ages, care-partners, families and friends – to attend.
To prepare for the upcoming meeting on FSGS, we would like your input on how FSGS affects your life.
Your responses will help us make the best meeting possible. All information you provide in the survey will be kept strictly confidential.
What are EL-PFDD meetings?
Externally led patient-focused drug development (EL-PFDD) meetings bring together patients and care partners, US Food and Drug Administration (FDA) representatives, pharmaceutical companies, and doctors who are experts in the particular disease. The goal is to hear from patients who have the disease, in order for the FDA and pharmaceutical companies to understand the patient experience.
The EL-PFDD meeting on FSGS
The National Kidney Foundation and NephCure Kidney International are conducting an EL-PFDD meeting on FSGS to inform the FDA about the patient perspective of living with this disease. Understanding the patient perspective may help the FDA make informed decisions regarding approvals of potential treatments for FSGS.
The meeting will be co-chaired by two leading nephrologists who specialize in FSGS:
Dr. Suneel Udani Nephrology Associates of Northern Illinois
Dr. Laura Mariani University of Michigan
Voice of the Patient
After the meeting, a report titled “Voice of the Patient” will be sent to the FDA. This will be a reference for future decisions about potential medicines for FSGS.
Being able to tell my story, be heard, and people empathizing and understanding the struggle this disease faces you with is indescribable. -Patient Participant
Who benefits from EL-PFDD meetings?
Food and Drug Administration (FDA)
- The FDA gains understanding of what it’s like to live with a particular disease.
- Inform the FDA of side effects and risks patients may be willing to accept to gain a certain level of symptom relief or slowing of their disease progression.
- Reveals patients needs regarding new drugs, and what their preferences are for clinical trials for their disease.
- Assists the FDA in knowing if a new drug addresses patient needs.
- Patients know the FDA and drug sponsors have heard their voices (in person).
- Patients’ experiences are validated, reducing feelings of isolation.
- Hearing other patients voice their experiences and needs helps patients to better self-advocate.
- All of these points give patients hope that new and effective drugs will become available.
Patient advocacy groups
- EL-PFDD Meetings help these groups identify what needs exist for patient education and advocacy.
- More effective advocacy increases public awareness and knowledge of the disease.
- In addition, these meetings help patient advocacy groups connect patients face-to-face with their peers.
- Drug sponsors gain insights into the major concerns of patients. This helps the companies develop treatments and design clinical trials that match patients’ needs and preferences.
- Drug sponsors learn which disease symptoms or treatment side effects are, or are not, tolerable by the patients. This helps the companies develop drugs that matter to patients.
- With knowledge gained from EL-PFDD Meetings, the FDA can advise pharmaceutical companies on developing potential drugs and therefore help to advance medicines that meet patients’ needs.
I think that your stories really highlight the urgency with which we need to find effective treatments for this disease, and also treatments that have better safety profiles than those that are currently out there. -FDA Participant
What do you do with the information from the patient survey?
The information you provide will remain strictly confidential and will be used for planning the meeting.
Some of your responses may be included in the meeting in the Voice of the Patient Report, or in other associated documents. Patient identification will always be removed and patient information will be presented as grouped data.
Is there a charge to attend the EL-PFDD meeting?
No, this meeting is free and open to the public.
How do I register to attend the EL-PFDD meeting?
Click here to register for our virtual meeting.
EACH PERSON IN YOUR PARTY MUST REGISTER INDIVIDUALLY (e.g. CHILD, SPOUSE, CARE-PARTNER)
Do I have to attend the meeting to have my voice heard?
By attending the meeting in person, you can share your experiences with FSGS during the audience discussion. Format TBD.
Where, when, and for how long is the EL-PFDD meeting on FSGS?
The meeting will be held on Friday, August 28, 2020 from 9:00am to 3:30pm on a virtual platform to be determined.
Can pediatric patients attend?
YES! We welcome FSGS patients of all ages.
Can I bring my care-partner? (parent, guardian, adult aid)
Yes, we want to hear from care-partners as well as patients.
What is my role as an attendee of the EL-PFDD meeting on FSGS?
Some patients will be asked to serve on a panel to discuss what it’s like to live with FSGS, including treatments and side effects.
If you are asked to be a panelist, you will be coached on how to do so effectively.
If you are not on a panel, we hope that you will participate in the audience discussion.
What happens after the meeting?
NKF and NephCure will write the Voice of the Patient Report. This will be sent to the FDA and will be used to help in their decisions to approve potential new treatments for FSGS.
The Voice of the Patient Report will be publicly posted on NKF’s and NephCure’s websites.